ISO 14001 Standards

ISO 9001 Standard - ISO 9001:2008 Standards

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What Is Environmental Management System?

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What Is ISO 14001 Environmental Management System?

ISO 14000 is primarily concerned with Environmental Management. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.

Improving the environmental performance of corporations is one way of limiting environmental damage. Environmental management systems (EMS’s), such as ISO 14001, provide a framework for organizations that wish to effectively manage their environmental affairs. Implementing an EMS that conforms to the ISO 14001 standard may help businesses integrate environmental values into their operations.

An EMS can be described as a program of continuous environmental improvement that follows a defined sequence of steps drawn from established project management practice and routinely applied in business management. In simple terms these steps are as follows:
• Review the environmental consequences of the operations.
• Define a set of policies and objectives for environmental performance.
• Establish an action plan to achieve the objectives.
• Monitor performance against these objectives.
• Report the results appropriately.
• Review the system and the outcomes and strive for continuous improvement.
Not every system will present these steps in exactly the same way, but the basic principles are clear and easily understandable.

The ISO 14000 series is a series of standards for different aspects of environmental management. A number of these standards relating to environmental management systems have been adopted formally by the members of the ISO, while others are in different stages of preparation.

ISO 14000 is a group of standards covering the following areas:
•Environmental Management Systems (14001,14002, 14004)
•Environmental Auditing (14010, 14011, 14012)
•Evaluation of Environmental Performance (14031)
•Environmental Labeling (14020, 14021, 14022, 14023, 14024, 14025)
•Life-Cycle Assessment (14040, 14041,14042, 14043)

The Development of EMS Standards

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The world’s first standard for environmental management systems (EMS) – BS 7750 – wasdeveloped and published by the British Standards Institution (BSI) in 1992. This standard was the model for the ISO 14000 Series developed by the International Organization for Standardization (ISO). ISO 14001, which establishes the requirements for an EMS, was finalized in 1996. BS 7750 was also the basis for the European Union’s Eco-Management and Audit scheme, known as EMAS.
ISO is an international standard and therefore must incorporate the different interests ofmany countries. This standard clearly has the weakest requirements. By contrast, EMAS is the most stringent and detailed standard reflecting the high environmental standards of German interests and companies which played a key role developing it.
Because ISO 14001 and EMAS are both based on BS 7750, all three standards arequite similar in their approach. If your organization complies with BS 7750 today, little effort will be needed to fullfill the requirements of ISO 14001 or EMAS. Be aware however, that EMAS emphasizes public environmental reporting.
Today there are two major areas in the evaluation of environmental management practice.One area focuses on organizational issues, and the other on products, services and processes.

1. Organization Evaluation
a. Environmental Management Systems (ISO 14001, 14004)
b. Environmental Performance Evaluation (ISO 14014, 14015, 14031)
c. Environmental Auditing (ISO 14010, 14011, 14012, 14013, 14014)

2. Products, Services and Processes

a. Life Cycle Assessment (ISO 14040, 14041, 14042, 14043)

b. Environmental Labeling (ISO 14020, 14021, 14022, 14023, 1402X)

c. Environmental Aspects in Product Standards (ISO 14060)

Conducting An Initial Environmental Review For EMS

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Conducting An Initial Environmental Review in ISO 14001 EMSAn initial environmental review covers all the aspects of an EMS. As a result of this review the organization knows its strengths and weaknesses, risks and opportunities regarding the current status of its EMS. The gap between the requirements of the EMS standard and the actual status of the organization shows which aspects the organization should focus its efforts on to improve the system. This leads directly to the development of an environmental management program that should fill the gaps.The Environmental review should focus on three key areas:- Examination of existing environmental management practices and procedures- Identification of significant environmental impacts and their priority- Identification of legal and regulatory requirements1. Examination of Existing Environmental Management Practices andProceduresThe methodology for assessing existing environmental management practices and procedures is proposed here using a questionnaire. The review team fills out this questionnaire by interviewing appropriate people, by analyzing existing documents and procedures dealing with environmental issues and by collecting information about environmental aspects of the organization’s operations, products and services.By conducting the initial environmental review, an organization-specific profile of strengths and weaknesses can be drawn up. Because the score in each EMS area shows the effort needed in terms of financial and human resources,the organization knows where to focus its efforts when building up an EMS and where the largest effort is needed.
2. Identification of Significant Environmental Aspects and their PriorityAn environmental policy requires top management to set priorities regarding environmental aspects. An initial review clearly shows where to set priorities regarding the EMS itself. But, it does not help to set priorities among different environmental problems. Many top managers feel pressure to do something for the environment and thus embark on some form of ?Eenvironmental activism?E often containing many isolated activities, but no clear direction. One way to solve this problem is to develop a so called ?Environmental exposure portfolio?EThe first step of this portfolio analysis is to assess the exposure and therefore the importance of different environmental aspects for an organization’s overall performance.The appropriate perspective and priorities of the environmental policy will differ depending on this preliminary analysis. The analysis should be conducted from the perspective of the stakeholders of the organization, their needs and their importance for the success of the organization. The degree of exposure to different environmental aspects should guide the involvement and perspective of an organization when implementing an EMS. Evaluating exposure to environmental aspects is important, because this exposure is likely to influence the organization’s success sooner or later, either through new legislation, public or consumer perception and behavior or otherwise.The analysis of the expected exposure of an organization to different environmental problems and the weight given to these aspects by various stakeholders enables management to focus on environmental issues that are a high priority to the organization. This is represented in the quadrant in the upper right corner of the environmental exposure portfolio. However, the two quadrants on the left must also be observed, although less vigorously. Issues with low public priority, to which the firm contributes heavily become a problem as soon as the perception of the stakeholders and the public environmental policy changes (the quadrant in the upper left corner of the portfolio). That this can happen very rapidly is obvious, for example from Shell`s ?Brent Spar?Edumping case (detailed information about this case is available from Shell or Greenpeace at their respective WWW-sites). Investments in new production technology, products and services can increase the environmental impact of the organization when not anticipated early enough. In this case, a problem ranked in the lower right corner of the portfolio would shift to the field with the highest priority. Problems ranked in the lower left corner are of no priority. No measures should be taken here.
3. Identification of Legal and Regulatory RequirementsThe identification of legal and regulatory requirements assesses two levels of an organization:- production-related environmental regulations- product- and service-related environmental regulationsThe former addresses the production department while the latter addresses the marketingand R&D departments. Basically, three questions must be answered:- Which are the relevant environmental regulations? (= target)- Is the current situation in the organization known? (= actual)- Does the organization comply with relevant regulations? (=gap)The methodology used here is a questionnaire. To obtain information about environmental regulations the following information sources can be used:- governmental authorities- industry associations- daily newspaper- university publications (law departments)

Emergency Preparedness and Response In ISO 14001

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Emergency Preparedness and Response In ISO 14001
Under the Emergency Preparedness and Response requirement of ISO 14001:2004 (§4.4.7), the organization is required to establish procedures for identifying the potential for and responding to emergency situations and accidents that can have an impact on the environment.
Identification of Potential Emergency and Accident Situations – Experience indicates that organizations infrequently have a preexisting procedure for identifying potential emergency and accident situations.The norm is to establish emergency and accident responses for a variety of emergency and accident situations irrespective of the potential for their occurrence. But ISO 14001 is specific about requiring a procedure to identify the potential for emergency situations and accidents. Adhering to the requirement of the procedure is a valuable exercise that helps organizations identify weaknesses in their own emergency planning and to plan for that which is most likely to occur.Because many environmental impacts of an emergency or accident situation are secondary in nature, it appears that all potential emergency or accident situations need to be identified before a determination of environmental impacts can be made. An organization that attempts to identify potential emergency or accident situations based on a review of its environmental aspects would likely miss the environmental impact potential of, say, an automobile accident.
There are five steps implied by the emergency preparedness and response requirement:
1) Identify the potential for emergency situations and accidents of all kinds;2) Paying particular attention to the potential environmental impacts of accidents and emergency situations, identify how the organization can prevent and mitigate associated adverse environmental impacts;3) Determine how the organization and its employees should respond to emergency situations and accidents;4) Periodically simulate emergency situations to test response capabilities; and,5) Review and revise procedures based on experience derived from actual and simulated emergency situations and accidents.
Accident and Emergency Situation Identification – In order to identify potential for and responding to emergency situations and accidents, the organization should develop a procedure for systematically identifying accident and emergency situations, evaluating their probability of occurrence, their likely consequences, and their severity.Organizations often engage risk management specialists to assist in the identification of potential emergency or accident situations that could lead to human injury, environmental damage, or economic loss. While many checklists are available to facilitate this kind of evaluation, there is virtually no substitute for physical evaluation of facilities by knowledgeable personnel, whether employees or outside professionals.
Emergency Response Procedures – The organization is required to develop procedures for responding to emergency situations and accidents when they occur. Typically, response procedures include identifying public emergency response agencies and their capabilities, identifying individuals within the organization who are trained and able to provide assistance in emergencies, establishing an emergency communications network, and providing emergency lighting, signage, and equipment. Because Emergency Response Procedures are based on identified potential emergency situations and accidents specific to the organization, the emergency response plan will be unique for each organization.
Periodic Testing – The value of conducting emergency response exercises lies not only with simulating situations that could occur but also in identifying flaws in the response plan. Practice drills can be the most effective test of the system to give employees, emergency response personnel, and management the opportunity to walk through the plan and gain familiarity with its procedures. While a full-dress response exercise is valuable, testing of procedures can be effectively done on much smaller scales and still provide the benefits of testing. Above all, the organization should not let the impracticality of a full-dress exercise keep it from testing sub elements of the emergency response plan.
Review and Revise – ISO 14001 calls for continual improvement of the EMS. Periodically reviewing and revising emergency response plans based on the experience gained from the occurrence of emergency situations or accidents or in testing response plans is an example of continual improvement.
Written Response Plans – Many written emergency response plans are too cumbersome to be of value in an emergency situation – their value depends entirely upon previous training of persons who will be called upon to execute them. Yet, many organizations fail to provide the emergency response training necessary to make the plans functional.Keeping in mind that even the simplest, most direct emergency response plan requires training for effective implementation, an alternative for organizations to consider is establishment of abbreviated, readily available Immediate Response Directions established for each kind of potential emergency situation or accident. Such an emergency response plan might consist of a laminated card prepared for each potential emergency situation or accident and providing specific responsibilities and associated actions for employees and visitors, supervisors, emergency coordinators, and emergency directors.

Migration to ISO 9001:2008

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Migration To ISO 9001:2008The International Accreditation Forum (IAF) and the International Organization forStandardization (ISO) have agreed on an implementation plan to ensure a smooth transition ofaccredited certification to ISO 9001:2008, the latest version of the world’s most widely usedstandard for quality management systems (QMS). The details of the plan are given in the jointcommuniqué by the two organizations which appears below.Like all of ISO’s more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that itis maintained at the state of the art and a decision taken to confirm, withdraw or revise thedocument.ISO 9001:2008, which is due to be published before the end of the year, will replace the year2000 version of the standard which is implemented by both business and public sectororganizations in 170 countries. Although certification is not a requirement of the standard, theQMS of about one million organizations have been audited and certified by independentcertification bodies (also known in some countries as registration bodies) to ISO 9001:2000.ISO 9001 certification is frequently used in both private and public sectors to increaseconfidence in the products and services provided by certified organizations, between partnersin business-to-business relations, in the selection of suppliers in supply chains and in the rightto tender for procurement contracts.ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing andcertification. These services are performed independently of ISO by certification bodies. ISOdoes not control such bodies, but does develop voluntary International Standards toencourage good practice in their activities on a worldwide basis. For example, ISO/IEC17021:2006 specifies the requirements for bodies providing auditing and certification ofmanagement systems.Certification bodies that wish to provide further confidence in their services may apply to be“accredited” as competent by an IAF recognized national accreditation body. ISO/IEC17011:2004 specifies the requirements for carrying out such accreditation. IAF is aninternational association whose membership includes the national accreditation bodies of 49economies.ISO technical committee ISO/TC 176, Quality management and quality assurance, which isresponsible for the ISO 9000 family of standards, is preparing a number of support documentsexplaining what the differences are between ISO 9001:2008 and the year 2000 version, whyand what they mean for users. Once approved, these documents will be posted on the ISOWeb site – probably in October 2008.
ISO (International Organization for Standardization) and the IAF (International AccreditationForum) have agreed an implementation plan to ensure a smooth migration of accreditedcertification to ISO 9001:2008, after consultation with international groupings representingquality system or auditor certification bodies, and industry users of ISO 9001 certificationservices.ISO 9001:2008 does not contain any new requirementsThey have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008only introduces clarifications to the existing requirements of ISO 9001:2000 based on eightyears of experience of implementing the standard world wide with about one millioncertificates issued in 170 countries to date. It also introduces changes intended to improveconsistency with ISO14001:2004The agreed implementation plan in relation to accredited certification is therefore thefollowing:Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO9001:2008 as an International Standard.Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issuedafter official publication of ISO 9001:2008 (which should take place before the end of 2008)and after a routine surveillance or recertification audit against ISO 9001:2008.Validity of certifications to ISO 9001:2000One year after publication of ISO 9001:2008 all accredited certifications issued (newcertifications or recertifications) shall be to ISO 9001:2008.Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issuedto ISO 9001:2000 shall not be valid.

Nonconformity, Corrective Action and Preventive Action in ISO 14001 EMS

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The intent of §4.5.3 is that the organization put in place procedures for 1) identifying actual and potential nonconformities to EMS requirements, 2) taking appropriate corrective or preventive action, and 3) reviewing the effectiveness of corrective or preventive actions taken.The nonconformity requirement of ISO 14001:1996 was a passive requirement in that it was only triggered when a nonconformity came to the attention of the organization through one of the other EMS procedures, such as the EMS audit or management review. ISO 14001:2004, however, requires that the organization establish and maintain procedures to identify actual or potential nonconformities, determine their causes, take action to avoid recurrence or occurrence, record results, and review effectiveness of corrective or preventive actions.
How the organization goes about identifying actual or potential nonconformities is up to it to determine. From the standpoint of registration auditors, it would seem that they would want to see a specific procedure requiring members of the organization to conduct some kind of periodic checklist driven, walk-through inspection for nonconformities. In addition, the procedure should allow for submission of nonconformities by any member of the organization. Actual nonconformities are usually fairly evident and relatively easy to investigate because there is a tangible occurrence with which to deal. The organization should also want to evaluate minor instances of nonconformity that, while not significant in and of themselves, if they occurred under different circumstances, could lead to a significant deviation from the EMS. Such “near misses” could be identified by the occurrence of a sudden, unexpected event, a failure to achieve an objective or target, or a deviation from the Environmental Policy.Potential nonconformities are more difficult to identify and correct. Here, application of Failure Mode and Effects Analysis would be appropriate for organizations having that capability.
When investigating nonconformities, organizations should focus on identifying underlying root causes, not just the immediate manifestation of the problem. If a chemical storage drum leaks, the organization should take action, first, to mitigate the damage and, then, to determine why the leak occurred; e.g., improper or negligent handling, mechanical failure, or lack of a leak detection system. Corrective or preventive actions should then focus on eliminating the cause through training, communication of procedures, use of leak-resistant drums, or installation of a leak detection system.
Other ISO 14001 sections, principally Emergency Preparedness and Response, Internal Audit, and Management Review, are tools that the organization implements in order to help identify instances of actual or potential nonconformity. The underlying principle of these sections is that the identification of nonconformities should be made by the organization through diligent application of these tools, not from the occurrence of an environmental event, a customer or community complaint, or investigation by a regulatory authority. While §4.5.3 does not specifically mention disciplinary action, in many cases disciplinary action or the threat of disciplinary action is appropriate to prevention of future nonconformities. Many organizations have written codes of conduct that give employees notice that deviations from the codes will not be tolerated and that prescribed penalties can result for infractions. These codes can be expanded to include penalties for deviations from the EMS. If so, penalties should be commensurate with the violation itself and should acknowledge the nature of the environmental damage, the degree of negligence, prior conduct, and the forthrightness of the employee being disciplined. Any such code and its remedies should be administered fairly and consistently and should have as its objective correction and prevention of EMS nonconformities, not punishment of employees.Finally, identification, investigation, and correction of nonconformities leads to the need to revise documented procedures.

Evaluation Of Compliance Of ISO 14001 EMS

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The requirement to establish a procedure for periodically evaluating compliance with applicable legal and other requirements falls short of specifically requiring regulatory compliance audits but, in fact, a system of regular regulatory compliance audits may be the most practical means for meeting this requirement of the standard. In the U.S., determination of whether to conduct a compliance audit will be governed in part by the particular jurisdiction’s approach to allowing a legal privilege for the self-assessment audit.
Evaluation vs. Audit – The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.

ISO 9001 – Compatibility with other management systems

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ISO 9001 – Compatibility with other management systems
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financialmanagement or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible foran organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.

Certification In ISO 9001 Standards

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Certification In ISO 9001 Standards
Certification involves an independent assessment of your quality system to confirm that it meets the requirements of ISO 9001. You will need to design, document and implement your own quality system. The system will need to cover all the requirements of the ISO 9001 standard. Many certification bodies will not conduct a formal assessment until the system has been operating for at least three months. Your quality system cannot be audited until you have generated documentary evidence to show that you are meeting the standard. To find a certification body with relevant experience in your sector and accreditation from the United Kingdom Accreditation Service (UKAS). Certification by a non-UKAS accredited body is likely to lead to credibility problems with your customers. Arrange a visit from the certification body’s auditors. UKAS prohibits auditors from acting as consultants. They will not tell you how to meet the standard but can offer advice. They will seek objective evidence that you are complying with each of the clauses of the ISO 9001 standard. The auditors will tell you of any shortcomings in your system. If you satisfy the standard, the auditors put your name forward for certification. You will be required to correct these problems within a specified timeframe. You can also be certificated if the auditors only identify a small number of ‘minor’ problems. Once you are certificated, you can display the certification body’s logo, and if the body is UKAS-accredited, the UKAS ‘tick and crown’ symbol (consult UKAS about exceptions to this rule). If the auditors identify more serious ‘major’ problems, you will be required to correct these before certification. These surveillance visits normally take place twice a year at agreed dates. All certification bodies are required to revisit registered companies to ensure they still meet the requirements of the standard. You will be given time to deal with any minor or major problems which are identified before any action is taken to withdraw your certificate.

Costs and resources Of ISO 9001 Standards

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Costs and resources Of ISO 9001 Standards
The largest cost of ISO 9001 is the involvement of company

employees. The ‘ownership’ created by involving employees in designing the quality system maximises the chances of them accepting it. Reducing this cost by minimising employee involvement is a false economy. The next largest cost will be for designing and developing the system. This needs to be led by someone with experience in this particular field. You may have someone within your own organisation who has carried out this role, perhaps with a former employer. Your Business Link may offer free or subsidised advice and training, and will be able to provide names of approved consultants. Grants for work in this area tend to be directed through Business Links. Different areas have different grants, which depend on local conditions. A typical grant may cover up to 50 per cent of the cost of an approved consultant. Certification fees are around £800 for the smallest companies. Overall costs depend upon company size and the number of locations involved. Ask certification bodies for quotes for initial audits and surveillance visits. Many will give an all-inclusive price, including surveillance visits for three years. Typically, special rates will depend on how long the assessment is likely to take and what the company’s turnover is. Ask your certification body if it offers special rates for small companies. The standard requires that companies have trained internal auditors to conduct audits on the system. An internal audit can provide an effective means of monitoring the system and identifying areas for improvement. For further details, contact the International Register of Certificated Auditors.

ISO 9000 family of standards and SMEs

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ISO 9000 family of standards and SMEs
The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.
It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.
The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.
The new standard has included a provision for deciding on the applicability of
certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.
It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.

Management Principles Of ISO 9001 Standards

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Management Principles Of ISO 9001 Standards
ISO 9000 is based on eight management principles:
• Customer focus, resulting in meeting customer requirements and striving to exceed them;
• Leadership, aiming to create an internal environment in which people are fully involved;
• Involvement of people who are the essence of an organization;
• Process approach, resulting in improved efficiency to obtain desired results;
• System approach to management, leading to improved effectiveness and efficiency through identification, understanding and management of interrelated processes;
• Continual improvement, which becomes a permanent objective of the organization;
• Factual approach to decision-making, based on the analysis of data and information; and
• Mutually beneficial supplier relationships, based on an understanding of their interdependence.
ISO 9000 encourages the adoption of the process approach to manage an organization. There are five main areas considered for the revised process model in ISO 9000:
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement.

Costs Of Setting Up A Quality Management System

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Costs Of Setting Up A Quality Management System
Common implementation costs that companies incur can be broken down into direct and indirect costs.
The direct costs include, inter alia, the following:
• hiring consultants or external trainers, if required;
• sending personnel for external training;
• acquiring relevant national and international standards of the ISO 9000 family and other related books and publications; and
• acquiring additional equipment, instruments and other resources as identified by the company.
The indirect costs include, inter alia, the following:
• time spent by the management and other staff in developing the system;
• reorganization of the processes, including improvements in the house-keeping, if required;
• external calibration charges for equipment to ensure national and/or international measurement traceability;
• organizing in-house training;
• time spent by internal auditors for periodic internal audits;
• corrective actions, including revision of manuals and procedures, if required; and
• expenditure on word-processing, stationery and other consumables required for the preparation of manuals and documenting procedures, etc.
Some factors can help to lower the above costs. They include:
• having people in the company already conversant with QMS requirements;
• having documented system-related activities such as work instructions, quality plans, procedures, etc. already in place;
• using consultants only for specific activities like gap analysis, training of
auditors, pre-assessment audits, etc., and having in-house staff oversee the remaining activities.
On the other hand, there are factors that can mean higher implementation costs for the company. For example, if your company carries out activities at different locations, or if your company is involved in product design and development, this may increase costs.

Benefits Of Obtaining ISO 9000 Certification

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Benefits Of Obtaining ISO 9000 Certification
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-à-vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the company’s products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
Refer http://www.iso9001-standard.us for more information.

Implementing A Quality Management System

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Implementing A Quality Management System
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.

ISO 9001 Standards – Management Review

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ISO 9001 Standards – Management Review
Review the quality management system at planned intervals to:- Assess possible opportunities for improvementEnsure a suitable, adequate, and effective system

- Evaluate the need for any changes to the system
- Consider the need for changes to the quality policy and objectives
Maintain records of the management reviews.
Inputs for management review must include information on:
- Results of audits
- Customer feedback
- Process performance and product conformity
- Status of preventive and corrective actions
- Follow-up actions from earlier reviews
- Changes that could affect the quality system
- Recommendations for improvement
Outputs from the management review must include any decisions and actions related to:
- Improvement of the effectiveness of the quality management system and its processes
- Improvement of product related to customer requirements
- Resource needs

ISO 9001 Standards – Design and Development

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ISO 9001 Standards - Design and Development
Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions
- Stages of design and development
- Appropriate review, verification, and validation activities for each stage
- Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Determine product requirement inputs and maintain records. The inputs must include:
- Functional and performance requirements
- Applicable statutory and regulatory requirements
- Applicable information derived from similar designs
- Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
- Meet design and development input requirements
- Provide information for purchasing, production, and service
- Contain or reference product acceptance criteria
- Define essential characteristics for safe and proper use
- Be approved before their release
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
- Evaluate the ability of the results to meet requirements
- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

ISO 9001 Standards – Control of Measuring and Monitoring Equipment

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ISO 9001 Standards - Control of Measuring and Monitoring Equipment
Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results:
- Calibrate and/or verify the measuring equipment at specified intervals or prior to use
- Calibrate the equipment to national or international standards (or record other basis)
- Adjust or re-adjust as necessary
- Identify the measuring equipment in order to determine its calibration status
- Safeguard them from improper adjustments
- Protect them from damage and deterioration
Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.
Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).
NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
For More Information Please Visit http://www.iso9001-standard.us

ISO 14001:2004 Standards Contents

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ISO 14001:2004 Standards
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.

ISO 9001 Standards New Blogs

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Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System

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ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System (QMS)
- An Romania Perspective
The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.
Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.
The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.
Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.
Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.
The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.
Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.
ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.
The documentation of QMS involves:
1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)
2. Management Responsibility
3. Resource Management
4. Product Realisation
5. Measurements, Analysis and Improvement
A well managed quality system will have impact on:
1. customer loyalty and repeat business
2. market share
3. operational efficiencies
4. flexibility and ability to respond to market opportunities
5. effective and efficient use of resources
6. cost reductions
7. competitive advantages

ISO 9001 Standards – Documented Procedures

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ISO 9001 Standards – Documented Procedures

The standard requires the management system documentation to include documented procedures required by ISO 9001 Standards.
ISO 9000 defines a procedure as a specified way to carry out an activity or a process. This definition is ambiguous because an activity is on a different scale than a process. Process outputs are dependent upon many factors of which activities are but one. An activity is the smallest unit of work. Several activities accomplish a task and several tasks reflect the stages in a process but there is more to a process than a series of tasks. This definition also esults in a belief that procedures are documented processes but this too is inaccurate. Procedures tell us how to proceed don‘t need to produce any others. The specific procedures required are:

(a) A documented procedure for document control
(b) A documented procedure for the control of records
(c) A documented procedure for conducting audits
(d) A documented procedure for nonconformity control
(e) A documented procedure for corrective action
(f) A documented procedure for preventive action
These areas all have something in common. They are what the authors of the early drafts of ISO 9000 :2008 referred to as system procedures ? they apply to the whole system and are not product, process or customer specific although it is not uncommon for customers to specify requirements that would impact these areas. Why procedures for these aspects are required and not for other aspects of the management system is unclear but it seems that the authors of ISO 9000 felt these were not processes ? a conclusion I find difficult to justify.
They are certainly not business processes but could be work processes. However, there is another message that this requirement conveys. It is that procedures are not required for each clause of the standard. Previously, countless organizations produced a manual of 20 procedures to match the 20 elements of ISO 9001. Some limited their procedures to the 26 procedures cited by the standard and others produced as many as were necessary to respond to the requirements.
Document control is a work process or a number of work processes because the inputs pass through a number of stages each adding value to result in the achievement of defined objectives. These are the acquisition, approval, publication, distribution, storage, maintenance, improvement, and disposal stages. These are not tasks but processes that achieve defined objectives and involve both physical, financial and human resources. Within these processes are tasks, each of which may require documented procedures as they are initiated.
Control of records is also a work process similar to document control. There are the preparation, storage, access, maintenance and disposal stages. This is not one uninterrupted flow but a life cycle. There is not one task but several performed at different times for different reasons.
Auditing is certainly a process with a defined objective. Without the provision of competent personnel and a suitable environment, audits will not achieve their objectives no matter how many times the procedure is implemented.
Nonconformity control like records control is a work process for the same reasons. The sequence of tasks is not in the form of an uninterrupted sequence. The sequence of stages may be identification, documentation, segregation, review, remedial action and disposal but this is not a continuous sequence. There are breaks and different procedures may apply at each stage depending on what it is that is nonconforming.
There is little merit in having one corrective action procedure when the source of problems that require corrective action is so varied. One Corrective Action Form might be appropriate but its application will be so varied that it is questionable whether one size fits all. Presenting top management with a nonconformity report because it has been detected that the organization charts are not promptly updated following a change, will not motivate them into action. Corrective action forms part of every process rather than being a separate process. It is unreasonable to force all actions aimed at preventing the recurrence of problems through one process. Many problems are prevented from recurring not by following a procedure, but by the designer, the producer, supplier, manager remembering they had a problem last time and doing it differently the next ? i.e. they learn from their mistakes. No forms filled in, no procedures followed ? just people using their initiative ? this is why corrective action is part of every process operation.
Preventive action remains one of the most misunderstood requirements of ISO 9001 because it is mistaken for corrective action but more on this. There is even less justification for one preventive action procedure because the source of potential problems is so varied. Preventive actions are taken in design, in planning, in training and in maintenance under the name of FMEA, Reliability Prediction, Quality Planning, Production Planning, Logistic Planning, Staff Development, Equipment Maintenance ? preventive actions are built into these processes and similar to corrective action are part of every process design.

ISO 9001 and ISO 14001 Information Site

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ISO 9001 and ISO 14001 Forum

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Introduction to ISO Certification

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Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.

Business benefits of ISO 14000

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Business Benefits Of ISO 14001
Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.

Requirements for Product Environmental Quality Assurance

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All Mandatory Requirements for Product Environmental Quality Assurance need to be carried out in the following manner1. Establish a system that meets all requirements2. Ensure the system is stable and efficient.3. Document the processes and procedures4. Keep records of the system’s performance.
The assigned management of the supplier shall establish a system to prevent BannedSubstances from being used in the products and packaging.(1) To determine policies and methods for ensuring Product Environment Quality.(2) To assign a person to be in charge of managing Product Environment Quality(“Product Environmental Quality Management Representative”)(3) To establish an organization in managing Product Environment Quality,determine responsibilities, authorities, roles of each department and familiarize allmembers in each department with the importance of Product Environment Quality.(4) To establish a “Cadmium-Free Factory”(5) To review the adequacy and efficiency of the system.
Maintenance of the SystemThe supplier shall maintain the system in a condition to be able to respond to therequests for Product Environment Quality and instruction letters to suppliers),ensure the system is properly functioning.(1) Plan and carry out an internal audit at least once a year.(2) When Non-conforming Products or defects are found in the system, the suppliershall conduct an internal audit immediately.(3) The assigned management for Product Environment Products at the suppliershall revise the system according to the results of the internal audit if necessary.
Documents, Data and RecordsThe supplier should manage documents, verification data related to ProductEnvironment Quality.(1) Keep documents, verification data for three years or longer, if required by law.(2) Provide documents and verification data when requested.(3) Review the documents regularly and keep them updated instructions
Selection of Materials and PartsThe supplier has to comply with the following request when selecting material and parts.(1) “No Use of Banned Substances Allowed” (or equal) must be mentioned in allrelevant documents (specifications, blueprints, purchase orders, etc)(2) Materials must not contain any Banned Substances.(3) Only purchase Designated Raw Materials from Green Partners.

ISO 9000 Standards

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ISO 9000 Standards
ISO 9000 is a written set of rules (a “Standard”) published by an internationalstandards writing body (International Organization for Standardization. The rules define practices that are universally recognized and accepted for assuring that organizations consistently understand and meet the needs of their customers.ISO 9000 is also highly generic. Its principles can be applied to any organization providing any product or service anywhere in the world.Since meeting customer needs is one of the (many) definitions of quality, ISO 9000 is often called a quality system or a quality management system. But the rules, referred to as requirements, go beyond quality matters as they are traditionally understood. The requirements fall roughly into the following types:
a. Requirements that help assure that the organization’s output (whether product, service, or both) meets customer specifications. (Making, and keeping, them happy.)
b. Requirements that assure that the quality system is consistently implemented and verifiable. (We must actually do what we say we are supposed to do. This must be verifiable via independent, objectiveaudit.)
c. Requirements for practices that measure the effectiveness of variousaspects of the system. (In God we trust; all others bring data.)
d. Requirements that support continuous improvement of the company’sability to meet customer needs. (We cannot sit still. We must strive to get better all the time, because customers change, and competitors gain strength.)
Nothing in ISO 9000 is new. The first edition, published by ISO in 1987, was drawn almost word for word from a British quality system standard. It in turn evolved from a long succession of written quality system specifications that had their ultimate origin in the defense and arms industries. Most of the practices required by ISO 9000 have been in use in industries of various kinds for decades. One intent of ISO 9000 is to simplify things for organizations. ISO 9000 strives to harmonize the sometimes conflicting, sometimes redundant quality programs that have traditionally been imposed by major corporations on their suppliers. (Note, however, that ISO 9000 is not meant to supersede customer, legal, or regulatory requirements.)
Very often, major customers require or strongly “suggest” that their suppliers implement ISO 9000 systems. Equally often, such customers require independent verification that suppliers are meeting the equirements.
So third-party registration bodies audit suppliers, confirm compliance to the ISO 9000 standard, and register the suppliers. It does not stop there. To stay registered, suppliers must undergo periodic (often semi-annual) surveillance audits, also carried out by their registration body.
Implementing an ISO 9000 quality system is neither cheap, nor easy. How costly and difficult it can be depends on:
a. The level of commitment of senior management. (The single most important factor.)
b. Where you are when you start. If you have already implemented a disciplined, documented quality system, you will have a less difficult time migrating to ISO 9000. (But that does not mean you will waltz to registration, either.)
c. Whether your company (or any part of it) is “design responsible” or not.
d. How much time you have. If you are under the customer’s gun and have merely months to get the job done, the process will be highly stressful.
e. The physical size and configuration of your company.
The bottom line is this. ISO 9000 is a comprehensive set of rules—a business system, really—that can cause the way your organization runs to profoundly change, almost always for the better. Yet, because it is often customer-mandated, many suppliers regard ISO 9000 as “just another hoop to jump through to keep our customers happy.”
They see their choice as swallow hard, pony up, and jump through the hoops; or walk away from the customer. What many do not fully appreciate is that implementing ISO 9000—expensive, exhausting, and annoying as it can be—can also have the salutary effect of improving the performance of your organization. Not just at first, but on an ongoing basis.

Goal and Scope of an ISO 9000 quality system

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Goal and Scope of an ISO 9000 quality system
The ISO 9000 Standard states its goal in two blunt words: customer satisfaction.How do we achieve customer satisfaction? By meeting customer requirements.The quality management system (QMS) helps us to dothis by:
a. Applying the system. Actually using it. Putting it at the heart ofour organization.b. Continually improving the system. The QMS is never done. Afterall, customer requirements do not stand still—they evolve and grow tougher.So we have to improve continually in order to survive.
(The guidance document, ISO 9004: 2000, sets a compatibleand in some respects more ambitious goal: “improving theprocesses of an organization to enhance performance.”) Prevention of nonconformity. Prevention is the key term here: prevention,rather than detection. Quality management has longsince evolved away from the old “inspect quality in” approach.Prevention is cheaper, more effective, and more protective of thecustomer. Detection is also a different mindset. It requires a veryhigh degree of process orientation, upstream thinking, and relentlessanalysis.To what types of organizations does the Standard apply? Alltypes. The requirements “are generic and applicable to all organizations,regardless of type and size.” A compliant QMS can be implementedby any organization, producing any product or service,anywhere in the world.Within the organization, the impact of the requirements and theQMS are similarly broad. The Standard “applies to the activities of organizationsfrom the identification of customer requirements, throughall quality management system processes, to the achievement of customersatisfaction.” Every activity within the organization that impactsthe process of creating customer satisfaction is affected by therequirements of the Standard.

ISO 9000 registration or certification

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ISO 9000 registration or certification
Registration is documented and objective evidence that an organization’squality system meets the requirements of ISO 9000.
Certification is a term often used interchangeably with registration.
In the context of ISO 9000, they mean the same thing. Registration isthe technically correct term for verification of compliance to standardsof quality systems. Certification usually applies to verification of thequality of products (as opposed to quality systems).
Registration is carried out by independent companies called registrars.These companies are:- Wholly independent.- Accredited by a recognized international accreditation body.- Selected, and paid, by you.
Registration can cover:- The sole location of a single-location organization.- Multiple locations of a multilocation organization.- Only certain parts of a multilocation organization (under certain conditions).- Separate locations under separate certificates. (This is a more costlyapproach.)The registration body audits your quality system against the requirementsof ISO 9000. It reports its findings in writing. These findings may (and usually do) include noncompliances (Question 96). Major noncompliances must be closed out prior to official registration.
When this has been done, the registration body:- Lists the organization’s name in its book of registered companies—in effect, registers the organization in its book.- Issues a certificate to the registered organization. This registrationincludes:— Identity of the organization.— Location(s) covered by the registration.— A list of products/services supplied by the registered locations.— Revision date of the Standard.— Registration effective dates.— Name and location of registrar.
Most registrars limit registrations to three years. After that, youmust renew your registration by undergoing another complete systemsaudit. Some registrars do not use the renewal approach. They simplykeep checking the system via surveillance audits.
Whichever the scheme, the organization, to keep registration, mustundergo a surveillance assessment every so often. Six months is the typicalinterval. Some registrars offer annual surveillance schemes (notrecommended except for firms with exceptionally well-implementedquality management systems). Surveillance assessments are scheduledevents (there is no such thing as a “surprise” surveillance audit). Onlypart of the quality system is checked at each surveillance. Usually, theregistrar does not disclose what part will be assessed until the day of theassessment, although some registrars will tell you everything up front.The entire quality system is usually checked via surveillance audits overthe course of three years.
There is no way to “fail” a surveillance assessment, just as there isno way to “fail” a registration audit—except by refusingto implement corrective action required by the registrar. Normally,registrars allow adequate time, but corrective actions must be done ina timely and agreed upon manner to keep registration.One final note: As mentioned, each registrar publishes a list ofthe firms it has registered to ISO 9000.

What is a quality systems registrar

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What is a quality systems registrar
A registrar, or registration body (the preferred term), is sometimes called a certification body. (Accreditation bodies are entirely different—they are the entities that audit/approve registration bodies.)
There are some 573 registration bodies in operation worldwide, including52 in the United States.
The registrar is the organization that checks your quality system and confirms that it meets ISO 9000 requirements for a prescribed and agreed period of time.
To do this, the registrar:a. Audits your organization’s quality system to determine the degree of conformity to ISO 9000 standards. The audit is carried out:— On paper (desktop study).— On site (throughout your facility).b. Registers your quality system, assuming it conforms, to ISO 9000.c. Monitors conformity on an ongoing basis by means of regular reauditsand other methods.All quality system registrars perform these functions, with certainvariations. Registrars differ in two principal ways:a. Accreditation status.b. Scope of accreditation
Reputable ISO 9000 registrars are accredited by international accreditationbodies. These enforce a standard, EN 45012 (European Standard for Bodies Certificating Suppliers’ Quality Systems), that governs the processes that registrars follow. This standard is quite strict:a. Registrars must make their services available to all qualified supplierswithout imposing undue financial or other conditions, andmust administer their regulations in a nondiscriminatory manner.b. The registrar’s organization must not engage in activities that mayaffect its impartiality. For example:— It must not provide consulting services “on matters to whichits certificates are related” (i.e., quality systems). This requirementis superseded by the ISO 9000 restriction noted earlier.— It must not directly engage in commerce with firms that it hasassessed and/or registered.— Individuals involved in the registration process must not haveprovided consulting services to registration clients, or any relatedfirms, within the previous two years.— Its employees and agents must not engage in business activitiesthat would cause others to question the firm’s impartiality.— The registrar may not market consultancy and registrationservices together, and may not recommend consulting servicesto clients.— Auditors may not give advice as part of registration audits.— The registrar must provide the accreditation body with documentationof its employees’ qualifications.— The registrar must have appropriate facilities for carrying outits activities.— The registrar must have a quality manual and documentedprocedures. (Curiously, EN 45012 does not require that registrarsregister to ISO 9000!)— Registrars may not grant or renew certificates of registration until all major noncompliances are eliminated.
Another point of differentiation is scope of accreditation. All registrarsare not accredited, or approved, to register firms in any line of business. Each registrar is accredited to operate within the business or industrial sectors about which it has documented expertise. This is generically referred to as the registrar’s scope.

How long does it take to register to ISO 9000?

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The time it takes to get ISO 9001 registered are varies. But it is talkingmonths here, not weeks. For one thing, you have to keep running yourbusiness. You cannot simply shut down while getting registered.The entire process can be broken down into the following generalphases:a. Implementing the ISO 9000 system.b. Operating it for the minimum time. (A minimum of three, andpreferably six, months before registration audit.)c. Selecting a registrar. This can be done during the registrationprocess, to save time.d. Interval between application and registration audit. This dependson the registrar’s backlog.
The time it takes to implement the ISO 9000 system depends in largepart on where you are when you start. If you already have any of thefollowing, implementation time should be relatively short:a. A documented quality system of any kind that is active, meaningful,but not necessarily compliant with any particular standard.b. Resources temporarily dedicated solely to implementing the system.c. The guidance of a good consultant
If you are starting from square one, implementation can take a longtime. (Unless you can shut down operations while implementing—butwho can do that?) Here are some other factors that can extend thetime it takes:a. Multiple locations.b. Head count.c. Whether or not you are design responsible.d. Corporate turmoil.e. Lack of ongoing, consistent, persistent top management commitment.This exhibits itself in a host of symptoms, including lack ofsufficient resources, other issues taking priority, vacillation, failureto pay attention, failure to learn and understand, and failureto lead.All that being said, experience has shown the following:a. On average, the shortest interval for the entire process—fromlaunch through registration audit—seems to be around 6 to 9months.b. At the other extreme, it’s been known to take 18 to 24 to 36months, even with significant resources and full managementcommitment.On average, for the typical organization (whatever that is), you arelooking at 10 to 18 months to get the job done.

What does ISO 9000 offer?

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What does ISO 9000 offer? For one thing, it offers you continuedbusiness with customers who may be requiring you to register. That isa pretty strong benefit right there.These customers may never question your quality, but these customersdepend heavily on their main suppliers. They know they canimprove their quality and through-put, if you improve yours. Just because you are great does not mean you are as great as you couldbe. ISO 9000 mandates a continuous improvement system. Youcan wriggle and fudge, but if you implement that system and workit conscientiously, you cannot help but improve. Continuous improvementis not just a buzz term. It is an imperative. Just because you are great today does not mean you will be great tomorrow.Has your industry changed? Has your organizationchanged? A well-implemented ISO 9000 helps your organizationadapt to change. It brings independence of individuals and consistencyof practices—two features that tend to resist declines inperformance.
What else does ISO 9000 bring you? When well implemented, anISO 9000 quality system improves organization performance. That is,after all, the whole point. In cases where it does not, the fault tendsnot to be in the ISO 9000 process (its inherent deficiencies notwithstanding).When an ISO 9000 system does not provide substantial benefits andimprovement in performance, it is usually because managementhas consciously chosen to cut corners, blowsmoke,stay uninvolved, and starve the system of all but the most essentialresources. “We’ll do this stupid thing, but we’re sure not goingto change the way we operate.”ISO 9000 registration brings you one more thing that your organizationmay not have today: International credibility. ISO 9000 is deployedand practiced in nearly 100 countries around the world. Intoday’s ever-growing international economic climate, this is not a bademblem to have, however narrow the scope of your market today.

Policy and Procedures for Quality Assurance

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Quality PolicyThe Institute seeks to ensure that the following standards, guidelines, requirements and procedures are adhered to:· European Standards and Guidelines for Quality Assurance in the European Higher Education Area;· All relevant HETAC Standards and Guidelines;· National Framework of Qualifications Standards;· Policies and Procedures approved by the Institute’s Academic Council;· All other relevant regulatory and professional requirements.The Institute also seeks to ensure that its education provision and services meet the requirements of its students in a learner centered and supportive environment.1.2 CommunicationThis Policy is published on the Institute website and communicated to stakeholders through email alerts. It will be formally published in Institute Yearbook from September 2009.1.3 ImplementationIt is the responsibility of the President, the Registrar, the Academic Council, Heads of School, Heads of Department and Heads of Function to ensure that this policy is implemented.1.4 MeasurementThe policy is measured by internal audits, Programmatic Review and external peer review.1.5 EvaluationEach quality process will be audited for compliance by the Registrar’s Office annually. This audit can include recommendations for minor changes to the process. The audit reports will be placed before the Academic Council.The Academic Council will conduct an evaluation of each process against national and international best practice on a three year cycle. The environmental scanning technique discussed in the Institute’s Self-Study 2009 will support this evaluation.1.6 Continuous ImprovementRecommendations for improvement will be generated through the measures indicated in 1.4 and 1.5 above. The implementation of these recomendations will ensure continuous improvement.1.7 Key Performance Indicators(i) Each of the seven areas identified under the European Standards and Guidelines will be revised on a three year cycle. See 1.8 below.(ii) Best practice will become an embedded feature of the process and external peer review reports will testify that minimum standards are surpassed.
1.8 Goals and Objectives

PRELIMINARY GAP ANALYSIS FOR ISO 9001:2008

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Quality Management System Preliminary Gap Analysis
Decide on a number from 0 to 5 for each item below. The scoring criteria are given in a table at the end. 1 to 5 Make notes to explain your score for future reference.
1. Have you established, documented, implemented and now maintain a Quality Management System (QMS) to any system including ISO 9001?
2. Have you identified the processes needed for your QMS and
a. the sequence of your production and service delivery processes,
b. the criteria and methods needed to ensure the processes are effective, and
c. have the resources and the information you need to support the processes?

3. Do you have
a. a Quality Manual including your Quality Policy and quality objectives, and
b. written procedures and work instructions?
4. Do your records provide evidence that your business processes are effective?
5. Is your Top Management committed to the development and implementation of a new QMS (i.e. based on the 2008 version of ISO 9001)?

6. Has your Top Management communicated the importance of meeting customer and other business requirements to all the employees?
7. Has your Top Management made a commitment to ensure your customers’ requirements are top priority?
8. Do your quality objectives include requirements for production and delivery?
9. Are your quality objectives measurable?
10. Have the responsibilities and authorities of managers and employees been defined and communicated to them?
11. Does your management have the drive and resources needed
a. to implement, and maintain a QMS and continually improve its effectiveness, and
b. to enhance customer satisfaction by meeting customer requirements?
12. Does your organization have procedures to select competent personnel for work activities?
13. Does your organization provide training or take other action to help develop your people?
14. Does your organization provide adequate:
a. buildings, workspace and utilities,
b. process equipment, and
c. supporting services such as transport or communication?
15. When you receive a customer order do you review it for
a. requirements specified by the customer, including the delivery and post-delivery activities,
b. requirements not stated by the customer but necessary for specified use or known and intended use, and
c. statutory and regulatory requirements related to the product?
16. Do you inform your customers concerning
a. product information,
b. enquiries, contracts or order handling, including changes, and
c. channels for customer feedback and complaints?
17. Does your organization plan and control product design and development activities?
18. Does your organization maintain records of design or development review, verification and validation activities and resulting action?
19. Does your organization inspect or otherwise confirm that purchased products, materials, components and services conform to your specified purchase requirements?
20. Does your organization select suppliers depending on how important the purchased product is for production?
21. Does your organization evaluate suppliers (subcontractors or vendors) based on their ability to satisfy your requirements?
22. Do you ensure production has
a. the information that describes the characteristics of the product,
b. the necessary work instructions,
c. suitable equipment, and
d. the monitoring and measuring devices needed?
23. Does your organization regularly confirm that your production and service processes are capable of consistently meeting your requirements?
24. Are parts, components, subassemblies and products identified throughout production or service delivery?
25. Are monitoring and measurement requirements clearly shown with the status of the product?
26. Where traceability is a requirement, does production keep records of unique product identification?
27. Do you care for and protect customers’ property under your control or being used by your people?
28. Do you look after your product (including the parts or components) during both production and delivery to the customer, by providing suitable identification, packaging, storage, preservation and handling?
29. Do you have instructions needed to identify inspection or monitoring activities to be done during production or service delivery and the devices to be used?
30. Is your measuring equipment:
a. Calibrated or verified at specified intervals, or prior to use?
b. Adjusted or re-adjusted as necessary?
c. Identified to enable the calibration status to be determined?
d. Safeguarded from adjustments that would invalidate the measurement result?
e. Protected from damage and deterioration during handling, maintenance and storage?
31. Does your organization monitor customer information that shows you have satisfied customer requirements?
32. Does your organization conduct internal quality audits at planned intervals?
33. Does your organization use suitable methods to monitor and, where practical, measure the performance of your processes?
34. Does your organization inspect or measure the characteristics of finished products and record the results?
35. Does your organization identify nonconforming products and review them for disposition?
36. Does your organization collect and analyze data to assess the suitability and effectiveness of the QMS?
37. Does your organization use data to evaluate or identify where continual improvement of the QMS can be made?
38. Does your organization continually improve the effectiveness of the QMS?
39. Does your organization take corrective action to eliminate the causes of problems and to prevent their recurrence?
40. Does your organization determine and eliminate potential nonconformities in order to prevent their occurrence?
To score this table:
0 – You do not understand what is required or believe it is necessary
1 – Your organization does not perform this activity
2.- You understand this activity is a good thing to do but do not do it
3 – You do this sometimes
4 – You do this but not very well
5 – You do this quite well.
Add all the points together.
150 – 200
You are almost ready to complete your ISO 9001 QMS and apply for certification/
registration.
100 – 149
You are ready to implement the QMS. This will likely improve your business results.
0 – 99
You have a lot to do but should begin. You could consider seeking help from a
consultant or specialist.

Improve your performance management with new version of ISO 9001

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A quality management system enables you to manage your business processes effectively:
it is much more than a set of rules and procedures. When properly implemented and maintained, a QMS addresses the needs of your organisation and delivers tangible business benefits.
The new version of ISO 9001 has recently been published. One of the main aims of ISO 9001:2008 is to facilitate integration with other standards. Although there are no new requirements as such, there are some key clarifications to be taken into account.
There are three main objectives to the new standard:
Detail, clarify, improve the understanding of ISO 9001:2000 (previous version)
Improve compatibility with ISO 14001:2004 Simplify the way in which ISO 9001 can be integrated with other management system standards (such as OHSAS 18001)
There are no new requirements in the new standard:
The title, scope, and structure of the standard are unchanged
The process approach is confirmed
Compatibility with the latest revision of ISO 14001:2004 is maintained and improved upon
Preservation of the quality management principles included in ISO 9000:2000
There are five main areas to note. The relevant sections of the standard are noted in brackets.
1. A reinforcement of the notion of product conformity
2. Compatibility with other standards is evolving
3. A better understanding of outsourced processes
4. An editorial clarification of some requirements – for instance;
A reinforcement of the notion of product conformity2.3.4.
An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolving
• (6.4) work environment, including an explanatory note on work environment giving examples,
to help meet product conformity requirements
• (8.2.1) measurement of customer satisfaction, including a note broadening the scope beyond
satisfaction surveys to include other channels such as customer feedback5.
• (Introduction) the notion of risk
• (5.5.2) appointment of a management représentative
• (6.2.2) assessing the effectiveness of achieving compétence
• (8.5.2 et 3) assessing the effectiveness of corrective and preventive actions?
Some additional explanations regarding the requirements of the standard;An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolvingA reinforcement of the notion of product conformity

The Similarity between ISO 9001 and BS 7799-2

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The Similarity between ISO 9001 and BS 7799-2
BS 7799-2:2002 is a specification for an Information Security Management System (ISMS). It is shortly to be upgraded to the status of a full
International Standard, and published as ISO/IEC 27001. The normative part of this standard has four sections and an annex . The requirements of the four sections are associated with the PDCA cycle. The annex defines all the controls that must be considered for generating the SOA. Thus the structure of BS 7799-2:2002, as will be ISO/IEC 27001, can be simply described as:
A PDCA framework;
An SOA.
ISO 9001:2000 is a specification for a Quality Management System (QMS). The normative part of this standard has five normative sections,
numbered 4 – 8. All of these requirements must be met in order to claim conformance with the standard, save for section 7 (Product Realisation),
where the standard states in paragraph 1.2 “Where exclusions are made, claims of conformity to this International Standard are not acceptable unless
these exclusions are limited to requirements within clause 7, an such exclusions do not affect the organisation’s ability, or responsibility, to provide
product that meets customer and applicable regulatory requirements”.
In Table 2 we relate the requirements of sections 4, 5, 6 and 8 to the PDCA framework. We treat section 7 as an SOA.
The BS 7799-2:2002 standard gives instruction on how the controls documented in BS 7799-2 Annex A are to be determined as being applicable or nonapplicable. In particular, if the control is applicable it must be justified in terms of the results of a risk assessment.
The controls listed in Section 7 of ISO 9001 may be excluded with justification. Thus, Section 7 of ISO 9001 may be treated in exactly the same manner as BS 7799-2 Annex A provided that applicable quality controls are also justified by
reference to a risk assessment. Conversely for an integrated MS, information security controls that are declared to be non-applicable should also be
justified as not applicable by reference to a risk assessment, in order to bring the two standards into line. Interestingly, this requirement was present in
BS 7799-2:1999 but was dropped in the 2002 revision.
The amalgamation of these two approaches in an integrated MS should not be seen as a disadvantage. The justification of non-applicable information security controls greatly simplifies the task of determining, given a change of threat or
business practice, whether a non-applicable control has now become applicable. The justification of Product Realisation controls by way of a reference to a risk assessment serves to remind us that, for many organisations, quality controls are not uniform across the whole organisation but are commensurate with the degree of risk involved.
For example, in the software business, a fixed price assignment with tight timescales to produce a bespoke software system has a greater risk than a
time and materials contract to supply programming staff, and the quality controls applied to management planning and reporting of the two projects would be very different.

BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS

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BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS
In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment)to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on Interpretations,
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categorie
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.- Maintains consistency with ISO 9000 family of standards.
-

Improves translatability.

Summaries of changes to ISO 14001

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Summaries of changes to ISO 14001
ISO 14001 year 2004 changes are consider having some effect on EMS ISO 14001, the changes require reviewing the EMS and taking action for transition (information is under control of TC 207). Considering the most relevant changes in advancing / transition to ISO 14001 2004 standard includes (an overview for transition / implementation):
Clause 4.1, Scope – requires defining the scope of the EMS (environmental management system) linking to the organizations activities, products, and services (and processes). First consider defining the scope of the EMS within the “boundaries” of products, services, activities, and processes as these relate [for ISO 9001:2000 organizations consider requirement 4.1, and organizations implementing ISO 14001 may be helpful reading ISO 9001:2000 clause 4.1]. The previous indicates an overview on how the EMS fulfills ISO 14001 2004 [some thoughts are internal auditing, management system review providing that these link].
Clause 4.2, Policy – The scope of the EMS and its policy must be consistent. The requirements for the policy remains about the same, now explicitly indicating that must be developed by top management, and other explicit terms in tune with the 1996 version.
Clause 4.3.1, Environmental Aspects Identification – Changes involve in assisting to clarifying statements from 1996 version and the change of the “or” for “and” (within the scope of the EMS); “… products and services…” Control and influence are now mutually exclusive, whilst introducing planned and new developments… new and modified activities… Considering identifying significant aspects must occur from development, implementation, and maintaining the EMS (see 4.1). Information on environmental aspects needs be in documentation format.
To a more assertive statement, “… over which it can be expected to have…” changes to the following “…those which it can influence.”
Clause 4.3.2, Legal and Other Requirements – The wording changes to “legal” in better addressing context to different world regions. Consideration must be given with changes to clause 4.1, for development, implementation, and maintaining the EMS.
Clause 4.3.3 – No significant change.
Clause 4.3.4 – No significant change.
Clause 4.4.1 , Resources, Roles, Responsibility and Authority, please note that this is a new title. This title reflects the importance and relevancy of each term to the EMS. Some minor wording changes include from “…provide…” to “…ensure the availability…” Do not forget that this will require reviewing auditing, planning, and responding to emergencies.
Clause 4.4.2, Competence, Training and Awareness – Whilst using the same
terms in the title notice the change in sequence. This change reflects the expected order of importance of the terms-subjects. Also consider that introduces a new phrase that broadens the individuals within an EMS; “…persons working for, or on behalf of …” Combining these previous two sentences, provides for the organization to include not only relevancy to significant environmental aspects but as well extending to those working for or in behalf of the organization . (Note: also consider that training provider and supporting services are inclusive to 4.4.6).
Clause 4.4.3, Communication – In specifically addressing the European Requirements (EMAR / EMAS), if the organization decides communicating externally the environmental aspects (environmental performance), ISO 14001:2004 address this issue. This is strictly on a volunteer globally, realizing that within the European Union is require.
Clause 4.4.4, Environmental Management System Documentation – in pursuit
of continuing compatibility with ISO 9001:2000 the term applied is “Documentation.”
Thereof, consider this clause also in the light of ISO 9001:2000 when integrating
EMS and QMS. The EMS documentation and records must be those to ascertain
objective evidence on the effectiveness of implementing the policy, planning, and
execution (including improving), control of operations, verification, and control,
improving, and reviewing the EMS.
Clause 4.4.5, Document Control – Again, changing the title and wording reflects
compatibility with ISO 9001:2000. Other than compatibility between QMS ISO
9001:2000 and EMS ISO 14001:2004 there are no significant changes.
4.4.6, Operational Control – No significant change.
4.4.7, Emergency Preparedness and Response – The structure changes by
placing some of its already content in bullets to emphasize each as pointer for the organization to address.
4.5.1, Monitoring and Measurement – Best to see new clause 4.5.2.
4.5.2, Evaluation of Legal Compliance – This is a new clause
[Note: addressing the concern of many government entities / authorities on
their responsibility on environmental and social issues and EMS ISO 14001 1996].
This is construe as the most impacting change to ISO 14001 2004 – this “new” clause brings the last paragraph of 4.5.1 as a separate clause. This clause brings the importance of periodically reviewing legal requirements / compliance under which the organization ascribes. It implies provision of records to demonstrate that this review occurs. This requires that the EMS be review to address the requirements of this “new” clause.
4.5.3, Non Conformance, Corrective and Preventive Action – Includes clarifications ascertaining that prevention (measures or potential of non conformity)and corrective action are two occurring events (which may be mutually inclusive).
Thereof, “action to eliminate the causes of potential non conformities to prevent their occurrence” can lead to changes in your EMS procedures.
4.5.4, Records – States that organizations need records to demonstrate
implementation of procedures and achieving results. These must demonstrate complying with the EMS (procedures and results). Whilst record retention times are not specifically required, record retention needs being specified (consider legal requirements and contractual agreements such that provide a demonstrable sustainable EMS).
4.5.5, Environmental Management System Audit – Whilst there are no wording changes, auditing must be reviewed in the light and effect of other changes (such as 4.5.1, 4.4.2).
4.6, Management Review – The wording provides (more direct) compatibility with ISO 9001:2000, which includes inputs and outputs for reviewing the EMS. Addition includes reviewing for improving the EMS (from target and not merely objectives).
The advent of ISO 14001:2004 shall not require additional training, unless otherwise the organization decides for a short review presentation or an “IMS” (integrated management systems,” integration of management systems such as ILO-OSH, OSH.MS, OSHAS 18001, ISO 9001 and variants with ISO 14001.) It will require reviewing the EMS by management, (perhaps a gap analysis), acting on any changes, inclusive to auditing against ISO 14001:2004 before transition.

ISO 9001 Standards – Control of Measuring and Monitoring Equipment

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ISO 14001:2004 Standards Contents

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