2000 version

ISO 9001:2000 combined the three standards9001, 9002, and 9003into one, called 9001. Design and development procedures were required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimisation of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit. The ISO 9000 standard is continually being revised by standing technical committees and advisory groups,

who receive feedback from those professionals who are implementing the standard.[1] [edit]2008

version

ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version. [edit]Auditing Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment to verify that the system is working as it is supposed to; to find out where it can improve; and to correct or prevent problems identified. It is

considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments. Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing":

Tell me what you do (describe the business process) Show me where it says that (reference the procedure manuals) Prove that this is what happened (exhibit evidence in documented records)

The 2000 standard uses a different approach. Auditors are expected to go beyond mere auditing for rote compliance by focusing on risk, status, and importance. This means they are expected to make more judgments on what is effective, rather than merely adhering to what is formally prescribed. The difference from the previous standard can be explained thus:

Under the 1994 version, the question was broad: "Are you doing what the manual says you should be doing?", whereas under the 2000 version, the questions are more specific: "Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?" [edit]Industry-specific

interpretations

The ISO 9001 standard is generalized and abstract; its parts must be carefully interpreted to make sense within a particular organization. Developing software is not like making cheese or offering counseling services, yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizationspolice departments (US), professionalsoccer teams (Mexico) and city councils (UK)have successfully implemented ISO 9001:2000 systems. Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure

that more appropriately trained and experienced auditors are sent to assess them.

The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development. AS9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt & Whitney, RockwellCollins, Sikorsky Aircraft, and Sundstrand. The current version isAS9100C. PS 9000 * QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS 16949. ISO/TS 16949:2009 is an interpretation agreed upon by major automotive manufacturers

(American and European manufacturers); the latest version is based on ISO 9001:2008. The emphasis on a process approach is stronger than in ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and automotive industry-specific requirements.

TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is 5.0; unlike ISO 9001 or other sector standards, TL 9000 includes standardized product measurements that can be benchmarked. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry. ISO 13485:2012 is the medical industry's equivalent of ISO 9001:2008. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Because ISO 13485 is relevant to

medical devices manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 does not necessarily mean compliance with ISO 9001:2008 (and vice versa).

ISO/IEC 90003:2004 provides guidelines for the application of ISO 9001:2000 to computer software. ISO/TS 29001 is quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries. It is equivalent to API Spec Q1 without the Monogram annex.

[edit]Effectiveness The debate on the effectiveness of ISO 9000 commonly centers on the following questions: 1. Are the quality principles in ISO 9001:2000 of value? (Note that the version date is important; in the 2000 version ISO attempted to address

many concerns and criticisms of ISO 9000:1994). 2. Does it help to implement an ISO 9001:2000compliant quality management system? 3. Does it help to obtain ISO 9001:2000 certification? Effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which are: 1. Commitment of senior management to monitor, control, and improve quality. Organizations that implement an ISO system without this desire and commitment often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits. 2. How well the ISO system integrates into current business practices. Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual instead of creating a manual that documents existing

practices and only adds new processes to meet the ISO standard when necessary. 3. How well the ISO system focuses on improving the customer experience. The broadest definition of quality is "Whatever the customer perceives good quality to be." This means that a company doesn't necessarily have to make a product that never fails; some customers will have a higher tolerance for product failures if they always receive shipments on-time or have a positive experience in some other dimension of customer service. An ISO system should take into account all areas of the customer experience and the industry expectations, and seek to improve them on a continual basis. This means taking into account all processes that deal with the three stakeholders (customers, suppliers, and organization); only then will a company be able to sustain improvements in the customer's experience. 4. How well the auditor finds and communicates areas of improvement. While ISO auditors may

not provide consulting to the clients they audit, there is the potential for auditors to point out areas of improvement. Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard; however, to most executives, this is like speaking a foreign language. Auditors that can clearly identify and communicate areas of improvement in language and terms executive management understands facilitate action on improvement initiatives by the companies they audit. When management doesn't understand why they were non-compliant and the business implications associated with non-compliance, they simply ignore the reports and focus on what they do understand. [edit]Advantages It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and

avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade and also to Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Implementing ISO often gives the following advantages:[citation needed] 1. Creates a more efficient, effective operation 2. Increases customer satisfaction and retention 3. Reduces audits 4. Enhances marketing 5. Improves employee motivation, awareness, and morale 6. Promotes international trade 7. Increases profit 8. Reduces waste and increases productivity 9. Common tool for standardization. [edit]Criticisms of ISO 9000 A common criticism of ISO 9000 and 9001 is the amount of money, time, and paperwork required for registration.[6] Dalgleish cites the "inordinate and

often unnecessary paperwork burden" of ISO, and says that "quality managers feel that ISO's overhead and paperwork are excessive and extremely inefficient."[30] According to Barnes, "Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed."[31] Wilson suggests that ISO standards "... elevate inspection of the correct procedures over broader aspects of quality," and therefore, "the workplace becomes oppressive and quality is not improved."[7] According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement.[8] Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality, ... [undermining] the need for an organization to set its own quality standards." [32] Paraphrased, Wade's argument is

that reliance on the specifications of ISO 9001 does not guarantee a successful quality system. The standard is seen as especially prone to failure when a company is interested in certification before quality.[8] Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality.[31][33] "If you just want the certificate on the wall, chances are you will create a paper system that doesn't have much to do with the way you actually run your business," said ISO's Roger Frost.[33] Certification by an independent auditor is often seen as the problem area, and according to Barnes, "has become a vehicle to increase consulting services." [31] Dalglesh argues that while "quality has a positive effect on return on investment, market share, sales growth, better sales margins and competitive advantage," that "taking a quality approach is unrelated to ISO 9000 registration."[34] In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved.[35]

Abrahamson argues that fashionable management discourse such as Quality Circles tends to follow a lifecycle in the form of a bell curve, possibly indicating a management fad.[36] [edit]See

also