ISO 9001
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Wikipedia-Article "ISO 9001"
The widely accepted ISO 9000 series of standards specifies requirements for a Quality Management System.
ISO 9000 was created by the British Standards Institute as BS 5750. The standard is now maintained by ISO (the International Organization for Standardization) and administered by accreditation and certification bodies.
It is widely accepted, although its high price and effort has led to many companies using alternatives such as IC9700, or IC9200, both of which are issued by the International Charter.
Some countries accepted ISO 9000 as their national standard. (e.g. IR 9000 in Iran).
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History
In World War II, United Kingdom, Britain had a serious problem with bombs going off in the weapons factories. In an attempt to solve the problem, the Ministry of Defense placed inspectors in the factories.
To supply to the Government, a company had to write up the procedure for making their product, have the procedure inspected by the Ministry and ensure their workers followed these procedures.
This, and similar problems in the nuclear/power industries over the following decades, were signs of rapid technological advance in manufacturing. Advances in science were pushed into manufacturing too fast to be properly managed. Furthermore, managers were seen as too often basing decisions on paper reports rather than on understanding what was happening on the factory floor.
In 1959, the United States developed Quality Program Requirements, a quality standard for military procurement, detailing what suppliers had to do to achieve conformance. By 1962, NASA had similarly developed Quality System Requirements for its suppliers. In 1968, NATO adopted the AQAP (Allied Quality Assurance Procedures) specifications for the procurement of NATO equipment.
The idea of quality assurance spread beyond the military. In 1966, the United Kingdom Goverment led the first national campaign for quality and reliability with the slogan "Quality is everybody's business." In 1969, the UK and Canada developed quality assurance standards for suppliers.
By this time, suppliers were being assessed by any number of their customers. It was widely recognized that this was a very wasteful duplication of effort. In 1969, a UK committee report on the subject recommended that suppliers' methods should be assessed against a generic standard of quality assurance.
In 1971, the British Standard Institute published the first UK standard for quality assurance, BS 9000, which was developed for the electronics industry. In 1974, BSI published BS 5179, Guidelines for Quality Assurance.
In order to shift the burden of inspection from the customer, quality assurance was guaranteed by the supplier through third-party inspection.
Through the 1970s, BSI organized meetings with industry to set a common standard. The result was BS 5750 in 1979. Key industry bodies agreed to drop their own standards and use it instead. The purpose of BS 5750 was to provide a common contractual document, demonstrating that industrial production was controlled.
Revisions
The standard has evolved over several revisions.
- The initial 1987 version, ISO 9000:1987, had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization. This initial document, while structured like the British Standard, drew heavily from numerous documents then in use around the world. Although the Standard has gone through two more iterations which have resulted in some radically changed language, all the core, prevention oriented quality assurance requirements were present in the 1987 document. Contrary to many claims, the Standard did not focus on quality control via retroactive checking and corrective actions. The language of this first version of the Standard was influenced by existing US and other Defence Military Standards ("MIL SPECS") so was more accessible to manufacturing, and was well-suited to the demands of a rigorous, stable, factory-floor manufacturing process. With its structure of twenty 'elements' of requirements, the emphasis tended to be overly placed on conformance with procedures rather than the overall process of management - which was the actual intent.
- The 1994 version, ISO 9000:1994, was an attempt to break from the practices which had somewhat corrupted the use of the 1987 standard. It also emphasized quality assurance via preventive actions, and continued to require evidence of compliance with documented procedures. Unfortunately, as with the first edition, companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. Adapting and improving processes could be particularly difficult in this kind of environment.
- The 2000 version, ISO 9000:2000, sought to make a radical change in thinking by actually placing the concept of process management front and centre in the Standard. Documents produced by the ISO Technical Committee which drafted the third edition make it clear that they didn't see any change in the essential goals of the standard, which had always been about 'a documented system' not a 'system of documents'. The goal was always to have management system effectiveness via process performance metrics. The third edition makes this more visible and so reduced the emphasis on having documented procedures if clear evidence could be presented to show that the process was working well. Expectations of continual process improvement and tracking customer satisfaction were made explicit at this revision. Unfortunately too many organizations continue to produce reams of unnecessary documents and to write quality systems around the paragraph structures of ISO 9001 rather than analysing their business processes and building systems around the process flow of the organization.
Certification
ISO does not itself certify organizations. Many countries have formed accreditation bodies to authorize certification bodies, which audit organizations applying for ISO 9001 compliance certification. * note * It is not possible to be certified to ISO 9000. Although commonly referred to ISO 9000:2000 certification, the actual standard to which an organization's quality management can be certified is ISO 9001:2000. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the Accredited Certification Bodies (CB) are accepted world-wide.
The applying organization is assessed based on an extensive sample of its sites, functions, products, services, and processes and a list of problems ("action requests" or "non-compliances") made known to the management. If there are no major problems on this list, the certification body will issue an ISO 9001 certificate (see note above) for each geographical site it has visited once it receives a satisfactory improvement plan from the management showing how any problems will be resolved.
An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body — usually around 3 years.
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's supposed 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 judgements.
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 that is what happened (exhibit evidence in documented records)
Under the 2000 standard, the approach should be different, reflecting the different aspects and the processs approach. While the auditor does perform some similar functions, they are expected to go beyond mere auditing for 'compliance' and to focus on risk, status and importance. This means they are expected to make more judgements on what is effective (or not), rather than merely adhering strictly and safely to what is formally prescribed. The difference could be exemplified thus: Under the 1994 version, the question was broadly: are you doing what the manual says you should be doing? whereas under the 2000 version, the question is more: will this process help you achieve your stated objectives? is it a good process or is there a better one/way to do it better?
The ISO 19011 standard for auditing should be applied to ISO 9000.
ISO 9000 document suite
ISO 9000 is composed of the following sections:
- ISO 9000:2000, Quality management systems — Fundamentals and vocabulary. covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. The latest version is ISO 9000:2004.
- ISO 9001 Quality management systems - Requirements is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. This is the only implementation for which third-party auditors may grant certifications. The latest version is :2000.
- ISO 9004 Quality management systems — Guidelines for performance improvements. covers continual improvement. This gives you advice on what you or could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation.
There are many different standards which are referenced in ISO 9001 family. A lot of them do not even carry "ISO 900x" numbers. For example, parts of the 10,000 range are also considered part of the 9000 family: ISO 10007:1995 discusses Configuration management, which for most organizations is just one element of a complete management system.
To the casual reader, it is usually sufficient to understand that when an organization claims to be "ISO 9000 compliant", it means they conform to ISO 9001:2000.
The ISO website and documentation give more detail on what each specification entails.
Industry-specific interpretations
As the paragraphs and clauses of the ISO 9001 standard have always been very generalized and abstract, they have to 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 industries. It should be noted that diverse organizations such as Police Departments (US), Professional Soccer 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.
- 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.
- AS 9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. The current version is AS 9100.
- PS 9000 is an application of the standard for Pharmaceutical Packaging Materials.
- QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP.
- ISO/TS 16949:2002 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2000. The emphasis on a process approach is stronger than in ISO 9001:2000. It also contains 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 3.5 and unlike ISO 9001 or the above sector standards, TL 9000 includes standardized product measurements that can be benchmarked.
Criticisms of ISO 9000
Criticisms of ISO 9000 generally concern inappropriate application or extension of its use in companies, and the effect this can have on organizational culture.
While the criticism focuses on the standard, the problems typically arise from a failure of organisations to understand the underlying philosophy and the fact that the standard describes a process-driven systematic approach. Benefits will be difficult to achieve where incomplete or incoherent implementations of ISO 9001-based quality management systems prevail.
The intent is that an organization implementing a management system based on ISO 9001 will have defined processes which enable it to clearly identify and understand 'customer' requirements - including understanding who the customer actually is - translate those requirements into deliverable products or services and then deliver those products or services on time and in a manner which completely satisfies the customer. Nothing black magic - just plain common sense.
- BS 5750 was designed to show that production was controlled. While it never contained the words 'continual improvement', it contained all the elements which drive improvement. Corrective action, preventive action, internal audits and management review have always been part of the Standards. Unfortunately few people understand that these are the tools of 'continual improvement'. Processes, technology and customer demands are ever-changing. A management system must therefore be as dynamic as products and processes; useful changes can be blocked for being non-compliant if the system isn't nimble. The work of W. Edwards Deming focuses on awareness of processes, thus harnessing workers' creativity. A good quality management system will do the same thing, whereas a bad system can create a culture of ritualizing processes — including creative ones — thus suppressing them.
- "When all you have is a hammer, every problem looks like a nail." It has been argued that it may not be appropriate to apply a process such as ISO 9000 to a field requiring creativity, such as software engineering, which is more analogous to designing factories than to operating a factory. However if the activity is called engineering, then it has processes - what ISO 9001 asks the user community to do is to understand and control those processes. It is sometimes used as an excuse for inappropriate Taylorisation.
- Bad managers still manage at arm's length, using paper reports rather than knowing what is happening on the factory floor. ISO 9000 can reinforce this behaviour. Instead of being seen as an opportunity to improve things, audits often become quite confrontational in structure.
- Many companies only register to ISO 9000 because they are forced to by the marketplace — whether or not ISO 9000 is in fact appropriate to their business. However once the basic intent of ISO 9001 is understood it is hard to argue that the concepts are not applicable to every form of human activity.
These problems were particularly pronounced with the ISO 9000:1994 revision. The 2000 revision was in part an attempt to address such criticisms, however inappropriate application of a standard is no reason to blame the document itself. Bad management practices have existed since long before ISO 9001 and will continue long after.
There are few objective metrics showing any effectiveness for ISO 9001. In 1997, two people took the BSI to the Advertising Standards Authority for claiming in an advertisement that ISO 9001 "improves productivity ... almost always gives an immediate result in terms of productivity and efficiency, and that means cost reductions ... pays for itself ... Staff morale is better because they understand what is expected of them and each other," whilst being unable to produce any objective metrics to substantiate these assertions. The complaint was upheld. However had the complainants studied US literature they would have discovered several surveys which show worth-while improvements to productivity, reduced scrap and waste and enhanced customer satisfaction from organizations using the Standards. (See QSU website).
Quality programmes are notoriously difficult to quantify as Crosby warned in 'Quality is Free' back in 1970, long before the first of these standard emerged. When an organization is measuring nothing, the only 'quality costs' it knows are the basics of scrap and rework, and often even these are not being tracked effectively. Once a formal system is introduced, much more accurate data starts to emerge and initial costs of quality often appear to increase, however stabilizing processes frequently produces quite dramatic drops in scrap and failure rates.
In Japan, amidst complaints of ISO 9000 undermining world-class thinking, Toyota abandoned the standard in 2000, moving back to their in-house Toyota Production System. However it should be understood that the 'Toyota Method' involves measuring everything constantly. Assurance isn't much of the process.
Related standards
{Needs revision}
External links
- ISO 9000 family — from ISO
- ISO Resources and Q&A — from Driso
- ISO Resources and FAQ — from Simply Quality
- [1] — Survey on effectiveness of ISO 9000 (Independent)
Critical links
- ASA complaint against BSI regarding ISO 9000 +
- The 'quality' you can't feel — John Seddon, The Observer, Sunday 19 November 2000 +
- A Brief History of ISO 9000: Where did we go wrong? — first chapter of The Case Against ISO 9000 by John Seddon, ISBN 1860761739 +
- So Many Standards To Follow, So Little Payoff; article by Stephanie Clifford in May 2005 issue of Inc Magazine