Quality

During WWII, there were quality problems in many British industries such as munitions, where bombs were exploding in factories during assembly. The adopted solution was to require factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The name of the standard was BS 5750, and it was known as a management standard because it specified not what to manufacture, but how the manufacturing process was to be managed. According to Seddon, "In 1987, the British Government persuaded the International Organization for Standardization to adopt BS 5750 as an international standard. BS 5750 became ISO 9000."

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:


ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.

ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, now called 9001. Design and development procedures are 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 centre ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product). The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is 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.

ISO 9001: 2008 introduces no new requirements. ISO 9001: 2008 only introduces clarifications to the existing requirements of ISO 9001: 2000 based on eight years of experience of implementing the standard worldwide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001: 2004. The good news is that the 2008 release will not have the same impact. In fact, the ISO technical committee (TC176) who develops the ISO 9000 series of standards is purposely planning the next release as an amendment rather than a formal revision. The difference is that an "amendment" is focused on making changes for clarification purposes only and for better alignment with ISO 14001, the standard for environmental management. With the 2008 release, the committee is purposely intending not to introduce substantive changes that will affect the QMS processes and documentation of currently certified organizations. Thus, the new ISO 9001:2008 standard should have limited impact on companies already certified

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. Although commonly referred to as ISO 9000:2000 certifications, 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; a list of problems ("action requests" or "non-compliances") is made known to the management. If there are no major problems on this list, the certification body will issue an ISO 9001 certificate 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 three years. In contrast to the Capability Maturity Model there are no grades of competence within ISO 9001

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 judgments.

Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing":


The 2000 standard uses the process approach. While auditors perform similar functions, they 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 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 way to do it better?".

The ISO 19011 standard for auditing applies to ISO 9001 besides other management systems like EMS ( ISO 14001), FSMS (ISO 22000) etc.

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 counselling services; yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations—manufacturing companies, software development companies, trading organizations, service organizations, police departments, professional soccer teams and city councils —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.

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 Barnes, who says "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Barnes also cites a survey by Lloyd's Register Quality Assurance which indicated that ISO 9000 increased net profit, and another by Deloitte-Touche which reported that the costs of registration were recovered in as less as three months. According to the Providence Business News, implementing ISO often gives the following advantages:


In today's service-sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability.