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put ISO 9001 to work for you |
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FAQs --> Which standardFAQ - Which ISO 9000 Standard?ISO 9000 refers to the family of documents around the ISO 9001 Standard. The actual Standard's full title is 'ISO 9001:2000 Quality Management Systems - Requirements'. While different countries insert different different identifiers before the ISO (eg, AS/NZS for Australia & NZ); the contents of the Standard are the same throughout the world The current version of the Standard is ISO 9001:2000, but that's about to change. A new version will be published later this year, and the current version will become ISO 9001:2008. What's new in ISO 9001:2008?There are no new requirements. At all. The changes are quite minor. They consist of minor changes to words or the addition of notes and examples, to clarify meaning. For example: a Note has been added to clarify that a single procedure can meet the
requirements of more than one clause. Finally this should put an end
(I hope!) to the old misbelief that you 'must' have 3
separate procedures to address the 3 different clauses on nonconformity, corrective and preventive
action. What changed between 1994 and the 2000 version?The 2000 Standard changed to a real focus on customers and on outcomes, away from the old emphasis on sheer conformance to process and 'QA' (good change). The previous manufacturing bias that had formerly made the Standard rather difficult to apply to services was removed. A wholly new 'process approach' now stressed the importance of identifying key processes in each organisation, and putting the focus on these processes rather than on mandatory procedures (lots of documentation). The role of senior management was clarified and emphasised; they are now referred to as 'top management' - that is, the people in charge, the decision-makers, whether that is a CEO, MD, Board of Directors, etc. It introduced a new requirement for measurable objectives. Requirements for mandatory documents were much reduced. And many clause numbers changed (those are the 2.3.4 and 4.8 type numbers). One consequence is that the awful old-style quality manuals specifically built upon the clause numbers of the Standard didn't work any more - hooray. Although alas, in some quarters they've ignored the process approach, and just renumbered and trotted out the same old stuff. It didn't work well then, and still doesn't! What happened to ISO 9002 and ISO 9003?Both obsolete. They were withdrawn in 2000 and replaced by just the single 9001 standard. Prior to 2000, there were 3 separate Standards in the family: ISO 9001, ISO 9002 and ISO 9003. In practice, most companies used either ISO 9001 (if their system included 'design') or ISO 9002 if it didn't. A very few companies did ISO 9003, which only covered installation/maintenance. Now, there is just one Standard, so everyone is certified to ISO 9001. So if you happen to come across any reference to 'ISO 9002' certification, someone is either very ignorant and/or years out of date. Exemptions or 'We don't do Design'When 9001, 9002 and 9003 existed, you chose the applicable Standard, and then met all its requirements. The biggest difference was whether 'design' applied or not: 9001 (if it did) vs 9002 (it didn't). That's all changed. With this single Standard (ISO 9001), you now may claim exemption from certain clauses but only within a single section: section 7. You must provide good reasons for any exemption, and it must not affect your ability or responsibility to provide product/services that meet requirements (customer or applicable regulatory ones). For example, if you just make the same things over and over again, and thus don't do any design-related activities, you could claim exemption for that clause (7.3) because it does not apply. Or if you don't use, acquire or hold any property from your customers (7.5.4), you could exclude that clause also as non-applicable. But you can't just choose to opt out from a clause because you prefer not to do it. For example, an architectural practice could not exclude 'design' from their business activities. A business that did repairs of products sold under warranty, which they must take to their premises to fix, could not claim exemption from 7.5.4 'customer property'. Where does a Standard come from?Producing a Standard is a lengthy process of gaining consensus between national delegations representing all the stakeholders concerned - suppliers, users, government regulators and other interest groups, such as customers and consumers to agree on the specifications and criteria to be applied. You can read the full process from the official ISO website - see Links. <-- More FAQs
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