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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 Standard's full title is 'ISO 9001:2008 Quality Management Systems - Requirements'. Different countries insert different different identifiers before the ISO (eg, AS/NZS for Australia & NZ), but the contents of the Standard are the same throughout the world The current version of the Standard is ISO 9001:2008. The 2008 refers to the year of release, replacing its predecessor, ISO 9001:2000. What was new in ISO 9001:2008?The 2008 version was very little changed. There were no new requirements. None at all. That's important, because a requirement is a 'must do'. The changes were fairly small. They are minor changes to words or small additions, such as notes and examples to clarify meaning, and align this Standard better with ISO 14001 (Environmental). For example, there is now a Note which clarifies that a single procedure can meet the
requirements of more than one clause. This should finally put an end
(I hope!) to the tired old misbelief that you 'must' have 3
separate procedures to address the 3 different clauses on nonconformity, corrective and preventive
action. What changed after the 1994 version?Since 2000 when a very new and completely revised Standard was published, it changed focus to customers and outcomes, away from the old emphasis on just conforming to process and 'QA' (good change). The previous manufacturing bias that formerly made the Standard difficult for services was removed. A wholly new 'process approach' stressed the importance of identifying key processes in each organisation, with a focus on processes rather than mandatory procedures (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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