9001? 9003? 9004? Which Standard?
ISO 9001 is one of a family of documents in the ISO 9000 group.
The current version of the Standard is ISO 9001:2008. The year after the number of the Standard (2008) always identifies the year of release. The 2008 one replaced its predecessor, ISO 9001:2000.
What was new in ISO 9001:2008?
Not much. There were no new requirements added. None at all. That's important, because a requirement is a 'must do'.
The changes are minor changes to wording, small additions such as notes and examples to clarify meaning, and modifications to 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
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 your company (or organisation) rather than having the focus on a prescribed number of mandatory procedures (documentats).
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?
They no longer exist and are thus 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 They were withdrawn in 2000 and replaced by just the single 9001 standard.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 a reference to 'ISO 9002 certification', someone is either very ignorant or many, many years out of date.
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.
Author: Jane Bennett