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The first draft of the update ISO 9001:2000 “ISO/CD 9001” has been issued for review and comment on 8th February 2007.
The official publication for the final version will not come into force until 1st September 2008, after which there will be an implementation period, which, as yet, has not been decided.
The structure and clause numbering of this new draft is the same as the 2000 version, there are no changes here at all. Most of the changes are grammatical, however, the most significant change is the alignment of the standard against ISO 14001: 2004.
The policy on the upgrading of existing clients to the revised Standard cannot be done until the International Accreditation Forum (IAF) issues the policy on implementation. It is, however, envisaged that no extra visits will be required and that audits against the new standard would be during routine surveillance visits, where the progress would be checked.
Proposed Changes
- Where the word “regulatory” is stated in the current standard the word “statutory” has been added alongside (Several Clauses).
- The management representative now has to be appointed from within the organization's management.
- Allowance is made for the manual to have one or more procedures contained within it instead of having a separate folder (Clause 4.2.1, Note1).
- Some clarity and examples have now been given for work environment. For example, clean rooms, antistatic precautions and hygiene controls (Clause 6.4, Note).
- Further explanation in the form of a note has been added under determination of customer requirements stating that post delivery activities may include things like warranty provisions, contractual obligations i.e.maintenance and supplementary services such as recycling or waste disposal (Clause 7.2.1, Note).
- The Standard now allows for design review, verification and validation to apply separately or on any combination (7.3).
- Two notes have been added under validation of processes for production and service provision and gives some examples of how this clause applies, eg welding, sterilization, training, heat treatment, call centre services or emergency response (Clause 7.5.2, Note 1 & 2).
- The clause for customer property now includes reference to personal data (Clause 7.5.4, Note).
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For any further clarification please contact CCAS HQ. |
