ISO 9001:2008 published
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16.11.2008
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The fourth edition of ISO 9001 was published on 15th Nov 2008. We have reviewed all the changes (see our
comparison table), and found a limited number of areas, where
additional action might be required from some of our clients who are already registered to ISO 9001, their
consultants, and our assessors.
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The vast majority of the roughly 100 changes from the third to the fourth edition serve to clarify existing
provisions, and none of the changes runs contrary to TÜV UK's previous interpretation of ISO 9001. In some
instances sentences of a particular clause have simply been "promoted" to paragraphs of bulletpoints, or they
have been added to a different paragraph in the same clause, to structure the same clause more logically.
Overall the revised ISO 9001:2008 puts more importance on product compliance to all requirements, not just
product quality. Where the "old" ISO 9001 only mentioned regulatory requirements applicable to the respective
product, the amended ISO 9001 now also makes reference to statutory requirements - most ISO 9001 registered
companies will have addressed both types of requirements in the past anyway, recognising them as "legal"
requirements.
The main areas where ISO 9001:2008 may require some additional action from companies currently complying with
ISO 9001:2000 are:
Clause 0.1, Sentence 2;
Clause 1.1, Bullet point a);
Clause 1.1, Bullet point b);
Clause 1.2, Paragraph 3;
Clause 4.1, Paragraph 4;
Clause 4.1, Note 1;
Clause 4.1, Note 2;
Clause 4.1, Note 3;
Clause 5.5.2, Paragraph 1;
Clause 6.4, (New) Note;
Clause 7.1, Bullet point c);
Clause 7.2.1, (New) Note;
Clause 7.3.3, (New) Note;
Clause 7.5.4, Note;
Clause 8.2.3, (New) Note;
Since there were only minor changes made to the standard, and most (if not all) companies complying with
ISO 9001:2000 will already comply with ISO 9001:2008, only
a short transition period of 2 years
has been allowed for "migration" of existing registrations to the new standard.
This makes things a bit complicated and messy for the Certification Bodies: following publication of
ISO 9001:2008 all our (re-) certifications issued against ISO 9001:2000 will have to have a validity until
14th Nov 2010 (or earlier). Once your Management System complies fully with the requirements of ISO 9001:2008,
however, the (three year) validity of your ISO 9001:2008 certificate will be based on the last (re-) certification visit.
During the next visit to your company TÜV UK Ltd will therefore assess your QMS against the requirements of
ISO 9001:2008. This will not require any additional time, nor will you incur additional charges. If you
require additional time to consider any necessary changes to your QMS following the amendments of ISO 9001,
please let your Assessor know (latest during the "Opening Meeting" on the day of the visit). We could then
postpone assessment against the revised version of the standard until the following visit.
In the
unlikely event that your company complies with ISO 9001:2000, but not with ISO 9001:2008, we would raise
observation(s) based on ISO 9001:2008. In this case we would continue with registration of your company's QMS
under ISO 9001:2000 until you have dealt with the observation(s) to our satisfaction, or until 14 Nov 2010,
depending on what occurs earlier. Improvement reports raised against requirements of ISO 9001:2000 and / or
ISO 9001:2008 should be dealt with as in the past, meaning you submit a "Corrective Action Proposal",
supported - where required - by documentary evidence of implementation.
If you require any additional information or clarification, we in the office in Croydon, or one of our
Assessors, or your Quality Consultant would all be pleased to assist you.
Your contact
TÜV UK Ltd
Surrey House
Surrey Street
Croydon CR9 1XZ
United Kingdom
Mr Peter Blackwell
Tel: 0044-(0)20-8680 7711
Fax: 0044-(0)20-8680 4035
E-Mail: uk @ tuv-nord.com
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