ISO 9001 Changes 2008
ISO 9001, like all standards is subject to periodic review to determine whether it is still relevant, whether it needs to be updated or whether it should be discarded. The review period is around 5 – 6 years so, since the current version was issued in the year 2000, the standard is due for revision and re-issue.
The revision process for ISO 9001 is designed such that whenever there are significant changes to be made (major revision), the next revision will be less significant (minor). Since the revisions issued in 2000 were major, it follows that the next one will be minor. Indeed, the proposed changes are more based on the clarification of points already in the standard rather than the inclusion of new requirements.
However, the proposed changes to ISO 9001’s ‘sister’ standard, ISO 9004, are much more significant though this is only a ‘guidance’ document rather than a requirements standard. ISO 9001:2000 is due for an update this year. It is currently at Draft International Standard (DIS) stage and is likely to be published in the autumn of 2008.
What does this mean for you, if you are already registered to ISO 9001:2000?
In reality there will be little impact, it seems that the changes to the standard are very small. It will replace ISO 9001:2000 but each organisation will be given approximately one year after its publication to make any updates. There should not be any major disruption to your organisation or your registration. Your assessor will guide you through the process.
ISO 9001 Changes
There are very few of any consequence and most organisations will have little problem adapting their system to satisfy these changes.
Section |
Changes |
0.1 |
Statement of where and who can use the standard now includes statutory requirements as well as customer and regulatory and clarifies that these requirements are restricted to those applicable to the product |
0.3 |
The guidance for an organisations overall performance and efficiency, as well as its effectiveness has been replaced with "managing for the sustainable success of an organisation". |
0.4 |
A comment has been added that the development of ISO 9001:2008 made due consideration to ISO 14001:2004 |
1.1 & 1.2 |
Again, statutory requirements have been added (as in 0.1) and Note 1 has been amended to include comments regarding purchased product as well as product from realisation processes. Note 2 has been added explaining that statutory and regulatory requirements may be expressed as legal requirements |
2 |
The reference to ISO 9000 now states the fact that is at version 2005 |
3 |
The explanation of who the ‘customer’, ‘organisation’ and ‘supplier’ are, has been removed |
4.1 |
a) The word ‘identify’ has been replaced with ‘determine’ |
4.2.1 |
The wording has been slightly re-modelled but the intent stays the same. |
4.2.3 f |
Clarification that the external documents referred to are those needed for use in the QMS |
4.2.4 |
This clause has been significantly reduced in length but the requirement remains unchanged |
5.5.2 |
The requirement that the management representative needs to be a member of the organisation’s management has been added |
6.2 |
Change in title but keeps same words (change in their order) |
6.3 |
c) now includes information systems |
6.4 |
A note has been added to clarify what work environment includes and gives some examples such as noise, temperature, humidity |
7.1 c |
The word measurement has been added |
7.2.1 |
a) slightly re-worded |
7.3.1 |
A note has been added to explain that design review, verification and validation are separate activities though they may be performed separately or in any combination e.g. verification and validation may be performed together |
7.3.2 |
‘These’ inputs becomes ‘the’ inputs (last para) |
7.3.3 |
The word ‘provided’ has been removed and the phrase ‘suitable for’ replaces ‘that enables’ |
7.5.1d |
The word ‘devices’ in the title has been changed to ‘equipment’ |
7.5.3 |
An added requirement to clarify that inspection and test status must be identified ‘throughout product realisation’ |
7.5.4 |
Re-wording of the requirement to inform the customer if there is a problem and keep records |
7.5.5 |
Re-wording of ‘conformity of’ to ‘in order to maintain conformity to requirements’ |
7.6 |
The word ‘devices’ in the title has been changed to ‘equipment’ |
8.2.1 |
A Note has been added to provide some ideas as to how customer satisfaction can be measured |
8.2.2 |
The requirement for a documented procedure has been re-worded but remains unchanged |
8.2.3 |
The phrase ‘to ensure conformity of the product’ has been removed |
8.2.4 |
The requirement to ‘maintain evidence of conformity with acceptance criteria’ has moved but is still a requirement |
8.3 |
The requirement for a documented procedure has been re-worded but remains unchanged |
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