ISO 9001: 2008

update by Nigel

ISO/DIS 9001:2008: Quality management systems - Requirements (DRAFT)

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Future Version: 2008
TC 176, the ISO 9001 technical committee , has started its review on the next version of ISO 9001, which will in all likelihood be termed the ISO 9001:2008 standard, assuming its planned release date of 2008 is met. Early reports are that the standard will not be substantially changed from its 2000 version.

As with the release of previous versions, organizations registered to ISO 9001 will be given a substantial period to transition to the new version of the standard, assuming changes are needed; organizations registered to 9001:1994 had until December of 2003 to undergo upgrade audits.

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"Lee Swee Huat" lsweehua@singnet.com.sg says:


The ISO Committee has proposed that only minor changes should be incorporated into the 2008 update:
Clause 0.2 (Process approach)
· Text added to emphasize the importance of processes being capable of achieving desired outputs

Clause 4.2.3 (Document control)
· Clarification that only external documents relevant to the QMS need to be controlled

Clause 4.2.4 (Records control)
· Editorial changes only (better alignment with ISO 14001)

Clause 5.5.2 (Management rep)
· Clarifies that this must be a member of the organization' s own management

Clause 6.2.1 (Human resources)
· Clarification that competence requirements are relevant for any personnel who are involved in the operation of the quality management system

Clause 6.3 (Infrastructure )
· Includes information systems as example

Clause 6.4 (Work environment)
· Clarifies that this includes conditions under which work is performed and includes, for example physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather

Clause 7.2.1 (Customer related processes)
· Clarifies that post-delivery activities may include:
o Actions under warranty provisions
o Contractual obligations such as maintenance services
o Supplementary services such as recycling or final disposal

Clause 7.3.1 (Design & development planning)
· Clarifies that design and development review, verification and validation have distinct purposes
· These may be conducted and recorded separately or in any combination as suitable for the product and the organization

Clause 7.3.3(Design & development outputs)
· Clarifies that information needed for production and service provision includes preservation of the product

Clause 7.5.4 (Customer property)
· Explains that both intellectual property and personal data should be considered as customer property

Clause 7.6 (Now retitled Control of Monitoring and Measuring equipment)
· Explanatory notes added regarding the use of computer software:
"Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use."

Clause 8.2.1 (Customer satisfaction)
· Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports

Clause 8.2.3 (Monitoring / Measurement of process)
· Note added to clarify that when deciding on appropriate methods, the organization should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.

The 2008 Standard is expected to be published in November 2008.

Best Regards
Swee Huat.
__._,_.___

another look at ISO 9001: 2008

The standard is being reviewed to bring the standard into bring it into align with other standard, such as ISO 14000

The International Standards Organisation is committed to reviewing and updating all of their standards on a regular basis, including ISO 9001. The latest review of ISO 9001 is now underway and the updated version is tentatively named"ISO9001:2008". Release date is targeted for 31st October 2008 (as of Dec 1st, 2007) and is approaching the end of the "enquiry stage". This means that it has only one set of actions (the "approval stage") before it is published.

What's likely to change?

The changes are defined by ISO as being for clarification and harmonization with ISO 14001. There are also some changes made for internal consistency (so that things are described in the same way throughout the standard and that each clause has a similar structure).The effect is that the changes are generally quite minor.

In some cases, your quality system may require less content than in the current version. But in some cases you may require more content. Please note that this review is based on the 8th Feb 2007 draft.The standard is likely to change without notice and you should not make any changes to your system based on this review or upon the draft standard.

In clause 4.1 (a), instead of requiring you to "identify" the processes needed in your system, it now requires that you "determine" them. This means that provided you know what they are, you don't need to specify them.

At the end of clause 4.1, you are now no longer required to define any outsourced processes. But you must define the controls used to control them.

Oddly enough, a new Note (2) in clause 4.1 now says that clause 7.4 may apply to outsourced processes.

The control of documents (Clause 4.2.3) has been amended slightly. The scope of "documents of external origin" has been clarified to state that it only applies to those external documents which are needed for the planning & operation of the system.

Clause 4.2.4 (control of records has been extensively rewritten but seems to mean exactly what it did before.

Clause 5 has only had two very minor clarifications. Neither of these should have any effect on your system.

Clause 5.1 (a) now says "statutory and regulatory" instead of "regulatory"

Clause 5.5.2 now states that the Management Representative must be a member of "the organisation's management", instead of just "of the management"

In clause 6.2.2, training is now only required "where applicable" to achieve the necessary competence. The other changes to this clause are just clarifications or changes for consistency with other clauses. Competence still remains a matter of interpretation rather than definition.

Clause 6.3 (c) now includes "information systems" under the "Infrastructure of the organisation. Since almost no-one could work out the difference between clause 6.3 (Infrastructure) and clause 6.4 (Work Environment), ISO have included a note which explains it for us.

In clause 7.2.1, ISO have added another new note. This one explains what they meant by the term "Post delivery activities". There are a few very minor clarifications in this clause

In clause 7.3.1, they have added yet another note, which explains that review, verification and validation are different processes.

There is another note in clause 7.3.3 which explains that "production and Service Provision" includes preservation of product.

Clause 7.5.2 has always been one which confuses people. In essence, if you can verify your products are correct before they leave the building you probably don't need to validate your processes.

Note 1 implies that the clause probably applies to service industries. Note 2 gives examples of some service industries and manufacturing industries to which this clause probably applies.

The requirements of clause 7.5.3 for Identification &traceability have been increased. Product status must be identified throughout the production process.

Clause 7.5.4 and clause 7.5.5 have been "harmonised" but their requirements have not altered at all.

Clause 7.6 has been "harmonised" but its requirements have not altered at all. The reference to ISO 10012 has been updated. Note 1 and Note 2 have been added to provide further clarifications.

In clause 8.2.1, it is now accepted that Customer perception of meeting requirements is just an "indicator", not a measurement of the performance of the system.

Clause 8.2.2 (auditing) has been "harmonised" but itsrequirements have not altered at all.

Clause 8.2.3 and clause 8.2.4 have been harmonised, but again, there is no impact on their requirements. More notes have been added to these clauses.

Clause 8.3 has been "harmonised". Two words have been added which could have a large impact on your system. The sub-clauses (a) - (d) only apply "where practicable". Also, the last sentence of the 2000 version of the standard has now been moved up to become sub-clause (d).

In both clause 8.5.2 (corrective action) and clause 8.5.4 you are now required to review the effectiveness of the actions taken. (Most assessors and auditors currently assume that it says this already, although it doesn't!).

Please be aware that these comments are based on a draft version. It can and will change, so don't try changing your system just yet based on this review.

Wait for the new version to be released (now targeted for Oct 31st, 2008, but could be delayed), the Quality System will contain a full list of the changes and how to modify your system, with examples and step by step guidance, when the Standard is finally released.

Our DIY course, available for download through our website, http://www.9001-quality.co.uk/ will be amended when the standard is finally released.

Best regards,

Hugh DentWinslade

SidmouthEX10 9EZ

United Kingdom

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