No New Requirements in ISO 9001:2008?

[John Broomfield]

ISO/TC 176 said "no new requirements", but I am not so sure. Let's get a poll going on this:

Depending on your interpretations of ISO 9001:2000, some of you will find new requirements in ISO 9001:2008. New notes may also change the interpretation of requirements by auditees and auditors. Below you can see questions arising from ISO 9001:2008 that may be new requirements for you:

4.1a: Do you have evidence of analysis of the system that runs your organization to determine its processes instead of a list that merely identifies the processes that you happen to have documented?

4.1e: Have you determined the applicability of process measurement?

4.1: Do your outsourced processes have their controls defined and applied in your system so they comply with legal (statutory and regulatory) requirements and conform to customer requirements?

4.2.1: Have you considered the value of combining two or more documented procedures in your system?

4.2.3f: Does your procedure control the external documents used for planning and operation of the system?

4.2.4: Does your procedure control records so they are retrievable and legible (even if no duration is specified)?

5.5.2: Is your Management Representative a member of your organization’s own management? And is the management representative competent (see 6.2.1 below)?

6.2.1: Do you have evidence of those who indirectly affect conformity to product requirements being competent?

6.3c: Does your system include information systems, an essential infrastructure (as for most organizations)?

7.1: Does your product realization planning include the required measurements?

7.2.1: Does your product and, therefore, system include your post-delivery services?

7.3.1: Do you consider the suitability of combining review, verification and validation when planning design?

7.3.3: Does your design output include appropriate information for product preservation (packaging and labeling)?

7.5.3: Do you keep the required traceability records instead of merely recording traceability?

7.5.4: Does your system keep customer records secure as customer property includes personal data?

7.5.5: Have you determined the applicable provisions for product preservation?

7.6: Are items of calibrated measuring equipment also verified between specified calibration intervals?

8.2.1: Have you considered other ways of monitoring customer satisfaction beyond or instead of surveys?

8.2.3: Does process monitoring result in action to improve the system even if product conformity is unaffected?

8.2.3: Have you planned process monitoring according to the impact of the process on product or system?

8.3: When delivering a service do you take action on nonconforming service per the effects/potential effects?

8.5.2: Does your procedure seek more than one root cause of nonconformity consistent with 8.5.2b?

8.5.2f: Does your procedure verify the effectiveness of corrective action instead of just verifying corrective action?

8.5.3e: Does your procedure verify the effectiveness of preventive action instead of just verifying preventive action?

I suspect in many cases your answers will be "yes". Of course you will be taking action to improve your system where your answer is "no".

Enjoy,

John

 

[Randy]

John, how dare you challenge TC176 and all their collective wisdom?

 

[Craig H.]

I voted "yes". I was required to rewrite our policy and manual to change ISO 9001:2000 to ISO 9001:2008.

Other than that, nada.

 

[JaneB]

I voted "yes". I was required to rewrite our policy and manual to change ISO 9001:2000 to ISO 9001:2008.

Other than that, nada.

Craig, could you quote the specific clause number in ISO 9001 (2008) that you say introduced this 'new requirement'?

 

[Jim Wynne]

Craig, could you quote the specific clause number in ISO 9001 (2008) that you say introduced this 'new requirement'?

The poll is awkwardly constructed. It asks if you agree that 9001-2008 contains no new requirements, and if you answer "yes," it means you disagree. It also has a poll option that's not a poll option.

 

[JaneB]

The poll is awkwardly constructed. It asks if you agree that 9001-2008 contains no new requirements, and if you answer "yes," it means you disagree. It also has a poll option that's not a poll option.

True, there's a bit of a basic logic/wording error.

I'm sure if we ask them nicely, one of the moderators could or would help with the rewording.

But I also think that we can credit people who respond with enough intelligence to cope even so, don't you?

 

[Craig H.]

Craig, could you quote the specific clause number in ISO 9001 (2008) that you say introduced this 'new requirement'?

Jane, that was my point. In OUR case, there were no material changes necessary. I did take the opportunity to go over our manual with a fine tooth comb and clean it up a bit. Our auditor does require that we claim compliance to the current ISO 9001 standard in our policy and manual, so that requirement resulted in the change I mentioned.

I can be a bit of a smart Aleck at times...

 

[howste]

...Our auditor does require...

And who gave your auditor authority to impose requirements?

 

[Stijloor]

Friends,

OK, OK....Let me offer a compromise...
Can we call these changes "Points of Emphasis?"

That's what they actually are....

Stijloor.

 

[SteelMaiden]

The new version of the standard only requires changes in you QMS if you need to beef up one of the "points of interest" (as Jan calls them, I like that)

More than worrying whether or not they are changes or not, we need to worry about whether or not we've assessed our systems against the new standard and identified any places we need to upgrade, or that we are good the way we are, and documenting the fact that this review was done and all who matter are in agreement. (management review, anyone?)

In our case, we decided there was nothing further to be done, and our registrar agreed with that assessment. What made it easy? Documentation.