No New Requirements in ISO 9001:2008?

[Craig H.]

And who gave your auditor authority to impose requirements?

Nobody. We (the Cove community) have discussed this before, but it has been a while. All auditors have their interpretations. This is the one and only one that I have been scratching my head about right now (there was one other issue several years ago, and that auditor was not allowed back and he is not even auditing any more). Other than this ONE area, I/we are VERY happy with our auditor/registrar. We feel that we get some great value out of our audits, beyond just a cert. They also offer some good support, such as a checklist that was emailed to me soon after the new standard was published. This enabled us to be ready, and our last audit, in January, resulted in us getting certified to the 2008 standard, much to my delight and surprise.

So, in short, I like to choose my battles, and this one issue is not worth the fight when everything else is going so well. The purists among us may not like it, but I am sitting here, and, well, they are not.

 

[JaneB]

Craig,

It's a very wise person who chooses the battles they will fight - as well as those they choose not to.

 

[JaneB]

John,

Good list. But I would argue that almost without exception, every single point was already included within the 2000 version but not necessarily explicit or perhaps not as clear as it could be.

 

[JaneB]

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.

Excellently said.

 

[Polly Pure Bread]

There are minor changes. See the underlined words for some changes.

1 Scope
1.1 General
a) “needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements”
b)” ….and the assurance of conformity to customer and applicable statutory requirements”.

Note: In this International Standard, the term “product” applies to the product intended for, or required by, a customer or the product realization processes. This applies to any intended output resulting from product realization processes, including purchasing.”

1.2 Application

“…applicable statutory and regulatory requirements.”

2. Normative Reference

ISO 9001:2005 Quality management systems – Fundamentals and vocabulary.

3. Terms and Definitions retained clause requirements)

4 Quality Management System
4.1 General Requirements
e. Monitor, measure (where applicable) and analyze the processes

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.


There are also changes in:

4.1
Notes:
1 “…. analysis and improvement.”

2 An outsourced process is identified as one being needed for the organization’s quality management system but chosen to be performed by a party external to the organization.”

3. (the whole statements)

Also, there are changes in the ff: (NOTE: can’t write down the exact changes, too long to do so.. but will try to list down the specific clauses)

4.2.1d
4.2.1 Notes a)
4.2.3f
4.2.4
5.5.2
6.2.1 General
Note
6.2.2a, b, c
6.3
6.4 Note
7.1 b, c
7.2.1a, d, note
7.3.1 added note
7.3.3 and its note
7.5.1d, f
7.5.2
7.5.3
7.5.4
7.5.5
7.6 Control of monitoring and measuring equipment
7.6c
7.6 note
8.1a
8.2.1 note
8.2.2
8.2.3 note
8.2.4
8.3 and d

 

[Randy]

There are minor changes. See the underlined words for some changes.

We really appreciate it, but you've only restated what 100 other people have already provided. Just follow along with the Threads about 9001:2008 and you'll see this has been continuously discussed since Oct-Nov 2008.

 

[Craig H.]

There are minor changes. See the underlined words for some changes.

1 Scope
1.1 General
a) “needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements”
b)” ….and the assurance of conformity to customer and applicable statutory requirements”.

Note: In this International Standard, the term “product” applies to the product intended for, or required by, a customer or the product realization processes. This applies to any intended output resulting from product realization processes, including purchasing.”

1.2 Application

“…applicable statutory and regulatory requirements.”

2. Normative Reference

ISO 9001:2005 Quality management systems – Fundamentals and vocabulary.

3. Terms and Definitions retained clause requirements)

4 Quality Management System
4.1 General Requirements
e. Monitor, measure (where applicable) and analyze the processes

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.


There are also changes in:

4.1
Notes:
1 “…. analysis and improvement.”

2 An outsourced process is identified as one being needed for the organization’s quality management system but chosen to be performed by a party external to the organization.”

3. (the whole statements)

Also, there are changes in the ff: (NOTE: can’t write down the exact changes, too long to do so.. but will try to list down the specific clauses)

4.2.1d
4.2.1 Notes a)
4.2.3f
4.2.4
5.5.2
6.2.1 General
Note
6.2.2a, b, c
6.3
6.4 Note
7.1 b, c
7.2.1a, d, note
7.3.1 added note
7.3.3 and its note
7.5.1d, f
7.5.2
7.5.3
7.5.4
7.5.5
7.6 Control of monitoring and measuring equipment
7.6c
7.6 note
8.1a
8.2.1 note
8.2.2
8.2.3 note
8.2.4
8.3 and d

Anybody doing their job would have already covered this. In spades. I changed the ISO 9000 release number in the policy and manual. Most anyone who has been around for a while would do the same. I am interested to hear from those who cannot just do this, those who have to make material changes as a result of the new standard. Any takers?

 

[Jim Wynne]

Anybody doing their job would have already covered this. In spades. I changed the ISO 9000 release number in the policy and manual. Most anyone who has been around for a while would do the same. I am interested to hear from those who cannot just do this, those who have to make material changes as a result of the new standard. Any takers?

It occurs to me that the changes were made because of confusion over requirements--why else would "clarifications" be thought necessary? If that's the case, there should be a lot of people who had to make changes, otherwise the clarifications serve no purpose. I'm with you--it would be interesting to hear from people who have (or are planning to) make changes.

 

[guna8184]

I maybe wrong here but what i have learned from a trainer recently is that Internal auditors that qualify for ISO 9001-2000 must be re-certified to 9001-2008 in order to preform their duties as internal auditors.


Guna8184

 

[Sam4Quality]

Originally Posted by guna8184

I maybe wrong here but what i have learned from a trainer recently is that Internal auditors that qualify for ISO 9001-2000 must be re-certified to 9001-2008 in order to preform their duties as internal auditors.


Guna8184

Sorry guna, your trainer needs some training himself on internal auditor qualification! Internal Auditors require competence over anything else for conducting efective audits. Your 2000 version Internal Auditor training will serve you as well as the 2008 version training, as there are NO new requirements on which you need to be trained.

So, there is NO such requirement. Such requirement would only apply to third party auditors who were certified with the 2000 version and now need to be re-certified to the 2008 version.

Ciao.