ISO 9001:2008 Clause 4.2.3 - What are the required documents?

[howste]

You're right. It shouldn't be complicated.

I cant see it in the ISO 9001:2008 guide...

I wouldn't expect that a guide to ISO 9001 would tell you what you need. Beyond the few documents specifically required in the standard, the organization gets to decide the rest based on what they need.

 

[Chennaiite]

You're right. It shouldn't be complicated.

I wouldn't expect that a guide to ISO 9001 would tell you what you need. Beyond the few documents specifically required in the standard, the organization gets to decide the rest based on what they need.

What if, difference of opinion comes into play on the *need* for a specific document between the Auditor and the Organization ?

 

[howste]

What if, difference of opinion comes into play on the *need* for a specific document between the Auditor and the Organization ?

Can you please clarify? Are you talking about a document that exists that the auditor thinks is unnecessary, or one that doesn't exist that the auditor thinks is needed?

If it's one that the auditor insists is needed, I would expect the auditor to show evidence that a process had negative outcomes because of lack of the document.

 

[jeddex]

Re: WHat are the required documents in ISO 9001:2008

"Perhaps no documents" is incorrect. Let's not forget the rest of 4.2.1, which calls for specifically the quality policy, quality objectives, quality manual, the procedures required by ISO 9001 (six places), and the records required by ISO 9001 (roughly 20 kinds).

Concise ANswer!! Thanks! it is now clear to me what documents are required by the ISO 9001:2008 standards...

 

[Chennaiite]

Can you please clarify? Are you talking about a document that exists that the auditor thinks is unnecessary, or one that doesn't exist that the auditor thinks is needed?

The latter, of course.

If it's one that the auditor insists is needed, I would expect the auditor to show evidence that a process had negative outcomes because of lack of the document.

Unfortunately, not all the Auditors are logical in their assessment of negative outcome.

 

[Robert jr]

Under Clause 4.2.3 CONTROL OF DOCUMENTS, it states that Documents required by the quality management system shall be controlled. Can anybody help me figure out what are these required documents??? I cant see it in the ISO 9001:2008 guide...

Hello Jeddex

I have attached Document Control manual (procedure). It covers the requirement as standards refer to procedure "Establish a documented procedure to:" and it needs to confirm how your organisation controls all documentation.

Hope that helps.

 

[somashekar]

Hello Jeddex

I have attached Document Control manual (procedure). It covers the requirement as standards refer to procedure "Establish a documented procedure to:" and it needs to confirm how your organisation controls all documentation.

Hope that helps.

Hello Robert.
Your attached document is one of the procedure about 'How to' control documents. Jeddex was asking about 'What are' the documents required to be controlled. Thanks for your response. Jeddex seems to have got his answer as he says in the post # 14 above.

 

[howste]

Unfortunately, not all the Auditors are logical in their assessment of negative outcome.

"Prove to me that we need a document here." Would be a good response to the auditor. Then I might have to show the auditor what it says in 4.2.1d again:

The quality management system documentation shall include... documents, including records, determined by the organization to be necessary...

I could ask to see what the auditor's copy of the standard said as well:

The quality management system documentation shall include... documents, including records, determined by the auditor to be necessary...

 

[jeddex]

If you need guidance, please describe your operation and what industries do you serve?

The last four companies that I worked for typically had procedures and work instruction to cover the same areas, but these companies were relativity small operations from 250 employees down to 10 employees in machining, assembly, and sheet metal fabrication.

We are into metal fabrication. We caters wide range of fabrication requirements from general industrial fabrication to tooling, fixtures, jigs, punch and dies, extrusion molds and high-precision parts with heat treatment. I'm looking forward for your bright ideas. Many thanks in advance!

 

[vanputten]

Check this out. ISO/TC176 created a guidline on documentation requirements. Instead of having peiople provide their opinion, let us see what ISO says....

"■ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action"

There are six activities that must be documented. This is the minimum. There is no limit on the maximum number of documented activities. The maximum is based on what the organzition needs. They can be documented in as many documents (electronic, paper, etc.) as the organzition needs. An organization can have one documented procedure that covers all six activities. Or two, or three, or 100.

http://www.iso.org/iso/iso_catalogu...cumentation_requirements_of_iso_9001_2008.htm