Documentation and Records Requirements for ISO 9001

[rharold]

Sort of a basic question but....

To be come ISO compliant, you need to have all the required documentation plus a quality management system in place. As far as documentation, what do you need?

-Quality manual
-Procedure manual
-Work instructions
-Records

A very general overview, but trying to gain a basic understanding.

[Marc]

The only requirement is for you to have about 6 documented procedures and related records, and a 'quality manual'.

Do you have a copy of ISO 9001?

4.2.3 Control of Documents
4.2.4 Control of Quality Records
8.2.2 Internal Audit
8.3 Control of Nonconformity
8.5.2 Corrective Action
8.5.3 Preventive Action

Some Other Expected Process Maps

Planning (5.4, 7.1, 8.1, 8.5.1)
Management Review (5.6)
Resource Management (6)
Training (6.2.2)
Customer Processes (7.2)
Customer Communication (7.2.3)
Design and Development (7.3)
Purchasing (7.4)
Operations Control (7.5.1)
Product ID / Traceability ( 7.5.2)
Customer Property (7.5.4)
Preservation of Product (7.5.5)
Validation of Processes (7.5.2)
Process Measurement / Monitoring (8.2.3)
Product Measurement / Monitoring (8.2.4)
Analysis / Improvement (8.4, 8.5)

Records Required By ISO 9001:2000

5.6.1 Management review minutes / etc.
6.2.2 (e) Education, training, skills and experience.
7.1 (d) Evidence that the realization processes and resulting product fulfill requirements.
7.2.2 Results of the review of requirements relating to the product and actions arising from the review.
7.3.2 Design and development inputs.
7.3.4 Results of design and development reviews and any necessary actions.
7.3.5 Results of design and development verification and any necessary actions.
7.3.6 Results of design and development validation and any necessary actions.
7.3.7 Results of the review of design and development changes and any necessary actions.
7.4.1 Results of supplier evaluations and actions arising from the evaluations.
7.5.2 (d) As required by the company to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement.
7.5.3 The unique identification of the product, where traceability is a requirement.
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use.
7.6 (a) Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist.
7.6 Validity of previous results when measuring equipment is found not to conform with its requirements.
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results.
8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained.
8.5.2 Results of corrective actions.
8.5.3 Results of preventive actions.

Note: Some of these may not be relevant to your company. An example is Product Identification and Traceability. If you are a service company, Product Preservation will probably not apply to your situation. Remember, however, that exclusions are limited to requirements within Element 7 - Product Realization.

[rharold]

Thanks a lot. That is a really helpful list.

[rharold]

Actually, the reason I asked is I have an older binder with "Quality Procedures" in it and has quite a few pages (maybe 100 or more). Reading through the Standard in a few books I have, it doesn't seem to explicitly say that things like work instructions need to be written and also that quality procedures need to be written for every single clause- ie all of section 7.

So that is where my questions stemmed from. Other than the places where it says Records need to be kept, I wasnt sure when you need to write work instructions and quality procedures.

[rharold]

A lot of basic questions here. So in order to meet ISO requirements, one would have to have the 6 procedures written, all of the records, all of the process maps you listed, plus have your quality system function as it is described in your procedures?

I'm sure there is more but is that all of the basics? (Lot of questions here)

btw, where did you get the process map list from, is that from experience or is it mentioned through the standard and I haven't noticed it yet?

[Marc]

Check the note: Some of these may not be relevant to your company. An example is Product Identification and Traceability. If you are a service company, Product Preservation will probably not apply to your situation.

The list is in several threads here. It is a matter of taking the standard, reading it and making a list as you go along.

I do recommend looking through the forums relevant to ISO 9001 and reading some discussion threads to get a better idea of specifics. Many 'basic' questions are already discussed in existing discussion threads.

As to "...plus have your quality system function as it is described in your procedures..." - That is the main point. If a procedure does not describe the actual process, what value is it?

You might want to take some time and go through Implementing a Quality System. Your original question about ISO 9001 Documentation and Records Requirements is answered in there as well.