Identifying procedures that are NOT required by ISO 9001

R

R. Harris

#1
This is my first post so I hope I am doing this properly.

I am in the prcoess of implementing ISO 9001 (to become certified). I have developed many quality system procedures for various departments to identify responsibility and authority as well as identify what is required by ISO 9001.

My question is how do I identify these procedures that are not required by ISO 9001 (ex: Design and Development Control)? Do I still identify them as quality sytem procedures or do most companies refer to them as work instructions? I am avoiding any reference to them in the Quality Manual.
 
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insect warfare

QA=Question Authority
Trusted Information Resource
#2
Re: Quality System Procedures

Most people that I know like to address the requirements of 5.5.1 (Responsibility and Authority) through the use of an organization chart, also in conjunction with documented job descriptions which address more specific roles. These 2 documents are not required by the Standard, though they do make good business sense in most cases.

Can you tell us a little more about what you do? Like:

1) What type of work do you do?
2) What industry do you work in?
3) Do you develop and design your company's product(s)? If no, you may be able to claim an exclusion to the requirements of 7.3

Brian
 
Last edited:
C

Chance

#3
Re: Quality System Procedures

The key is to document the vital elements of how the business operates. This can be documented in a form of a work instruction. You can indicate in your work instruction the purpose, scope, responsibilities, then action steps...
The standard ISO requirements can be documented in a separate work instruction for each of the following items:
1. control of documents
2. control of nonconfomity
3. internal audits
4. corrective action
5. preventive action
6. control of records
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Re: Quality System Procedures

My question is how do I identify these procedures that are not required by ISO 9001 (ex: Design and Development Control)? Do I still identify them as quality sytem procedures or do most companies refer to them as work instructions? I am avoiding any reference to them in the Quality Manual.
Welcome to The Cove. Despite the fact that you can "identify" those documents any way you like, don't try to find a loophole in the standard. If you deem necessary a document to describe and control your product design and development process, EVEN if you call that document a work instruction, it falls under the auspices of a procedure (for 4.2.2 b) purposes); pay close attention to the following ISO 9001:2008 requirement
The quality management system documentation shall include documents determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
Such documents include the ones referred to in 4.2.2 b). So, do NOT avoid including/referring to them in the Quality Manual. You would be doing yourself a big disservice.
 
S

ssz102

#5
Re: Quality System Procedures

i think you need to more read the standard of ISO9001, most of people mentioned only you development 6 documents to establish QMS, so except for these documents, other you can as WI to develop
 

somashekar

Staff member
Super Moderator
#6
This is my first post so I hope I am doing this properly.

I am in the prcoess of implementing ISO 9001 (to become certified). I have developed many quality system procedures for various departments to identify responsibility and authority as well as identify what is required by ISO 9001.

My question is how do I identify these procedures that are not required by ISO 9001 (ex: Design and Development Control)? Do I still identify them as quality sytem procedures or do most companies refer to them as work instructions? I am avoiding any reference to them in the Quality Manual.
When you identify your processes that interact in your QMS operation, which is a requirement in ISO9001, and shows up in the quality manual, you will see clarity of what procedures applicable to the various processes are required by you. The rest are not required.
As a crude example.,
The maintaining procedure of your motor that runs your air compressor required for your manufacturing line is a requirement, while the maintaining procedure of your motor that operates your landscape fountain is not a requirement.
Since QMS is dynamic, your constant review and update of your process and interactions is required.
 
R

Richard Davison

#7
This is my first post so I hope I am doing this properly.

I am in the prcoess of implementing ISO 9001 (to become certified). I have developed many quality system procedures for various departments to identify responsibility and authority as well as identify what is required by ISO 9001.

My question is how do I identify these procedures that are not required by ISO 9001 (ex: Design and Development Control)? Do I still identify them as quality sytem procedures or do most companies refer to them as work instructions? I am avoiding any reference to them in the Quality Manual.
As we do not engage in any Design & Development activities we have excluded clause 7.3 from our QMS which is totaly acceptable. We have kept a reference to this in our Quality Manual as follows;

7.3 Design & Development

At (our Company) we do not engage in designing, developing or changing the design of the products we supply. To this end, our quality management system does not encompass product design and development processes and therefore, clause 7.3 is not applicable to our business and has been excluded.

 
R

R. Harris

#8
Thanks for the variety of responses. It seems we have some companies that reference all the quality system procedures and some that do not (if they are not required by ISO).

I recently had a consultant tell me that it's best not to refer to the procedures in your quality manual if they are not required. So I was considering making them work instructions so they are not as easily audited in the registration audit.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#9
I have seen companies who write out each and every procedure in their quality manual only to update it frequently when a procedure goes obsolete. On the flipside, I have seen quality manuals that reference the webpage or shared folder itself, whatever you like, and this (I think) satisfies the 4.2.2b requirement to at least reference your procedures.

It would also protect your manual from redundant updates as your QMS documentation matures over time.

Something to chew on...:D

Brian
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
I recently had a consultant tell me that it's best not to refer to the procedures in your quality manual if they are not required. So I was considering making them work instructions so they are not as easily audited in the registration audit.
I am sorry to say, but this is another case of poor advice/consulting. Not only from an ISO 9001 implementation perspective, but from a business perspective.

Consultants that (try to) find loopholes to make their clients pass audits easier are a big part of the problem. Organizations that hire them are just adding to the problem, not the solution.

Documentation should not exist in order for organizations to pass an audit, but instead, to help them in planning, executing and monitoring their business processes. It is sad to see organizations continually misperceiving ISO 9001 certification as a "pass-the-audit-and-get-the-cert" exercise.

25 years after the introduction of ISO 9001, we still struggle with this.
 
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