ISO 9001:2008 Permissible Exclusions

[R Blaise]

Hello,
I am new to the Cove and seeking advice. Currently, I am reviewing our quality manual preparing for the certification audit to 9001:2008. I am still a novice with less than 1 year experience. My question is regarding exclusions:

Exclusions are taken as follows:
ISO 9001:2000 Section 7.3 Design and Development is excluded as XXXXXXXX does not perform product design and development activities. 7.5.1.5 Control of Service Operations is excluded, as XXXXXXX does not provide service operations to outside organizations. 7.5.2 Validation of processes for Production and Service Provision is excluded due to the fact that XXXXXXXX does not have special processes.

I believe Clause 7.5.1.5 is from the AS9100 standard. We are a mining company and do not and have not ever provided products to the Aerospace Industry. I am perplexed as why this has been on page one of our manual for 3 years and 3 audits!!!! I have asked several people why this exclusion is included, nobody has any idea why!!!! Am I missing some information that would make this all seem logical???
Thanks,
R Blaise

 

[DannyK]

Re: 9001:2008 Exclusions

Hello R. Blaise,

You are right! Clause 7.5.1.5 is not part of ISO 9001:2008 therefore you cannot exclude it.

Unfortunately not everyone reads quality documents as thoroughly as they should.

 

[arin_23]

Re: ISO 9001:2008 Exclusions

Hello,
I am new to the Cove and seeking advice. Currently, I am reviewing our quality manual preparing for the certification audit to 9001:2008. I am still a novice with less than 1 year experience. My question is regarding exclusions:

Exclusions are taken as follows:
ISO 9001:2000 Section 7.3 Design and Development is excluded as XXXXXXXX does not perform product design and development activities. 7.5.1.5 Control of Service Operations is excluded, as XXXXXXX does not provide service operations to outside organizations. 7.5.2 Validation of processes for Production and Service Provision is excluded due to the fact that XXXXXXXX does not have special processes.

I believe Clause 7.5.1.5 is from the AS9100 standard. We are a mining company and do not and have not ever provided products to the Aerospace Industry. I am perplexed as why this has been on page one of our manual for 3 years and 3 audits!!!! I have asked several people why this exclusion is included, nobody has any idea why!!!! Am I missing some information that would make this all seem logical???
Thanks,
R Blaise

Dear Blaise,

You said you are a mining company, but did not mention in detail what are the process steps (roughly) you are following, if we have information on that we might be in a better place to provide some insights to the exclusion of clauses.

As of now I can suggest that exclusions are only permissible under clause no.7, and this is a very much generic statement.


Regards,

Arin

 

[R Blaise]

Re: ISO 9001:2008 Exclusions

Thank you for the replies.
Our company mines and processes an ore used as a filler and binder for various paints(some used in the auto industry), plastics, ceramics, steel ect... This product can be treated or untreated depending on the customer's need.

After looking at this again I believe our only exclusion should be 7.3 Design and Development
7.5.2 really does not apply since the standard reads as applicable. I will clarfiy the not applicable portion in our manual.

 

[trainerbob]

Re: ISO 9001:2008 Exclusions

You probably are not responsible for design and development of your product, however keep in mind that 7.3 of the standard also includes design and development of the prosesses used to make your finished product.(See ISO 9001 7.3.1) If you are responsible for the design and development of the process you cannot exclude 7.3.

 

[Jim Wynne]

Re: ISO 9001:2008 Exclusions

You probably are not responsible for design and development of your product, however keep in mind that 7.3 of the standard also includes design and development of the prosesses used to make your finished product.(See ISO 9001 7.3.1) If you are responsible for the design and development of the process you cannot exclude 7.3.

FWIW, I've never agreed with this interpretation of 7.3.1. It deals with companies that do design and development, not any company that has designed processes for "product realization." There's simply nothing there that states or implies that companies (such as job shops) that do not design products must include 7.3.

 

[Qualqueen]

Re: ISO 9001:2008 Exclusions

Hello,
Exclusions are taken as follows:
ISO 9001:2000 Section 7.3 Design and Development is excluded as XXXXXXXX does not perform product design and development activities. 7.5.1.5 Control of Service Operations is excluded, as XXXXXXX does not provide service operations to outside organizations. 7.5.2 Validation of processes for Production and Service Provision is excluded due to the fact that XXXXXXXX does not have special processes. Am I missing some information that would make this all seem logical???
Thanks,
R Blaise

7.5.2

The Company shall validate processes for production where the resulting output cannot be verified by subsequent monitoring or measurement. This validation activity demonstrates the ability of these processes to achieve planned results.

The Company shall establish arrangements for these processes as applicable:

Ÿ defined criteria for review and approval of the processes
Ÿ approval of equipment and qualification of personnel
Ÿ use of specific methods and procedures
Ÿ requirements for records
Ÿ revalidation

Your company doesn't do approval of equipment or qualification of personnel? If I were auditing, I would definately question that one. Any input???

 

[Stijloor]

Re: ISO 9001:2008 Exclusions

7.5.2

The Company shall validate processes for production where the resulting output cannot be verified by subsequent monitoring or measurement. This validation activity demonstrates the ability of these processes to achieve planned results.

The Company shall establish arrangements for these processes as applicable:

Ÿ defined criteria for review and approval of the processes
Ÿ approval of equipment and qualification of personnel
Ÿ use of specific methods and procedures
Ÿ requirements for records
Ÿ revalidation

Your company doesn't do approval of equipment or qualification of personnel? If I were auditing, I would definately question that one. Any input???

Your company doesn't do approval of equipment or qualification of personnel? If I were auditing, I would definately question that one. Any input???

I can imagine that organizations do this. However, that list of activities under 7.5.2 specifically pertains to what we refer to as "special process."

Stijloor.

 

[Qualqueen]

Re: ISO 9001:2008 Exclusions

Stijloor,
Gotcha. Thanks

 

[R Blaise]

Re: ISO 9001:2008 Exclusions

Wow!
Thanks for all of the responses.
I was almost in a panic with TrainerBob's response! Thanks Jim for calming me down! We have been taking 7.3.1 exclusion for a very long time. I have interperted this clause the same way you do.
Amazing how one word, process, can change everything.

Regarding 7.5.2- we do not have any special processes-all required product inspections can be performed at our company. As explained before this will not be an exclusion on our scope(clause states as applicable) I will clarify the clause is not applicable in our Quality Manual.