Addressing ISO 9001 Section 7 in the Quality Manual when Design is Excluded

T

tomjess

#1
This might have been covered, have searched but cannot find it.

A company that manufactures a product or two, but does not design them, do they need to include section 7 in their Quality manual or do they perhaps have to have certain sections of section 7 included?

Thanks in advance
 
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S

somerqc

#2
Re: Section 7

You would need to evaluate which sections of Section 7 apply to you. For instance, if you use measuring devices that require calibration - section 7.6 applies. If you produce anything (which you have said you do), Section 7.5 applies. The only section that seems doesn't apply to you is 7.3 Design and Development.

Basically, review each part of Section 7 to see if it applies. Then you will have your answer. Make sure you have your reasoning for excluding any section outlined in your manual as well.
 
#3
This might have been covered, have searched but cannot find it.

A company that manufactures a product or two, but does not design them, do they need to include section 7 in their Quality manual or do they perhaps have to have certain sections of section 7 included?

Thanks in advance
You have to show the sequence and interaction of your organization's processes, not 'address section 7' in your manual.:mg:

Sure, you have to meet the requirements of each of the relevant requirements of section 7 in your system (e.g if you do purchasing, then you have to have some method of evaluating and re-evaluating suppliers against defined criteria) but you don't have to say that in a quality manual or have a 'procedure' for it.;)

Andy
 

Randy

Super Moderator
#4
Try this from ISO 9001:2000

1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.


Also don't forget.......

4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system
 
V

vanputten

#5
Hello Tomjess:

Have you read section 7 of ISO 9001?

Are you proposing that if an organization is not design responsible, then they do not do any Purchasing (clause 7.4) either?

Regards,

Dirk
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#6
I have moved this post to this forum since it specifically is asking for clarification of ISO9001 for better responses.
 
M

Martijn

#7
This might have been covered, have searched but cannot find it.

A company that manufactures a product or two, but does not design them, do they need to include section 7 in their Quality manual or do they perhaps have to have certain sections of section 7 included?

Thanks in advance
I hope your answer's been answered by now, describe processes and name exclusions of ISO 9001. Read chapter 7, exclude what's not applicable, describe the rest as part of your process description.

Excluding all of chapter 7 in a quality manual does not make a lot of sense, since there is hardly anything left to have a management system for. I guess it's technically possible to exclude all of chapter 7, but you'll end up having chapter 4, 5 & 8 to manage chapter 6. Seems a bit overkill to me.
 
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