ISO 9001:2015 4.3 - Determining the scope of the quality management system

#1
Is it possible for an organisation to restrict the scope of the management system to certain functions?....for example

Design - Fabrication - Distribution - Installation.

Could the scope be limited to Fabrication and Distribution?
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Look at the last paragraph of 9001:2015 4.3. If your organization is responsible for product design and installation, you can not exclude such processes from the quality system and still claim compliance (much less achieve accredited certification) to ISO 9001.
 
#4
another perspective from a consultancy in the UK.....

"The scope of the QMS may include the whole of the organisation, specific and identified functions within the organisation, specific sections of the organisation, or one or more cross functions across a group of organisations."

This is clearly at odds with the "all in" approach
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
You are obviously hunting for an answer that gives you the loophole you are looking for. So, if you are comfortable with the UK consultancy take, go with it.

If you "choose" to exclude product design and installation, are you willing to have such exclusions CLEARLY documented? ISO 9001:2015 mandates you do that. Are you comfortable with the idea of your customers reading that you don't have a quality system that includes product design and installation? They (the customers) might not appreciate that.

Organizations come in all sizes, shapes and degrees of complexity, so for a multinational organization, with multiple divisions, business units, sites all over the place they MUST be very careful when determining the boundaries of their respective systems.

And don't forget the fundamental distinction between scope of the system and scope of certification. When it comes to certification, yes, you can limit the scope of certification.
 

howste

Thaumaturge
Super Moderator
#6
There used to be three standards in the ISO 9000 series that organizations could be certified to. ISO 9001 included all requirements, ISO 9002 excluded design & development, and ISO 9003 was for organizations that did inspection & testing. Many organizations saw ISO 9002 as a loophole where they could still get a "9000" certification without having to reign in all those design engineers who wanted to be creative but couldn't be bothered to follow standard processes.

When ISO 9001:2000 was published, the 9002 and 9003 versions were eliminated. I believe this was, in part, to ensure that organizations designing products and services included this function in their QMS. I still believe, like Sidney said above, that if you design product that you can't exclude it. How could you say that it doesn't affect your organization's "ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction" in good conscience? The same goes for installation.
 

Ian_Morris

Involved In Discussions
#7
As your scope statement needs to include any clauses you wish to be exempted from and a clear justification for exemption. It is therefore up to you to determine what should and should not be included, especially with the design function.

Your auditor should be asking about exclusions and the justification for doing so and I am not sure I know any credible auditors, or customers for the matter, that would accept the design of the product being excluded from your scope.

:2cents:
 

Big Jim

Super Moderator
#8
Auditors are trained to look for evidence that you are a design company if you claim design nonapplicability.

For example, they should be looking at your web site as well as your literature to see if you say anything about design.

I have run into this, most usually on a stage 1 audit.

As a consultant, one of my clients added it to their web site after I was there, and it was caught by the CB auditor.

One auditee had been doing it for years, claiming it was OK because they sublet design, and put up quite a fight about it. Of curse, you cannot claim an exclusion for something you sublet.

So if you think you want to try it, proceed at your own risk, and the risk is high.
 
Thread starter Similar threads Forum Replies Date
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
F Logistics and IT clauses in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
V Quality Objectives - ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
Gun46 ISO 9001 : 2015 Lead Auditor Exam General Auditing Discussions 5
Q ISO 9001:2015 man days for surveillance audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I ISO 9001:2015 Section 9.3.2 C1 "customer satisfaction and feedback from relevant interested parties" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
I ISO-9001:2015 and "Relevant Parties" Management Review Meetings and related Processes 2
I Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
qualprod Why new clause (7.1.6) in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M ISO 9001:2015 8.2.1 Contingency Plan required for small Business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V ISO 9001:2015 7.2 Competence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
A Process Documentation for ISO 9001:2015 Internal Auditing 2
C Migrate ISO 9001:2015 Certificate Registrars and Notified Bodies 4
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W ISO 9001:2015 Management Review Input Template wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
N ISO 9001:2015 Customer Complaints Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
O Performance Measurement ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V ISO 9001: 2015 Production drawing Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
KCalaba21 ISO 9001:2015 6.2.2 E - "e) how the results will be evaluated." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S ISO 9001:2015 & ISO 14001 Re-Certification Audit Preparation ISO 14001:2015 Specific Discussions 8
S ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning ISO 14001:2015 Specific Discussions 2
N ISO 9001:2015 - 5.3 - The roles and responsibilities matrix rears it's head ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 9001:2015 Excel Gap Analysis wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D ISO 9001:2015 Internal Audit Training Advice Internal Auditing 10
M IATF 16949:2016 clause 8.4.2.3 - We don't have ISO 9001:2015 certificate IATF 16949 - Automotive Quality Systems Standard 26
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E ISO 9001:2015 - Record requirements for out of calibration tool ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
GreatNate ISO 9001:2015 Lead Auditor Course? (who to take with) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
S ISO 9001:2015 Clause 9.3.2 - MR (Management Review) - Adequacy of resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S ISO 9001:2015 Clause 8.7 Control of Nonconforming Outputs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
qualprod ISO 9001:2015 8.2.3.2 and 8.5.5 - Guidance for Reviews ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D ISO 9001:2015 Clause 8.4.3 "Information for External Providers" buying from online retailers. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L ISO 9001:2015 standard documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Z Training Qualification Matrix for ISO 9001:2015 Audit General Auditing Discussions 8

Similar threads

Top Bottom