Exclusions to ISO 9001 section 7

All parts of sections 4, 5, 6 and 8 of ISO 9001 apply in their entirety to all organisations, and there are no circumstances under which an organisation may claim exclusion to any parts of these sections. Exclusions to parts of section 7 can be considered, but this is only permissible where the requirement does not apply to the organisation (refer to clause 1.2 of ISO 9001). That is, if the organisation has no design function, there is no design work to be controlled or audited, so it is permissible to exclude clause 7.3 from the scope of certification. It is not permissible to exclude a design function from scope because it is very poor and you would rather it wasn’t assessed

The following table summarises the circumstances under which an organisation may consider excluding a part of section 7 from the scope of certification. The most common exclusions are clauses 7.3, 7.6, 7.5.2 and 7.5.4:

ISO 9001 Clause

Justification for exclusion

7.1 Planning of product
realisation

It is hard to contemplate a situation where an organisation would be able to justify this exclusion. The clause covers production planning or, for a service provider, planning of service delivery. Consequently it would encompass scheduling of work, rotas, shifts, organising deliveries, ordering of materials, holiday cover and more

Effectively a company would be asking to be excluded from the “P” of PDCA. PDCA is fundamental and underpinning principle of ISO 9001 – this exclusion isn’t going to happen, so don’t even go there

7.2 Customer related processes

All organisations will have processes with inputs, activities and outputs, and there will always be a customer at one end or, more commonly, at both ends. This could be an end-consumer or end-user, or it could be an internal customer, but your processes must be working for the benefit or convenience of someone. Again this part of the standard would be impossible to exclude and reasonably justify

7.3 Design and development

Many organisations don’t have a design function. They may provide a service (such as an advice line) or they may manufacture items to customer supplied designs

In considering “design” it is important that we differentiate clearly between “design” and “planning”. I once had a heated argument with a third party auditor about the applicability of the design requirements to a client’s scope. His argument was that the company (an installer of domestic central heating systems) must “design” how they will deliver their work. THIS IS NOT DESIGN. Everyone has to “design” how they deliver their work – but unless they are developing something conceptually new, then this is just good old fashioned planning. My argument was that my client was doing nothing new or innovative in the field of heating installation, they were merely executing a jobs in line with established codes of practice. There was nothing new or novel in this regard. They had not created a new concept in heating systems. IT WAS NOT DESIGN

Design is the most common exclusion to the scope of certification. Many companies happily go about their business, satisfying their customers, without creating anything conceptually new

7.4 Purchasing

This is a rare exclusion but it is feasible. Although it covers the selection of suppliers, and you may think that everyone must have some suppliers, there is not always any economic benefit in applying any sort of selection and approval controls to them. For example if an organisation only buys standard catalogue or boxed items (stationery, manuals, off-the-shelf hardware and software for example) and it does not use sub-contractors or agency staff, then an exclusion to 7.4 is a possibility

Since these circumstances rarely apply without some sort of exception, it is a very rare exclusion

7.5.1 Control of production and
service provision

The scope of this sub-clause is very broad. It includes the provision of workplace instructions, product specifications, equipment, and monitoring activities. An attempt to exclude this clause would
be tantamount to asking to be excused from controlling activities full stop.

Again, don’t go there

7.5.2 Validation of processes
for production and service provision

At first sight this may look like another unthinkable contender for consideration, but it is in fact a fairly common candidate. A common misconception is that this clause requires an organisation to exercise generic process control across its operational activities, but its application is in fact much, much narrower than that. The clause requires an organisation to establish process validation methods only for those processes whose outputs cannot be verified by subsequent monitoring or measurement. ISO 9001:1994 used to call them “Special Processes”. Think about that for a moment. Many companies only produce outputs that CAN be tested, they don’t have any of these so called special processes, so they can exclude this clause as it is inapplicable to them

It applies when the output can only be fully tested in a destructive way (e.g. a weld) or when it is impractical to test, for example there may simply be no time to test (e.g. in a radiological treatment agent with a half-life of 2 hours)

In those cases, because we can’t test the output, we have to have absolute faith in the process, so we need additional process controls and validation. It is in these circumstances that clause 7.5.2 applies

7.5.3 Traceability

Manufacturers of high volume, low value, low risk items (e.g.
clothes pegs, many items of clothing) may have no legal or customer requirement for item or batch traceability. This is a fairly common exclusion

7.5.4 Customer property

Many manufacturers and service providers do not hold any
customer property or perform work on a customer’s premises. This is a very common exclusion – but note that it can include certain types of customer information and intellectual property

7.5.5 Preservation of product

This clause requires the “product” be protected from damage or deterioration. If an organisation provides a service such as “advice” then there is no potential for the output to “spoil” in any way and this clause may well be excluded

7.6 Control of monitoring and
measuring equipment

Many service providers don’t use measuring devices that require
special controls (calibration in other words), as they don’t produce anything with specific (for example) dimensional characteristics

Need more?

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7 Responses to Exclusions to ISO 9001 section 7

  1. Pingback: Beginner's guide to ISO 9001 | Capable People Blog

  2. christine says:

    Hi,

    I am a QA Engineer from LED lighting product assembly field. We are buying components from different suppliers then assemble the components into a product. Recently I just had my stage 1 ISO 9001 audit. But i was given a finding to establish a design procedure. The auditor claimed that we are doing design for PCB layout so we must have a design procedure. But actually we do not manufacture the pCB ourselves. We are only giving our concept to the subcontractor then the subcontractor will build the PCB based on our requirement. By giving a concept, does it mean I need to have design procedure?

    Thank you

  3. Shaun says:

    Thanks for taking an interest in Capable Blog, Christine. Based on the information you have provided, it sounds like Design in this case is an outsourced process and, so far as ISO 9001 is concerned, needs to be controlled in accordance with the requirements in 4.1 (last paragraph) which cross refers to your purchasing process. That means that it is your supplier that controls the design process. In conformance terms, in this case, your main responsibility is to demonstrate how you chose the supplier and have confidence that their design process is likely to meet your customers’ requirements. That could include getting evidence from them of certifications they hold or perhaps customer testimonies. If you do not do any other design activities, then it sounds as if an exclusion should apply. My first action when this happens is to request that the CB conducts an internal technical review of the finding. CBs are required to do this and quite often you can get some sense out of their technical person. When contacting your CB please DO NOT allow them to refer your query back to the original auditor. You already know what he/she thinks on the matter, it is a second opinion you are after and they have to give it. Design (if it applies) is a hefty process and adds time to the audit. If it does not apply, then your quotation from them should not be prepared on the basis that it does. Hope that helps.

  4. kamran says:

    Hello , I am a bit confused about the exclusions , can you please help me with it and reply on my email . our company is going for ISo 9001 certification and i have the task to make the quality manual , company is an inspection and sourcing company , we do inspections for customers and find suppliers for customers . we just provide them with the reports of our findings and its up to the customer whatever he decides , can you please tell me which exclusions I may have in Quality Manual . please help me as I am confused and time is running out .

  5. Shaun says:

    My advice would be to open a discussion in the Capable People Discussion Group on LinkedIn. You haven’t provided enough information for anyone to give you accurate advice. We’ll need to gather more information, so an open discussion is probably the quickest way for you to get your answers. Although you may have to be prepared to answer questions from the auditor on your own competence for this task if you are building the system without a basic knowledge.

  6. Batanai says:

    Hi. Our consulting engineering company is working towards ISO 9001 2008 certification and I have been working on implementing the QMS. I am having problems with choosing exclusions on clause 7.3 and 7.5.3. Basically, we are contracted to mantain a power plant by the client and most of our work we dont design.Will the design and development clause apply to us?

    Then on validation of 7.5.2 validation of processes for service provision, how best can we fullfill this requirement as an engineering company.

    Many thanks

  7. Shaun says:

    Is there a reason why you are pursuing ISO 9001:2008 as opposed to ISO 9001:2015? It seems to me that no sooner will you achieve certification then you will have to start looking at transition? It seems like more work in the long run

    Shaun

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