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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