Request for clarification on ISO 9001 Clause 7.2.2 (Contract Review)

morteza

Trusted Information Resource
#1
Hello all,

In clause 7.2.2, ISO 9001:2008 states:
Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
There are some questions for me about this requirement as follow:
1- Do product requirements also include requirements related to supplier QMS or its processes?
2- Does above requirement is applicable either before acceptance of a contract or a change to contract or after acceptance of a contract or a change?
Overview for this question:
Contract review is done before acceptance of a contract or change to contract. It seems before acceptance of any change to contract, there is no requirement fore document amendment. But after acceptance of any change to contract, amendment of documents is necessary.
Thanks all.
 
Elsmar Forum Sponsor
T

The Specialist

#2
Re: request for clarification on clause 7.2.2

For clarification:


Customer-related processes
(Please refer to Clause 7.2 of ISO9001:2008)

There are following clauses under this clause:
7.2.1 – Determination of requirements related to the product
7.2.2 – Review of requirements related to the product
7.2.3 – Customer communication

Determination of requirements related to the product
(Please refer to Clause 7.2.1 of ISO9001:2008)

The organization must determine:
customer requirements,
requirements for delivery and post-delivery activities,
requirements, necessary for specified or intended use of the product, although not stated by the customer,
applicable legal (statutory and regulatory) requirements related to the product,
any other requirements, that are considered necessary by the organization.

Note at the end of this clause clarifies the term post-delivery activities. Actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling, final disposal) are part of post delivery activities.

If we compare ISO 9001:2000 (old version) and ISO9001:2008 (new version), we find that requirement has been slightly re-worded. The word ‘related’ has been changed to ‘applicable’. The wordings of clause 7.2.1 (d) that ‘any additional requirements determined by the organization’ (in ISO 9001:2000 Standard) have been changed to ‘any additional requirements considered necessary by the organization’ (in ISO9001:2008). Accordingly, now the organization must determine any additional requirements considered necessary by the organization.

A note has been added at the end of sub clause 7.2.1 in ISO9001:2008 clarifying the post delivery activities to include actions under warranty provisions, contractual obligations (such as maintenance services) and supplementary services (such as recycling and final disposal). Old version did not clarify what post delivery meant; now the new version has clarified the same.

Review of requirements related to the product
(Please refer to Clause 7.2.2 of ISO9001:2008)

The organization must review, the requirements related to the product, prior to the organization’s commitment to supply a product to the customer. Accordingly, the organization must review the requirements related to the product before submission of tenders, acceptance of contracts, acceptance of orders, acceptance of changes to the contracts, or acceptance of changes to orders.

The organization must also ensure the following:
to define product requirements,
to resolve contract or order requirements differing from those previously expressed,
the organization has the ability to meet requirements that are defined.

The organization must maintain following records:
results of the review, and
actions arising from the review.

Sometimes customer provides its requirements verbally (not written requirements), in such situation, the organization must confirm such customer requirements before acceptance to supply the product to the customer.

There may be instances when product requirements are changed, in such situation, the organization must ensure that relevant documents are amended and information about the changed requirements is made aware to relevant personnel.

A note at the end of the clause provides clarification that a formal review of requirements is impractical for organization and customer in some situations, as in the case of internet sales. In such cases, the review of requirements can cover relevant product information, such as catalogues and adverting material.

If we compare ISO 9001:2000 (old version) and ISO9001:2008 (new version) there is no change in the requirements of clause 7.2.2.
 

somashekar

Staff member
Admin
#3
Re: request for clarification on clause 7.2.2

1- Do product requirements also include requirements related to supplier QMS or its processes?
It can be and depends upon the product and your QMS deployment.
2- Does above requirement is applicable either before acceptance of a contract or a change to contract or after acceptance of a contract or a change?
It is applicable as and when a customer comes up with one.

Your QMS wants you to review them as and when they arise and redefine and document the exact final requirement before any commitment to supply.
The word contract review is no more in use. The focus is on customer related processes. Depending upon the type of product and / or service, the determination of requirements may be once and review of requirements may be as and when customer makes a knock on your door for supply of a product. In some type of products and / or service, both determination and review of requirements can happen several times, each being a new or a slight modification of the earlier supply.
 
Last edited:
J

JaneB

#5
Re: request for clarification on clause 7.2.2

It can be and depends upon the product and your QMS deployment.

It is applicable as and when a customer comes up with one.

Your QMS wants you to review them as and when they arise and redefine and document the exact final requirement before any commitment to supply.
The word contract review is no more in use. The focus is on customer related processes. Depending upon the type of product and / or service, the determination of requirements may be once and review of requirements may be as and when customer makes a knock on your door for supply of a product. In some type of products and / or service, both determination and review of requirements can happen several times, each being a new or a slight modification of the earlier supply.
Excellent answer. I agree. :yes:

The only slight quibble I'd have is about you saying one must 'document' the exact final requirement before any commitment to supply.

It doesn't actually say that. What it actually requires is (as you say) for the organisation to review requirements (and to have some kind of record of that review) and ensure that it can supply.
How you demonstrate that 'review of requirements' varies enormously, depending on the nature of the business. For example, online businesses take an order the instant that the 'buy' button is clicked. An engineering job shop may/may not provide a written quote for each sale. An IT development shop would almost certainly write up a fairly detailed system specification. It all depends on your business. Sometimes the deliverable is fairly vague in the early stages (eg, some service businesses, some iterative development IT projects), and successively clarified as time goes on.

But oh yes, please do let us forget that old, outworn phrase 'contract review'!
 

somashekar

Staff member
Admin
#6
Re: request for clarification on clause 7.2.2

Excellent answer. I agree. :yes:

The only slight quibble I'd have is about you saying one must 'document' the exact final requirement before any commitment to supply.

It doesn't actually say that. What it actually requires is (as you say) for the organisation to review requirements (and to have some kind of record of that review) and ensure that it can supply.
How you demonstrate that 'review of requirements' varies enormously, depending on the nature of the business. For example, online businesses take an order the instant that the 'buy' button is clicked. An engineering job shop may/may not provide a written quote for each sale. An IT development shop would almost certainly write up a fairly detailed system specification. It all depends on your business. Sometimes the deliverable is fairly vague in the early stages (eg, some service businesses, some iterative development IT projects), and successively clarified as time goes on.

But oh yes, please do let us forget that old, outworn phrase 'contract review'!
Thanks Jane for that correction and your compliments ~~~
You know I get into this ISO13485 stuff so often and perhaps its effect.
ISO13485 at 7.2.2 a) products requirements are defined and documented,
ISO9001 at 7.2.2 a) product requirements are defined,
 
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