Re: What exactly is "Contract Review"?
What exactly is "contract review"?
I'm working within an ISO13485 environment, specifically looking at remodelling our supplier management systems.
I don't know, but I do not fully understand what is meant by the term 'contract review'
Is it:
a) reviewing customer orders, and assessing our ability to fulfil that order to the required customer spec
b) reviewing our orders/contracts with our suppliers, to ensure that our agreements and contracts adequately cover our requirements
c) both of the above
I believe it's a), others in my organisation believe it's b)
Help!
Until 13485:2003, this was a topic of confusion for many companies. Many companies had interpreted this requirement to imply "any and all contracts", not just customer-related arrangements. But, it remained unclear exactly what they were reviewing in different situations. On the contrary, I've seen many companies state that contract review was not applicable to their organizations at all, because they didn't manufacture "custom" orders and/or were not contract manufacturers. In both cases, they missed the point.
Consequently, "Contract Review" was never intended to implicate purchasing or any other contracts. Contract review requirements in the standard are intended to assure that the organization understands customer requirements and fulfills them.
13485:2003 really clarifies this and removes the ambiguity. We no longer call it, "Contract Review" - the term was confusing and vague.
13485:1996 4.3 Contract Review translates to 13485:2003 5.2 Customer Focus which states:
"Top management shall ensure that customer requirements are determined and are met (see 7.2.1 and 8.2.1)."
Here, it's clear that contract review = determination of customer requirements (and meeting them). 7.2 goes on to explain:
"7.2.1 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities
7.2.2 Review of requirements related to the product
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined and documented,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organization has the ability to meet the defined requirements.
7.2.3 Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in relation to
b) enquiries, contracts or order handling, including amendments,"
As to "b) reviewing our orders/contracts with our suppliers, to ensure that our agreements and contracts adequately cover our requirements", these requirements are covered in Purchasing and acceptance activities. 7.4.1 and 7.4.2 clearly define the requirements:
7.4.1 Purchasing process
The organization shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements
(e.g. specifications).
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements
(e.g. product requirements, customer requirements, regulatory requirements, etc).
Criteria for selection, evaluation and re-evaluation shall be established.
7.4.2 Purchasing information
Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
So, in purchasing, we establish the criteria to "qualify" suppliers. We conduct the appropriate review (e.g. quality audit, financial review, etc). We provide detailed purchasing information (specifications, requirements, inspection criteria, etc). Then we verify, either at the supplier's location or our own, that the purchased product meets the specification. We then periodically requalify the supplier, and monitor acceptance activities. The purchasing procedures will somewhat mirror "contract review", in that there is a series of verification steps required to assure that requirements are met. In essence, it's the same type of process, but spelled out with specific criteria in the standard.