Is a Contract Review Procedure necessary to comply with ISO 13485:2003?

[OCCUL]

Perhaps someone can assist me.... Is a Contract Review Procedure necessary to comply with ISO 13485:2003 (only finding section 7.2 in the standard for reference)? I am torn between including a section on it in our Quality Manual or a procedure...

[rmacd]

ISO provides guidance on the Documentation Requirements of ISO 9001:2000(ISO/TC 176/SC 2/N525RR) available free at www.ISO.org. Although published for 9001:2000, the requirements for "documented procedures" for 13485 4.2.1.c) are the same. It lists the 6 required "documented procedures"required by the standard. However 4.2.1.d) also requires that the QMS include "documents needed by the org. to ensure the effective planning, operation and control of its processes. So you must determine where other "documented procedures" are necessary in your company. Good Luck.

[Sidney Vianna]

Originally Posted by rmacd

Although published for 9001:2000, the requirements for "documented procedures" for 13485 4.2.1.c) are the same. It lists the 6 required "documented procedures"required by the standard. However 4.2.1.d) also requires that the QMS include "documents needed by the org. to ensure the effective planning, operation and control of its processes. So you must determine where other "documented procedures" are necessary in your company. Good Luck.

This is NOT correct. ISO 13485 has additional requirements for DOCUMENTED procedures, compared to ISO 9001:2000. Read the individual clauses of ISO 13485 and you will find additional requirements for documenting procedures.

[Aaron Lupo]

Originally Posted by OCCUL

Perhaps someone can assist me.... Is a Contract Review Procedure necessary to comply with ISO 13485:2003 (only finding section 7.2 in the standard for reference)? I am torn between including a section on it in our Quality Manual or a procedure...

No, ISO 13485:2003 does not state that you need a documented procedure for contract review.

Some questions to ask are do you currenlty have a Contract review Procedure, if so why get rid of it if it serves a purpose. If you don't have one should you, to ensure that the important parts of the contract review process are not missed.

See

section 7.2.2 :

"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.

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

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.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

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.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material."

Asy Sidney already stated 13485:2003 requires more that they 6 documented procedures than that of 9001:2000. I may be off by a couple but I think it is around 19 or so that are actually needed.

[rmacd]

Originally Posted by OCCUL

Perhaps someone can assist me.... Is a Contract Review Procedure necessary to comply with ISO 13485:2003 (only finding section 7.2 in the standard for reference)? I am torn between including a section on it in our Quality Manual or a procedure...

I am sorry for the incorrect information in my earlier post. As Sidney and Aaron have pointed out I was way off on the number of "documented procedures" required in 13485. Again, I appologize for the bad information.

[OCCUL]

Thanks for the info...I appreciate the assistance