Tag: ANSI/ISO/ASQ Q9001:2008

Approved Supplier List

Mr. Pareto Head and Supply Chain comic strip

Question

I would like to know how supplier status in the Approved Supplier List (ASL) should be managed so that there is complete traceabilty.  For instance, a vendor status is changed from approved to not approved in the ASL for reasons other than substandard performance which is documented in an audit report, how should QA document such change to ensure that these changes are tracked. Could QA make changes in the ASL without notifying the Purchasing Department and without any documentation?

Answer

Thanks for contacting ASQ’s Ask the Experts program.  Concerning your questions, about supplier status traceability, and ASL management, the following response is provided.

Dependent on the number of suppliers involved and the availability resources, an organization may choose to utilize a single or combination of methods to monitor supplier performance and supplier status.  These methods may range from using an MS Word or Excel spreadsheet, Access database to a multi-user database.

As you are aware, ISO 9001:2008, Clause 7.4.1, requires the organization to establish criteria for selection, evaluation and re-evaluation of suppliers.  This clause also requires records of results of evaluations to be maintained.  This includes any necessary actions taken as a consequence of the evaluations conducted, such as the removal of a supplier from the ASL or changed approval status.

ISO 9001:2008 does not limit a company’s ability to remove a supplier from the ASL.  This is an internal decision based on the company’s established criteria.  So there could be various reasons for removing a supplier from the ASL.  Likewise, with changing a supplier’s status from pending, approved to not approved.  As mentioned, ISO 9001:2008, Clause 7.4.1, requires records of supplier evaluations to be maintained, and any actions taken as a result of the evaluation to be retained.

The a primary purpose of the ASL is to ensure the placement of purchase orders or contracts are limited to those suppliers that meet the company’s established criteria for supplier selection, evaluation, and re-evaluation.  For this reason, Purchasing must be included in any changes made that may affect their use of the ASL.

Generally speaking, Purchasing is responsible for maintaining and updating the ASL, which includes ensuring the current status of suppliers of products and services are identified.   The company’s internal audit process is typically used to assess Purchasing’s conformance with established criteria for supply chain management.

In summary, I would not recommend that changes be made to any QMS process without the involvement of the QMS process owner and management as applicable.  ISO 9001:2008, Clause 5.4.2, sub b., requires top management to ensure that the integrity of the QMS is maintained when changes are planned and implemented.  If changes are made to the ASL, Purchasing should certainly be involved.

I hope this helps.

Best regards,

Bill

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
Kingwood, TX 77339
Office: (281) 359-ATCS (2827) or Toll Free: (888) 968-9891
Website: www.astontechconsult.com

For more on this topic, please visit ASQ’s website.

ISO 9001:2008 Quality Manager Titles

Workplace safety, OHSAS 18001, work environments

Question:

Is it a requirement that a person in an ISO 9001 registered organization who is responsible for fulfilling the duties and requirements of the management representative hold the title of Management Representative, i.e., is it a noncompliance that such person holds a different title, e.g., specifically, Quality Representative?

Response:

I have seen this question come up at other times.  Basically, I refer to how we need to understand the word “shall”.  “Shall”, when used in the ISO standards,  indicates a requirement.

Therefore, when clause 5.5.2 in ISO 9001:2008 says, “Top management shall appoint a member of the organization’s management . . . .”, then it is a requirement. There are good reasons for this. For one, the Management Representative must have the authority to perform those duties necessary for the successful implementation and continuation of a quality management system. Generally, a person in management knows the company’s business and has a working relationship with all the departments.
It is sometimes a practice to give a person a management title but limit their authority to that which is related to the QMS.

I hope this is helpful to you and thank you for sending your question.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Follow Up Question:

Hello,

I appreciate and fully understand your answer, however, I probably did not pose my question adequately. The responsibilities of the MR is clearly assigned to a member of management, and, in fact is the QM, but does not use the title “Management Representative”, but instead uses “Quality Representative”.  So, in affect, there is no “MR” in the company.  Is this an issue?

Thanks.

Response:

If you wanted to add verbiage to your Quality Manual or one of your documented procedures (i.e. Management Responsibility) which clarifies this you could. However, you do not have to.

The standard says your MR shall be a member of management. The standard does not direct you to make this an official “title”.  It just needs to be clear that someone from management fulfills all the responsibilities of the MR. Those responsibilities can be in addition to that individual’s primary function.

It sounds like you are doing OK.

Bud Salsbury
ASQ Senior Member, CQT, CQI

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What is ANSI/ISO/ASQ Q9001:2008?

ISO documentation practices, requirements

Question

Is there any difference between ANSI/ISO/ASQ Q9001:2008 and ISO 9001:2008? Is it just semantic, or is it ASQ’s take on ISO 9001:2008 Quality management systems–Requirements?

Answer

The ANSI designation shows it has been adopted as an American National Standard (ANS), and that U.S. experts believe the standard is a good one and should be followed by the U.S. Since ASQ is the administrator of the group (known as a Technical Advisory Group/TAG in the standards development world) that develops ISO 9001, we are the only organization allowed to put its name in the designation. ASQ is a member of ANSI and is accredited by them to be a standards-developing organization.

For more about this topic, please visit ASQ’s website.