Asides

ISO 9001:2008 Impact on ISO 13485:2003

ISO 13485, medical devices, medical device manufacturing

Q: Why does Annex B of ISO 13485:2003: Medical devices — Quality management systems — Requirements for regulatory purposes address ISO 9001:2000?

Shouldn’t it be ISO 9001:2008 Quality management systems–Requirements?

A: ISO 9001 is “controlled” by Technical Committee (TC) 176 while ISO 13485 is “controlled” by TC 210. They are two separate, independent technical committees that write and revise standards.

ISO 13485:2003 is founded on ISO 9001:2000, with additional requirements added for the medical device industry. In other words, ISO 13485:2003 is ISO 9001:2000 (but with the requirement for “continual improvement” removed) and additional requirements for the medical device industry

When TC 176 revised ISO 9001 in 2008,  TC 210 decided not to make a change to ISO 13485 because ISO 9001 requirements didn’t change substantially.   It is important to note that many governments such as Health Canada have adopted ISO 13485:2003 as their law or have their medical device law based on 13485:2003. Many medical device companies today get ISO 13485:2003 registered and have dropped ISO 9001:2008 altogether as not being necessary.

By the way, TC 210 issued a technical corrigendum to ISO 13485:2003 in August of 2009 correcting its reference to “ISO 9001” to “ISO 9001:2000” to make this clear.

Jim Werner
Voting member to the U.S. TAG to ISO TC 176
Medical Device Quality Compliance (MDQC), LLC.
ASQ Senior Member
ASQ CQE, CQA, RABQSA Lead QMS Assessor

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

Resources about Quality Culture

ASQ Global State of Quality 2016

Q: I am a senior member of ASQ.  I plan on giving a two to three hour workshop on quality culture at my company.  Do you have any audiovisual materials and/or examples from other successful companies that I could use for my slide presentation?  I would really appreciate it if you could provide me with more information on creating a quality culture.

A: According to The Quality Improvement Glossary by Donald L. Siebels, quality culture “consists of employee opinions, beliefs, traditions, and practices concerning quality within an organization”.

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

ISO 9001 Management Representative

About ASQ's Ask the Standards Expert program and blog

Q: ISO 9001:2008 Quality management systems — Requirements defines the responsibilities of the management representative (MR). To carry out these responsibilities, the MR needs certain defined authorities. What principle authorities should a MR posses to meet the responsibilities defined? I am a quality manager and I report to the project director, who reports to the CEO. While auditing other directors in the organization, my boss (the project director), requested from me to discuss with him the audit results of other director’s’ audit findings since I am reporting to him. I pointed out that the MR Role is independent and it is not a part of the function of Quality Manager where I report to him.

How can I make it clearer that I need independent authorities to perform the role of the MR?
 
A: Section 5.5.2 Management Representative: defines the appointment and responsibilities of the management representative. He/she is appointed by top management. The implication is that top management can ask for reports on the MR’s responsibilities. A summary of these are:

  • Ensure QMS process are established, implemented and maintained
  • Reporting to top management on performance of QMS and need for improvement
  • Ensure promotion of customer Requirements in the Org.

It is true that management representative responsibilities are not those of the quality manager. But, ISO 9001 does not define responsibilities of the quality manager.

My suggestion is to go to the person who appointed you management representative and ask him if you should provide the information requested.

Sandford Liebesman, Ph.D.
Voting member of the U.S. TAG to ISO/TC 176
ASQ Fellow
Morristown, NJ

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

ISO/TS 16949 Clause 8.2.4.1, Product Testing

Automotive inspection, TS 16949, IATF 16949

Q: Can you please clarify a requirement in clause 8.2.4.1 in ISO/TS 16949 Quality management systems—Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations. The requirement is as follows: “A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans.”

We have a third-party auditor claiming that “product” means every part number.  Our belief is that this is every product family, not every part number.   As a company trying to stay in business, testing every part number is not feasible or cost efficient.

A: This is a controversial area as all production parts that conform to TS 16949 must be PPAPed which is, in effect, an inspection of each part that is produced. If parts produced have different part numbers depending on whom they are supplied to, then one PPAP would be OK. Also, it would be OK if the supplier can get a variance from its customers to the requirement “A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for ‘each product’ as specified in the control plans.” The supplier may want to seek a sanctioned interpretation by the International Automotive Oversight Bureau.

Ron Berglund
Voting member of the U.S. TAG to ISO/TC 176
ASQ Fellow
Canton, MI