ISO 17025 and Business Changes

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratoriesQuestion

My organization has just been recently accredited to ISO/IEC 17025:2005. Shortly thereafter, changes were made to the organization’s structure and business operations.  I would like to know:

1) When should these changes be reflected in the Quality Manual?

2) Do I need to advise the local registrar about the changes?

3) Are these changes time-sensitive that need to be reported to the certifying body to maintain certification or, should I just wait for the next surveillance audit coming in about six (6) months?

Answer

Thank you for your question.  Updates to your Quality Management System and Quality Manual should be made as soon as they are implemented.  I would suggest notifying your CB of the changes now and let them plan for auditing these changes.  They will likely want to roll that into your next surveillance and not make a special visit.  That decision, of course, would be up to them.

Denis.

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

Six Sigma Black Belt

Question

I am currently an Executive Chef working that has been taking online classes for Green & Black Belt Six Sigma.  I am about halfway through my Black Belt classes and would like to pursue my certifications.  However, my company does not have a Six Sigma department and seem to be getting no where on working on a Six Sigma project so I could qualify for the Black Belt certification.  Do you have any advice or guidance that could help.

Answer

This is not an uncommon issue with a number of people.  What he should look into is to work as a volunteer at some non-profit organization on a Black Belt improvement project.  These organizations are always looking for help and this is a win-win for both him and the organization.  He will need to talk to them about what Six Sigma is and the type of project he is interested in doing.

Another possibility is to look at his place of work and if there is a part of the job that has to be done but no one likes doing it. If it is a process, then he could follow the DMAIC process and show improvement.  This could also serve as BB project if he can show the time savings was greater than 50%.

Jim

Jim Bossert
SVP Process Design Manger, Process Optimization
Bank of America
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CSSMBB
Fort Worth, TX

Writing ISO 9001:2015 Procedures

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Question

I am in the process of implementing ISO 9001:2015 at a heavy civil construction company. I do not have any prior experience implementing but did work in an ISO environment for 13 years. I am looking for assistance on how to go about writing procedures to ensure that they incorporate the ISO requirements.

Answer

Thanks for contacting ASQ’s Ask the Experts program.  Concerning writing procedures, there are a few things to consider.  In general, a procedure should be structured to define its purpose or scope.  If the procedure is intended to address an identified risk or opportunity, it should be stated.  Likewise, consider including specific references to customer, industry standards, and internal requirements that are being addressed in the procedure.

Other key points to consider include structuring the procedure to be consistent with the flow of the process or activities controlled by the procedure.  Also, if appropriate, include reference to acceptance criteria, identify who, when, and how these activities will be conducted.  References to any required records to be maintained to provide evidence of conformance should also be a part of the procedure.  The importance of ensuring the participation of the process owner as well as others responsible for performing the activities identified in the procedure can’t be overstated.  If possible, the process owner and other interested parties should be involved in the development, review and approval of the procedure.

I hope this helps.

Best regards,

Bill

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
Kingwood, TX 77339
Office: (281) 359-2827

Dual Certifications

Question

Our company currently holds dual certifications to API Q1 and ISO 9001:2008 that are not set to expire until November 2017. When making the transition to ISO 9001:2015 and re-certifying in November 2017, will we be able to do dual certifications or will we have to do API Q1 separate from ISO 9001:2015?

Answer

Hello,

Thank you for contacting ASQ’s Ask the Experts program.  In response to your inquiry, the timing for transitioning your existing QMS from ISO 9001:2008 to ISO 9001:2015 is dependent upon your Registrar’s timeline to begin issuing ISO 9001:2015 certifications.  I highly recommend that you discuss this subject with your Registrar to determine how and when this transition will take place.  In my professional opinion, this transition process may be similar to the recent move from API Q1, 8th edition to API Q1, 9th edition.

Since your current certification expires November 2017, transitioning sooner rather than later is recommended.  Especially since unlike API Q1, the ISO 9001 certification expiration date cannot be extended.

I hope this helps.

Best regards,

Bill

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
800 Rockmead, Suite 170, Kingwood, TX 77339
Office: (281) 359-2827
Website: www.astontechconsult.com