Quality Progress - August 2015 - (Page 8)

EXPERTANSWE ISO 9001 internal audit Also, consider reviewing the eight quality management principles provided more complicated to try to have two sys- can we include the total quality manage- in subclause 0.2 of the introduction to tems for automotive and nonautomotive ment (TQM) function? If so, which clause ISO 9000:2005. These principles are ap- products. If you have only one certifica- of ISO 9001 refers to it? plicable to all the whole family of quality tion, the scope of your audits should management system standards. include your whole product line, not just 2 A: With regard to the ISO 9001:2008 Bill Aston internal audit process and its relationship Managing director to TQM, it should be noted that TQM was Aston Technical Consulting Services LLC a concept used by many organizations Kingwood, TX worldwide prior to the existence of ISO 9001 quality management systems. include their focus on: * Reducing costs. FOR MORE INFORMATION shared between TQM and ISO 9001:2008 * Increasing profits. * Leadership's involvement. * Ensuring customer satisfaction. your automotive products. The answer to your second question also is related to the scope of your certification. If you are not design-responsible for the automotive side of your business, there REFERENCES 1. Joseph M. Juran, Juran's Quality Handbook, fifth edition, McGraw-Hill, 1999. 2. International Organization for Standardization, ISO 9000:2005-Quality management systems-Fundamentals and vocabulary, Introduction, subclause 0.2. A few of the commonalities that are is a risk that your TS 16949 audits (internal and external) do not include your design function. If you want your design activity in scope, work with your registrar to roll it For more information about TQM, visit ASQ's Knowledge Center TQM page at http://bit.ly/TQMresources. into your scope of certification. Find more information about ISO 9000 at http://bit. ly/9000seriesstandards. it under one certification, it will be up to * Ensuring employee competency and Although you should be able to cover the registrar if it will want you to split it Separate certifications? out into a separate ISO 9001 certification. * Resource management. Q: Our company designs and manufac- The impact of that difference should be * Quality system planning. tures commercial and automotive semi- minimal. * Developing of mutually beneficial sup- conductor products. We used to maintain Denis J. Devos dual certification (ISO 9001 and TS 16949) Professional engineer for all of our manufacturing and assembly Devos Associates Inc. involvement. plier relationships. * Accomplishing of objectives that support the organization's mission (such locations, but recently dropped the ISO as quality policy). 9001 certification. My questions are: The primary difference that sets ISO 1. If we manufacture automotive and London, Ontario Raw data required? 9001:2008 apart from TQM is that ISO nonautomotive products in the same lo- Q: I sent a sample for testing to a lab 9001 has defined requirements for es- cation site, without dedicated separation, that is ISO/IEC 17025-accredited, and it tablishing documented procedures and does the TS 16949 certification eligibility provided me with the test results. How- records to provide evidence of confor- apply to the entire site? ever, when I asked the lab for the raw mance. The concepts of TQM permeate 2. Can we include the nonautomotive data to support the testing performed quality systems that are based on ISO designs in the TS 16949 certificate scope, so I could keep it on record for future 9001:2008 requirements. or would we need a separate ISO 9001 investigational use, it refused and stated certificate to cover those activities? it is not a good manufacturing practices If your internal audit criteria are based on ISO 9001, you're also verifying 8 way you'd want to do it-it would be Q: In an ISO 9001 internal audit process, (GMP) lab, and as an ISO/IEC 17025-ac- that TQM concepts are being used in the A: Yes, TS 16949 requirements would credited lab, it is not obligated to provide quality system. More information regard- apply to all of your automotive processes the raw data. It said the raw data could ing TQM is provided in Juran's Quality whether they produce or support only be shown to the regulatory authorities. Is Handbook, fifth edition.1 automotive products. This is actually the this true? QP * www.qualityprogress.com http://www.bit.ly/TQMresources http://bit.ly/9000seriesstandards http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - August 2015

Up Front
LogOn
Expert Answers
Keeping Current
Mr. Pareto Head
Under Construction
Creative by Design
Coming Together
All the Right Moves
3.4 per Million
Quality in the First Person
Career Corner
Statistics Roundtable
Standards Outlook
QP Toolbox
QP Reviews
One Good Idea
Back to Basics

Quality Progress - August 2015

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