iso 9001, iso 14001, quality assurance, iso 9001
5s, 6 sigma, as 9000, as 9100, cgmp, current good manufacturing practices, iso 9000, iso 9001, iso 14000, iso 14001, iso 15161, iso 22000, iso 22002, iso/ts 16949, jaeger holland, jaeger-holland, lean, marty jaeger, martin jaeger, martin j jaeger, kanban, office kaizen, quality assurance, quality systems, tpm, sarbanes oxley, sarbanes-oxley, sox, total productive maintenance

5s, 6 sigma, as 9000, as 9100, cgmp, current good manufacturing practices, iso 9000, iso 9001, iso 14000, iso 14001, iso 15161, iso 22000, iso 22002, iso/ts 16949, jaeger holland, jaeger-holland, lean, marty jaeger, martin jaeger, martin j jaeger, kanban, office kaizen, quality assurance, quality systems, tpm, sarbanes oxley, sarbanes-oxley, sox, total productive maintenance

5s, 6 sigma, as 9000, as 9100, cgmp, current good manufacturing practices, iso 9000, iso 9001, iso 14000, iso 14001, iso 15161, iso 22000, iso 22002, iso/ts 16949, jaeger holland, jaeger-holland, lean, marty jaeger, martin jaeger, martin j jaeger, kanban, office kaizen, quality assurance, quality systems, tpm, sarbanes oxley, sarbanes-oxley, sox, total productive maintenance

5s, 6 sigma, as 9000, as 9100, cgmp, current good manufacturing practices, iso 9000, iso 9001, iso 14000, iso 14001, iso 15161, iso 22000, iso 22002, iso/ts 16949, jaeger holland, jaeger-holland, lean, marty jaeger, martin jaeger, martin j jaeger, kanban, office kaizen, quality assurance, quality systems, tpm, sarbanes oxley, sarbanes-oxley, sox, total productive maintenance

5s, 6 sigma, as 9000, as 9100, cgmp, current good manufacturing practices, iso 9000, iso 9001, iso 14000, iso 14001, iso 15161, iso 22000, iso 22002, iso/ts 16949, jaeger holland, jaeger-holland, lean, marty jaeger, martin jaeger, martin j jaeger, kanban, office kaizen, quality assurance, quality systems, tpm, sarbanes oxley, sarbanes-oxley, sox, total productive maintenance

5s, 6 sigma, as 9000, as 9100, cgmp, current good manufacturing practices, iso 9000, iso 9001, iso 14000, iso 14001, iso 15161, iso 22000, iso 22002, iso/ts 16949, jaeger holland, jaeger-holland, lean, marty jaeger, martin jaeger, martin j jaeger, kanban, office kaizen, quality assurance, quality systems, tpm, sarbanes oxley, sarbanes-oxley, sox, total productive maintenance

 

 

Implementing ISO/TS 16949:2009 …

 

If your implementation is mainly focused on writing procedures you may not be headed in the right direction.  Consider these requirements:

·  Clause 4.1 in the new revision explicitly requires a process approach that encompasses process inputs, outputs and controls as well as steps, tasks, activities

·  Clause 5.2 requires that top management ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction

·  Clause 5.4.1 requires the establishment of measurable quality objectives

·  Clause 6.2.2.2 requires a process to motivate employees to achieve quality objectives, to make continual improvements and to create an environment to promote innovation

·  Clause 7.3.2.2 requires manufacturing process design input including targets for productivity, process capability and cost

·  Clause 7.3.3.2 requires manufacturing process design output including control plans, work instructions and results of error proofing activities, as appropriate

·  Clause 7.5.2.1 requires validation of all processes for production and service provision

·  Clause 8.2.3 requires that the organization apply suitable methods for monitoring and where applicable, measurement of the quality management system processes, and

·  Clause 8.5.1.2 explicitly requires continual focus upon control and reduction of variation in product characteristics and manufacturing process parameters

Notice that the standard does not use the words ‘documented procedure’ in any of these clauses!

However it should be noted that the North American Automotive Industry infers that processes have certain consistent characteristics1):

·  They are defined

·  They have owners

·  They are documented (see an example)

·  Their linkages are established

·  They are monitored

·  Records are maintained

The intent of the new revision is the adoption of a process approach to enhance customer satisfaction which should lead to customer retention, increased sales, fewer problems, and although not stated or required – but if done right – improvement in your organization’s bottom-line.

1)Kalogeridis, Carla, "ISO/TS 16949:2002 and the Process Approach", Exploring ISO/TS 16949:2002, Special Edition, 2003

Consider also the Rules for achieving IATF recognition for ISO/TS 16949:2009 which requires:

  The organization shall provide

·  Description of processes showing the sequence and interactions, including key indicators and performance trends for the previous 12 months minimum

·  List of customer specific requirements

·  Evidence that all of the requirements of ISO/TS 16949:2009 are addressed by the organization's processes

·  List of qualified internal auditors

·  Customer satisfaction and complaints status, including customer reports and scorecards

ISO/TS 16949 Quality Management Systems Automotive suppliers — Particular requirements for the application of ISO 9001:2008
was prepared by the International Automotive Task Force (IATF) and representatives from ISO/TC 176, Quality Management and quality assurance, and its subcommittees. To obtain recognition of certification to the "Automotive Certification Scheme for ISO/TS 16949:2009 Rules for achieving IAFT recognition," noted above must be followed. Some differences in  the new standard include:
QS-9000:1998 ISO/TS16949:2009
142 pages 34 pages
Customer-specific requirement
 included
Customer-specific requirements not included,
found on customer's websites, and
they "shall be audited"
ISO 9001:1994 text is in
 italics
ISO 9001:2008 text is
boxed
Appendices A through I 1 Annex:
Glossary

Appendix J:
Control Plans
an example form
Appendix C:
Standard Characteristics
Special Characteristics and Symbols
Terms and definitions

Annex A
Control plan
Approximately 20+ procedures Only seven (7) "documented procedures"
292 Shalls 292 Shalls

QS-9000 is obsolete and ISO/TS 16949:2009 registration is currently required for tier-1 suppliers of the subscribing organizations.  The 2009 revision includes the ISO 9001:2008 requirements as a baseline.
Organizations interested in this automotive standard should consider the advice of Radley Smith, co-author of QS-9000 First Edition,  and "Rethink your entire Quality Management System"

For more ISO/TS16949 content reference also:
  Management overview
  How to transition
  
ISO/TS 16949 Internal auditor training

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