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Bob Doering
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Currently Active Discussions:
 
Labeling requirements for individual units for medical devices
      Last Post or Poll Vote: 25th June 2016 08:16 PM by Ronen E » Replies: 1
Product Audit - Explanation and samples of the report - TS 16949
      Last Post or Poll Vote: 25th June 2016 06:59 PM by INTERACTION38 » Replies: 53
Confusion about Risks for Processes in ISO 9001:2015
      Last Post or Poll Vote: 25th June 2016 02:45 PM by howste » Replies: 19
Could I issue major finding for Inadequate Procedures
      Last Post or Poll Vote: 25th June 2016 02:23 PM by howste » Replies: 7
FDA 510(k) required? US company Private Labeling an FDA Class II Device
      Last Post or Poll Vote: 25th June 2016 02:56 AM by Ronen E » Replies: 23
ISO 11135:2014 cancels and replaces ISO 11135-1:2007 and ISO/TS 11135-2:2008
      Last Post or Poll Vote: 25th June 2016 02:48 AM by Ronen E » Replies: 8
5.4.1 Quality Objectives - Nonconformity: The process was not fully effective
      Last Post or Poll Vote: 25th June 2016 02:45 AM by LUV-d-4UM » Replies: 36
Performance Indicators for Document Control
      Last Post or Poll Vote: 24th June 2016 10:22 PM by tony s » Replies: 11
IRCA Application form fill - Guidance
      Last Post or Poll Vote: 24th June 2016 10:05 PM by Adaym » Replies: 9
ISO/TS 16949 CBs & Auditors not following up on the schedules
      Last Post or Poll Vote: 24th June 2016 07:02 PM by howste » Replies: 31
Abuse of work transfer? (per AS9100)
      Last Post or Poll Vote: 24th June 2016 04:35 PM by RCW » Replies: 4
Disaster Contingency - Is it a requirement in ISO 9001?
      Last Post or Poll Vote: 24th June 2016 02:52 PM by BoardGuy » Replies: 11
CAPA (Corrective and Preventive Action) - ISO 13485
      Last Post or Poll Vote: 24th June 2016 02:37 PM by Ninja » Replies: 1
Dispute a Credit Card Debt or Offer to Settle?
      Last Post or Poll Vote: 24th June 2016 01:50 PM by Ninja » Replies: 20
FDA Consensus Standard for PMA (Pre-Market Approval)
      Last Post or Poll Vote: 24th June 2016 01:01 PM by Ajit Basrur » Replies: 1

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Manufacturing, Service, and Business Systems Processes
Please use these forums to discuss manufacturing, services, processes, materials and related Business Systems Process aspects.
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Human Factors and Ergonomics in Engineering related discussions
55 584
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Lean Manufacturing, including Lean in Service Industries, questions and discussions.
12th June 2016 07:28 PM Go to last post
491 4,508
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Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
1,160 8,233
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Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
by harry
6th June 2016 12:11 AM Go to last post
181 2,405
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Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
1st June 2016 08:57 AM Go to last post
226 1,420
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Service Industry specific and related discussions.
by coelk
17th June 2016 02:02 PM Go to last post
189 1,383
National and International Business System Standards
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by RCW
24th June 2016 04:35 PM Go to last post
1,766 15,481
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Business continuity planning (BCP) identifies an organization's exposure to internal and external threats and provides for effective prevention and recovery for the organization.
by SteveK
24th May 2016 10:11 AM Go to last post
42 308
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CE Marking (Conformité Européene) / CB Scheme discussions - CE Marking and the CB Scheme help manufacturers improve their marketing efficiency by establishing a way to meet one Standard for their products which will harmonize with Standards from different governments.
20th June 2016 06:36 AM Go to last post
330 1,964
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Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
by Randy
15th May 2016 08:58 PM Go to last post
796 7,276
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by yodon
23rd June 2016 09:41 AM Go to last post
1,112 6,014
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All topics connected to Food management systems to include ISO 22000, Hazard Analysis and Critical Control Points (HACCP) and other related food safety systems.
13th June 2016 08:31 AM Go to last post
313 2,059
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JCAHO, CCHSA, HQA, ANAES, JSQua, ACHS, NZCHS, MSQH, NCAIO - Best Practices" accreditation organizations, in the US, Canada, UK, France, Japan, Australia, New Zealand and Malaysia, and the CMS-approved (in the USA) accreditation organization.
by Raffy
1st June 2016 11:45 PM Go to last post
60 385
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IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
14th June 2016 02:29 AM Go to last post
115 634
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IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
by QAMTY
20th June 2016 11:09 AM Go to last post
20 113
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TL 9000 is a two book standard created by QuEST (Quality Excellence for Suppliers of Telecommunications) Forum based on ISO 9001.
by AndyN
12th January 2014 06:12 PM Go to last post
42 303
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Occupational Safety and Health Administration (OSHA), Occupational Health & Safety Management Standards (OHSAS 18001, ANSI Z10, CSA Z1000, ILO-OSH, GOST 12.0.230, AS/NZS 4801, etc...)
22nd June 2016 01:41 PM Go to last post
263 2,894
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Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
by jrw5369
12th May 2016 12:54 PM Go to last post
93 787
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by howste
25th June 2016 02:45 PM Go to last post
4,908 59,676
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RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
7th June 2016 08:04 AM Go to last post
241 1,843
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The ISO PAS 28001 addresses potential security issues at all stages of the supply process, thus targeting threats such as terrorism, fraud and piracy.
31st May 2016 11:49 PM Go to last post
7 31
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Sustainability is the reconciliation of environmental, social and economic demands - often known as the "three pillars". Ecology is the scientific study of the distributions, abundance, share affects, and relations of organisms and their interactions with their environment. ISO 50001 addresses Sustainability, Green Initiatives and Ecology.
by John P
31st May 2016 04:12 AM Go to last post
57 408
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In 2000, TS 16949 evolved from QS-9000. TS16949 is an automotive sector specific standard.
by howste
24th June 2016 07:02 PM Go to last post
2,848 23,075
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Verband der Automobilindustrie e. V. (VDA) - VDA 6.1 is the German Quality Management System for the automotive industry. Based on ISO 9001:1994, it includes all elements of QS-9000.
21st June 2016 03:20 PM Go to last post
99 670
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Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
by Frypot
13th June 2016 03:14 AM Go to last post
595 4,142
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ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
18th June 2016 05:20 PM Go to last post
597 3,598
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device, Medical Information Technology, Medical Software and Health Informatics and related discussion topics.
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by Ronen E
25th June 2016 08:16 PM Go to last post
3,170 19,644
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Medical devices standards, national and international. Standards are published by standards writing bodies (such as ISO and IEC internationally, ANSI, CEN, CENELEC, CSA and others nationally) and are generally voluntary. You can use standards to fulfill regulations, depending on the way the regulation uses standards.
by Ronen E
25th June 2016 02:48 AM Go to last post
3,217 23,943
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Information Technology used in medicine including includes topics (which are used interchangeably sometimes) such as medical Information technology, medical software (software used in healthcare) and health informatics, including Health Information and Communications Technology (ICT). Examples are standards from the IEC 80001 series and the works of ISO TC 215.
7th June 2016 07:15 AM Go to last post
30 127
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Other various Medical Device and Orthopedic related discussions.
by rob73
23rd June 2016 08:03 AM Go to last post
269 1,681
Common Quality Assurance Processes and Tools
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For discussion of Definitions, Acronyms, Abbreviations and Interpretations
9th June 2016 08:49 AM Go to last post
584 5,528
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Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
by SQ_Joe
11th June 2016 11:51 PM Go to last post
869 6,252
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Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
25th June 2016 06:59 PM Go to last post
1,775 24,166
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Benchmarking (1 Viewing)
Benchmarking Methods and Related General Discussions.
by Marc
4th June 2016 05:51 AM Go to last post
116 806
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Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
24th May 2016 09:17 AM Go to last post
422 3,738
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Consultants and discussions related to consultants including ISO 10019 "Guidelines for the selection of quality management system consultants and use of their services" aspects / requirements.
by lawcch
20th March 2015 04:31 AM Go to last post
110 1,251
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Contract Review Process Discussions and Information
22nd October 2013 04:31 PM Go to last post
60 483
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Customer Complaints (2 Viewing)
Dealing with Customer complaints/concerns.
by Bev D
28th April 2015 12:25 PM Go to last post
135 1,299
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Customer Requirements and Company Specific Requirements - including Ford's Q1 'Award' program. GM has it's GM-9000. Etc. Nissan and Honda have their requirements. Company specific requirements questions here, please!
25th June 2015 03:39 PM Go to last post
450 3,118
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Process and Product Design and Development discussion discussions. Design Verification and Validation included.
7th June 2016 12:58 PM Go to last post
503 3,644
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Documentation Systems (Document Control), including Procedures, Forms, and Templates.
4th June 2016 12:26 PM Go to last post
2,195 20,570
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Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
by SQ_Joe
2nd June 2016 06:42 AM Go to last post
830 6,715
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Calibration "Catch All" forum - ISO 17025, Calibration of Measurement Devices, Measurement Devices, Metrology (Calibration) and Test Laboratory related discussions. Many discussions in this forum are beyond ISO 17025 specific topics.
22nd June 2016 10:10 AM Go to last post
4,113 30,370
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Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
by Mike S.
22nd June 2016 11:43 AM Go to last post
1,560 12,014
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Management Review related Discussions and Information.
by Ninja
20th May 2016 01:05 PM Go to last post
145 2,097
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Various other quality assurance and business systems related topics like Cost of Quality and other focused topics. Topics outside Quality and Environmental are allowed.
13th June 2016 01:29 AM Go to last post
753 7,385
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Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
by Ninja
24th June 2016 02:37 PM Go to last post
671 7,638
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Let's talk Deming! And who doesn't have a copy of Juran's 15 pound tome Quality Control Handbook? We all do. For discussion of Sarasohn, Protzman, Armand V. Feigenbaum, Crosby, Ishikawa, Taguchi, Shewhart, Imai and others. Philosophy, Gurus, Innovation and Evolution.
19th December 2014 06:01 PM Go to last post
209 3,886
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What is a Corrective Action vs. a Preventive Action?
by Koala
1st June 2016 11:23 AM Go to last post
210 3,038
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Principles and generic guidelines on Risk Management.
by Juzaili
16th September 2014 11:22 PM Go to last post
12 70
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Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
24th June 2016 11:51 AM Go to last post
157 2,294
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Quality Manual Development and Quality Systems Manual related Discussions.
by howste
16th June 2016 04:40 PM Go to last post
277 4,119
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Quality Manager and Quality Assurance Management Issues/questions
24th June 2016 09:14 AM Go to last post
647 6,402
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Balanced ScoreCard, QFD, Taguchi & Shainin's Techniques, Pre-Control, Pareto, etc. - How to use them - When to use them - How to analyze the results - Success stories - Failures - Questions and general discussions.
by Marc
16th June 2016 11:12 PM Go to last post
1,601 12,795
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Includes legal and other related records and data discussions. What is a Quality Record and what quality records are required? What other required records are there in your company? Records are Evidence. What is Data?
12th June 2015 04:48 AM Go to last post
302 2,992
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Six Sigma (1 Viewing)
Love it or hate it, what ever six sigma is, it's been around for quite a while and looks to stay for quite a while.
10th June 2015 06:37 AM Go to last post
372 3,892
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Software Quality Assurance topics including CMMI (Capability Maturity Model Integrated), TickIT, Information Security Management (ISO 17799 and BS 7799), ISO/IEC 12207 Software Life Cycle Processes, ISO 15504, etc.
by Ettore
13th June 2016 03:01 PM Go to last post
218 1,138
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SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
by Miner
15th June 2016 07:58 AM Go to last post
1,315 10,692
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A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
by howste
25th June 2016 02:23 PM Go to last post
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Training and related topic discussions.
14th June 2016 01:57 PM Go to last post
739 6,257
Registrars and National / International Organizations
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ASQ (American Society for Quality), IRCA (International Register of Certified Auditors), IATF (International Automotive Task Force), RABQSA, IMDRF (International Medical Device Regulators Forum), and related discussions.
by Adaym
24th June 2016 10:05 PM Go to last post
234 2,976
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The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
5th June 2015 03:54 PM Go to last post
384 5,902
Information Resources - Files - Papers - Articles - Etc.
This forum contains various information resources.
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Read a book you would like to share or find a good web site or blog? Tell us! This forum is for books and sites from all quality and environmental arenas and branches.
by DRAMMAN
26th June 2015 11:09 AM Go to last post
270 1,844
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Various Uploaded Data and other Information Files
Sub-Forum(s): Outdated Threads
22nd August 2013 07:29 AM Go to last post
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Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
17th May 2016 12:03 PM Go to last post
154 1,894
Professional Employment and Occupation Related
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Questions, discussions and comments about careers and occupations. Resume content and other information can be discussed here as well.
by Miner
9th June 2016 07:57 AM Go to last post
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What hotels do you stay at? Have you traveled by train? Which airline do you prefer and why? Travel discussions, experiences, news and recommendations.
19th May 2015 01:49 PM Go to last post
143 2,533
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Many people now work outside their 'native' countries either for a foreign company or for a company in their home country. Thinking of moving? Questions and discussions here.
8th April 2014 08:37 PM Go to last post
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Members, Companies and Recruiters - If you have a position opening (job opening), please post it in this forum. Please - ONLY post for specific, available positions (including consulting). Please - No 'Fishing'. Need to outsource Internal Audits? Find someone here!
Look! Full Time Direct Hire: RAQA Coordinator Position...
by Marc
15th April 2015 02:55 PM Go to last post
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Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
17th June 2016 04:18 PM Go to last post
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Looking for a job? Post the position you are seeking, your resume, and/or your qualifications, here. But remember - You never know who may see it! Interview and related discussions are welcome as well.
22nd September 2008 05:47 AM Go to last post
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by John P
5th June 2016 10:33 AM Go to last post
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How To Do Things in the Forums - Detailed Use ("Work") Instructions - This forum contains information on 'How To' do things, such as Start a New Discussion Thread, or Add a Poll to a Thread or Attach a File to a Post in a Thread. Explanations of how the software features work.
by John P
8th June 2016 04:08 PM Go to last post
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Something new happening? Please post related topics here.
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24th June 2015 02:40 PM Go to last post
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Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
Yin Yang Problem Report: Please Post Any TapaTalk...
by Marc
15th June 2016 06:12 PM Go to last post
154 1,670
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Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.
29th June 2015 03:11 PM Go to last post
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Discussions of all sizes, shapes, forms and opinions that are NOT 'business' related. In short, Chit Chat and Community Discussions.
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13th May 2015 01:48 PM Go to last post
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