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Currently Active Discussions:
It's good to be back! May 2016
      Last Post or Poll Vote: 6th May 2016 12:12 PM by John Peachfarm » Replies: 13
Are dermal fillers & PDO sutures for aesthetic purpose under CE MDD?
      Last Post or Poll Vote: 30th June 2015 09:43 PM by Julie O » Replies: 5
Goodbye, Farewell and Amen
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Giving out a Medical Device DRLM Listing
      Last Post or Poll Vote: 30th June 2015 08:34 PM by divineliving » Replies: 3
Which Internet Social Groups do you participate in?
      Last Post or Poll Vote: 30th June 2015 07:05 PM by qdelta9 » Replies: 58
How many Elsmar Covers does it take to change a light bulb?
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Suggested software for the Elsmar Cove substitute?
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Squeeze in one more - Rate of failure
      Last Post or Poll Vote: 30th June 2015 03:48 PM by Miner » Replies: 6
Does Medical Device Usability Study = Clinical Trial?
      Last Post or Poll Vote: 30th June 2015 03:39 PM by Julie O » Replies: 26
Recertification without setting targets.
      Last Post or Poll Vote: 30th June 2015 03:25 PM by John Broomfield » Replies: 3
21CFR820 as it was in 1993 or 1997?
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Creating an Internal Audit Schedule
      Last Post or Poll Vote: 30th June 2015 01:28 PM by Patricia Ravanello » Replies: 48
Light Emitting Devices
      Last Post or Poll Vote: 30th June 2015 10:48 AM by John Broomfield » Replies: 1
Are the ISO Standards actually required for health product registration on ANVISA?
      Last Post or Poll Vote: 30th June 2015 09:31 AM by rafaelbpa » Replies: 4
What is the difference between record and document?
      Last Post or Poll Vote: 30th June 2015 08:52 AM by qualityfox » Replies: 8

Welcome to the The Elsmar Cove Quality Assurance Discussion Forums.
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  Forum Last Post or Poll Vote Threads Posts
Manufacturing, Service, and Business Systems Processes
Please use these forums to discuss manufacturing, services, processes, materials and related Business Systems Process aspects.
Human Factors and Ergonomics in Engineering related discussions
55 583
Lean Manufacturing, including Lean in Service Industries, questions and discussions.
10th June 2015 04:26 AM Go to last post
491 4,506
Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
by ScottK
30th June 2015 08:15 AM Go to last post
1,158 8,214
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
20th May 2015 08:53 AM Go to last post
180 2,398
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
225 1,411
Service Industry specific and related discussions.
16th June 2015 09:20 AM Go to last post
188 1,380
National and International Business System Standards
This forum is for Aerospace and Aviation Standards and related Requirements.
25th June 2015 03:42 PM Go to last post
1,756 15,414
Business continuity planning (BCP) identifies an organization's exposure to internal and external threats and provides for effective prevention and recovery for the organization.
24th June 2015 09:46 PM Go to last post
42 305
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.
24th June 2015 05:36 AM Go to last post
328 1,945
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
30th June 2015 03:25 PM Go to last post
796 7,272
30th June 2015 08:34 PM Go to last post
1,107 5,996
All topics connected to Food management systems to include ISO 22000, Hazard Analysis and Critical Control Points (HACCP) and other related food safety systems.
16th May 2015 10:31 AM Go to last post
313 2,059
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 RoxaneB
18th March 2015 09:06 AM Go to last post
60 384
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
15th June 2015 02:59 AM Go to last post
114 627
IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
by B00M3R
9th June 2015 07:58 PM Go to last post
18 102
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
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...)
by subin
16th June 2015 01:57 PM Go to last post
261 2,881
Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
24th June 2015 11:43 AM Go to last post
86 764
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards and related discussions.
30th June 2015 08:52 AM Go to last post
4,885 59,430
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
30th June 2015 02:30 AM Go to last post
240 1,833
The ISO PAS 28001 addresses potential security issues at all stages of the supply process, thus targeting threats such as terrorism, fraud and piracy.
28th February 2013 12:26 AM Go to last post
6 26
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.
29th May 2015 11:25 AM Go to last post
56 406
In 2000, TS 16949 evolved from QS-9000. TS16949 is an automotive sector specific standard.
by lk2012
30th June 2015 06:39 AM Go to last post
2,838 22,960
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.
25th June 2015 03:48 AM Go to last post
99 668
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
21st June 2015 08:32 AM Go to last post
593 4,099
ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
by CBAL08
28th May 2015 08:28 AM Go to last post
597 3,597
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device, Medical Information Technology, Medical Software and Health Informatics and related discussion topics.
Medical device regulations around the world. Regulations are laws set by a regulatory authority of a country or region and are generally mandatory.
by Julie O
30th June 2015 09:43 PM Go to last post
3,110 19,333
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.
30th June 2015 10:48 AM Go to last post
3,188 23,791
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.
20th June 2015 02:17 AM Go to last post
28 119
Other various Medical Device and Orthopedic related discussions.
by Julie O
30th June 2015 03:39 PM Go to last post
267 1,669
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
21st May 2015 10:45 PM Go to last post
584 5,522
APQP and PPAP (1 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
by Marc
26th May 2015 01:48 PM Go to last post
864 6,226
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
1,767 24,097
Benchmarking Methods and Related General Discussions.
116 805
- - -
Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
by Bev D
22nd June 2015 09:32 AM Go to last post
421 3,736
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
Contract Review Process Discussions and Information
22nd October 2013 04:31 PM Go to last post
60 483
Dealing with Customer complaints/concerns.
by Bev D
28th April 2015 12:25 PM Go to last post
135 1,299
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
Process and Product Design and Development discussion discussions. Design Verification and Validation included.
by AndyN
24th June 2015 07:02 AM Go to last post
502 3,639
Documentation Systems (Document Control), including Procedures, Forms, and Templates.
24th June 2015 09:40 PM Go to last post
2,188 20,537
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
28th June 2015 10:34 AM Go to last post
830 6,705
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.
by Bev D
30th June 2015 08:49 AM Go to last post
4,101 30,298
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
by jager
29th June 2015 02:52 PM Go to last post
1,557 11,994
Management Review related Discussions and Information.
by Julie O
29th June 2015 12:46 PM Go to last post
144 2,095
- - -
Various other quality assurance and business systems related topics like Cost of Quality and other focused topics. Topics outside Quality and Environmental are allowed.
24th June 2015 12:31 PM Go to last post
750 7,375
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
by ramya
22nd June 2015 01:16 AM Go to last post
666 7,608
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
What is a Corrective Action vs. a Preventive Action?
1st June 2015 09:29 AM Go to last post
210 3,035
Principles and generic guidelines on Risk Management.
by Juzaili
16th September 2014 11:22 PM Go to last post
12 70
Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
19th June 2015 01:58 AM Go to last post
156 2,277
Quality Manual Development and Quality Systems Manual related Discussions.
23rd June 2015 12:46 PM Go to last post
275 4,067
Quality Manager and Quality Assurance Management Issues/questions
by SteveQM
9th June 2015 02:03 AM Go to last post
646 6,382
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 Miner
30th June 2015 07:50 AM Go to last post
1,600 12,789
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
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
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 mihzago
11th June 2015 08:46 PM Go to last post
218 1,134
SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
by Miner
30th June 2015 03:48 PM Go to last post
1,313 10,688
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
24th June 2015 12:49 AM Go to last post
661 5,699
Training and related topic discussions.
22nd June 2015 03:45 PM Go to last post
736 6,239
Registrars and National / International Organizations
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 AndyN
28th June 2015 08:25 AM Go to last post
232 2,958
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 - Papers - Articles - Etc.
This forum contains various information resources.
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.
26th June 2015 11:09 AM Go to last post
270 1,844
Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
26th October 2014 10:59 PM Go to last post
154 1,891
The $ Contributor's forum - Data files for folks who donate $ to help finance the Elsmar Cove Forums and Web Site. Donations are appreciated!
Sub-Forum(s): Outdated Threads
by J0anne
25th September 2013 09:49 AM Go to last post
36 126
Professional Employment and Occupation Related
Questions, discussions and comments about careers and occupations. Resume content and other information can be discussed here as well.
by lk2012
29th June 2015 12:24 PM Go to last post
793 10,922
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
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
28 286
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
15 40
Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
13th June 2015 08:42 AM Go to last post
381 3,220
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
1 1
Elsmar Cove Forum Essentials
Elsmar Cove Forum ToS (Terms of Service) and Policies are documented here.
25th June 2014 03:48 AM Go to last post
24 342
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 Marc
16th May 2015 10:48 AM Go to last post
108 855
Something new happening? Please post related topics here.
by BradM
24th June 2015 02:40 PM Go to last post
323 5,684
Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
30th June 2015 04:10 PM Go to last post
154 1,668
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
9 60
Elsmar Cove Forum Community Forums
Discussions of all sizes, shapes, forms and opinions that are NOT 'business' related. In short, Chit Chat and Community Discussions.
Looking for used equipment or trying to sell equipment? Books? Other stuff? Whatever. Post it here. PLEASE! NO COMMERCIAL ADVERTISEMENTS!
13th May 2015 01:48 PM Go to last post
246 1,124
Elsmar Cove Forum Community Discussions.
2,899 49,050
News! (1 Viewing)
17th June 2015 02:09 PM Go to last post
693 4,991
by qdelta9
30th June 2015 07:05 PM Go to last post
702 6,284

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