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Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
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International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

Ajit Basrur
Claritas Consulting, LLC

International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Currently Active Discussions:
Go to first new post Medical Device Class 2A, non sterile bodyworn packaging requirements
Last Post or Poll Vote: 24th March 2018 12:56 AM by Ashwath » Replies: 2 » Views: 54
Go to first new post Escalation Process - IATF 16949 Clause
Last Post or Poll Vote: 23rd March 2018 07:45 PM by Marioalberto83 » Replies: 9 » Views: 1,984
Go to first new post Top 10 Major and minor NC's during IATF 16949:2016 Audits
Last Post or Poll Vote: 23rd March 2018 03:16 PM by Golfman25 » Replies: 6 » Views: 152
Go to first new post MSAs are now required on every feature of the control plan - IATF 16949
Last Post or Poll Vote: 23rd March 2018 02:49 PM by PruAngie » Replies: 13 » Views: 258
Go to first new post IATF 16949 Clause 10.2.4 - Error Proofing
Last Post or Poll Vote: 23rd March 2018 02:33 PM by Stijloor » Replies: 19 » Views: 5,907
Go to first new post Delivery Schedule Performance - IATF 16949 Cl.
Last Post or Poll Vote: 23rd March 2018 01:32 PM by Golfman25 » Replies: 3 » Views: 77
Go to first new post Corrective Action from Internal Audits not performed
Last Post or Poll Vote: 23rd March 2018 01:22 PM by AndyN » Replies: 7 » Views: 159
Go to first new post Applying for 510K - What is a significant process change and what is not
Last Post or Poll Vote: 23rd March 2018 11:48 AM by JasonDanner13 » Replies: 0 » Views: 45
Go to first new post Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
Last Post or Poll Vote: 23rd March 2018 11:45 AM by JasonDanner13 » Replies: 36 » Views: 30,177
Go to first new post Customer rejected MDS - easiest resolution?
Last Post or Poll Vote: 23rd March 2018 11:10 AM by Kimmy » Replies: 1 » Views: 82
Go to first new post Accelerated Stability Studies - Duration and Conditions - Class III Medical Device
Last Post or Poll Vote: 23rd March 2018 10:50 AM by Statistical Steven » Replies: 6 » Views: 14,248
Go to first new post Rules or guidelines for quoting FDA announcements and such?
Last Post or Poll Vote: 23rd March 2018 10:30 AM by katastic2908 » Replies: 0 » Views: 52
Go to first new post IATF bringing stakeholders together to ensure Transition by the 2018-09-14 deadline
Last Post or Poll Vote: 23rd March 2018 09:03 AM by Stijloor » Replies: 10 » Views: 1,858
Go to first new post IATF 16949 Stakeholder Event Presentations - London, UK - 7 March 2018
Last Post or Poll Vote: 23rd March 2018 08:56 AM by Stijloor » Replies: 0 » Views: 66
Go to first new post Medical device non sterile packaging requirement
Last Post or Poll Vote: 23rd March 2018 08:24 AM by noorain » Replies: 0 » Views: 56

Some Random Registered User Album Pictures
Air and Space museum in Paris
Howard Atkins
Air and Space museum in Paris
Southwestern VA in the Fall 2008
Southwestern VA in the Fall 2008
1st Centennary of the Mexican Revolution 1910-2010
1st Centennary of the Mexican Revolution 1910-2010
Just some fun pics
Just some fun pics
Image bucket
Sidney Vianna
Image bucket

Welcome to the The Elsmar Cove Business Systems and Standards 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
20th March 2018 05:57 AM Go to last post
61 657
Lean Manufacturing, including Lean in Service Industries, questions and discussions.
by Mike S.
12th February 2018 08:59 AM Go to last post
505 4,636
Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
21st March 2018 04:40 PM Go to last post
1,248 8,846
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
27th January 2018 11:44 AM Go to last post
186 2,469
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
8th March 2018 09:23 PM Go to last post
247 1,573
Service Industry specific and related discussions.
2nd February 2018 04:59 PM Go to last post
200 1,447
National and International Business System Standards
22nd March 2018 11:50 PM Go to last post
1,973 17,044
Business continuity planning (BCP) identifies an organization's exposure to internal and external threats and provides for effective prevention and recovery for the organization.
14th January 2018 11:28 AM Go to last post
45 341
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.
by Ashwath
24th March 2018 12:56 AM Go to last post
393 2,252
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
by Marc
1st March 2018 06:48 AM Go to last post
824 7,484
23rd March 2018 11:48 AM Go to last post
1,180 6,290
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 2017 06:43 AM Go to last post
321 2,093
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 pkost
8th February 2018 04:36 AM Go to last post
68 434
In 2000, TS 16949 evolved from QS-9000. In 2016 it became IATF 16949 (an automotive sector specific "standard").
23rd March 2018 07:45 PM Go to last post
3,128 25,263
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
19th March 2018 06:39 AM Go to last post
133 709
ISO 900x Quality Management Systems related discussions.
by AndyN
23rd March 2018 01:22 PM Go to last post
5,239 63,079
IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
15th December 2017 05:43 AM Go to last post
25 136
TL 9000 is a two book standard created by QuEST (Quality Excellence for Suppliers of Telecommunications) Forum based on ISO 9001.
by patkim
27th October 2017 06:00 PM Go to last post
47 315
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 Henria
21st March 2018 04:42 AM Go to last post
279 3,026
Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
20th March 2018 10:35 AM Go to last post
106 881
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
by Kimmy
23rd March 2018 11:10 AM Go to last post
265 1,953
The ISO PAS 28001 addresses potential security issues at all stages of the supply process, thus targeting threats such as terrorism, fraud and piracy.
21st December 2017 01:58 AM Go to last post
9 40
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.
30th December 2017 01:12 AM Go to last post
61 424
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.
16th March 2018 05:21 PM Go to last post
111 746
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
20th March 2018 11:15 AM Go to last post
630 4,315
ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
by qpled
5th March 2018 10:53 AM Go to last post
609 3,657
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device, Medical Information Technology, Medical Software and Health Informatics and related discussion topics.
23rd March 2018 11:45 AM Go to last post
3,718 23,076
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 DENich
23rd March 2018 03:46 AM Go to last post
3,633 26,650
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.
by csa14
8th December 2017 05:20 AM Go to last post
35 159
Other various Medical Device and Orthopedic related discussions.
305 1,868
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
by Marc
16th March 2018 12:11 PM Go to last post
612 5,668
APQP and PPAP (7 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
20th March 2018 12:57 PM Go to last post
906 6,497
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
22nd March 2018 03:42 PM Go to last post
1,862 25,033
Benchmarking Methods and Related General Discussions.
21st February 2018 11:36 AM Go to last post
121 832
- - -
Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
21st March 2018 08:16 AM Go to last post
444 3,918
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 ScottK
5th March 2018 11:53 AM Go to last post
119 1,294
Contract Review Process Discussions and Information
6th March 2018 05:25 PM Go to last post
63 496
Customer Complaints (2 Viewing)
Dealing with Customer complaints/concerns.
by Marc
28th February 2018 03:43 PM Go to last post
149 1,385
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!
12th March 2018 11:10 AM Go to last post
457 3,172
Process and Product Design and Development discussion discussions. Design Verification and Validation included.
3rd March 2018 11:38 AM Go to last post
520 3,719
Documentation Systems (Document Control), including Procedures, Forms, and Templates.
by ScottK
13th March 2018 09:18 AM Go to last post
2,261 21,097
FMEA and Control Plans (11 Viewing)
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
7th March 2018 12:56 PM Go to last post
884 7,086
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 Marc
22nd March 2018 07:11 PM Go to last post
4,417 32,436
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
by OmarEn
20th March 2018 12:00 AM Go to last post
1,624 12,417
Management Review related Discussions and Information.
by DeeDeeM
28th February 2018 05:58 AM Go to last post
154 2,216
- - -
Various other quality assurance and business systems related topics like Cost of Quality and other focused topics. Topics outside Quality and Environmental are allowed.
by Marc
18th March 2018 02:14 PM Go to last post
781 7,519
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
22nd March 2018 03:17 PM Go to last post
702 7,924
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.
by cal guy
21st March 2018 01:47 PM Go to last post
210 3,896
What is a Corrective Action vs. a Preventive Action?
by Bev D
9th January 2018 01:59 PM Go to last post
211 3,050
Principles and generic guidelines on Risk Management.
28th February 2018 10:48 AM Go to last post
17 101
Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
1st March 2018 04:49 PM Go to last post
166 2,385
Quality Manual Development and Quality Systems Manual related Discussions.
by titan4
19th January 2018 08:44 AM Go to last post
283 4,204
Quality Manager and Quality Assurance Management Issues/questions
by QuinnM
2nd March 2018 05:50 PM Go to last post
659 6,564
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 titan4
9th March 2018 08:54 AM Go to last post
1,652 13,115
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?
15th March 2018 12:11 PM Go to last post
310 3,067
Six Sigma (3 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.
by Miner
17th January 2018 08:58 AM Go to last post
378 3,911
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 yodon
19th March 2018 11:51 AM Go to last post
221 1,152
SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
4th March 2018 03:48 PM Go to last post
1,361 10,989
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
8th February 2018 11:42 PM Go to last post
688 5,924
Training and related topic discussions.
3rd March 2018 08:07 PM Go to last post
774 6,453
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.
11th January 2018 11:22 AM Go to last post
242 3,039
The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
by RCW
19th March 2018 03:21 PM Go to last post
404 6,170
Information Resources - Files - 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.
by reynald
12th September 2017 02:24 AM Go to last post
272 1,851
Various Uploaded Data and other Information Files
Sub-Forum(s): Outdated Threads
14th March 2018 01:48 PM Go to last post
36 123
Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
by Marc
26th January 2018 04:54 AM Go to last post
156 1,921
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 Ninja
12th March 2018 05:54 PM Go to last post
819 11,250
What hotels do you stay at? Have you traveled by train? Which airline do you prefer and why? Travel discussions, experiences, news and recommendations.
by john.b
10th January 2018 04:45 AM Go to last post
145 2,541
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.
3rd February 2018 07:40 AM Go to last post
29 296
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: Tier 1 Automotive Quality...
8th March 2018 04:19 PM Go to last post
20 51
Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.
20th January 2018 02:23 PM Go to last post
12 80
Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
8th March 2018 07:38 PM Go to last post
395 3,349
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!
28th February 2018 02:30 AM Go to last post
263 1,179
by Marc
22nd March 2018 03:54 PM Go to last post
2,983 50,214
News! (4 Viewing)
by Marc
23rd October 2017 11:26 AM Go to last post
710 5,063
by Marc
27th January 2018 06:17 PM Go to last post
721 6,526
Elsmar Cove Forum Essentials
Elsmar Cove Forum ToS (Terms of Service) and Policies are documented here.
by Randy
17th February 2018 02:37 PM Go to last post
30 354
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
24th January 2018 10:41 AM Go to last post
114 874
Something new happening? Please post related topics here.
by Miner
10th January 2018 10:37 AM Go to last post
327 5,694
Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
10th December 2017 10:44 AM Go to last post
169 1,794

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