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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

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:
Is anyone changing their 14001:2004 EMS Policy?
      Last Post or Poll Vote: 21st February 2017 12:39 PM by dsantos24 » Replies: 4
Writing a Pre-Submission to the FDA
      Last Post or Poll Vote: 21st February 2017 11:59 AM by RunningMommaCT » Replies: 3
"On An Annual Basis" - Definition
      Last Post or Poll Vote: 21st February 2017 11:21 AM by Marc » Replies: 7
Using a different Notified Body for ISO 13485 Certification & Device Certificate
      Last Post or Poll Vote: 21st February 2017 11:04 AM by Tatian » Replies: 6
PPAP Rejection for "MSA-GR&R are not using the latest AIAG format"
      Last Post or Poll Vote: 21st February 2017 11:01 AM by Golfman25 » Replies: 5
Gauge CAD certification to Part CAD vs. Gauge certification to Part CAD
      Last Post or Poll Vote: 21st February 2017 10:31 AM by biker6977 » Replies: 0
CE Marking of Robotic Devices which use 5 Bar Pneumatics
      Last Post or Poll Vote: 21st February 2017 10:26 AM by McQueenster » Replies: 2
Same Medical Device, Different Classifications By Different NB?
      Last Post or Poll Vote: 21st February 2017 09:49 AM by chris1price » Replies: 7
FDA Class I Medical Device Safety and Efficacy Data Requirements
      Last Post or Poll Vote: 21st February 2017 06:55 AM by Ronen E » Replies: 4
What is the relationship with the CSA group?
      Last Post or Poll Vote: 21st February 2017 04:11 AM by shimonv » Replies: 10
Research Use Only (RUO) Medical Devices in China
      Last Post or Poll Vote: 21st February 2017 03:19 AM by Jamiechina » Replies: 2
Solder Technician / Inspector - How to get Certified to NASA-STD-8739.3(.7)
      Last Post or Poll Vote: 21st February 2017 01:56 AM by soldertraining » Replies: 9
Breach of Contract from Registrar (Auditor Payment Issue)
      Last Post or Poll Vote: 20th February 2017 09:46 PM by Randy » Replies: 18
The Top Quality Questions
      Last Post or Poll Vote: 20th February 2017 04:19 PM by paccnc » Replies: 56
Heated Sealed Packages - Sample Size for OQ (Operational Qualification) and PQ
      Last Post or Poll Vote: 20th February 2017 03:03 PM by Learning Bob » Replies: 2

Some Random Registered User Album Pictures
Bangalore, my city walls get a facelift .....
Bangalore, my city walls get a facelift .....
From my USA business tour Oct 2011
From my USA business tour Oct 2011
37th Annual Cake Show in Bangalore
37th Annual Cake Show in Bangalore
Landmark structures in my city Bangalore ...
Landmark structures in my city Bangalore ...
Las vegas
Las vegas

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
12th February 2017 03:03 PM Go to last post
55 607
Lean Manufacturing, including Lean in Service Industries, questions and discussions.
by btu32s
14th February 2017 03:18 AM Go to last post
500 4,596
Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
17th February 2017 12:30 PM Go to last post
1,187 8,456
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
by _Jens_
13th January 2017 07:05 AM Go to last post
183 2,433
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
30th January 2017 01:34 PM Go to last post
233 1,498
Service Industry specific and related discussions.
2nd February 2017 01:21 PM Go to last post
195 1,416
National and International Business System Standards
20th February 2017 02:01 PM Go to last post
1,829 15,899
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 kgott
4th August 2016 11:02 PM Go to last post
42 323
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 Tatian
21st February 2017 11:04 AM Go to last post
345 2,061
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
21st February 2017 12:39 PM Go to last post
810 7,398
15th February 2017 07:19 PM Go to last post
1,136 6,114
All topics connected to Food management systems to include ISO 22000, Hazard Analysis and Critical Control Points (HACCP) and other related food safety systems.
by harry
22nd January 2017 10:07 AM Go to last post
319 2,087
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 Monirh
6th November 2016 01:45 PM Go to last post
65 401
In 2000, TS 16949 evolved from QS-9000. In 2016 it became IATF 16949 (an automotive sector specific "standard").
by Marc
18th February 2017 01:00 PM Go to last post
2,907 23,581
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
18th February 2017 02:35 PM Go to last post
122 667
ISO 900x Quality Management Systems related discussions.
by Mike S.
20th February 2017 08:51 AM Go to last post
5,010 60,839
IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
by Sguy84
8th November 2016 10:51 PM Go to last post
22 120
TL 9000 is a two book standard created by QuEST (Quality Excellence for Suppliers of Telecommunications) Forum based on ISO 9001.
by weabow
3rd October 2016 06:04 PM Go to last post
45 312
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...)
18th February 2017 11:29 AM Go to last post
271 2,942
Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
by harry
16th February 2017 08:47 PM Go to last post
99 826
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
23rd January 2017 09:02 AM Go to last post
248 1,882
The ISO PAS 28001 addresses potential security issues at all stages of the supply process, thus targeting threats such as terrorism, fraud and piracy.
by Bev D
11th January 2017 01:17 PM Go to last post
9 38
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.
7th February 2017 09:59 PM Go to last post
60 421
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.
by okamoto
15th February 2017 01:34 PM Go to last post
103 704
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
15th February 2017 09:31 PM Go to last post
608 4,197
ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
by Marc
16th February 2017 01:09 PM Go to last post
598 3,601
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device, Medical Information Technology, Medical Software and Health Informatics and related discussion topics.
21st February 2017 11:59 AM Go to last post
3,385 21,111
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 Marc
21st February 2017 11:21 AM Go to last post
3,341 24,761
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 shimonv
20th February 2017 02:25 AM Go to last post
33 138
Other various Medical Device and Orthopedic related discussions.
by Ronen E
3rd February 2017 08:48 PM Go to last post
285 1,766
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
15th December 2016 08:30 PM Go to last post
601 5,607
APQP and PPAP (15 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
21st February 2017 11:01 AM Go to last post
887 6,401
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
15th February 2017 01:53 PM Go to last post
1,806 24,523
Benchmarking (1 Viewing)
Benchmarking Methods and Related General Discussions.
by filen
20th February 2017 09:24 AM Go to last post
118 813
- - -
Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
by Bev D
31st January 2017 10:00 AM Go to last post
430 3,795
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.
16th February 2017 10:33 AM Go to last post
115 1,303
Contract Review Process Discussions and Information
7th February 2017 12:36 PM Go to last post
62 487
Customer Complaints (2 Viewing)
Dealing with Customer complaints/concerns.
22nd January 2017 12:49 PM Go to last post
141 1,332
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!
19th February 2017 02:35 AM Go to last post
452 3,131
Process and Product Design and Development discussion discussions. Design Verification and Validation included.
12th January 2017 12:12 PM Go to last post
509 3,680
Documentation Systems (Document Control), including Procedures, Forms, and Templates.
by Bayoo
19th February 2017 11:17 PM Go to last post
2,222 20,765
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
12th February 2017 12:37 PM Go to last post
852 6,848
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.
21st February 2017 10:31 AM Go to last post
4,267 31,504
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
20th February 2017 03:03 PM Go to last post
1,573 12,142
Management Review related Discussions and Information.
by Andrej
18th January 2017 08:58 AM Go to last post
146 2,120
- - -
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 paccnc
20th February 2017 04:19 PM Go to last post
762 7,427
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
14th February 2017 12:46 AM Go to last post
679 7,690
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 November 2016 12:35 PM Go to last post
210 3,038
Principles and generic guidelines on Risk Management.
by Mor628
15th December 2016 10:16 PM Go to last post
13 79
Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
16th February 2017 11:42 AM Go to last post
163 2,349
Quality Manual Development and Quality Systems Manual related Discussions.
17th February 2017 11:59 AM Go to last post
271 4,073
Quality Manager and Quality Assurance Management Issues/questions
6th February 2017 03:31 AM Go to last post
651 6,444
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 Eveons
14th February 2017 04:31 AM Go to last post
1,620 12,947
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?
21st December 2016 03:41 PM Go to last post
303 3,001
Six Sigma (5 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
2nd February 2017 05:46 PM Go to last post
375 3,902
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 Marc
29th November 2016 01:43 AM Go to last post
218 1,139
SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
15th February 2017 08:31 PM Go to last post
1,323 10,819
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
8th February 2017 12:21 PM Go to last post
677 5,856
Training and related topic discussions.
by bigqman
15th February 2017 05:01 PM Go to last post
755 6,356
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.
8th February 2017 09:06 AM Go to last post
238 3,010
The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
by Randy
20th February 2017 09:46 PM Go to last post
391 5,973
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 Mike S.
26th September 2016 07:55 AM Go to last post
271 1,849
Various Uploaded Data and other Information Files
Sub-Forum(s): Outdated Threads
by John P
29th August 2016 03:09 PM Go to last post
35 126
The Reading Room (1 Viewing)
Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
by bpritts
8th September 2016 12:36 PM Go to last post
155 1,898
Professional Employment and Occupation Related
Questions, discussions and comments about careers and occupations. Resume content and other information can be discussed here as well.
15th February 2017 06:09 AM Go to last post
803 11,045
What hotels do you stay at? Have you traveled by train? Which airline do you prefer and why? Travel discussions, experiences, news and recommendations.
25th July 2016 11:37 PM Go to last post
144 2,537
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 August 2016 11:33 PM Go to last post
29 290
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!
Contract Position: Freelance ISO 17025 (Chemist...
11th February 2017 10:39 AM Go to last post
15 43
Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.
by Julie O
25th November 2016 11:03 PM Go to last post
8 61
Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
21st February 2017 01:56 AM Go to last post
387 3,290
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!
by lihong
11th January 2017 12:35 PM Go to last post
252 1,138
16th February 2017 03:03 PM Go to last post
2,951 49,752
News! (4 Viewing)
18th January 2017 01:37 PM Go to last post
707 5,055
30th November 2016 09:06 AM Go to last post
715 6,485
Elsmar Cove Forum Essentials
Elsmar Cove Forum ToS (Terms of Service) and Policies are documented here.
15th December 2016 09:35 PM Go to last post
26 358
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 Ninja
13th January 2017 05:37 PM Go to last post
111 875
Something new happening? Please post related topics here.
by Marc
30th January 2017 08:31 AM Go to last post
326 5,690
Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
by Marc
14th November 2016 05:54 PM Go to last post
159 1,727

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