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Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

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

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IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Currently Active Discussions:
New EU Medical Device Regulations - Q1/2 2017 and Human Factors
      Last Post or Poll Vote: 24th October 2016 02:56 AM by Tobias_HF » Replies: 7
Organizing Risk Analysis and Controls for a New Medical Device (ISO 14971)
      Last Post or Poll Vote: 24th October 2016 02:20 AM by Gert Sorensen » Replies: 1
What is the relationship with the CSA group?
      Last Post or Poll Vote: 24th October 2016 01:55 AM by MDD_QNA » Replies: 8
ISO 9001 Ergonomics and Manual Handling Requirements
      Last Post or Poll Vote: 24th October 2016 01:30 AM by auditorsos » Replies: 7
Receiving Goods Inwards - Identification
      Last Post or Poll Vote: 24th October 2016 12:59 AM by auditorsos » Replies: 0
How to Convert Micro Volts into Temperature Uncertainty
      Last Post or Poll Vote: 24th October 2016 12:08 AM by neoth » Replies: 0
Looking for an example of Issues Log
      Last Post or Poll Vote: 23rd October 2016 09:59 PM by randomname » Replies: 1
EU Definition of Labeling or the meaning of the MDD (Medical Devices)
      Last Post or Poll Vote: 23rd October 2016 06:56 PM by Marcelo Antunes » Replies: 5
ISO/IEC 27001:2016 Overview and Vocabulary - FREE!
      Last Post or Poll Vote: 23rd October 2016 06:46 PM by Ajit Basrur » Replies: 2
6 Requirements for an ISO 9001:2015 Transition Audit
      Last Post or Poll Vote: 23rd October 2016 06:30 PM by Kales Veggie » Replies: 12
What is Ethics Escalation (“Whistle-Blowing”) Policy - Corporate Responsibility
      Last Post or Poll Vote: 23rd October 2016 01:41 PM by Sidney Vianna » Replies: 2
Scheduling IATF 16949 Audits - Audit Man-Days
      Last Post or Poll Vote: 23rd October 2016 10:14 AM by Howard Atkins » Replies: 7
Gage R&R - Is my sheet calculation wrong?
      Last Post or Poll Vote: 23rd October 2016 10:07 AM by kedarg6500 » Replies: 0
Transition Audits - AS9100 Revision D
      Last Post or Poll Vote: 22nd October 2016 08:21 PM by Sidney Vianna » Replies: 3
Update our PFMEA update after Supplier updates their PFMEA
      Last Post or Poll Vote: 22nd October 2016 11:06 AM by Booker » Replies: 0

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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
18th October 2016 12:10 PM Go to last post
55 598
Lean Manufacturing, including Lean in Service Industries, questions and discussions.
20th October 2016 05:19 PM Go to last post
493 4,531
Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
22nd October 2016 01:35 AM Go to last post
1,182 8,406
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
9th September 2016 09:41 AM Go to last post
182 2,418
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
by Bev D
21st October 2016 01:19 PM Go to last post
232 1,471
Service Industry specific and related discussions.
by Marc
21st October 2016 02:59 AM Go to last post
192 1,406
National and International Business System Standards
22nd October 2016 08:21 PM Go to last post
1,795 15,690
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 Marc
19th August 2016 03:40 PM Go to last post
43 325
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.
18th October 2016 12:18 PM Go to last post
337 2,013
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
by Randy
18th October 2016 08:15 PM Go to last post
806 7,368
21st October 2016 06:48 PM Go to last post
1,124 6,061
All topics connected to Food management systems to include ISO 22000, Hazard Analysis and Critical Control Points (HACCP) and other related food safety systems.
11th August 2016 09:55 PM Go to last post
315 2,070
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.
21st August 2016 05:49 PM Go to last post
64 399
In 2000, TS 16949 evolved from QS-9000. In 2016 it became IATF 16949 (an automotive sector specific "standard").
23rd October 2016 01:41 PM Go to last post
2,857 23,237
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
23rd October 2016 06:46 PM Go to last post
119 652
ISO 900x Quality Management Systems related discussions.
24th October 2016 01:30 AM Go to last post
4,948 60,326
IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
7th September 2016 03:25 PM Go to last post
22 119
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...)
30th September 2016 12:52 PM Go to last post
266 2,920
Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
6th October 2016 09:45 AM Go to last post
96 805
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
by sinned
19th October 2016 05:21 AM Go to last post
246 1,873
The ISO PAS 28001 addresses potential security issues at all stages of the supply process, thus targeting threats such as terrorism, fraud and piracy.
19th September 2016 03:17 AM Go to last post
8 34
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.
24th August 2016 10:34 AM Go to last post
58 417
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 plliew
21st October 2016 03:38 AM Go to last post
102 693
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
by paulag
7th October 2016 01:46 AM Go to last post
600 4,168
ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
20th October 2016 11:27 AM Go to last post
596 3,588
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device, Medical Information Technology, Medical Software and Health Informatics and related discussion topics.
24th October 2016 01:55 AM Go to last post
3,276 20,393
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.
24th October 2016 02:56 AM Go to last post
3,270 24,299
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
Other various Medical Device and Orthopedic related discussions.
by SteveK
19th October 2016 03:56 AM Go to last post
280 1,738
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
12th October 2016 08:45 AM Go to last post
594 5,547
APQP and PPAP (20 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
by Marc
20th October 2016 07:05 AM Go to last post
877 6,313
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
by LMills
20th October 2016 08:49 AM Go to last post
1,790 24,376
Benchmarking (3 Viewing)
Benchmarking Methods and Related General Discussions.
by Marc
4th June 2016 05:51 AM Go to last post
116 806
- - -
Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
23rd September 2016 08:29 AM Go to last post
424 3,764
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 Hershal
10th July 2016 01:34 PM Go to last post
110 1,254
Contract Review Process Discussions and Information
28th August 2016 02:19 AM Go to last post
61 485
Customer Complaints (1 Viewing)
Dealing with Customer complaints/concerns.
14th September 2016 11:30 AM Go to last post
137 1,316
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!
14th October 2016 06:12 AM Go to last post
451 3,123
Process and Product Design and Development discussion discussions. Design Verification and Validation included.
by yodon
22nd September 2016 09:41 AM Go to last post
507 3,660
Documentation Systems (Document Control), including Procedures, Forms, and Templates.
by Marc
19th October 2016 09:47 AM Go to last post
2,210 20,679
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
by Booker
22nd October 2016 11:06 AM Go to last post
844 6,807
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 neoth
24th October 2016 12:08 AM Go to last post
4,229 31,273
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
by Ninja
18th October 2016 08:49 AM Go to last post
1,567 12,081
Management Review related Discussions and Information.
23rd September 2016 02:37 PM Go to last post
145 2,103
- - -
Various other quality assurance and business systems related topics like Cost of Quality and other focused topics. Topics outside Quality and Environmental are allowed.
3rd October 2016 09:58 AM Go to last post
758 7,405
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
by Mike_H
27th July 2016 06:26 PM Go to last post
673 7,665
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?
2nd October 2016 05:39 PM Go to last post
210 3,036
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.
24th June 2016 11:51 AM Go to last post
157 2,294
Quality Manual Development and Quality Systems Manual related Discussions.
by SteveK
17th October 2016 06:39 AM Go to last post
271 4,069
Quality Manager and Quality Assurance Management Issues/questions
by Mike S.
17th October 2016 08:12 AM Go to last post
649 6,420
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.
19th October 2016 06:18 PM Go to last post
1,610 12,875
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?
24th October 2016 12:59 AM Go to last post
303 2,993
Six Sigma (7 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
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.
218 1,138
SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
by Bev D
19th October 2016 01:31 PM Go to last post
1,319 10,743
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
20th October 2016 04:07 PM Go to last post
670 5,781
Training and related topic discussions.
6th October 2016 11:55 AM Go to last post
744 6,296
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.
19th October 2016 01:06 PM Go to last post
237 3,004
The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
11th October 2016 04:15 AM Go to last post
385 5,906
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.
by Ronen E
30th September 2016 08:31 PM Go to last post
797 11,013
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!
15th October 2016 08:48 AM Go to last post
12 33
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
8 57
Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
by David-D
10th October 2016 01:50 PM Go to last post
384 3,250
Elsmar Cove Forum Essentials
Elsmar Cove Forum ToS (Terms of Service) and Policies are documented here.
by John P
5th June 2016 10:33 AM Go to last post
25 356
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
25th August 2016 08:42 AM Go to last post
111 870
Something new happening? Please post related topics here.
by Marc
2nd October 2016 01:17 AM Go to last post
323 5,684
Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
by Marc
26th September 2016 03:09 PM Go to last post
157 1,723
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!
22nd October 2016 09:38 AM Go to last post
248 1,130
by BradM
20th October 2016 12:08 AM Go to last post
2,923 49,504
News! (1 Viewing)
12th September 2016 09:57 PM Go to last post
702 5,031
31st August 2016 05:18 AM Go to last post
714 6,483

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