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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:
Interesting Purchase Order for its Terms and Conditions
      Last Post or Poll Vote: 9th December 2016 04:31 PM by Ninja » Replies: 38
MEDDEV 2.7/1 rev.4 published - June 2016
      Last Post or Poll Vote: 9th December 2016 04:04 PM by Chrisx » Replies: 15
Migrating to an ISO 13485:2016 Compliant Document Control System
      Last Post or Poll Vote: 9th December 2016 03:55 PM by gretzles » Replies: 6
Evolving Quality Levels - Expectations for Lowered Defect Levels
      Last Post or Poll Vote: 9th December 2016 03:05 PM by Ninja » Replies: 21
Calibration and Testing Laboratory Startup Consultation Services
      Last Post or Poll Vote: 9th December 2016 02:34 PM by Ninja » Replies: 1
Sampling Plan questions from CQE practice exam
      Last Post or Poll Vote: 9th December 2016 01:55 PM by JeantheBigone » Replies: 0
How to put in place a Risk Assessment of Vulnerabilities & Corruption...
      Last Post or Poll Vote: 9th December 2016 12:17 PM by ncwalker » Replies: 2
Terms "Customer-directed sources" and "Directed-Buy"
      Last Post or Poll Vote: 9th December 2016 12:03 PM by ncwalker » Replies: 3
Is APQP Required for All Projects?
      Last Post or Poll Vote: 9th December 2016 11:57 AM by ncwalker » Replies: 4
Safety Instruction Card and Safety Work Instruction
      Last Post or Poll Vote: 9th December 2016 10:58 AM by howste » Replies: 2
Employee Training Database wanted
      Last Post or Poll Vote: 9th December 2016 10:24 AM by howste » Replies: 112
Update of SOPs for ISO 13485:2016 / MDSAP
      Last Post or Poll Vote: 9th December 2016 10:04 AM by cdhoopes » Replies: 5
Subcontractor site in EC certificate
      Last Post or Poll Vote: 9th December 2016 06:37 AM by Pang Chia Boon » Replies: 2
Happy Birthday BradM!
      Last Post or Poll Vote: 9th December 2016 12:02 AM by somashekar » Replies: 3
How do you handle damaged IM&TE in your organization?
      Last Post or Poll Vote: 9th December 2016 12:00 AM by somashekar » Replies: 2

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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
by Monirh
5th November 2016 01:51 PM Go to last post
55 602
Lean Manufacturing, including Lean in Service Industries, questions and discussions.
23rd November 2016 02:32 PM Go to last post
496 4,559
Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
7th December 2016 07:15 PM Go to last post
1,186 8,426
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
2nd December 2016 10:26 AM Go to last post
183 2,424
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
6th December 2016 06:59 AM Go to last post
233 1,495
Service Industry specific and related discussions.
21st November 2016 10:31 AM Go to last post
194 1,413
National and International Business System Standards
by al40
8th December 2016 09:31 AM Go to last post
1,812 15,773
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 Ronen E
6th December 2016 09:14 PM Go to last post
340 2,020
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
by Randy
21st November 2016 11:14 AM Go to last post
808 7,377
6th December 2016 08:29 PM Go to last post
1,131 6,091
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 ronoele
4th December 2016 08:13 PM Go to last post
316 2,078
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").
9th December 2016 12:03 PM Go to last post
2,879 23,375
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
14th November 2016 01:51 AM Go to last post
121 657
ISO 900x Quality Management Systems related discussions.
8th December 2016 06:17 PM Go to last post
4,969 60,460
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...)
by baljit1
15th November 2016 03:49 AM Go to last post
269 2,928
Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
29th November 2016 06:57 PM Go to last post
97 814
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
by Alex73
20th November 2016 03:51 PM Go to last post
247 1,879
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.
9th December 2016 12:17 PM Go to last post
59 420
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
29th November 2016 10:55 AM Go to last post
102 700
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
7th December 2016 02:46 AM Go to last post
604 4,180
ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
16th November 2016 10:35 PM Go to last post
596 3,589
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device, Medical Information Technology, Medical Software and Health Informatics and related discussion topics.
by Chrisx
9th December 2016 04:04 PM Go to last post
3,321 20,691
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.
9th December 2016 03:55 PM Go to last post
3,301 24,492
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 paulag
5th December 2016 09:11 AM Go to last post
30 128
Other various Medical Device and Orthopedic related discussions.
by Metron
4th December 2016 08:37 AM Go to last post
282 1,754
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
8th December 2016 02:02 AM Go to last post
600 5,597
APQP and PPAP (10 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
9th December 2016 11:57 AM Go to last post
882 6,369
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
5th December 2016 01:42 AM Go to last post
1,796 24,446
Benchmarking Methods and Related General Discussions.
by Marc
6th November 2016 01:56 PM Go to last post
118 809
- - -
Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
8th December 2016 05:59 AM Go to last post
426 3,773
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 Julie O
17th November 2016 10:34 PM Go to last post
112 1,269
Contract Review Process Discussions and Information
28th August 2016 02:19 AM Go to last post
61 485
Customer Complaints (2 Viewing)
Dealing with Customer complaints/concerns.
28th October 2016 09:50 AM Go to last post
138 1,317
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!
7th November 2016 06:50 AM Go to last post
452 3,128
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 howste
9th December 2016 10:58 AM Go to last post
2,214 20,706
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
24th November 2016 11:10 AM Go to last post
846 6,817
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 Ninja
9th December 2016 02:34 PM Go to last post
4,244 31,379
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
by Ninja
9th December 2016 03:05 PM Go to last post
1,571 12,125
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.
24th October 2016 12:52 PM Go to last post
758 7,402
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
by msr0143
8th December 2016 09:51 PM Go to last post
674 7,668
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 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.
30th November 2016 10:46 AM Go to last post
162 2,337
Quality Manual Development and Quality Systems Manual related Discussions.
6th December 2016 04:03 PM Go to last post
271 4,071
Quality Manager and Quality Assurance Management Issues/questions
by Ninja
9th December 2016 04:31 PM Go to last post
649 6,426
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.
5th December 2016 08:05 PM Go to last post
1,617 12,930
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?
by 6 SIGMA
26th October 2016 02:49 PM Go to last post
303 3,000
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
18th November 2016 09:01 AM Go to last post
373 3,894
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!
by v9991
31st October 2016 11:39 PM Go to last post
1,320 10,757
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
7th December 2016 09:14 PM Go to last post
675 5,837
Training and related topic discussions.
by mgcm1
28th November 2016 08:32 AM Go to last post
750 6,323
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.
26th October 2016 04:01 PM Go to last post
237 3,006
The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
by Marc
6th December 2016 02:18 PM Go to last post
388 5,929
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
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.
28th November 2016 01:59 PM Go to last post
800 11,025
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.
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.
6th December 2016 11:07 AM Go to last post
385 3,255
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 howste
21st November 2016 11:05 AM Go to last post
111 872
Something new happening? Please post related topics here.
by Marc
6th November 2016 02:03 PM Go to last post
324 5,686
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
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!
4th December 2016 08:35 PM Go to last post
250 1,133
9th December 2016 12:02 AM Go to last post
2,933 49,574
News! (1 Viewing)
by Marc
28th October 2016 11:45 PM Go to last post
703 5,032
30th November 2016 09:06 AM Go to last post
715 6,485

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