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Currently Active Discussions:
 
Go to first new post List of Contents - Medical Device - Interpreting EU Directive 93/42/EEC
Last Post or Poll Vote: 28th July 2017 06:55 AM by rob73 » Replies: 1 » Views: 41
Go to first new post Page Numbering requirement for DHR Report
Last Post or Poll Vote: 28th July 2017 04:38 AM by pkost » Replies: 2 » Views: 48
Go to first new post What level of control should be exercised on distributors?
Last Post or Poll Vote: 28th July 2017 04:31 AM by pkost » Replies: 9 » Views: 995
Go to first new post Proposed change to 3rd Party Audit Process - Limiting Scope of Audit
Last Post or Poll Vote: 28th July 2017 02:10 AM by Randy » Replies: 10 » Views: 242
Go to first new post Calibration and Verification requirement for foreign EASA Part 145
Last Post or Poll Vote: 28th July 2017 02:05 AM by AEOS_QA » Replies: 2 » Views: 54
Go to first new post Contract (Commitment) between Project Team and Production
Last Post or Poll Vote: 27th July 2017 10:52 PM by Seeldrayers » Replies: 13 » Views: 3,168
Go to first new post Mitutoyo LH-600E Motorized Height Gage, 112 Piece Metric Grade 00 Gage Blocks New
Last Post or Poll Vote: 27th July 2017 10:01 PM by thnksnow247 » Replies: 0 » Views: 29
Go to first new post Software for Medical Devices - Requirements Content for compliance with IEC 62304
Last Post or Poll Vote: 27th July 2017 04:07 PM by Mark Meer » Replies: 1 » Views: 42
Go to first new post Where to obtain training to program the Keyence Measurement System IM6120
Last Post or Poll Vote: 27th July 2017 01:58 PM by Gowithqlty1 » Replies: 0 » Views: 44
Go to first new post Is ISO 15254:2009 a requirement for China for ophthalmic products market?
Last Post or Poll Vote: 27th July 2017 12:13 PM by blah01 » Replies: 0 » Views: 47
Go to first new post Registration of Ophthalmic Optics Devices (Contact Lens) in China
Last Post or Poll Vote: 27th July 2017 12:06 PM by blah01 » Replies: 2 » Views: 1,845
Go to first new post Letter to your CEO on Quality
Last Post or Poll Vote: 27th July 2017 10:52 AM by Skpevans » Replies: 32 » Views: 14,702
Go to first new post FDA guidance for MDDS, Medical Images Storage, Medical Image Communications
Last Post or Poll Vote: 27th July 2017 10:38 AM by kreid » Replies: 12 » Views: 1,954
Go to first new post Preventative Action vs. Opportunity for Improvement
Last Post or Poll Vote: 27th July 2017 10:33 AM by xfngrs » Replies: 19 » Views: 11,894
Go to first new post FDA PreCert Program for Software (Companies) - 2017
Last Post or Poll Vote: 27th July 2017 10:32 AM by yodon » Replies: 0 » Views: 45

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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
29th June 2017 05:51 AM Go to last post
57 626
Lean Manufacturing, including Lean in Service Industries, questions and discussions.
19th July 2017 09:03 AM Go to last post
502 4,609
Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
by J Allen
12th July 2017 11:55 AM Go to last post
1,206 8,590
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
20th June 2017 08:06 AM Go to last post
185 2,448
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
by leaning
22nd July 2017 09:44 AM Go to last post
238 1,528
Service Industry specific and related discussions.
6th July 2017 05:55 PM Go to last post
197 1,434
National and International Business System Standards
by AEOS_QA
28th July 2017 02:05 AM Go to last post
1,890 16,436
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 howste
31st May 2017 09:21 AM Go to last post
42 325
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.
by rob73
28th July 2017 06:55 AM Go to last post
356 2,116
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
21st July 2017 08:07 PM Go to last post
813 7,424
27th July 2017 05:57 AM Go to last post
1,150 6,177
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 chris_j
11th June 2017 02:30 AM Go to last post
66 405
In 2000, TS 16949 evolved from QS-9000. In 2016 it became IATF 16949 (an automotive sector specific "standard").
27th July 2017 10:52 PM Go to last post
2,990 24,043
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
by john.b
16th June 2017 04:06 AM Go to last post
123 670
ISO 900x Quality Management Systems related discussions.
27th July 2017 07:06 AM Go to last post
5,114 61,753
IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
by john.b
25th April 2017 01:02 AM Go to last post
23 132
TL 9000 is a two book standard created by QuEST (Quality Excellence for Suppliers of Telecommunications) Forum based on ISO 9001.
by qusys
24th May 2017 10:53 AM Go to last post
46 314
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 NGurney
24th July 2017 02:36 AM Go to last post
272 2,957
Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
25th July 2017 02:12 AM Go to last post
102 854
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
24th July 2017 12:37 PM Go to last post
256 1,913
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 DeeDeeM
25th July 2017 03:19 AM Go to last post
106 719
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
20th July 2017 01:55 PM Go to last post
619 4,245
ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
by Omar.
1st July 2017 12:43 PM Go to last post
602 3,623
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 blah01
27th July 2017 12:13 PM Go to last post
3,504 21,856
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.
27th July 2017 04:07 PM Go to last post
3,446 25,420
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.
25th July 2017 06:32 PM Go to last post
33 140
Other various Medical Device and Orthopedic related discussions.
21st July 2017 02:53 AM Go to last post
293 1,816
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
16th July 2017 11:56 AM Go to last post
607 5,639
APQP and PPAP (10 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
18th July 2017 08:46 AM Go to last post
897 6,435
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
by cettina
26th July 2017 07:54 PM Go to last post
1,820 24,653
Benchmarking (3 Viewing)
Benchmarking Methods and Related General Discussions.
by BradM
6th June 2017 09:23 AM Go to last post
119 820
- - -
Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
by Miner
25th July 2017 03:24 PM Go to last post
436 3,852
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.
14th June 2017 09:05 PM Go to last post
114 1,278
Contract Review Process Discussions and Information
31st March 2017 07:06 PM Go to last post
62 488
Customer Complaints (1 Viewing)
Dealing with Customer complaints/concerns.
142 1,340
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!
by elkel
19th July 2017 03:06 PM Go to last post
454 3,152
Process and Product Design and Development discussion discussions. Design Verification and Validation included.
by leaning
20th July 2017 10:28 PM Go to last post
515 3,698
Documentation Systems (Document Control), including Procedures, Forms, and Templates.
25th July 2017 08:52 AM Go to last post
2,235 20,882
FMEA and Control Plans (15 Viewing)
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
by flagman
26th July 2017 02:12 PM Go to last post
866 6,936
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.
26th July 2017 10:38 AM Go to last post
4,326 31,857
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
21st July 2017 01:21 PM Go to last post
1,598 12,277
Management Review related Discussions and Information.
19th July 2017 10:34 AM Go to last post
151 2,185
- - -
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
27th July 2017 09:38 AM Go to last post
773 7,467
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
12th July 2017 09:55 AM Go to last post
687 7,783
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?
by xfngrs
27th July 2017 10:33 AM Go to last post
210 3,048
Principles and generic guidelines on Risk Management.
by Bonew
23rd June 2017 04:37 AM Go to last post
14 81
Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
17th May 2017 10:12 AM Go to last post
165 2,374
Quality Manual Development and Quality Systems Manual related Discussions.
12th July 2017 08:12 AM Go to last post
276 4,137
Quality Manager and Quality Assurance Management Issues/questions
30th June 2017 01:03 PM Go to last post
655 6,512
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 howste
24th July 2017 10:23 AM Go to last post
1,634 13,007
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 pkost
28th July 2017 04:38 AM Go to last post
305 3,008
Six Sigma (4 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
9th May 2017 07:51 AM Go to last post
376 3,904
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 Ninja
23rd May 2017 11:56 AM Go to last post
219 1,148
SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
by rmedi
21st July 2017 11:20 PM Go to last post
1,343 10,913
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
by pkost
28th July 2017 04:31 AM Go to last post
681 5,876
Training and related topic discussions.
27th July 2017 01:58 PM Go to last post
765 6,409
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.
14th July 2017 02:04 AM Go to last post
239 3,018
The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
by Randy
28th July 2017 02:10 AM Go to last post
395 6,014
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.
20th July 2017 12:28 PM Go to last post
273 1,858
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
35 120
The Reading Room (4 Viewing)
Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
27th July 2017 10:52 AM Go to last post
156 1,910
Professional Employment and Occupation Related
Questions, discussions and comments about careers and occupations. Resume content and other information can be discussed here as well.
24th July 2017 10:14 AM Go to last post
804 11,064
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
25th April 2017 01:40 AM Go to last post
145 2,539
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.
by john.b
16th June 2017 05:50 AM Go to last post
29 294
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!
I Say... Full Time Direct Hire: Risk management Leader -...
by tazer
21st April 2017 07:23 AM Go to last post
19 47
Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.
by Ronen E
5th June 2017 07:15 PM Go to last post
11 71
Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
30th June 2017 12:32 PM Go to last post
387 3,294
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!
27th July 2017 10:01 PM Go to last post
256 1,148
by Corca
25th July 2017 05:31 PM Go to last post
3,589 64,834
News! (1 Viewing)
18th June 2017 08:11 PM Go to last post
709 5,062
by Marc
16th July 2017 09:06 AM Go to last post
717 6,490
Elsmar Cove Forum Essentials
Elsmar Cove Forum ToS (Terms of Service) and Policies are documented here.
by Marc
25th February 2017 04:26 PM Go to last post
28 351
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.
23rd February 2017 09:03 PM Go to last post
112 875
Something new happening? Please post related topics here.
by DianaBC
6th July 2017 07:46 AM Go to last post
326 5,689
Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
20th July 2017 05:38 PM Go to last post
164 1,765


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