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Go to first new post Documenting Self-Training and Effectiveness - ISO 13485:2016
Last Post or Poll Vote: 21st August 2017 02:17 PM by rm3chris » Replies: 0 » Views: 26
Go to first new post AS9100 Rev D Quality Manual Rewritten - Feedback Appreciated
Last Post or Poll Vote: 21st August 2017 02:02 PM by J.Enger » Replies: 9 » Views: 916
Go to first new post ITAR Document Types and Training
Last Post or Poll Vote: 21st August 2017 01:24 PM by sspatriots » Replies: 5 » Views: 309
Go to first new post Does nonconforming product disposition include parts bought from the supplier?
Last Post or Poll Vote: 21st August 2017 01:21 PM by Golfman25 » Replies: 7 » Views: 97
Go to first new post VDA Trigger Matrix in the VDA 6.2 Manual - Interpretation and Use
Last Post or Poll Vote: 21st August 2017 12:40 PM by Dukesmom2 » Replies: 0 » Views: 29
Go to first new post INDIA - GSR 78 (E) - New Medical Device Rules - 2017
Last Post or Poll Vote: 21st August 2017 12:11 PM by mpfizer » Replies: 0 » Views: 42
Go to first new post Short Term vs. Long Term SPC Study - Where is Cp and Cpk Defined
Last Post or Poll Vote: 21st August 2017 12:04 PM by Bev D » Replies: 7 » Views: 164
Go to first new post SWOT Outputs - Risks, Opportunities and Improvements
Last Post or Poll Vote: 21st August 2017 09:38 AM by Jen Kirley » Replies: 1 » Views: 103
Go to first new post Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines
Last Post or Poll Vote: 21st August 2017 09:27 AM by jmlbell » Replies: 0 » Views: 38
Go to first new post IATF 16949 Cl. 8.6.6 - Acceptance Criteria - Zero Defects Attribute Data Sampling
Last Post or Poll Vote: 21st August 2017 09:18 AM by Johnnymo62 » Replies: 1 » Views: 60
Go to first new post ISO 9001:2015 - Required Processes and required Documented Processes
Last Post or Poll Vote: 21st August 2017 08:52 AM by Marc » Replies: 4 » Views: 197
Go to first new post Quality Assurance and Quality Control - Which clauses of ISO 9001 deal with each?
Last Post or Poll Vote: 21st August 2017 08:11 AM by ousgg » Replies: 2 » Views: 264
Go to first new post AS9100D Internal Audit Process Checklists
Last Post or Poll Vote: 21st August 2017 07:39 AM by Mike S. » Replies: 7 » Views: 148
Go to first new post Label Expiration Date - Single Use Combination Medical Device
Last Post or Poll Vote: 21st August 2017 06:30 AM by iceviper » Replies: 0 » Views: 46
Go to first new post Adverse Event Reported during Non-Approved Indication Use
Last Post or Poll Vote: 21st August 2017 03:40 AM by iVivien » Replies: 0 » Views: 48

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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
14th August 2017 03:47 PM Go to last post
59 641
Lean Manufacturing, including Lean in Service Industries, questions and discussions.
19th August 2017 06:41 AM Go to last post
502 4,611
Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
by Ninja
17th August 2017 10:52 AM Go to last post
1,209 8,605
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
15th August 2017 04:48 PM Go to last post
185 2,450
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
by Miner
16th August 2017 07:59 AM Go to last post
240 1,532
Service Industry specific and related discussions.
8th August 2017 03:25 PM Go to last post
197 1,436
National and International Business System Standards
by Big Jim
18th August 2017 12:28 PM Go to last post
1,899 16,511
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 JuneFoo
3rd August 2017 10:14 PM Go to last post
43 328
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 ernieto
16th August 2017 02:26 PM Go to last post
361 2,137
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
813 7,428
by jmlbell
21st August 2017 09:27 AM Go to last post
1,153 6,188
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").
21st August 2017 01:21 PM Go to last post
3,009 24,150
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
by Valli
5th August 2017 11:03 AM Go to last post
124 673
ISO 900x Quality Management Systems related discussions.
21st August 2017 09:38 AM Go to last post
5,127 61,874
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
10th August 2017 01:23 AM Go to last post
272 2,959
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
by jgdavis
10th August 2017 11:31 AM Go to last post
257 1,918
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.
21st August 2017 12:40 PM Go to last post
107 720
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
21st August 2017 01:24 PM Go to last post
619 4,250
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 3,622
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 mpfizer
21st August 2017 12:11 PM Go to last post
3,523 22,023
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 rothlis
19th August 2017 02:33 AM Go to last post
3,470 25,586
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.
by Marc
11th August 2017 01:07 PM Go to last post
294 1,820
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
1st August 2017 01:13 PM Go to last post
607 5,641
APQP and PPAP (16 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
by TPMB4
9th August 2017 11:39 AM Go to last post
898 6,438
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
by Big Jim
10th August 2017 08:52 PM Go to last post
1,823 24,682
Benchmarking (1 Viewing)
Benchmarking Methods and Related General Discussions.
17th August 2017 09:28 AM Go to last post
120 825
- - -
Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
by Jkuba
21st August 2017 03:10 AM Go to last post
438 3,860
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.
by howste
14th August 2017 10:40 AM Go to last post
144 1,362
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!
8th August 2017 02:57 PM Go to last post
454 3,153
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.
by QAMTY
19th August 2017 12:47 PM Go to last post
2,242 20,943
FMEA and Control Plans (13 Viewing)
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
by Miner
17th August 2017 08:26 AM Go to last post
866 6,940
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.
19th August 2017 04:11 AM Go to last post
4,332 31,917
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
18th August 2017 02:58 PM Go to last post
1,599 12,283
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
19th August 2017 04:38 AM Go to last post
775 7,470
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
19th August 2017 11:07 AM Go to last post
687 7,788
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?
4th August 2017 08:12 AM Go to last post
210 3,050
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.
by J.Enger
21st August 2017 02:02 PM Go to last post
277 4,144
Quality Manager and Quality Assurance Management Issues/questions
30th June 2017 01:03 PM Go to last post
655 6,510
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 Miner
14th August 2017 08:49 AM Go to last post
1,637 13,017
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 ricky07
8th August 2017 09:48 AM Go to last post
306 3,016
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.
1st August 2017 09:11 AM Go to last post
377 3,905
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 Bev D
21st August 2017 12:04 PM Go to last post
1,344 10,921
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
by Marc
20th August 2017 08:56 AM Go to last post
682 5,882
Training and related topic discussions.
21st August 2017 02:17 PM Go to last post
766 6,414
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.
by yodon
15th August 2017 03:36 PM Go to last post
240 3,022
The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
by Big Jim
29th July 2017 04:40 PM Go to last post
395 6,023
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
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.
20th August 2017 01:45 PM Go to last post
809 11,082
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!
by Marc
14th August 2017 03:55 AM Go to last post
20 49
Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.
11th August 2017 06:30 PM Go to last post
12 87
Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
19th August 2017 11:49 PM Go to last post
388 3,300
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 kostaus
11th August 2017 04:11 AM Go to last post
257 1,149
by Marc
16th August 2017 06:56 AM Go to last post
3,592 64,861
News! (3 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.
by Marc
3rd August 2017 01:55 PM Go to last post
165 1,775


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