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Currently Active Discussions:
 
Go to first new post Questions about the Risk-based approach to QMS processes
Last Post or Poll Vote: 16th August 2018 02:39 AM by RichardJ_CH » Replies: 8 » Views: 961
Go to first new post Importing Medical devices class I in EU
Last Post or Poll Vote: 16th August 2018 02:21 AM by sss16 » Replies: 0 » Views: 10
Go to first new post Is something happening with Linkedin "Groups"? July 2018
Last Post or Poll Vote: 16th August 2018 01:02 AM by Marc » Replies: 7 » Views: 1,100
Go to first new post AIAG's IATF 16949 section 7.1.5.1.1 - Torque MSA Requirement
Last Post or Poll Vote: 15th August 2018 11:10 PM by CorpMetro » Replies: 8 » Views: 1,091
Go to first new post ISO 45001:2018 - Occupational Health and Safety Management Standard
Last Post or Poll Vote: 15th August 2018 10:16 PM by Randy » Replies: 73 » Views: 28,768
Go to first new post Medical device file for components such as adhesives, gaskets, films, etc.?
Last Post or Poll Vote: 15th August 2018 06:16 PM by cubix rube » Replies: 3 » Views: 83
Go to first new post Control of outsourced processes - drop shipped products
Last Post or Poll Vote: 15th August 2018 05:43 PM by qualprod » Replies: 2 » Views: 76
Go to first new post Expiry date vs. Best Before Date - Reagents
Last Post or Poll Vote: 15th August 2018 03:15 PM by Edward Reesor » Replies: 9 » Views: 273
Go to first new post We are planning to sell a Medical Device Group
Last Post or Poll Vote: 15th August 2018 03:02 PM by Marcelo Antunes » Replies: 1 » Views: 59
Go to first new post How do you approach the "Safe Launch" Process
Last Post or Poll Vote: 15th August 2018 01:58 PM by ncwalker » Replies: 15 » Views: 8,837
Go to first new post Test Certificate Validation
Last Post or Poll Vote: 15th August 2018 01:51 PM by Sidney Vianna » Replies: 2 » Views: 82
Go to first new post Software validation (4.1.6 ISO 13485:2016)
Last Post or Poll Vote: 15th August 2018 12:12 PM by Marcelo Antunes » Replies: 1 » Views: 58
Go to first new post Transport validation to different climate zones
Last Post or Poll Vote: 15th August 2018 11:25 AM by Wolf.K » Replies: 2 » Views: 93
Go to first new post Medical Devices in Japan - Conformity of QMS to ISO 13485
Last Post or Poll Vote: 15th August 2018 10:55 AM by JeantheBigone » Replies: 0 » Views: 34
Go to first new post Looking for English Copy of MHLW 169 regulation
Last Post or Poll Vote: 15th August 2018 10:46 AM by JeantheBigone » Replies: 5 » Views: 1,433

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Little River Falls and Canyon, DeKalb County, Alabama
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Fruit, Veggie, & Wire poses
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Red Sea Reef

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
Manufacturing, services, processes, materials and related Business Systems Process aspect discussions.
Human Factors and Ergonomics in Engineering related discussions
14th August 2018 08:52 AM Go to last post
62 664
Lean Manufacturing, including Lean in Service Industry discussions.
10th August 2018 03:50 AM Go to last post
505 4,638
Specific manufacturing process(es) & systems, materials, and related discussions.
15th August 2018 05:18 AM Go to last post
1,265 8,956
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
by AndyN
19th June 2018 04:11 PM Go to last post
189 2,492
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
27th July 2018 03:56 PM Go to last post
249 1,580
Service Industry specific and related discussions.
15th August 2018 01:51 PM Go to last post
203 1,466
National and International Business System Standards
14th August 2018 02:19 PM Go to last post
2,019 17,371
Business continuity planning (BCP) identifies an organization's exposure to internal and external threats and provides for effective prevention and recovery for the organization.
14th January 2018 11:28 AM Go to last post
45 341
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.
14th August 2018 05:20 PM Go to last post
412 2,347
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
24th July 2018 06:10 AM Go to last post
838 7,560
14th August 2018 10:20 AM Go to last post
1,191 6,354
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 Deli88
1st August 2018 10:44 AM Go to last post
322 2,095
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.
9th June 2018 08:16 AM Go to last post
69 436
In 2000, TS 16949 evolved from QS-9000. In 2016 it became IATF 16949 (an automotive sector specific "standard").
by Hendor
13th August 2018 04:51 PM Go to last post
3,180 25,839
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
9th August 2018 02:48 PM Go to last post
139 733
ISO 900x Quality Management Systems related discussions.
15th August 2018 05:43 PM Go to last post
5,287 63,662
IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
23rd July 2018 11:21 AM Go to last post
25 143
TL 9000 is a two book standard created by QuEST (Quality Excellence for Suppliers of Telecommunications) Forum based on ISO 9001.
by patkim
27th October 2017 06:00 PM Go to last post
47 315
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 Randy
15th August 2018 10:16 PM Go to last post
279 3,059
Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
106 891
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
by Kimmy
25th July 2018 10:44 AM Go to last post
270 1,972
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 yodon
23rd July 2018 12:10 PM Go to last post
10 42
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.
30th December 2017 01:12 AM Go to last post
61 424
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.
23rd July 2018 01:47 AM Go to last post
115 765
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
27th July 2018 09:03 AM Go to last post
642 4,347
ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
12th July 2018 12:38 AM Go to last post
614 3,686
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device, Medical Information Technology, Medical Software and Health Informatics and related discussion topics.
15th August 2018 03:02 PM Go to last post
3,871 23,774
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.
16th August 2018 02:39 AM Go to last post
3,779 27,582
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 QuinnM
8th August 2018 05:08 PM Go to last post
39 182
Other various Medical Device and Orthopedic related discussions.
by sss16
16th August 2018 02:21 AM Go to last post
310 1,893
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
10th July 2018 06:14 PM Go to last post
617 5,701
APQP and PPAP (5 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
15th August 2018 01:58 PM Go to last post
912 6,550
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
10th August 2018 07:30 AM Go to last post
1,876 25,168
Benchmarking (1 Viewing)
Benchmarking Methods and Related General Discussions.
21st February 2018 11:36 AM Go to last post
121 833
- - -
Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
12th July 2018 08:32 AM Go to last post
448 3,933
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.
20th April 2018 01:54 PM Go to last post
120 1,296
Contract Review Process Discussions and Information
by Mike S.
2nd April 2018 11:15 AM Go to last post
64 500
Customer Complaints (2 Viewing)
Dealing with Customer complaints/concerns.
149 1,391
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!
31st July 2018 12:46 PM Go to last post
460 3,182
Process and Product Design and Development discussion discussions. Design Verification and Validation included.
14th August 2018 06:58 AM Go to last post
524 3,738
Documentation Systems (Document Control), including Procedures, Forms, and Templates.
14th August 2018 02:06 AM Go to last post
2,268 21,156
FMEA and Control Plans (12 Viewing)
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
13th August 2018 03:55 AM Go to last post
892 7,144
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.
15th August 2018 11:10 PM Go to last post
4,456 32,733
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
by pmanmuk
1st August 2018 04:49 PM Go to last post
1,634 12,466
Management Review related Discussions and Information.
by DeeDeeM
28th February 2018 05:58 AM Go to last post
154 2,216
- - -
Various other quality assurance and business systems related topics like Cost of Quality and other focused topics. Topics outside Quality and Environmental are allowed.
4th June 2018 09:25 AM Go to last post
784 7,548
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
9th August 2018 12:50 AM Go to last post
712 8,005
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.
by Ninja
28th March 2018 01:16 PM Go to last post
210 3,900
What is a Corrective Action vs. a Preventive Action?
by qcman
25th May 2018 04:41 PM Go to last post
212 3,056
Principles and generic guidelines on Risk Management.
13th August 2018 10:54 AM Go to last post
17 108
Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
1st August 2018 12:35 PM Go to last post
168 2,407
Quality Manual Development and Quality Systems Manual related Discussions.
23rd May 2018 02:51 PM Go to last post
283 4,208
Quality Manager and Quality Assurance Management Issues/questions
3rd August 2018 12:56 PM Go to last post
660 6,575
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.
14th August 2018 09:58 AM Go to last post
1,666 13,227
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?
28th July 2018 10:05 PM Go to last post
311 3,084
Six Sigma (2 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 Bev D
14th May 2018 01:00 PM Go to last post
378 3,915
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 TCHQA
9th July 2018 03:59 AM Go to last post
222 1,157
SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
by Matt33
12th July 2018 09:30 AM Go to last post
1,375 11,083
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
31st July 2018 09:45 AM Go to last post
697 6,022
Training and related topic discussions.
12th August 2018 05:31 AM Go to last post
779 6,471
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 tampk
9th July 2018 09:18 AM Go to last post
241 3,040
The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
by Marc
10th August 2018 07:53 PM Go to last post
413 6,264
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.
18th April 2018 08:28 AM Go to last post
272 1,852
Various Uploaded Data and other Information Files
Sub-Forum(s): Outdated Threads
31st July 2018 10:47 PM Go to last post
37 126
Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
12th July 2018 06:41 PM Go to last post
157 1,949
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 Donetta
6th July 2018 05:05 PM Go to last post
824 11,306
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
10th January 2018 04:45 AM Go to last post
145 2,541
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.
3rd February 2018 07:40 AM Go to last post
29 296
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!
14th August 2018 02:07 AM Go to last post
23 57
Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.
20th January 2018 02:23 PM Go to last post
12 80
Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
2nd August 2018 08:27 AM Go to last post
398 3,369
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!
3rd July 2018 08:09 AM Go to last post
270 1,201
by Marc
16th August 2018 01:02 AM Go to last post
2,991 50,311
by Marc
23rd October 2017 11:26 AM Go to last post
710 5,063
by Manix
29th June 2018 02:24 PM Go to last post
722 6,534
Elsmar Cove Forum Essentials
Elsmar Cove Forum ToS (Terms of Service) and Policies are documented here.
by Randy
17th February 2018 02:37 PM Go to last post
30 354
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
1st May 2018 08:50 PM Go to last post
116 878
Something new happening? Please post related topics here.
by Marc
14th August 2018 02:42 PM Go to last post
328 5,716
Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
by Marc
17th July 2018 03:00 PM Go to last post
172 1,813


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