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Currently Active Discussions:
Go to first new post "Parking" on the forum Home Page
Last Post or Poll Vote: 16th July 2018 02:34 AM by Marc » Replies: 6 » Views: 139
Go to first new post EU User manual / operator manual / service manual guidance document(s)
Last Post or Poll Vote: 16th July 2018 12:19 AM by shrutisancheti » Replies: 0 » Views: 29
Go to first new post Pressure requirement of home based Class II Medical Device
Last Post or Poll Vote: 15th July 2018 11:40 PM by ctct61t » Replies: 0 » Views: 27
Go to first new post Post Market Surveillance SOP - Word Version
Last Post or Poll Vote: 15th July 2018 10:09 PM by JOSEMELETH » Replies: 27 » Views: 21,671
Go to first new post IATF 16949 Clause Quality Management System Audit
Last Post or Poll Vote: 15th July 2018 08:10 PM by iatf16949vip » Replies: 4 » Views: 284
Go to first new post Virtual manufacturers/OEM - CE/ISO requirements
Last Post or Poll Vote: 15th July 2018 07:28 PM by pankracy » Replies: 2 » Views: 340
Go to first new post FDA regulations vs. IEC 60601-1 Labeling Requirements
Last Post or Poll Vote: 15th July 2018 10:15 AM by Java23 » Replies: 0 » Views: 76
Go to first new post Cleanrooms - Particle Measuring - ISO 14644
Last Post or Poll Vote: 15th July 2018 10:07 AM by Ninja » Replies: 2 » Views: 522
Go to first new post Auditing Product and Services doubts
Last Post or Poll Vote: 15th July 2018 03:25 AM by John Broomfield » Replies: 3 » Views: 122
Go to first new post "Fast action" claim and MDR (Medical Device Regulations)
Last Post or Poll Vote: 15th July 2018 03:17 AM by Marc » Replies: 1 » Views: 272
Go to first new post IVDD - IFU related requirements - Type of information/statement expected
Last Post or Poll Vote: 15th July 2018 03:15 AM by Marc » Replies: 1 » Views: 104
Go to first new post "It depends on the Auditor" Is excessive variation jeopardizing system certification?
Last Post or Poll Vote: 14th July 2018 07:54 PM by Jen Kirley » Replies: 30 » Views: 2,854
Go to first new post Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Last Post or Poll Vote: 14th July 2018 03:35 PM by qualprod » Replies: 63 » Views: 77,246
Go to first new post 510(k) Exempt OTC - Can we sell this device on Amazon?
Last Post or Poll Vote: 14th July 2018 09:43 AM by Oslap » Replies: 0 » Views: 84
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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
Manufacturing, services, processes, materials and related Business Systems Process aspect discussions.
Human Factors and Ergonomics in Engineering related discussions
18th June 2018 12:39 AM Go to last post
61 659
Lean Manufacturing, including Lean in Service Industry discussions.
by ngkjrs
24th May 2018 05:32 AM Go to last post
505 4,637
Specific manufacturing process(es) & systems, materials, and related discussions.
by Miner
10th July 2018 02:57 PM Go to last post
1,261 8,934
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.
6th June 2018 08:21 AM Go to last post
248 1,574
Service Industry specific and related discussions.
23rd April 2018 03:00 PM Go to last post
201 1,461
National and International Business System Standards
by Illek
13th July 2018 12:56 PM Go to last post
2,005 17,282
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.
16th July 2018 12:19 AM Go to last post
408 2,335
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
28th June 2018 09:55 AM Go to last post
835 7,547
by paulag
5th July 2018 04:32 AM Go to last post
1,186 6,327
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 vardag
28th May 2018 08:50 AM Go to last post
322 2,094
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").
15th July 2018 08:10 PM Go to last post
3,170 25,709
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
by AndyN
29th May 2018 11:17 AM Go to last post
136 721
ISO 900x Quality Management Systems related discussions.
5,279 63,559
IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
15th December 2017 05:43 AM Go to last post
25 136
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...)
279 3,048
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 carladu
9th July 2018 03:01 AM Go to last post
268 1,963
The ISO PAS 28001 addresses potential security issues at all stages of the supply process, thus targeting threats such as terrorism, fraud and piracy.
21st December 2017 01:58 AM Go to last post
9 40
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.
10th July 2018 05:02 AM Go to last post
115 759
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
11th July 2018 08:27 AM Go to last post
640 4,344
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.
by ctct61t
15th July 2018 11:40 PM Go to last post
3,832 23,587
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.
13th July 2018 01:53 PM Go to last post
3,743 27,354
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.
27th June 2018 10:27 AM Go to last post
37 174
Other various Medical Device and Orthopedic related discussions.
by Ninja
15th July 2018 10:07 AM Go to last post
308 1,888
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 (13 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
10th July 2018 05:16 AM Go to last post
912 6,538
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
by Marc
12th July 2018 02:49 PM Go to last post
1,871 25,134
Benchmarking (1 Viewing)
Benchmarking Methods and Related General Discussions.
21st February 2018 11:36 AM Go to last post
121 832
- - -
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 (5 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!
20th June 2018 08:28 AM Go to last post
458 3,176
Process and Product Design and Development discussion discussions. Design Verification and Validation included.
21st June 2018 09:13 AM Go to last post
523 3,737
Documentation Systems (Document Control), including Procedures, Forms, and Templates.
8th July 2018 09:02 AM Go to last post
2,265 21,143
FMEA and Control Plans (10 Viewing)
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
12th July 2018 12:03 PM Go to last post
891 7,130
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.
14th July 2018 03:11 AM Go to last post
4,448 32,651
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
6th July 2018 01:51 PM Go to last post
1,632 12,454
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?
by psp1234
7th July 2018 04:20 PM Go to last post
710 7,983
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.
24th April 2018 10:25 AM Go to last post
17 103
Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
29th May 2018 12:35 PM Go to last post
167 2,397
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
29th June 2018 02:56 PM Go to last post
660 6,574
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.
12th July 2018 08:07 AM Go to last post
1,662 13,194
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?
311 3,074
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.
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.
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.
by Ninja
25th June 2018 01:12 PM Go to last post
695 6,008
Training and related topic discussions.
by yodon
29th May 2018 01:16 PM Go to last post
777 6,465
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.
14th July 2018 07:54 PM Go to last post
407 6,213
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
14th March 2018 01:48 PM Go to last post
36 123
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!
Full Time Direct Hire: Fremont, CA - Quality Systems...
24th April 2018 05:25 PM Go to last post
22 53
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.
by Ettore
14th June 2018 08:27 AM Go to last post
396 3,362
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
11th July 2018 01:37 AM Go to last post
2,989 50,300
News! (2 Viewing)
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.
3rd July 2018 08:32 PM Go to last post
327 5,697
Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
by Marc
16th July 2018 02:34 AM Go to last post
172 1,808

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