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Currently Active Discussions:
Go to first new post Internal Audits performed by another local business
Last Post or Poll Vote: 21st February 2018 09:19 AM by SpinDr99 » Replies: 12 » Views: 323
Go to first new post AS9100D Requirements vis-a-vis Section
Last Post or Poll Vote: 21st February 2018 09:08 AM by Mike S. » Replies: 2 » Views: 119
Go to first new post FDA's DRLM (Device Registration & Listing Module) Listing Number Question
Last Post or Poll Vote: 21st February 2018 08:57 AM by piccoto » Replies: 0 » Views: 11
Go to first new post PMCF study plan is same to clinical investigation plan?
Last Post or Poll Vote: 21st February 2018 06:28 AM by FoGia » Replies: 1 » Views: 58
Go to first new post Going into IATF 16949 transition without Internal Audits
Last Post or Poll Vote: 21st February 2018 06:09 AM by benmg » Replies: 0 » Views: 42
Go to first new post Medical Device Final Assembly Labelling
Last Post or Poll Vote: 21st February 2018 04:02 AM by dgrainger » Replies: 2 » Views: 216
Go to first new post UDI Labeling for Clinical Investigational Device
Last Post or Poll Vote: 21st February 2018 12:59 AM by Avilaw Singh » Replies: 3 » Views: 917
Go to first new post IATF 16949 - Manufacturing and Product Audit Approach
Last Post or Poll Vote: 21st February 2018 12:45 AM by AMIT BALLAL » Replies: 10 » Views: 1,210
Go to first new post NC if word "development" stated in Policy?
Last Post or Poll Vote: 20th February 2018 09:56 PM by AndyN » Replies: 11 » Views: 272
Go to first new post FDA Medical Device Accessory Packaging Requirements
Last Post or Poll Vote: 20th February 2018 09:27 PM by duduky23 » Replies: 6 » Views: 1,560
Go to first new post Management representative transition checklist
Last Post or Poll Vote: 20th February 2018 08:32 PM by Richard Regalado » Replies: 6 » Views: 219
Go to first new post Web based tool for benchmarking audit findings
Last Post or Poll Vote: 20th February 2018 06:26 PM by BradM » Replies: 5 » Views: 53
Go to first new post High number of certificate suspensions in the IAQG OASIS database
Last Post or Poll Vote: 20th February 2018 05:24 PM by Sidney Vianna » Replies: 0 » Views: 81
Go to first new post CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
Last Post or Poll Vote: 20th February 2018 03:31 PM by Harini17 » Replies: 4 » Views: 200
Go to first new post EQI Prelaunch Control Plan - Definition
Last Post or Poll Vote: 20th February 2018 02:52 PM by Jeff Putman » Replies: 0 » Views: 60

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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
25th October 2017 05:45 PM Go to last post
60 647
Lean Manufacturing, including Lean in Service Industries, questions and discussions.
by Mike S.
12th February 2018 08:59 AM Go to last post
505 4,636
Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
by Randy
16th February 2018 03:21 PM Go to last post
1,243 8,821
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
27th January 2018 11:44 AM Go to last post
186 2,469
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
by Omar.
22nd January 2018 05:05 PM Go to last post
244 1,554
Service Industry specific and related discussions.
2nd February 2018 04:59 PM Go to last post
200 1,447
National and International Business System Standards
by Mike S.
21st February 2018 09:08 AM Go to last post
1,961 16,979
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.
20th February 2018 03:31 PM Go to last post
382 2,221
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
7th February 2018 05:31 PM Go to last post
823 7,482
20th February 2018 09:27 PM Go to last post
1,173 6,258
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 pkost
8th February 2018 04:36 AM Go to last post
68 434
In 2000, TS 16949 evolved from QS-9000. In 2016 it became IATF 16949 (an automotive sector specific "standard").
by benmg
21st February 2018 06:09 AM Go to last post
3,107 25,058
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
20th February 2018 08:32 PM Go to last post
129 691
ISO 900x Quality Management Systems related discussions.
21st February 2018 09:19 AM Go to last post
5,223 62,919
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...)
by Henria
2nd February 2018 03:07 AM Go to last post
277 3,007
Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
by r1ch481
8th January 2018 04:33 AM Go to last post
106 879
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
by TPMB4
20th February 2018 08:27 AM Go to last post
263 1,943
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.
15th February 2018 05:11 PM Go to last post
111 741
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
30th January 2018 08:24 PM Go to last post
629 4,302
ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
by Emmyd
15th January 2018 02:57 PM Go to last post
608 3,653
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 piccoto
21st February 2018 08:57 AM Go to last post
3,683 22,902
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.
19th February 2018 06:19 PM Go to last post
3,610 26,515
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 csa14
8th December 2017 05:20 AM Go to last post
35 159
Other various Medical Device and Orthopedic related discussions.
by yogmata
18th February 2018 05:57 PM Go to last post
302 1,857
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
1st February 2018 08:22 AM Go to last post
611 5,661
APQP and PPAP (14 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
18th February 2018 11:03 AM Go to last post
905 6,492
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
13th February 2018 03:22 PM Go to last post
1,858 25,009
Benchmarking Methods and Related General Discussions.
by BradM
20th February 2018 06:26 PM Go to last post
121 831
- - -
Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
10th February 2018 02:46 PM Go to last post
443 3,903
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.
28th November 2017 12:19 PM Go to last post
117 1,287
Contract Review Process Discussions and Information
by Marc
21st September 2017 01:40 AM Go to last post
62 489
Customer Complaints (1 Viewing)
Dealing with Customer complaints/concerns.
by Scanton
16th February 2018 07:34 AM Go to last post
148 1,382
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 February 2018 02:52 PM Go to last post
457 3,170
Process and Product Design and Development discussion discussions. Design Verification and Validation included.
16th February 2018 12:58 PM Go to last post
520 3,718
Documentation Systems (Document Control), including Procedures, Forms, and Templates.
19th February 2018 12:11 PM Go to last post
2,260 21,094
FMEA and Control Plans (13 Viewing)
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
20th February 2018 02:38 PM Go to last post
882 7,074
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.
20th February 2018 01:04 PM Go to last post
4,404 32,348
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
20th February 2018 12:00 PM Go to last post
1,618 12,379
Management Review related Discussions and Information.
12th January 2018 01:04 AM Go to last post
154 2,215
- - -
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 _Jens_
26th January 2018 01:11 PM Go to last post
778 7,509
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
16th February 2018 02:03 PM Go to last post
699 7,892
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 Bev D
9th January 2018 01:59 PM Go to last post
211 3,050
Principles and generic guidelines on Risk Management.
by Big Jim
20th October 2017 08:53 PM Go to last post
16 100
Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
by Ninja
4th January 2018 05:32 PM Go to last post
165 2,379
Quality Manual Development and Quality Systems Manual related Discussions.
by titan4
19th January 2018 08:44 AM Go to last post
283 4,204
Quality Manager and Quality Assurance Management Issues/questions
by Bev D
15th February 2018 01:48 PM Go to last post
658 6,559
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
15th February 2018 09:37 AM Go to last post
1,648 13,094
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
13th November 2017 06:12 AM Go to last post
309 3,056
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
17th January 2018 08:58 AM Go to last post
378 3,911
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 RCd2018
5th February 2018 07:03 AM Go to last post
1,360 10,988
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
8th February 2018 11:42 PM Go to last post
688 5,924
Training and related topic discussions.
20th January 2018 12:39 PM Go to last post
771 6,447
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.
11th January 2018 11:22 AM Go to last post
242 3,039
The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
10th February 2018 01:48 PM Go to last post
401 6,163
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 reynald
12th September 2017 02:24 AM Go to last post
272 1,851
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 (2 Viewing)
Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
by Marc
26th January 2018 04:54 AM Go to last post
156 1,921
Professional Employment and Occupation Related
Questions, discussions and comments about careers and occupations. Resume content and other information can be discussed here as well.
19th February 2018 02:35 PM Go to last post
818 11,235
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: Automotive/Aero Experience...
25th January 2018 09:01 PM Go to last post
19 50
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.
14th February 2018 10:44 AM Go to last post
394 3,338
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
13th February 2018 06:34 AM Go to last post
263 1,176
13th February 2018 05:37 PM Go to last post
2,979 50,169
News! (2 Viewing)
by Marc
23rd October 2017 11:26 AM Go to last post
710 5,063
by Marc
27th January 2018 06:17 PM Go to last post
721 6,526
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
24th January 2018 10:41 AM Go to last post
114 874
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.
10th December 2017 10:44 AM Go to last post
169 1,794

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