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Currently Active Discussions:
 
Go to first new post Secondary packaging operations in medical device facility
Last Post or Poll Vote: 21st October 2017 02:28 AM by Ronen E » Replies: 1 » Views: 44
Go to first new post Harmonized Standards on Medical Device IFU (Instructions for Use)
Last Post or Poll Vote: 21st October 2017 02:03 AM by Ronen E » Replies: 7 » Views: 2,344
Go to first new post Sampling for stability studies - Class II surgically invasive devices
Last Post or Poll Vote: 21st October 2017 01:52 AM by Ronen E » Replies: 1 » Views: 64
Go to first new post Which Medical Device Standard Registrar would you recommend?
Last Post or Poll Vote: 20th October 2017 11:19 PM by DSurber » Replies: 4 » Views: 300
Go to first new post Medical Device File Requirements (ISO 13485 Cl. 4.2.3)
Last Post or Poll Vote: 20th October 2017 10:13 PM by Ronen E » Replies: 5 » Views: 203
Go to first new post Risk Based Approach for ISO 13485:2016 Form/Procedure
Last Post or Poll Vote: 20th October 2017 10:04 PM by Ronen E » Replies: 11 » Views: 1,280
Go to first new post Question about ISO 13485:2003 - Production Provisions - Contract Manufacturer
Last Post or Poll Vote: 20th October 2017 10:01 PM by Ronen E » Replies: 10 » Views: 217
Go to first new post When are Medical Device Accessories MD's?
Last Post or Poll Vote: 20th October 2017 09:41 PM by Ronen E » Replies: 7 » Views: 721
Go to first new post Example of Turtle Diagram with Risk/Opportunities
Last Post or Poll Vote: 20th October 2017 09:23 PM by Jen Kirley » Replies: 1 » Views: 73
Go to first new post Background of Annex X section 1.1d of MDD 93/42/EEC
Last Post or Poll Vote: 20th October 2017 09:03 PM by Ronen E » Replies: 73 » Views: 1,930
Go to first new post How will you handle Clause 6.1 - Risks and Opportunities for AS9100 Rev. D Auditors?
Last Post or Poll Vote: 20th October 2017 08:53 PM by Big Jim » Replies: 13 » Views: 3,111
Go to first new post Not having an internal audit during the year!
Last Post or Poll Vote: 20th October 2017 08:49 PM by Big Jim » Replies: 5 » Views: 189
Go to first new post IATF 16949 Clause 6.1.1 my first major NCR
Last Post or Poll Vote: 20th October 2017 08:42 PM by Big Jim » Replies: 20 » Views: 505
Go to first new post Kobe Steel material data falsification
Last Post or Poll Vote: 20th October 2017 05:24 PM by Leite » Replies: 15 » Views: 470
Go to first new post AS9100 - No NCR's or CA's during Stage 2 Audit
Last Post or Poll Vote: 20th October 2017 05:08 PM by Golfman25 » Replies: 8 » Views: 153

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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
by tazer
14th September 2017 05:08 AM Go to last post
59 644
Lean Manufacturing, including Lean in Service Industries, questions and discussions.
17th October 2017 10:38 AM Go to last post
502 4,612
Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
by Ronen E
21st October 2017 02:28 AM Go to last post
1,218 8,649
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
by Chris81
20th September 2017 07:05 AM Go to last post
185 2,456
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
by qcman
16th October 2017 02:10 PM Go to last post
242 1,539
Service Industry specific and related discussions.
by Boboy
28th September 2017 01:42 PM Go to last post
198 1,440
National and International Business System Standards
20th October 2017 05:08 PM Go to last post
1,931 16,774
Business continuity planning (BCP) identifies an organization's exposure to internal and external threats and provides for effective prevention and recovery for the organization.
6th October 2017 04:12 AM Go to last post
43 331
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 DSurber
20th October 2017 11:19 PM Go to last post
369 2,183
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
4th October 2017 10:34 AM Go to last post
816 7,441
by Sheila1
18th October 2017 08:56 AM Go to last post
1,162 6,223
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 Well12
3rd October 2017 06:28 AM Go to last post
66 406
In 2000, TS 16949 evolved from QS-9000. In 2016 it became IATF 16949 (an automotive sector specific "standard").
by Big Jim
20th October 2017 08:42 PM Go to last post
3,048 24,510
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
5th October 2017 05:42 AM Go to last post
128 685
ISO 900x Quality Management Systems related discussions.
by Big Jim
20th October 2017 08:49 PM Go to last post
5,164 62,220
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...)
25th September 2017 12:58 PM Go to last post
273 2,970
Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
31st August 2017 09:28 AM Go to last post
103 864
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
by oktayg
20th September 2017 07:12 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.
8th September 2017 06:35 PM Go to last post
61 422
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 MEXPZN
25th September 2017 06:56 PM Go to last post
109 728
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
13th October 2017 11:09 PM Go to last post
623 4,272
ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
by greif
12th October 2017 03:19 PM Go to last post
606 3,631
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 Ronen E
20th October 2017 09:41 PM Go to last post
3,571 22,318
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 Ronen E
21st October 2017 02:03 AM Go to last post
3,512 25,865
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 marciag
18th October 2017 04:27 PM Go to last post
35 157
Other various Medical Device and Orthopedic related discussions.
by Ronen E
21st October 2017 01:52 AM Go to last post
297 1,838
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
25th August 2017 03:00 PM Go to last post
608 5,646
APQP and PPAP (22 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
19th October 2017 06:23 PM Go to last post
899 6,454
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
20th October 2017 09:23 PM Go to last post
1,837 24,800
Benchmarking (2 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 reynald
19th September 2017 09:35 PM Go to last post
439 3,874
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.
22nd September 2017 10:06 AM Go to last post
116 1,283
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.
25th September 2017 06:41 AM Go to last post
145 1,366
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 howste
27th September 2017 05:39 PM Go to last post
455 3,162
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 Eredhel
16th October 2017 04:54 PM Go to last post
2,251 20,996
FMEA and Control Plans (11 Viewing)
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
16th October 2017 06:04 AM Go to last post
870 6,983
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.
by Ninja
20th October 2017 10:26 AM Go to last post
4,369 32,147
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
by howste
19th October 2017 12:42 PM Go to last post
1,605 12,308
Management Review related Discussions and Information.
by jiligan
28th September 2017 09:14 AM Go to last post
152 2,200
- - -
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 Leite
20th October 2017 05:24 PM Go to last post
778 7,501
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
by JNIKQ
19th October 2017 08:08 PM Go to last post
690 7,811
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 3,048
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.
17th May 2017 10:12 AM Go to last post
165 2,374
Quality Manual Development and Quality Systems Manual related Discussions.
4th October 2017 10:05 AM Go to last post
278 4,155
Quality Manager and Quality Assurance Management Issues/questions
9th October 2017 11:49 AM Go to last post
656 6,519
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 sam_ck
10th October 2017 10:07 PM Go to last post
1,639 13,030
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 howste
5th October 2017 01:12 PM Go to last post
308 3,037
Six Sigma (9 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.
29th August 2017 08:32 PM Go to last post
377 3,906
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!
12th October 2017 12:25 PM Go to last post
1,351 10,959
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
by Eredhel
16th October 2017 04:38 PM Go to last post
684 5,888
Training and related topic discussions.
by yodon
18th October 2017 02:44 PM Go to last post
768 6,424
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.
22nd September 2017 12:41 PM Go to last post
396 6,029
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 (4 Viewing)
Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
25th September 2017 11:21 AM Go to last post
156 1,912
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 Randy
19th October 2017 02:28 PM Go to last post
812 11,109
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 monaads
24th August 2017 04:09 AM Go to last post
29 295
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!
Look! Full Time Direct Hire: Quality Engineer ISO...
by kareno
4th October 2017 04:28 AM Go to last post
22 52
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.
4th October 2017 01:16 PM Go to last post
388 3,301
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 moreaux
18th October 2017 04:50 PM Go to last post
260 1,160
18th October 2017 05:16 PM Go to last post
3,598 64,934
18th June 2017 08:11 PM Go to last post
709 5,062
by Ronen E
6th October 2017 09:16 PM Go to last post
719 6,517
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
6th September 2017 04:14 PM Go to last post
166 1,785


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