The Elsmar Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Failure Modes Services and Solutions to ProblemsElsmar cove Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Forum Username

Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links

Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality
Currently Active Discussions:
Issues with UDI additions to 21 CFR 820 requirements
      Last Post or Poll Vote: 26th March 2015 11:05 PM by Mark Meer » Replies: 0
Available ISO 9001 Consultants
      Last Post or Poll Vote: 26th March 2015 11:03 PM by lawcch » Replies: 19
Interpreting Process Controls - 21 CFR Part 820.70(a)
      Last Post or Poll Vote: 26th March 2015 10:12 PM by Mark Meer » Replies: 3
FDA requirements for servicing and refurbishment of Medical Devices
      Last Post or Poll Vote: 26th March 2015 10:01 PM by Mark Meer » Replies: 17
Quality Systems Manager for mobile medical device start-up (San Francisco, CA)
      Last Post or Poll Vote: 26th March 2015 08:24 PM by Ajit Basrur » Replies: 1
Failure Mode Identification in PFMEA according to AIAG FMEA Rev.4
      Last Post or Poll Vote: 26th March 2015 06:16 PM by Zbigniew Huber » Replies: 5
Auto Industry Resume Template for a Quality Manager
      Last Post or Poll Vote: 26th March 2015 06:08 PM by Wes Bucey » Replies: 1
IVD ANVISA Registration Process in Brazil and Registration Change
      Last Post or Poll Vote: 26th March 2015 05:21 PM by spectra123 » Replies: 8
5.4.1 Quality Objectives - Nonconformity: The process was not fully effective
      Last Post or Poll Vote: 26th March 2015 04:53 PM by Kronos147 » Replies: 14
USB power between Medical Device Data Collection Device Component
      Last Post or Poll Vote: 26th March 2015 03:37 PM by rschumin » Replies: 0
New to Metrology and told to complete Gage R&R with AIAG compliant software
      Last Post or Poll Vote: 26th March 2015 02:47 PM by Brackish » Replies: 16
Due Diligence - IGC USA - Anybody know anything about them?
      Last Post or Poll Vote: 26th March 2015 02:45 PM by Reg Morrison » Replies: 8
Verification that Manufacturing Equipment has maintained a Validated State
      Last Post or Poll Vote: 26th March 2015 02:12 PM by dedvalson » Replies: 0
TS 16949 Clause 7.1.1 Process Planning-Operation Sheet Example wanted
      Last Post or Poll Vote: 26th March 2015 01:51 PM by Brannan » Replies: 4
FMEA's - Severity and Classification of Print Characteristics
      Last Post or Poll Vote: 26th March 2015 12:56 PM by Bev D » Replies: 1

Some Random Registered User Album Pictures
Travel Pictures 1
Travel Pictures 1
Flower Show Aug 2012, Bangalore
Flower Show Aug 2012, Bangalore
Fall 2009 at the Elsmar Ranch
Fall 2009 at the Elsmar Ranch
Fruit, Veggie, & Wire poses
Fruit, Veggie, & Wire poses
Mysore city ...
Mysore city ...

Welcome to the The Elsmar Cove Discussion Forums.
If this is your first visit, please read the FAQ (Frequently Asked Questions) and please read the Basic "How To's" in the Elsmar Cove Discussion Forums discussion 'threads'. Registering to participate in the Elsmar Cove Forums is Free. If you would like to Register, click HERE. You DO have to Register for many Forum Software Features and Functions, such as E-Mail Digests, Notification of New Posts and/or Threads, Personal Messaging, downloading of Post Attachments, etc., to work. See This instructional discussion Thread for more specific information.
To browse the forums and discussion threads without Registering, go to the forum or discussion thread that you want to view and click on it. A 'Lock' icon on a forum only means you can not Start a New Discussion Thread, Post a Reply in an existing Discussion Thread, or download Post Attachments.

  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 Ronen E
5th March 2015 06:30 PM Go to last post
53 564
Lean Manufacturing, including Lean in Service Industries, questions and discussions.
by Ninja
24th March 2015 10:17 AM Go to last post
489 4,493
Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
25th March 2015 07:13 AM Go to last post
1,127 8,006
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
by Eredhel
17th March 2015 02:43 PM Go to last post
180 2,380
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
by Miner
12th February 2015 04:26 PM Go to last post
218 1,369
Service Industry specific and related discussions.
17th February 2015 11:37 AM Go to last post
183 1,363
Quality Manager Issues
A forum for Quality Manager Issues and Discussions
Basic concerns dealing with Customer complaints/concerns including ISO 10002.
10th March 2015 05:15 AM Go to last post
133 1,283
Issues/questions dealing with Quality Management concerns.
20th March 2015 02:04 PM Go to last post
563 5,186
Issues/questions dealing with Upper Management Support.
by Vthouta
24th March 2015 01:09 PM Go to last post
69 1,111
ISO (International Organization for Standardization) Standards
ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards and related discussions.
26th March 2015 04:53 PM Go to last post
4,820 58,693
Customer Satisfaction - Guidelines for complaints handling in organizations.
- - -
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.
by lawcch
20th March 2015 04:31 AM Go to last post
110 1,251
ISO 10013 - Quality Manual Development and Quality Systems Manual related Discussions.
22nd December 2014 07:53 PM Go to last post
272 4,019
Medical Device Manufacturer Quality Management Systems Discussions
- - -
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
by JLyt207
20th March 2015 08:31 AM Go to last post
790 7,227
Medical Device Risk Management Discussions.
- - -
In 2000, TS 16949 evolved from QS-9000. TS16949 is an automotive sector specific standard.
by NikolaV
23rd March 2015 11:31 AM Go to last post
2,817 22,792
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.
26th March 2015 02:47 PM Go to last post
4,039 29,886
Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
25th March 2015 02:12 AM Go to last post
1,753 23,917
ISO/IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
19th March 2015 02:08 PM Go to last post
18 101
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 J0anne
23rd March 2015 04:46 PM Go to last post
312 2,055
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 deephsd
3rd February 2015 12:18 PM Go to last post
41 297
ISO/IEC 27001 is part of a growing family of ISO/IEC Information Security Management Systems (ISMS) standards.
24th March 2015 09:18 PM Go to last post
112 606
The ISO 28001 addresses potential security issues at all stages of the supply process, thus targeting threats such as terrorism, fraud and piracy.
27th February 2013 11:26 PM Go to last post
6 26
ISO 31000 is a family of standards relating to risk management. The purpose of ISO 31000 is to provide principles and generic guidelines on Risk Management.
by Juzaili
16th September 2014 11:22 PM Go to last post
12 70
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.
18th March 2015 07:12 AM Go to last post
54 397
Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
26th March 2015 10:50 AM Go to last post
590 4,078
Aerospace and Aviation Standards and Requirements
This forum is for Aerospace and Aviation Standards and related Requirements.
AS9100, AS9101, AS9110, AS9120, Nadcap and related questions and discussions.
by AndyN
26th March 2015 12:01 PM Go to last post
1,521 13,959
EASA (European Aviation Safety Agency) and JAA (Joint Aviation Authorities) related questions and discussions.
18th March 2015 05:14 PM Go to last post
78 441
FAA - Federal Aviation Administration (US) related questions and discussions.
20th October 2014 04:56 PM Go to last post
113 680
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device, Medical Information Technology, Medical Software and Health Informatics and related discussion topics.
Medical device regulations around the world. Regulations are laws set by a regulatory authority of a country or region and are generally mandatory.
26th March 2015 11:05 PM Go to last post
2,997 18,672
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.
26th March 2015 03:37 PM Go to last post
3,118 23,318
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 February 2015 06:43 AM Go to last post
24 100
Other various Medical Device and Orthopedic related discussions.
24th March 2015 08:38 AM Go to last post
257 1,587
National and International Business Standards and Requirements
Normas Nacionales e Internacionales
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 SteveK
26th March 2015 10:41 AM Go to last post
317 1,884
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!
5th February 2015 10:59 AM Go to last post
446 3,078
24th March 2015 02:06 PM Go to last post
1,079 5,890
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.
18th March 2015 09:06 AM Go to last post
60 384
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 March 2015 11:00 AM Go to last post
255 2,810
Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
by DP561
26th March 2015 07:00 AM Go to last post
80 736
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
by Alex73
19th March 2015 05:14 PM Go to last post
235 1,801
TL 9000 is a two book standard created by QuEST (Quality Excellence for Suppliers of Telecommunications) Forum based on ISO 9001.
by AndyN
12th January 2014 05:12 PM Go to last post
42 303
ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
26th March 2015 10:54 AM Go to last post
596 3,592
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 lk2012
6th March 2015 08:02 AM Go to last post
96 649
Common Quality Assurance Processes and Tools
For discussion of Definitions, Acronyms, Abbreviations and Interpretations
25th March 2015 12:43 PM Go to last post
582 5,506
APQP and PPAP (1 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
by vardar3
26th March 2015 09:25 AM Go to last post
860 6,167
Benchmarking (4 Viewing)
Benchmarking Methods and Related General Discussions.
by Marc
17th February 2015 04:51 AM Go to last post
115 800
- - -
Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
24th March 2015 12:53 PM Go to last post
418 3,686
Contract Review Process Discussions and Information
22nd October 2013 04:31 PM Go to last post
60 483
Process and Product Design and Development discussion discussions. Design Verification and Validation included.
26th March 2015 02:12 PM Go to last post
499 3,601
Documentation Systems (Document Control), including Procedures, Forms, and Templates.
by Brannan
26th March 2015 01:51 PM Go to last post
2,164 20,336
Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
26th March 2015 06:16 PM Go to last post
824 6,662
Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
25th March 2015 08:45 PM Go to last post
1,534 11,903
Management Review related Discussions and Information.
by Big Jim
26th March 2015 02:30 AM Go to last post
144 2,094
- - -
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 Alpine
24th March 2015 11:26 PM Go to last post
745 7,329
Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
21st March 2015 11:45 AM Go to last post
655 7,457
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 05:01 PM Go to last post
209 3,886
What is a Corrective Action vs. a Preventive Action?
by AndyN
28th January 2015 06:35 PM Go to last post
209 3,032
Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
154 2,263
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.
26th March 2015 10:51 AM Go to last post
1,587 12,708
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?
25th March 2015 07:08 AM Go to last post
299 2,954
This is a link to the ISO 31000:2009 forum here and is to provide a place for discussions of principles and generic guidelines on risk management.
- - -
Six Sigma (1 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
12th March 2015 09:26 AM Go to last post
370 3,882
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 ndtqc
25th March 2015 08:25 AM Go to last post
214 1,114
SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
25th March 2015 10:40 AM Go to last post
1,295 10,572
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
5th March 2015 05:08 PM Go to last post
652 5,630
Training and related topic discussions.
23rd March 2015 10:32 AM Go to last post
727 6,191
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.
232 3,088
The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
26th March 2015 02:45 PM Go to last post
383 5,921
Information Resources - 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 Ettore
25th March 2015 03:43 AM Go to last post
266 1,812
Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
26th October 2014 10:59 PM Go to last post
154 1,891
The $ Contributor's forum - Data files for folks who donate $ to help finance the Elsmar Cove Forums and Web Site. Donations are appreciated!
Sub-Forum(s): Outdated Threads
by J0anne
25th September 2013 09:49 AM Go to last post
36 126
Professional Employment and Occupation Related
Questions, discussions and comments about careers and occupations. Resume content and other information can be discussed here as well.
26th March 2015 06:08 PM Go to last post
788 10,894
What hotels do you stay at? Have you traveled by train? Which airline do you prefer and why? Travel discussions, experiences, news and recommendations.
15th January 2015 01:44 PM Go to last post
143 2,531
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.
8th April 2014 08:37 PM Go to last post
28 286
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 Systems Manager for...
26th March 2015 08:24 PM Go to last post
22 55
Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
25th March 2015 11:12 AM Go to last post
379 3,192
Looking for a job? Post the position you are seeking, your resume, and/or your qualifications, here. But remember - You never know who may see it! Interview and related discussions are welcome as well.
9th December 2014 10:56 AM Go to last post
5 15
Elsmar Cove Forum Essentials
Elsmar Cove Forum ToS (Terms of Service) and Policies are documented here.
25th June 2014 03:48 AM Go to last post
24 344
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
5th January 2015 10:21 PM Go to last post
108 853
Something new happening? Please post related topics here.
23rd March 2015 04:20 PM Go to last post
323 5,773
Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
by Marc
23rd January 2015 01:01 PM Go to last post
153 1,629
Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.
by lawcch
26th March 2015 11:03 PM Go to last post
8 45
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!
26th March 2015 09:48 AM Go to last post
243 1,117
Elsmar Cove Forum Community Discussions.
by Marc
26th March 2015 11:13 AM Go to last post
2,893 48,969
News! (2 Viewing)
27th January 2015 06:25 AM Go to last post
688 4,968
16th February 2015 03:59 PM Go to last post
702 6,251

Contains New Posts   Forum Contains New Posts
Contains No New Posts   Forum Contains No New Posts

The time now is 11:34 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


Marc Timothy Smith -
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".