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Quality Forum and Business Standards Discussions

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Manufacturing, Service, and Business Systems Processes Manufacturing, services, processes, materials and related Business Systems Process aspect discussions.

Human Factors and Ergonomics in Engineering

Human Factors and Ergonomics in Engineering related discussions
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70
Posts
789
Threads
70
Posts
789
Aircraft Cockpit Automation - Good or Bad

Lean in Manufacturing and Service Industries

Lean Manufacturing, including Lean in Service Industry discussions.
Threads
524
Posts
4,783
Threads
524
Posts
4,783
Lean Manufacturing Concepts Discussion

Manufacturing and Related Processes

Specific manufacturing process(es) & systems, materials, and related discussions.
Threads
1,396
Posts
9,716
Threads
1,396
Posts
9,716
Medical Device logistics providers in the US

Process Maps, Process Mapping and Turtle Diagrams

Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
Threads
202
Posts
2,614
Threads
202
Posts
2,614
New CAPA Work Flow with Revised 8D Approach

Reliability Analysis - Predictions, Testing and Standards

Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
Threads
280
Posts
1,718
Threads
280
Posts
1,718
The correct way of doing a 2 Sample T test

Service Industry Specific Topics

Service Industry specific and related discussions.
Threads
219
Posts
1,516
Threads
219
Posts
1,516
Quality at Logistical Service Porvider

National and International Business System Standards

Aviation, Space and Defense Standards and Requirements

Please choose one of the more definitive Sub-Forums. Thank you!
Threads
2,182
Posts
18,775
Sub-forums:
  1. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements
  2. EASA and JAA Aviation Standards and Requirements
  3. Federal Aviation Administration (FAA) Standards and Requirements
Threads
2,182
Posts
18,775
Counterfeit parts prevention - Audit Nonconformance - AS9100 8.2.2
  • Kirby

Business Continuity & Resiliency Planning (BCRP)

Business continuity planning (BCP) identifies an organization's exposure to internal and external threats and provides for effective prevention and recovery for the organization.
Threads
51
Posts
359
Threads
51
Posts
359
Resources for Planning for top quality

CE Marking (Conformité Européene) / CB Scheme

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.
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519
Posts
2,837
Threads
519
Posts
2,837
Custom made medical device MDD vs MDR definition

Environmental Related Standards

Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
Threads
894
Posts
7,844
Sub-forums:
  1. ISO 14001:2015 Specific Discussions
  2. REACH and RoHS Conversations
  3. Miscellaneous Environmental Standards and EMS Related Discussions
Threads
894
Posts
7,844
Acceptable limits for Spills - Tracking Hydraulic Spills

Food and Drug (Pharmaceuticals) related Regulations

Threads
1,335
Posts
6,978
Sub-forums:
  1. US Food and Drug Administration (FDA)
  2. Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)
  3. Qualification and Validation (including 21 CFR Part 11)
Threads
1,335
Posts
6,978
Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant)

Food Safety - ISO 22000, HACCP (21 CFR 120)

All topics connected to Food management systems to include ISO 22000, Hazard Analysis and Critical Control Points (HACCP) and other related food safety systems.
Threads
330
Posts
2,120
Threads
330
Posts
2,120
ISMS - Seeking VAPT Consultant

Hospitals, Clinics & other Health Care Providers

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.
Threads
70
Posts
450
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70
Posts
450
The hospital: Worst place to be, especially if you're sick

ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards

ISO 900x Quality Management Systems related discussions.
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5,496
Posts
66,530
Threads
5,496
Posts
66,530
Help with Drawing Review - ISO 9001:2015

IATF 16949 - Automotive Quality Systems Standard

In 2000, TS 16949 evolved from QS-9000. In 2016 it became IATF 16949 (an automotive sector specific "standard").
Threads
3,348
Posts
27,289
Sub-forums:
  1. QS-9000 - American Automotive Manufacturers Standard
Threads
3,348
Posts
27,289
Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA?

IT (Information Technology) Service Management

IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
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26
Posts
153
Threads
26
Posts
153
Which ISO certification is ideal for my IT company?

ISO/IEC 17025 - Calibration Laboratories

ISO/IEC 17025 - Calibration Laboratory Discussions

TL 9000 Telecommunications Standard and QuEST

TL 9000 is a two book standard created by QuEST (Quality Excellence for Suppliers of Telecommunications) Forum based on ISO 9001.
Threads
49
Posts
334
Threads
49
Posts
334
NPR Metric - What if Customer has relaxed measure?

IEC 27001 - Information Security Management Systems (ISMS)

IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
Threads
156
Posts
841
Threads
156
Posts
841
What are Practical data center best practices

Occupational Health & Safety Management Standards

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...)
Threads
300
Posts
3,259
Threads
300
Posts
3,259
MSDS process audit - Can any one give idea for checklist of the same

Oil and Gas Industry Standards and Regulations

Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
Threads
118
Posts
1,006
Threads
118
Posts
1,006
API Q1 9th Edition Internal Audit Checklist /Report
  • Marc

RoHS, REACH, ELV, IMDS and Restricted Substances

RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
Threads
267
Posts
1,987
Threads
267
Posts
1,987
IMDS - Help (Common Warning and Error Fixes)

Supply Chain Security Management Systems

The ISO PAS 28001 addresses potential security issues at all stages of the supply process, thus targeting threats such as terrorism, fraud and piracy.
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15
Posts
52
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15
Posts
52
Risk Classification For Supplier - Clinical Research Organisation (CRO)

Sustainability, Green Initiatives and Ecology

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.
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69
Posts
502
Threads
69
Posts
502
What companies think climate change will have a material impact on their business?

VDA Standards - Germany's Automotive Standards

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.
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128
Posts
826
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128
Posts
826
Is there any pre-defined Control plan format/template acc. VDA?

Other ISO and International Standards and European Regulations

Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
Threads
693
Posts
4,524
Threads
693
Posts
4,524
Implementing ISO 20000-1 - Where to start

Various Other Specifications, Standards, and related Requirements

ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
Threads
627
Posts
3,747
Threads
627
Posts
3,747
Correct way to certify hydrostatic testing when it is not 100% (and Sample Size)

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 and FDA Regulations and Standards News

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385
Posts
640
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385
Posts
640
Need clarification on requirements.... Class i, gmp & 510(k) exempt

Medical Device Related Standards

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.
Threads
4,308
Posts
31,016
Sub-forums:
  1. ISO 13485:2016 - Medical Device Quality Management Systems
  2. ISO 14971 - Medical Device Risk Management
  3. IEC 60601 - Medical Electrical Equipment Safety Standards Series
  4. IEC 62304 - Medical Device Software Life Cycle Processes
  5. IEC 62366 - Medical Device Usability Engineering
  6. Other Medical Device Related Standards
  7. The US's FDA (Food and Pharma/Drug) Forum
Threads
4,308
Posts
31,016
Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation

Medical Device Related Regulations

Medical device regulations around the world. Regulations are laws set by a regulatory authority of a country or region and are generally mandatory.
Threads
4,562
Posts
27,826
Sub-forums:
  1. Canada Medical Device Regulations
  2. China Medical Device Regulations
  3. EU Medical Device Regulations
  4. Japan Medical Device Regulations
  5. US Medical Device Regulations
    1. 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
    2. Other US Medical Device Regulations
  6. Other Medical Device Regulations World-Wide
Threads
4,562
Posts
27,826
Sterile medical device expiration date

Other Medical Device and Orthopedic Related Topics

Other various Medical Device and Orthopedic related discussions.
Threads
357
Posts
2,072
Sub-forums:
  1. MedAccred Industry Group Program
Threads
357
Posts
2,072
Handling of contaminated medical equipment

Medical Information Technology, Medical Software and Health Informatics

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.
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50
Posts
268
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50
Posts
268
Product-Lifecycle-Management Experience

Common Quality Assurance Processes and Tools

Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically

For discussion of Definitions, Acronyms, Abbreviations and Interpretations
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627
Posts
5,770
Threads
627
Posts
5,770
Key Supplier - Definition of

APQP and PPAP

Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
Threads
957
Posts
6,943
Threads
957
Posts
6,943
PPAP - Appearance Approval Report - I need help

Auditing Quality and Environmental Management Systems

Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
Threads
1,944
Posts
26,042
Sub-forums:
  1. Internal Auditing
  2. General Auditing Discussions
  3. Process Audits and Layered Process Audits
Threads
1,944
Posts
26,042
AS9100D Internal auditing requirements

Benchmarking

Benchmarking Methods and Related General Discussions.
Threads
122
Posts
842
Sub-forums:
  1. Benchmarking - Methods and General Discussions
Threads
122
Posts
842
How to Benchmark? Is Benchmarking of any value? Seeking advice

Calibration of Measurement, Monitoring and Test Equipment

Capability, Accuracy and Stability - Processes, Machines, etc.

Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
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468
Posts
4,066
Threads
468
Posts
4,066
Interpretation with regards to Ppk > Cpk

Consultants and Consulting

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.
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64
Posts
982
Threads
64
Posts
982
Looking for Tips on finding an IATF consultant

Contract Review Process

Contract Review Process Discussions and Information
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66
Posts
533
Threads
66
Posts
533
When Customers Make Changes to Orders

Customer Complaints

Dealing with Customer complaints/concerns.
Threads
164
Posts
1,508
Threads
164
Posts
1,508
PPM calculation of customer complaints for PMS

Customer and Company Specific Requirements

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!
Threads
472
Posts
3,240
Threads
472
Posts
3,240
GM BIQS level 5 requirements

Design and Development of Products and Processes

Process and Product Design and Development discussion discussions. Design Verification and Validation included.
Threads
549
Posts
3,888
Threads
549
Posts
3,888
Design Development MDR

Document Control Systems, Procedures, Forms and Templates

Documentation Systems (Document Control), including Procedures, Forms, and Templates.
Threads
2,339
Posts
21,916
Threads
2,339
Posts
21,916
CLOUD BASED QUALITY DOCUMENTATION vs. SERVER BASED
  • Randy

FMEA and Control Plans

Failure Modes Effects Analysis (FMEA) and Control Plan discussions.
Threads
956
Posts
7,825
Threads
956
Posts
7,825
Significant Characteristics (SC) to Control Plan

General Metrology, Measurement Device, Calibration and Test Laboratories

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.

Threads
4,675
Posts
34,133
Sub-forums:
  1. General Measurement Device and Calibration Topics
  2. ISO 17025 related Discussions
  3. Calibration Frequency (Interval)
  4. Calibration and Metrology Software and Hardware
  5. Gage R&R (GR&R) and MSA (Measurement Systems Analysis)
  6. Measurement Uncertainty (MU)
Threads
4,675
Posts
34,133
Issues in Uncertainty Estimation

Inspection, Prints (Drawings), Testing, Sampling and Related Topics

Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
Threads
1,686
Posts
12,775
Sub-forums:
  1. AQL - Acceptable Quality Level
Threads
1,686
Posts
12,775
Measuring thread flank angle on a screw

Management Review Meetings and related Processes

Management Review related Discussions and Information.
Threads
159
Posts
2,282
Threads
159
Posts
2,282
Management Review Agenda

Measurement, Monitoring and Test Equipment

Misc. Quality Assurance and Business Systems Related Topics

Various other quality assurance and business systems related topics like Cost of Quality and other focused topics. Topics outside Quality and Environmental are allowed.
Threads
805
Posts
7,793
Threads
805
Posts
7,793
Attend FREE Safety Training Webinar LOCK-OUT/TAG-OUT (LOTO) (February 6)

Nonconformance and Corrective Action

Significant Systems, including 8-D / 7-D, etc. Can you proveEffectiveness (for example) of a Corrective Action?
Threads
733
Posts
8,226
Threads
733
Posts
8,226
Question about Non-conformances during New Product Introduction

Philosophy, Gurus, Innovation and Evolution

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.
Threads
210
Posts
3,902
Threads
210
Posts
3,902
My Class Assignment on Quality Assurance Gurus

Preventive Action and Continuous Improvement

What is a Corrective Action vs. a Preventive Action?
Threads
217
Posts
3,146
Threads
217
Posts
3,146
Evaluating the need for preventive action

Risk Management Principles and Generic Guidelines

Principles and generic guidelines on Risk Management.
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22
Posts
156
Threads
22
Posts
156
Risk and Corrective actions - Currently no FMEA's - Car systems

Problem Solving, Root Cause Fault and Failure Analysis

Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
Threads
185
Posts
2,550
Threads
185
Posts
2,550
New to QC, looking for resources

Quality Management System (QMS) Manuals

Quality Manual Development and Quality Systems Manual related Discussions.
Threads
294
Posts
4,282
Threads
294
Posts
4,282
Contract manufacturer MDR

Quality Manager and Management Related Issues

Quality Manager and Quality Assurance Management Issues/questions
Threads
669
Posts
6,674
Threads
669
Posts
6,674
Did somebody drop the ball at Boeing?

Quality Tools, Improvement and Analysis

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.
Threads
1,701
Posts
13,470
Sub-forums:
  1. Quality Assurance and Compliance Software Tools and Solutions
    1. Using Minitab Software
    2. Excel .xls Spreadsheet Templates and Tools
Threads
1,701
Posts
13,470
Analysis of half normal distribution in minitab
  • Bev D

Records and Data - Quality, Legal and Other Evidence

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?
Threads
314
Posts
3,137
Threads
314
Posts
3,137
Record Management - Does the QMS need to control templates of records?

Six Sigma

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.
Threads
380
Posts
3,924
Threads
380
Posts
3,924
Looking for a good Six Sigma book

Software Quality Assurance

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.
Threads
229
Posts
1,196
Threads
229
Posts
1,196
Software SOP - Use and maintenance of an ERP system

Statistical Analysis Tools, Techniques and SPC

SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
Threads
1,411
Posts
11,347
Threads
1,411
Posts
11,347
Is SPC (Statistical Process Control) useful?

Supplier Quality Assurance and other Supplier Issues

A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
Threads
709
Posts
6,094
Threads
709
Posts
6,094
ASL - Buying from unqualified manufacturers through qualified distributors

Training - Internal, External, Online and Distance Learning

Training and related topic discussions.
Threads
798
Posts
6,637
Threads
798
Posts
6,637
Seven Basic Quality Tools (January 23) [Paid]

Registrars and National / International Organizations

ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations

Threads
260
Posts
3,171
Sub-forums:
  1. ASQ - American Society for Quality
Threads
260
Posts
3,171
ASQ CQE Exam Group for Dec 2019 / Jan 2020 Preparation

Registrars and Notified Bodies

Registrar and Notified Body Discussions
Threads
438
Posts
6,485
Threads
438
Posts
6,485
Should customers influence a supplier's registrar selection?

Information Resources - Files - Papers - Articles - Etc. This forum contains various information resources.

Book, Video, Blog and Web Site Reviews and Recommendations

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.
Threads
273
Posts
1,853
Threads
273
Posts
1,853
Has anyone played the Quality Board Game?

General Information Resources

Various Uploaded Data and other Information Files
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18
Posts
51
Threads
18
Posts
51
ISO 22379 for citywide events now in development

Imported Legacy Blogs

Legacy Blogs imported from the old vBulletin "Blog" mod.
Threads
221
Posts
861
Threads
221
Posts
861
FMEA for Business Process

The Reading Room

Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
Threads
157
Posts
1,956
Sub-forums:
  1. Registered Visitor Articles Archive
Threads
157
Posts
1,956
Identifying Causes (book chapter 4 on problem solving)

Professional Employment and Occupation Related

Career and Occupation Discussions

Questions, discussions and comments about careers and occupations. Resume content and other information can be discussed here as well.
Threads
837
Posts
11,419
Threads
837
Posts
11,419
How does one get into the Quality Control (Quality Management) field?

Travel - Hotels, Motels, Planes and Trains

What hotels do you stay at? Have you traveled by train? Which airline do you prefer and why? Travel discussions, experiences, news and recommendations.
Threads
107
Posts
1,418
Threads
107
Posts
1,418
The Golden Age of Travel

Immigration and Expatriate Topics

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.
Threads
29
Posts
296
Threads
29
Posts
296
Afghanistan - Anybody on this website working for companies in Afghanistan

Job Openings, Consulting and Employment Opportunities

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!
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5
Posts
6
Threads
5
Posts
6
Design Quality Manager US Citizen based in Germany

Paid Consulting, Training and Services

Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.
Threads
13
Posts
108
Threads
13
Posts
108
MDR consultants - in search of recommendations for a consultant for MDR transition.

Professional Certifications and Degrees

Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
Threads
404
Posts
3,411
Threads
404
Posts
3,411
RAC-US Spring 2020 Study group_Discussions

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.

Buy, Sell or Trade - NO Commercial Advertisements

Looking for used equipment or trying to sell equipment? Books? Other stuff? Whatever. Post it here. PLEASE! NO COMMERCIAL ADVERTISEMENTS!
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3
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11
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3
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11
Buy-Sell Forum Cleaned Up - 20181029

Community Discussion Topics

Elsmar Cove Forum Community Discussions.
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49,380
Sub-forums:
  1. Brain Teasers and Puzzles
  2. Coffee Break and Water Cooler Discussions
  3. Covegratulations
  4. Funny Stuff - Jokes and Humour
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2,569
Posts
49,380
Book recommendation

World News

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719
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719
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5,112
Fiat Chrysler merges with PSA Group, owner of Peugeot and Citroën - Oct 2019

After Work and Weekend Discussion Topics

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726
Posts
6,605
Threads
726
Posts
6,605
Stepping Down from my quality manager position soon

Elsmar Cove Forum Essentials

Elsmar Cove Forum ToS and Forum Policies

Elsmar Cove Forum ToS (Terms of Service) and Policies are documented here.
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31
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364
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General Elsmar Cove Forum Participation Rules and Guidelines

Elsmar Xenforo Forum Software Instructions and Help

Elsmar Xenforo software Instructions and Help Listed Alphabetically
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30
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90
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90
Conversations - Limitations for New Registered Members

Forum News and General Information

Something new happening? Please post related topics here.
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Inactive Members "Pruned" / Deleted - 3 January 2019

Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports

Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
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Conway Business Services

Bob Doering
Bob Doering's Blogs and,
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International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

ASQ - American Society for Quality

IEST - Institute of Environmental Sciences and Technology
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