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: 357

Threads: 51

Posts: 357

Resources for Planning for top quality

Today at 7:59 PM
Marc

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.

Threads: 510

Posts: 2,777

Threads: 510

Posts: 2,777

New MDR restrictions are...

Tuesday at 3:38 PM
Ed Panek

Environmental Related Standards

Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.

Threads: 893

Posts: 7,840

Sub-forums:

Threads: 893

Posts: 7,840

6 Risks and Opportunities ISO 14001:2015

Nov 3, 2019
Randy

Food and Drug (Pharmaceuticals) related Regulations

Threads: 1,327

Posts: 6,937

Sub-forums:

Threads: 1,327

Posts: 6,937

Medical System with non-medical device and FCC

Tuesday at 10:22 PM
Al Rosen

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: 328

Posts: 2,117

Threads: 328

Posts: 2,117

ISO 22000 Audit Checklist wanted

Oct 4, 2019
hoangvu1511

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: 448

Threads: 70

Posts: 448

Quality Assurance for Complementary and Alternative Medicine (CAM)

Jun 8, 2019
Ettore

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

ISO 900x Quality Management Systems related discussions.

Threads: 5,483

Posts: 66,370

Threads: 5,483

Posts: 66,370

Controlled sticker for product identification?

Today at 8:24 PM
Ronen E

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: 3,341

Posts: 27,212

Sub-forums:

QS-9000 - American Automotive Manufacturers Standard

Threads: 3,341

Posts: 27,212

Can we provide training plan as corrective action for IATF 16949 Non conformity?

Yesterday at 9:23 AM
John Predmore

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.

Threads: 26

Posts: 150

Threads: 26

Posts: 150

Review the IT Disaster Recovery Planning Process

Jul 24, 2019
Tagin

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: 333

Threads: 49

Posts: 333

TL-9000 Certifying Body Issue - Auditor failed to find an issue for 10 years

Jul 19, 2019
Tagin

IEC 27001 - Information Security Management Systems (ISMS)

IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.

Threads: 155

Posts: 838

Threads: 155

Posts: 838

Best Practices for IT auditing - Is a session-id necessary for a complete audit trail?

Dec 5, 2019
gmctec

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: 298

Posts: 3,230

Threads: 298

Posts: 3,230

Excel Dashboard for Health Safety and Environmental KPI's for Multiple Sites

Today at 2:49 PM
selorm

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: 1,000

Threads: 118

Posts: 1,000

API monogram mark requirements

Wednesday at 4:16 PM
Sidney Vianna

RoHS, REACH, ELV, IMDS and Restricted Substances

RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics

Threads: 267

Posts: 1,986

Threads: 267

Posts: 1,986

ROHS : Applicability for AIMDs

Monday at 4:04 AM
Maeli

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.

Threads: 14

Posts: 48

Threads: 14

Posts: 48

Suppliers re-classification from Critical to Significant or from Significant to Non-critical

Apr 11, 2019
ciclozan

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.

Threads: 69

Posts: 484

Threads: 69

Posts: 484

Cleaning plastic from our oceans - The Ocean Cleanup Venture

Yesterday at 4:24 PM
Sidney Vianna

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.

Threads: 127

Posts: 825

Threads: 127

Posts: 825

VDA 6.3 questions vs IATF 16949 clauses

Dec 5, 2019
qusys

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: 689

Posts: 4,514

Threads: 689

Posts: 4,514

Specific Absorption Rate (SAR) Testing - What Standard to Use?

Tuesday at 3:04 PM
Mark Meer

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: 626

Posts: 3,740

Threads: 626

Posts: 3,740

USA Federal Court Upholds Copyright Protections for Standards Organizations

Dec 6, 2019
RSEGRIGGY

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

Threads: 382

Posts: 617

Threads: 382

Posts: 617

Global distributor vigilance responsibility

Monday at 8:54 AM
Watchcat

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: 4,272

Posts: 30,762

Sub-forums:

Threads: 4,272

Posts: 30,762

Auditor driving us nuts - ESD requirements

Today at 12:43 PM
Al Rosen

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: 4,511

Posts: 27,446

Sub-forums:

Threads: 4,511

Posts: 27,446

We have a device with two intended uses and we want to remove one

17 minutes ago
Ronen E

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.

Threads: 49

Posts: 258

Threads: 49

Posts: 258

QMS and PLM software recommendations

Today at 11:48 AM
lilybef

Common Quality Assurance Processes and Tools

Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically

For discussion of Definitions, Acronyms, Abbreviations and Interpretations

Threads: 625

Posts: 5,760

Threads: 625

Posts: 5,760

Rework vs. Repair - ISO 13485 definition

Dec 6, 2019
John Broomfield

APQP and PPAP

Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).

Threads: 953

Posts: 6,918

Threads: 953

Posts: 6,918

IMDS for Like Components (Interior Plastic, Leather/vinyl Armrest, etc.)other than Color

Dec 5, 2019
pziemlewicz

Auditing Quality and Environmental Management Systems

Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums

Threads: 1,941

Posts: 26,021

Sub-forums:

Threads: 1,941

Posts: 26,021

ISO 14001 9.2.2 Internal Audit Programme Content

Dec 5, 2019
John Broomfield

Benchmarking

Benchmarking Methods and Related General Discussions.

Threads: 122

Posts: 842

Sub-forums:

Benchmarking - Methods and General Discussions

Threads: 122

Posts: 842

How to Benchmark? Is Benchmarking of any value? Seeking advice

Jan 11, 2019
DrTBurns

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).

Threads: 468

Posts: 4,066

Threads: 468

Posts: 4,066

Interpretation with regards to Ppk > Cpk

Yesterday at 7:58 AM
John Predmore

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.

Threads: 90

Posts: 1,179

Threads: 90

Posts: 1,179

CER (Clinical Evaluation Report) Writer Wanted - Nov 2017

Today at 4:18 AM
thinqbetter

Contract Review Process

Contract Review Process Discussions and Information

Threads: 64

Posts: 505

Threads: 64

Posts: 505

AS9100D Contract Review

Nov 21, 2018
Sidney Vianna

Customer Complaints

Dealing with Customer complaints/concerns.

Threads: 163

Posts: 1,497

Threads: 163

Posts: 1,497

Best software for customer support/complaints?

Nov 14, 2019
SSchoepel

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

Sep 16, 2019
David V

Design and Development of Products and Processes

Process and Product Design and Development discussion discussions. Design Verification and Validation included.

Threads: 545

Posts: 3,870

Threads: 545

Posts: 3,870

Product Lifecycle Procedure Guidance

Yesterday at 6:41 PM
Ronen E

Document Control Systems, Procedures, Forms and Templates

Documentation Systems (Document Control), including Procedures, Forms, and Templates.

Threads: 2,333

Posts: 21,875

Threads: 2,333

Posts: 21,875

Blank Fields on CAPA Form

Dec 4, 2019
Al Rosen

FMEA and Control Plans

Failure Modes Effects Analysis (FMEA) and Control Plan discussions.

Threads: 953

Posts: 7,791

Threads: 953

Posts: 7,791

New AIAG PFMEA Process - Excel Template Attached

Today at 2:05 PM
Bill Levinson

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: 4,655

Posts: 34,001

Sub-forums:

Threads: 4,655

Posts: 34,001

Does pitch/increment/resolution of a ruled scale apply to measurement uncertainty as line item?

Yesterday at 8:13 AM
greif

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

Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.

Threads: 1,683

Posts: 12,772

Sub-forums:

AQL - Acceptable Quality Level

Threads: 1,683

Posts: 12,772

Determining sample size for device sterility

Dec 5, 2019
planB

Management Review Meetings and related Processes

Management Review related Discussions and Information.

Threads: 157

Posts: 2,257

Threads: 157

Posts: 2,257

ISO 9001 - 9.3.1 Management Review - Content and Frequency

Aug 12, 2019
outdoorsNW

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: 802

Posts: 7,772

Threads: 802

Posts: 7,772

ATP 5-19 "Risk Management"

Yesterday at 7:55 PM
Bill Levinson

Nonconformance and Corrective Action

Significant Systems, including 8-D / 7-D, etc. Can you proveEffectiveness (for example) of a Corrective Action?

Threads: 729

Posts: 8,184

Threads: 729

Posts: 8,184

CAPA effectiveness check

Nov 19, 2019
Vobro

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

Jan 31, 2019
caseywhite

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

Dec 1, 2019
Bill Levinson

Risk Management Principles and Generic Guidelines

Principles and generic guidelines on Risk Management.

Threads: 22

Posts: 156

Threads: 22

Posts: 156

Risk and Corrective actions - Currently no FMEA's - Car systems

Nov 9, 2019
Bill Levinson

Problem Solving, Root Cause Fault and Failure Analysis

Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.

Threads: 184

Posts: 2,545

Threads: 184

Posts: 2,545

Struggling with a root cause analysis - Customer Returns - Escape issue

Dec 3, 2019
optomist1

Quality Management System (QMS) Manuals

Quality Manual Development and Quality Systems Manual related Discussions.

Threads: 293

Posts: 4,280

Threads: 293

Posts: 4,280

QMS Standard appilications on different Defense Sector

Nov 18, 2019
Sidney Vianna

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?

Oct 4, 2019
Marc

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: 1,699

Posts: 13,447

Sub-forums:

Quality Assurance and Compliance Software Tools and Solutions
1. Using Minitab Software
2. Excel .xls Spreadsheet Templates and Tools

Threads: 1,699

Posts: 13,447

QMS Document Management Software Recommendations

Dec 4, 2019
Watchcat

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: 313

Posts: 3,115

Threads: 313

Posts: 3,115

Certificate of Compliance - Put a form number on it or not?

Sep 9, 2019
Ninja

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

Jun 10, 2019
Welshwizard

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: 1,197

Threads: 229

Posts: 1,197

Software SOP - Use and maintenance of an ERP system

Nov 25, 2019
QANowatzke

Statistical Analysis Tools, Techniques and SPC

SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!

Threads: 1,409

Posts: 11,333

Threads: 1,409

Posts: 11,333

Interactive visualization through graphical simulation of statistical concepts

Today at 2:27 PM
Daniel Cruz

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: 6,093

Threads: 709

Posts: 6,093

ASL - Buying from unqualified manufacturers through qualified distributors

Today at 10:38 AM
Jen Kirley

Training - Internal, External, Online and Distance Learning

Training and related topic discussions.

Threads: 797

Posts: 6,628

Threads: 797

Posts: 6,628

Four Key Performance Indicators for Continual Improvement (Dec. 3 2019) [Deleted]

Monday at 12:38 PM
Bill Levinson

Registrars and National / International Organizations

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

Threads: 259

Posts: 3,167

Sub-forums:

ASQ - American Society for Quality

Threads: 259

Posts: 3,167

ASQ Chicago Training Institute - If any of you are interesting in teaching ASQ Certification preparation

Monday at 7:57 PM
Bill Levinson

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?

Saturday at 4:50 PM
Sidney Vianna

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?

Dec 11, 2018
Marc

General Information Resources

Various Uploaded Data and other Information Files

Threads: 17

Posts: 49

Threads: 17

Posts: 49

A Thread of Attached Files circa 2004

Dec 26, 2018
Marc

Imported Legacy Blogs

Legacy Blogs imported from the old vBulletin "Blog" mod.

Threads: 221

Posts: 861

Threads: 221

Posts: 861

FMEA for Business Process

Sep 24, 2019
Marc

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:

Registered Visitor Articles Archive

Threads: 157

Posts: 1,956

Identifying Causes (book chapter 4 on problem solving)

Aug 16, 2019
Kiran Walimbe

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: 11,412

Threads: 837

Posts: 11,412

Looking for example aerospace part CAD files to be used for a case study

Dec 6, 2019
DuncanGibbons

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: 1,413

Threads: 107

Posts: 1,413

A 20 Hour Non-Stop Flight - (October 2019)

Oct 23, 2019
mattador78

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

Feb 3, 2018
6thsense

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!

Threads: 5

Posts: 6

Threads: 5

Posts: 6

Design Quality Manager US Citizen based in Germany

Dec 2, 2019
John Broomfield

Paid Consulting, Training and Services

Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.

Threads: 16

Posts: 105

Threads: 16

Posts: 105

FDA consultant or consultancy required.

Today at 3:30 PM
Watchcat

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.