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: 50

Posts: 355

Threads: 50

Posts: 355

SOP Sample for BC/ISO22301 (Business Continuity) wanted

Nov 2, 2019
Richard Regalado

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: 503

Posts: 2,745

Threads: 503

Posts: 2,745

CE for Class 1 medical device

Yesterday at 3:45 PM
Watchcat

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: 1,322

Posts: 6,913

Sub-forums:

Threads: 1,322

Posts: 6,913

Examples of software changes that required a 510k

Friday at 10:04 AM
yodon

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: 5,472

Posts: 66,243

Threads: 5,472

Posts: 66,243

When exactly can a corrective action be closed?

Yesterday at 9:55 PM
Big Jim

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: 3,333

Posts: 27,157

Sub-forums:

QS-9000 - American Automotive Manufacturers Standard

Threads: 3,333

Posts: 27,157

IATF 16949 8.4.2.4 Supplier Monitoring

Friday at 4:02 PM
Sidney Vianna

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: 154

Posts: 833

Threads: 154

Posts: 833

How many mandays required for the below mentioned standards

Saturday at 4:31 PM
Jen Kirley

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: 296

Posts: 3,220

Threads: 296

Posts: 3,220

What is OHSAS 18000, OHSAS 18001 and OHSAS 18002?

Oct 27, 2019
Henria

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: 116

Posts: 996

Threads: 116

Posts: 996

API Q1 9th Edition Internal Audit Checklist /Report

Sep 11, 2019
mike10

RoHS, REACH, ELV, IMDS and Restricted Substances

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

Threads: 266

Posts: 1,983

Threads: 266

Posts: 1,983

IMDS for double sourced component

Oct 14, 2019
sinned

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: 483

Threads: 69

Posts: 483

Cleaning plastic from our oceans - The Ocean Cleanup Venture

Oct 27, 2019
Marc

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: 126

Posts: 824

Threads: 126

Posts: 824

VDA 6.3 Qualification as Process Auditor training course and exam

Nov 1, 2019
batteryguy

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: 685

Posts: 4,506

Threads: 685

Posts: 4,506

Can a calibration lab still use ISO 6789:2003 as guide for torque calibrations

Nov 9, 2019
dwperron

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: 3,739

Threads: 626

Posts: 3,739

Post Market Surveillance Standard

Oct 8, 2019
Marcelo

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: 377

Posts: 581

Threads: 377

Posts: 581

Significant change notice for outsourced warehouse

Saturday at 9:09 AM
craiglab

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: 4,249

Posts: 30,553

Sub-forums:

Threads: 4,249

Posts: 30,553

An example of risk analyisis of class I MD

Today at 3:23 AM
Marco83

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: 4,475

Posts: 27,170

Sub-forums:

Threads: 4,475

Posts: 27,170

Manufacturer address on the label

Today at 1:56 AM
monoj mon

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: 257

Threads: 49

Posts: 257

GDPR - Is anonymizing sufficient to address right to erasure?

Nov 4, 2019
dsheaffe

Common Quality Assurance Processes and Tools

Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically

For discussion of Definitions, Acronyms, Abbreviations and Interpretations

Threads: 625

Posts: 5,757

Threads: 625

Posts: 5,757

Product Audit vs. Dock Audit vs. Layout Audit - Differences

Sep 12, 2019
duminy331

APQP and PPAP

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

Threads: 951

Posts: 6,910

Threads: 951

Posts: 6,910

APQP Relationship Diagram

Wednesday at 9:53 AM
sbutler

Auditing Quality and Environmental Management Systems

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

Threads: 1,938

Posts: 25,982

Sub-forums:

Threads: 1,938

Posts: 25,982

Process Documentation for ISO 9001:2015

Yesterday at 7:47 PM
Jen Kirley

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: 466

Posts: 4,042

Threads: 466

Posts: 4,042

Machine Setup for a CNC Machine Capability Study

Nov 5, 2019
s_am__

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: 1,177

Threads: 90

Posts: 1,177

CER (Clinical Evaluation Report) Writer Wanted - Nov 2017

Oct 20, 2019
zidah

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?

Thursday at 3:37 PM
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: 542

Posts: 3,853

Threads: 542

Posts: 3,853

Change Management vs Change Control?

Nov 5, 2019
Jim Wynne

Document Control Systems, Procedures, Forms and Templates

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

Threads: 2,332

Posts: 21,851

Threads: 2,332

Posts: 21,851

Controlling Quick Reaction Checklists

44 minutes ago
John Broomfield

FMEA and Control Plans

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

Threads: 952

Posts: 7,761

Threads: 952

Posts: 7,761

What are the changes in 5th Edition of FMEA manual?

Saturday at 10:51 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: 4,638

Posts: 33,919

Sub-forums:

Threads: 4,638

Posts: 33,919

Determination of Calibration Intervals and Frequency Analysis

Yesterday at 3:47 PM
Nicole Desouza

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

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

Threads: 1,681

Posts: 12,763

Sub-forums:

AQL - Acceptable Quality Level

Threads: 1,681

Posts: 12,763

Angle between two surfaces

Thursday at 9:43 PM
bguarino

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: 800

Posts: 7,762

Threads: 800

Posts: 7,762

ATP 5-19 "Risk Management"

Saturday at 10:57 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: 727

Posts: 8,176

Threads: 727

Posts: 8,176

How to write a proper defect description in a NCR

Friday at 12:58 PM
Jim Wynne

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: 216

Posts: 3,137

Threads: 216

Posts: 3,137

MIL-STD-105E vs MIL-STD-1916 - Is 1916 the same as C=0?

Jul 16, 2019
v9991

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: 181

Posts: 2,522

Threads: 181

Posts: 2,522

Working on a Root Cause

Thursday at 3:02 PM
Bill Levinson

Quality Management System (QMS) Manuals

Quality Manual Development and Quality Systems Manual related Discussions.

Threads: 292

Posts: 4,278

Threads: 292

Posts: 4,278

Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing?

Oct 16, 2019
hogheavenfarm

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: 1,697

Posts: 13,434

Sub-forums:

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

Threads: 1,697

Posts: 13,434

Statistical Analysis - Check if these organisms at different concentrations affect the growth of wheat seedlings

Oct 21, 2019
Miner

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: 227

Posts: 1,195

Threads: 227

Posts: 1,195

Benefits of electronic QMS software

Saturday at 12:15 AM
qualprod

Statistical Analysis Tools, Techniques and SPC

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

Threads: 1,406

Posts: 11,312

Threads: 1,406

Posts: 11,312

Recommendation about h and k values when CUSUM charts are used

Sep 17, 2019
japayson

Supplier Quality Assurance and other Supplier Issues

A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.

Threads: 708

Posts: 6,091

Threads: 708

Posts: 6,091

Supplier Quality Standard vs Senior Management Direction

Friday at 1:22 PM
optomist1

Training - Internal, External, Online and Distance Learning

Training and related topic discussions.

Threads: 793

Posts: 6,614

Threads: 793

Posts: 6,614

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

Nov 7, 2019
Bill Levinson

Registrars and National / International Organizations

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

Threads: 258

Posts: 3,148

Sub-forums:

ASQ - American Society for Quality

Threads: 258

Posts: 3,148

IAF CertSearch Database - Repository of (properly) Accredited Management System Certs

Friday at 12:47 PM
Sidney Vianna

Registrars and Notified Bodies

Registrar and Notified Body Discussions

Threads: 437

Posts: 6,479

Threads: 437

Posts: 6,479

Migrate ISO 9001:2015 Certificate

Thursday at 11:45 AM
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: 836

Posts: 11,409

Threads: 836

Posts: 11,409

From the "I'm glad I'm retired" Department (Oct 2019)

Oct 23, 2019
Ronen E

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: 3

Posts: 3

Threads: 3

Posts: 3

US Dept of Defense College Acquisition Internship - Summer 2020 - Suspense 1 Oct.

Sep 26, 2019
Marc

Paid Consulting, Training and Services

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

Threads: 15

Posts: 103

Threads: 15

Posts: 103

Available ISO 13485 Consultants

Yesterday at 7:02 PM
Sam Lazzara

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.