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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Lean in Manufacturing and Service Industries
Lean Manufacturing, including Lean in Service Industry discussions.
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Manufacturing and Related Processes
Specific manufacturing process(es) & systems, materials, and related discussions.
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Process Maps, Process Mapping and Turtle Diagrams
Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
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Reliability Analysis - Predictions, Testing and Standards
Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
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Service Industry Specific Topics
Service Industry specific and related discussions.
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National and International Business System Standards
Aviation, Space and Defense Standards and Requirements
Please choose one of the more definitive Sub-Forums. Thank you!
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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.
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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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Environmental Related Standards
Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
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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
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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.
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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
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IEC 27001 - Information Security Management Systems (ISMS)
IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
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ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
ISO 900x Quality Management Systems related discussions.
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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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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.
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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...)
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Oil and Gas Industry Standards and Regulations
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RoHS, REACH, ELV, IMDS and Restricted Substances
RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
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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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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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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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Other ISO and International Standards and European Regulations
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Various Other Specifications, Standards, and related Requirements
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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
Marcelo follows sandards closely. A link to his website is in all the threads he has posted in this forum. If you like, you can post Medical Device and FDA Regulations and Standards News, too. Just start a New Discussion (thread).
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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.
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- ISO 13485:2016 - Medical Device Quality Management Systems
- ISO 14971 - Medical Device Risk Management
- IEC 60601 - Medical Electrical Equipment Safety Standards Series
- IEC 62304 - Medical Device Software Life Cycle Processes
- IEC 62366 - Medical Device Usability Engineering
- Other Medical Device Related Standards
- The US's FDA (Food and Pharma/Drug) Forum
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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.
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Other Medical Device and Orthopedic Related Topics
Other various Medical Device and Orthopedic related discussions.
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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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Common Quality Assurance Processes and Tools
Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically
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APQP and PPAP
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Auditing Quality and Environmental Management Systems
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Consultants and Consulting
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Contract Review Process
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Customer Complaints
Dealing with Customer complaints/concerns.
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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!
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Design and Development of Products and Processes
Process and Product Design and Development discussion discussions. Design Verification and Validation included.
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Document Control Systems, Procedures, Forms and Templates
Documentation Systems (Document Control), including Procedures, Forms, and Templates.
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FMEA and Control Plans
Failure Modes Effects Analysis (FMEA) and Control Plan discussions.
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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.
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Inspection, Prints (Drawings), Testing, Sampling and Related Topics
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Management Review Meetings and related Processes
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Misc. Quality Assurance and Business Systems Related Topics
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Nonconformance and Corrective Action
Significant Systems, including 8-D / 7-D, etc. Can you proveEffectiveness (for example) of a Corrective Action?
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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.
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Preventive Action and Continuous Improvement
What is a Corrective Action vs. a Preventive Action?
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Risk Management Principles and Generic Guidelines
Principles and generic guidelines on Risk Management.
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Problem Solving, Root Cause Fault and Failure Analysis
Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
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Quality Management System (QMS) Manuals
Quality Manual Development and Quality Systems Manual related Discussions.
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Quality Manager and Management Related Issues
Quality Manager and Quality Assurance Management Issues/questions
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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.
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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?
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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.
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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.
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Statistical Analysis Tools, Techniques and SPC
SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
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Supplier Quality Assurance and other Supplier Issues
A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
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Training - Internal, External, Online and Distance Learning
Training and related topic discussions.
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Registrars and National / International Organizations
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Registrars and Notified Bodies
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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.
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General Information Resources
Various Uploaded Data and other Information Files
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Imported Legacy Blogs
Legacy Blogs imported from the old vBulletin "Blog" mod.
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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.
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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.
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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.
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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.
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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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Paid Consulting, Training and Services
Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.
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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.
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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.
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Elsmar Cove Forum Community Discussions.
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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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Elsmar Xenforo software Instructions and Help Listed Alphabetically
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Latest resources
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Free Medical Device Registration in Brazil - ANVISAMarcelo Antunes' Series about Medical Device Registration in Brazil- Marc
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Free Steve Prevette's Statistical Process Control (SPC) "Library"Some good information and files Steve has shared here.- Marc
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Free Bob Doering's Blog Post SeriesBob Doering's Blog Post Series mainly related to SPC in Precision Machining- Marc
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International Standards Bodies - World Wide Standards Bodies
AIAG - Automotive Industry Action Group
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NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest
IEST - Institute of Environmental Sciences and Technology