Medical Device, Risk Analysis, Quality Assurance, and Business Standards Information

Miner's MSA (Measurement Systems Analysis) Blog

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To be a free Business Standards Compliance and Business Systems Information Resource to Quality Assurance, Engineering and Management Professionals. People Helping People since 1996!

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Business Standards Discussions and Information
A bit about Elsmar.com... The Elsmar Cove has been on the internet longer than any other quality assurance / business standards web site of its kind. The Elsmar Cove website has been on the internet for almost 21 years, having come online on 5 January 1996 - First as QS9000.com and around mid-2000 I changed to the 16949.com domain. A brief history of Elsmar.com can be found here: A History of the Elsmar (aka Cayman) Cove. Elsmar started out with a focus on automotive's QS-9000 and automotive related requirements, and ISO 9001, but has evolved to include discussions of various regulatory affairs issues, manufacturing issues, a bit of six sigma and other quality assurance related tools and aspects - Business Systems are the focus. Once composed mostly of static pages focusing on ISO 9001 and QS-9000, the Elsmar Cove forum is now the main focus of the Elsmar Cove site and the breadth of topics has significanly widened to address many more business / manufacturing system and standards compliance issues. ISO 9001:2015, AS9100:2016 Rev. D, Six Sigma, Lean, and Quality Assurance tools are only a few of the topics discussed. From manufacturing to training discussions, there's a lot in the forums. While the initial focus of the site included automotive's QS-9000 and ISO9001, that focus has broadened to include ISO / TS 16949 and much more. Automotive manufacturing is a primary topic. We have also broadened the site to address ISO 13485 (Medical Devices), ISO 17025 (Calibration and test laboratories), ISO 14001 (the 'Environmental' standard) and numerous other business standards. Several thousand professionals from all over the world meet in the forum every day during the work week. One on the nice things about the Elsmar Cove is there is a lot of free information, free forms and free example quality manuals, Gage R&R spreadsheets, various document example templates and other things you would pay for at many sites. Some files are Attachments to Forum Posts in the forums (Look for this symbol in forum thread listings) and some are in the 'Free Files Directory'. Several other areas of focus include the requirements of ISO 17025 (Calibration and Test Laboratories) and ISO 13485 (Medical Devices). If you're in need of information about ISO 9001 (often referred to as ISO9001, ISO9000 or ISO 9000), IATF 16949, AS9100, ISO 14001 or other business standard, you're at the right place. We eat, sleep and breath business standards. If you need something and you can't find it (or if what you're looking for isn't already here), if you ask someone will typically help out by pointing you to an existing document here or attaching what you're looking for in a post. This is a site where you find People Helping People through sharing and online discussions.	Current Elsmar Quality Forum Discussions

**The Elsmar Cove National and International Business Standards Compliance Discussion Forums**
	National and International Business Standards AS9100 - Aerospace CE Marking (Conformité Européene) / CB Scheme FDA (United States Food and Drug Administration) Federal Aviation Administration (FAA - FAR Requirements) ISO 9001 and the ISO 9000 Quality Management Systems Standards Series ISO 14001 and Environmental Related Standards Energy, 'Green' and Sustainable Development Standards and Initiatives IEC 60601 - Medical Electrical Products Collateral Standards ISO 13485 - Medical Devices ISO 17025 - Calibration and Test Laboratories ISO 22000, HACCP (21 CFR 120) and Food Safety Other ISO and International Standards and Regulations Other Various Specifications, Standards and Test Procedures Service Industry Specific Topics Software Quality Assurance	Common Quality Assurance Topics and Tools Documentation Systems, Procedures, Forms and Templates Misc. Quality Assurance and Business Systems Related Topics Nonconformance and Corrective Action Preventive Action and Continuous Improvement Quality Assurance and Compliance Software Tools / Solutions Quality Philosophy, Gurus, Controversy and Evolution Quality Tools, Improvement and Analysis Quality Management System (QMS) Manuals Records - Quality and Other Evidence SPC Monitoring and Statistical Analysis Techniques Six Sigma Training - Internal, External and Distance Learning
Manufacturing Process Topics and Business System Human Factors and Ergonomics in Engineering Lean Manufacturing Manufacturing and Related Processes Reliability Analysis, Predictions, Testing and Standards Service Industry Specific Topics	Misc. Topics Customer (Company) Specific Requirements Hospital & Health Care Providers - Best Practices and ISO 9001 ISO and IEC Medical Device Standards Lean - Lean in Manufacturing and Services Manufacturing and Related Processes Occupational Health & Safety Management Standards RoHS, REACH, ELV, IMDS and Restricted Substances Related Regulations SPC Monitoring and Statistical Analysis Techniques	Auditing, Consultants and Registrars Auditing including ISO 19011 Registrars and Registration Consultants and Consulting ASQ, IRCA, IATF, RABQSA, and Related Information
Information Resources Book, Video and Web Site Reviews Hotels, Motels, Planes and Trains - Travel Manufacturing and Related Processes Registered User Articles Archive Service Industry Specific Topics The Reading Room Forum 'How To' and User Information Forum Software Instructions --> How To use the Elsmar Cove Forum Software	Professional Employment Occupation Discussions Professional Certifications and Degrees	Community Forums Buy and Sell - NO Commercial advertisments Coffee Break & Water Cooler Chatter Photo Albums
	Common Quality Assurance Topics Capability, Accuracy and Stability - Process, Machine, etc. Contract Review Process Documentation Control Systems, Procedures, Forms and Templates Inspection and Test, Sampling and Related Topics Management Review Process Nonconformance and Corrective Action Preventive Action and Continuous Improvement Training - Internal, External and Distance Learning	Automotive Sector Topics APQP and PPAP FMEA and Control Plans IATF 16949 Measurement Systems Analysis (MSA) Germany's VDA Series

***"Canned" Presentations and Various Site Links***
Taguchi Loss Function animation	The Deming PDCA Cycle animation	ISO 9001:2015	Quality Management System (QMS) Implementation	8-D Problem Solving
Auditing Information	APQP Information	FMEA Information	Process Loop animation	Fishbone / Cause and Effects animation
Brainstorming	Discovering Change	Histogram animation	Process Capability - Cp vs. Cpk animation	Error Proofing (Poka Yoke)
Planned Maintenance	Pull Systems	Lead Time Reduction	Some Basic Statistics	Identifying Waste
Quick Setup	Thoughts on Teams		Basic Statistics Glossary	Reliability, Maintainability, and Dependability Standards List
Elsmar Cove Forums Index

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