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ISO 13485 Resources

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• Medical Device Organizations
• Quality and Standards Related Organizations
• Quality Publications
• Registrars
• Consultants
• List of Certified Parties
• Federal Quality Organizations
• Other Links

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Buy a copy of ISO 13485 Standard

Medical Device Industry Organizations

US Food & Drug Association (www.fda.gov) websites:

• Compliance Program Guidance Manual
• Device Advice
• FDA Warning Letters
• Guide to Inspection of Quality Systems
• Inspections Operations Manual
• Laws Enforced By the Food and Drug Administration
• ORA Field Management Directive
• Quality System Regulation

Medical Device Link

Global Harmonization Task Force

Health Canada

The Medical Devices Bureau of Health Canada

The Medicines and Healthcare products Regulatory Agency (MHRA)

Australian Government Department of Health & Ageing

Consultants

Methodize Inc. - a consulting and training firm specializing in regulatory, clinical and quality services.

Quality Related Organizations

ISO
International Standards for Organization

ASQ
The world's leading membership organization devoted to quality

ANSI-ASQ National Accreditation Board (ANAB)
The US accreditation body for QMS certification. They offer a directory of Registrars and other resources.

NQI National Quality Institute

RABQSA
Designs, develops, and delivers personnel and training certification for various standards (ISO 9001, etc.)

Society for Quality Assurance
Research and Regulatory Information

American National Standards Institute
American National Standards Institute (ANSI) web site offers up-too-date resources on national and international standards activities.
International Quality Organizations by Country: Please contact us to add your info.

Quality Publications

Quality Digest

Quality Magazine

Registrars

See our Registrars pag

List of Certified Companies

Who's Registered

QSU Online ISO 9000 Registered Company Directory

Quality Digest ISO 9000 Directory

Federal Quality Organizations

MEP (Manufacturing Extension Partnerships)
A nationwide network of resources transforming manufacturers to compete globally.

National Institute of Standards & Technology
A federal technology agency that works with industry to develop and apply technology, measurements, and standards.

Other Links

ISO 9001 Compliance & ISO 9001:2008 - ISO 9001 Compliance: Your ISO 9001 Resource for information, books, article, consulting, and more. Including the new ISO 9001 2008 Standard. Total Quality Management at its best!