ISO 13485 Standard - 13485store

ISO 13485 - 2003 - Medical devices - Quality management systems - Requirements for regulatory purposes

ISO 13485/Cor1:2009 Medical devices - Quality management systems - Requirements for regulatory purposes - Corrigendum 1

ISO 15189 - 2007 - Medical Laboratories - Particular Requirements for Quality and Competence

ISO 15378 - 2006 - Quality Management Systems - Primary Packaging Materials for Medicinal Products - Particular Requirements for the Application of ISO 9001:2000, with Reference to Good Manufacturing Practice (GMP)

ISO 9001 - 2008 - Quality Management Systems Requirements

ISO 14971 - 2007 - Medical devices - Application of risk management to medical devices

ISO Guide 73 - 2009 - Risk management - Vocabulary

AAMI QSC - The Quality System Compendium: GMP Requirements and Industry Practice, 2nd Edition

IEC 62366 Ed. 1.0 b - 2007 - Medical devices - Application of usability engineering to medical devices

ISO 2859 - 1999 Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection

ISO 9000 - 2005 - Quality management systems - Fundamentals and vocabulary

ISO 9004 - 2009 - Managing for the sustained success of an organization - A quality management approach

ISO 15489 - 2001 - Information and documentation - Records management - Part 1: General

ISO 19011 - 2011 - Guidelines for quality and/or environmental management systems auditing

ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment

ISO/TR 10013 - 2001 - Guidelines for quality management system documentation

ISO/TR 14969 - 2004 - Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003

ISO/TR 16142 - 2006 - Medical Devices - Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices

ISO/TS 20993 - 2006 - Biological Evaluation of Medical Devices - Guidance on a Risk Management Process

AAMI TIR32 - 2004 - Medical device software risk management

AAMI TIR36 - 2007 - Validation of software for regulated processes

IEC 62304 Ed. 1.0 b - 2006 - Medical device software - Software life cycle processes

IEC/TR 80002 - 2009 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

Why aren't ISO standards free? ISO standards cost money to develop, publish and distribute. Someone has to pay. The current system whereby users are requested to pay for the standards they use, not only sustains the development process but also, very importantly, ensures that the balance of independent vs. government, private vs. public interests can be maintained.

Buy ISO 13485 & other Medical Device Standards

by clicking on the links (Risk Management in Medical Devices, etc.)

> These links bring you to the Tech Street website, the reseller of ISO & SAE Standards.
> Transaction is conducted on their secure site and is not combined with a purchase from The 13485 Store.
> The 13485 Store can assist you if needed.

Why aren't ISO standards free?

Buy ISO 13485 & other Medical Device Standards

by clicking on the links (Risk Management in Medical Devices, etc.)

> These links bring you to the Tech Street website, the reseller of ISO & SAE Standards. > Transaction is conducted on their secure site and is not combined with a purchase from The 13485 Store. > The 13485 Store can assist you if needed.

Why aren't ISO standards free?

> These links bring you to the Tech Street website, the reseller of ISO & SAE Standards.
> Transaction is conducted on their secure site and is not combined with a purchase from The 13485 Store.
> The 13485 Store can assist you if needed.