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The scope adds wording to define use of the QMS throughout the product lifecycle, the idea that an organization should identify outsourced processes, the ability to declare non-applicable sections of the standard for the organization’s QMS (from sections 6, 7, or 8), and some clarifications of terminology and phrases used. To document a requirement means firms must establish, implement, and maintain the procedures to accomplish that requirement. The new edition also outlines several key concepts, including the risk-based approach. The inclusion of “associated activities” (e.g., service of product at customer)Ī need to identify the organization’s role for regulatory purposes (e.g., distributor, supplier, manufacturer, etc.)įurther clarification that the standard does not include other management systems (e.g., environmental) Introduction and Scope Statement Clarifications (Sections 0, 1, and 2)Īdding to what was listed in the previous edition, the scope of a quality management system includes:Įxplicit inclusion of storage and distribution as well as final decommissioning and disposal of the product within the QMSĪ new statement that this standard may be used by organizations in the supply chain (voluntarily or by contract)
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(This article will cover points 1-7 remaining points will be explained in part two of this article which can be found here.)ġ.
Iso 13485:2016 iso#
Increased focus regarding feedback mechanismsįollowing is an overview of 17 key differences between ISO 13485:2003 and ISO 13485:2016. Strengthening of supplier control processes Inclusion of risk management throughout the QMSįurther clarity regarding validation, verification, and design activities The proposed revisions to the current version of ISO 13485 can be summarized in these points: The transition period ends in March 2019, leaving any ISO 13485:2003 certification invalid. Over half the transition time from the 2003 edition to the new ISO 13485:2016 is behind us. With an emphasis on risk management in the quality system process, the changes impact organizations in the medical device supply chain, auditors/certification bodies, training providers, and consultants.
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For the first time in 13 years, the International Organization for Standardization (ISO) has updated ISO 13485, the medical device industry’s framework for quality management systems (QMS).