ISO 13485:2016. Kimberly A. Trautman. Executive Vice President, Medical Device International Services

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1 ISO 13485:2016 Kimberly A. Trautman Executive Vice President, Medical Device International Services

2 This document is intended to facilitate an oral briefing. It is not intended for use as a stand-alone report. 2

3 Background ISO International Organization Standardization (ISO) standard published first in 1996, revised in 2003, and now in 2016 Sector specific standard based off ISO 9001 Represents the requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices and in vitro diagnostic devices, as well as their related processes and services 3

4 Why was ISO revised? Since 2003, new medical device regulatory activities emerged in South American nations, Asian Pacific nations, and more recently in African nations Global Harmonization Task Force (GHTF) in 2011 requested TC210 to consider revisions in light of the ISO Technical Management Board s decision on the QMS High Level Structure and requirements Sweden challenged the EU designation of EN ISO 13485:2003 as a harmonized standard in a formal process within the EU 4

5 Why was ISO revised? In 2011, ISO/TC 201 Working Group 1 conducted a web-based user survey to determine need for revision of the standard Responses from every global region Responses from a range of size and types of organizations Responses from a range of medical device manufacturers of different regulatory classification 5

6 Results of User Survey 83% surveyed stated the standard was highly effective or effective, while only 1% stated it was ineffective 60% surveyed supported revision to improve effectiveness 30% cautioned on problems integrating with other QMS standards 6

7 New Work Item In 2012, a New Work Item Proposal was drafted and submitted for ballot 23 of 24 voting members voted affirmatively on the New Work Item Proposal to revise ISO with the original goal of publication in

8 Objectives Improve clarity of the requirements Increase confidence that the requirements are consistent with cgmps or current Quality System regulatory requirements/objectives Increase harmonization of QMS regulatory requirements Increase medical device manufacturers ability to meet customer requirements 8

9 Intended Benefit To serve as a harmonized model to be used by national and regulatory bodies in charge of QMS regulatory requirements 9

10 Design Specifications for 13485:

11 Purpose and Scope Purpose: to enhance the clarity of ISO 13485:2003 and to enhance its compatibility with the latest regulatory requirements and expectations Scope: intention to maintain the general scope of ISO while taking into consideration the latest QMS regulatory requirements and the need to avoid: Hindering the application of new technologies for meeting QMS requirements Including requirements outside those of the QMS, and Including QMS requirements that are not appropriate as regulatory requirements 11

12 Compatibility Common elements of the standard can be implemented by organizations without unnecessary duplication or imposing conflicting requirements compatibility related activities include efforts: To converge its requirements further with those in the US FDA 21 CFR Part 820, the Japanese MHLW Ministerial Ordinance No. 169: 2004, and the conformity assessment requirements of the European medical device legislation To address developments in regulatory requirements for QMS in other jurisdictions To maintain requirements compatibility with ISO 9001:2008 and ISO 9000:

13 Consistency Consistent with other documents currently existing within the ISO family May refer to, but does not include duplication of requirements from other horizontal or vertical ISO standards (e.g., software, risk management, usability, sterilization) Consistency maintained between the requirements contained in the revised ISO standard and any guidance contained in the revision of the ISO/TR technical report 13

14 Subjects to Be Addressed Scope Management Responsibilities Corrective and Preventive Actions Software Validation Supply Chain Outsourcing Risk Management Post-Market Information Gathering Adverse Event Reporting Design Verification & Validation Complaint Handling Handling of Returned Product Environment Controls Process Validation Records Management Process Approach Annex Z to EN ISO13485:2012 Alignment with ISO 9001:2008 Product Lifecycle Management Emerging Markets 14

15 General Guidelines on Drafting Original intent is to be maintained Outputs of justification study and translated into requirements Free from cultural bias Written in a clear style and can be understood by persons who have a working knowledge of quality systems Written to be unambiguous, to give a common understanding that prevents multiple interpretations Sentences are kept short to reduce excessive wordiness without becoming ambiguous 15

16 General Guidelines on Drafting (cont.) Consistent use of terminology is maintained, and that terminology issues are resolved by reference to ISO 9000:2005 Effect of any proposed change on the other requirements of ISO 13485:2003 is considered before it is implemented Requirements written in such a manner as to enable them to be audited Account taken of comments received through the process Can be translated into other languages Due consideration given to the issue of compatibility and consistency with other management system standards and ISO/CASCO standards and guidelines 16

17 Questions? 17

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