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What’s New In 2016? Section 6 - Resource Management 6.2 – Human Resources/ Competence Regular references to the regulatory requirements (*New sub-clause) What’s New In 2016? Section 4 - Quality Management System *4.2.3 - Medical Device File: For each medical device type or medical device family, the organization shall establish and maintain a file(s) either containing or referencing documents generated to demonstrate conformity with the requirement of this International Standard and compliance with applicable regulatory requirements.
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What’s New In 2016? Section 4 - Quality Management System 4.1 – General (software): New Technologies 4.1.6 – Requires documented procedures for the validation of software used in the Quality Management System 4.1.6 – Such software shall be validated prior to initial use, and as appropriate, after changes What’s New In 2016? Section 1.2 – Scope Of Particular Note in 1: “The processes required by this International Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.” What’s New In 2016? Section 1 – Scope 1.2 - Any requirement of Clause 6, 7, or 8 can be deemed “not applicable” to the organization (with documented justification) What’s New In 2016? Introduction - General The standard “can be used by an organization involved in one or more stages of the life-cycle of a medical device” And, by suppliers and other external parties providing product to such organizations *(excluding: Scope, Normative References, Terms & Definitions)
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ISO 13485:2016 retains 5* QS core “Processes”Īnnex B of ISO 13485:2016 provides a handy cross-reference between ISO 9001:2015 and ISO 13485:2016 normative requirements.ISO 9001:2015 now has 7* QS core “Processes”.What’s New in ISO 13485:2016? ISO 13485:2016 did NOT follow ISO 9001:2015 into the Higher Level Structure format QI Conference November 201:2016/17 ‘Understanding the Changes’Īre you ready for ISO 13485:2016? New Technologies New Regulations New Era NSAI Dedicated NSAI team Jackie Mateer – Medical Devices E: T:01 8073861 Gwen Thornberry – Medical Devices E: T:01 8073929 Jennifer Casey – General Management Systems E: T: 01 8073817 Patricia Whelan – General Management Systems E: T: 01 8073993Įvents: ‘A Clients perspective’ ISO 9001:2016 & ISO 14001:2015 – Autumn 2016 Need to map the gaps – guidance to follow ISO TC 210 ducked the HLS for 3 and possibly 5 years ISO 13485:2016 revised but not in line with the HLS Scope Normative references Terms and definitions Context of the organization Leadership Planning Support Operation Performance evaluation Improvement
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High level structure 1 2 3 4 5 6 7 8 9 10 Management Systems Certification Main Certification schemes – a time of great change All HLS ISO 9001:2008 to 2015, Quality ISO 14001:2004 to 2015, Environment OHSAS 18001:2007 to ISO 45001:2016/17 Occupational Health & Safety Three year transition period – period of co-existence Common Language Common Structure - HLS Ease of integration Reduced: work, costs, less disruption, better understanding Aligned with the business - a Business Standard See ISO guide NSAI audits, reports and audit teams delivered an integrated service – the HLS in practice Standards needed to catch up A time of change for many Certification Management Standards Understanding changes & their impacts Management Standards – general ISO 13485:2016 Medical Devices -QMS change ISO Standards? ISO Review and Revise to support Continual Improvement and Best Practice – the HLS ISO has supported the mantra of ‘Integration’ for many years – the HLS. Presenters Fergal O’Byrne Head, Business Excellence, NSAI Susan Murphy European Medical Device Operations Manager Mary Murphy Lead Auditor, Medical Device Department Aishling Owens Lead Auditor, Medical Device Department Lisa Mee Lead Auditor, Medical Device Department MEDICAL DEVICE SEMINAR ISO 13485:2016 & MDR May 2016