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Aligning ISO 13485:2016 with Annex L structure will require the consideration of a process-based, holistic approach to addressing the needs of the entire management system.
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One primary difference between the standards deals with how organizations consider risk. While these standards differ in structure and terminology, there is enough overlap for them to be implemented simultaneously and without conflict.
#QMS ISO 13485 MANUALS#
A cursory look at the two standards might lead an organization to believe they need two quality manuals to address the requirements of each however, this effort isn’t necessary. ISO 13485:2016 retains the clause structure of ISO 13485:2003 and ISO 9001:2008, but because ISO 13485:2016 hasn’t changed much from its predecessor, organizations can benefit from the familiarity of the old standard as they work towards alignment with ISO 9001:2015. For those specifically integrating ISO 9001 and ISO 13485, even with the structural differences that now exist, there are steps that can be taken to minimize the amount/need for modification. In all cases, the goal of reusing as much of the system (documentation, training, internal auditing approaches, etc.) as possible without modification greatly saves time and resources.
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There are many situations that may benefit from certifying to multiple quality management standards, for example: ISO 13485 PowerPoint Training Materials.ISO 13485 Online Training Course Listing.ISO 13485 Internal Auditor Training Courses.ISO 13485 Lead Auditor Training Courses.Simple Steps to ISO 13485 Certification Follow our proven and manageable step-by-step process for a successful ISO implementation project.