ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration


All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.

Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2016 revision changes.  They will have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.

The webinar will first present the key differences between ISO 13485 2016 versus ISO 13485 2003.

Next, the speaker will provide an overview of the updated standard.

Course Objective:

The changes to this standard will have profound implications to how Quality Management Systems (QMSs) interact internally and between different supply chain agents.

It would be a major oversight to think of these changes as anything but a game-changer in terms of expectations and requirements.

Rather than wait to be surprised by unexpected requirements, or to implement them haphazardly, it is better to understand what is coming and begin to plan for the changes that will permeate throughout all areas of your organization’s quality processes.

If you are already constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, and now realize a different way is needed, this webinar is something that will give you a different perspective and a very different approach that you can use.

This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.

Course Outline:

Changes to ISO 13485 2016, although allowing more flexibility, introduces significant, comprehensive, and systemic changes involving the following areas:

  • Regulatory requirements
  • Risk-based approach
  • Medical device file
  • Record keeping
  • Product realization
  • User training
  • Design and development
  • Purchasing
  • Process validation
  • Servicing
  • Complaints
  • Delivery of nonconforming product
  • Improvement

What You Get:

  • Training Materials
  •  Live Q&A Session with our Expert
  • Participation Certificate
  • Access to Signup Community (Optional)
  • Reward Points

Who Will Benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
• R&D
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Operations
• Document Control

Jose Mora,

Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, Jose served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health Company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, Jose managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.

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