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

3884
Duration : 90 Minutes

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 Co Read more


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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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