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


Get Much Needed Updates on the New ISO 13485 2016 Requirements to Prepare Your Quality Management Systems

The changes to the ISO 13485 2016 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.

Changes to ISO 13485 2016, although allowing more flexibility, introduce 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

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

If you now realize a different way is needed, join this webinar with industry expert José Mora who will provide quality personnel with a different perspective and a very different approach that they can use. Get an overview of the coming changes and their implications, using a new approach that is still based upon solid principles and proven practices.

This webinar will first present the key differences between ISO 13485 2016 versus ISO 13485 2003, and then provide an overview of the standard, including systemic, management, resource, realization and remedial requirements.

Session Highlights:

Overview of ISO 13485 2016:

  • ISO 13485 2016 versus ISO 13485 2003
  • Systemic Requirements
  • Management Requirements
  • Resource Requirements
  • Realization Requirements
  • Remedial Requirements

Session Benefits:

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.

Who should attend?

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

  • R&D
  • Manufacturing
  • Engineering
  • Design Assurance
  • Quality Assurance
  • Operations
  • Document Control

Target Companies / Industries /Associations

  • Medical Device Manufacturers
  • Associations like ASQ, RAPS, AAMI

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