ISO 13485:2016 using Lean Principles – Don’t let the New Requirements Surprise You
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Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2016 revision changes. There is an 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.
It would be a major oversight to think of these changes as anything but a profound 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.
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.
Viewing this in the context of Lean Documents and Lean Configuration will provide clarity prior to embarking upon these changes.
Areas Covered in the Session :
- Brief introduction to Lean Documents and Lean Configuration
- ISO 13485:2016 versus ISO 13485:2003
- Overview of ISO 13485:2016
- Systemic Requirements
- Management Requirements
- Resource Requirements
- Realization Requirements
- Remedial Requirements
- Changes to ISO 13485:2016
- 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
- How to apply the principles of lean documents and lean configuration provide a unique approach to creating continuity between the various elements of the Quality Management System (QMS) while avoiding unnecessary complexity and redundancy.
- Bringing it all together
Who Should Attend:
A must attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Research & Development
- Design Assurance
- Quality Assurance
- Operations
- Document Control
- Manufacturing Engineering
Course Director: JOSÉ MORA
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