The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation.
This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns.
Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. The EU is not participating, has published its own version, EN ISO 13485:2016, and will continue with the Notified Body system. However, the EU intends to replace the directives with new regulations resulting in new versions of EN ISO 13485:2016 and EN ISO 14971:2012.
The workshop covers implications in particular regulatory systems including MDASP and its nonconformity grading system.
Why should you attend:
The transition to ISO 13485:2016 can be complicated and, for some companies, the period is short, depending on when the current certificate expires. Start planning and implementing as soon as possible. This workshop provides the knowledge and understanding to update your QMS.
Participants will learn the major changes in the new version of the standard. In addition, they will understand where the new standard and QSR do not agree. The primary objective is to give participants the understanding needed for an efficient and effective QMS update.
Who Will Benefit:
- Quality managers
- Management Representatives
- Quality engineers
- Quality assurance and quality control
- Regulatory affairs managers
- Regulatory affairs professionals
- R&D managers
- R&D engineers
- Product design and development
- Operations managers
- Production managers and supervisors
- Manufacturing engineers
- Risk managers
- Complaint system team members
- CAPA team members
Day 1 Schedule
Overview of ISO 13485:2016
- Summary of the differences between ISO 13485:2003 and ISO 13485:2016
- High level comparison with FDA QSR
- Transition period for certificates
- Canada - MDSAP v CMDCAS
- EN ISO 13485:2016 and the MDD
- The new QMS audit findings/nonconformance grading system
- Implications of the EU's Medical Device Regulations
- Quality Policy and Objectives
- Responsibility and Authority
- Internal Quality Audits
- Management Review
- Competence and Training
- Work Environment and Contamination Control
Design and Development
- Design Planning
- Design Inputs and Design Outputs
- Design Verification and Design Validation
- Design Review
- Design Transfer
- Design Changes
- Design Files
Day 2 Schedule
- Purchasing Information
- Written Quality Agreements
- Purchased Product Verification
- Production Control
- Installation and Servicing
- Identification and Traceability
- Control of Nonconforming Product
- When to Validate
- Validation Requirements
- Software Validation
Monitoring and Measuring
- Control of Equipment
- Processes and Products
- Data Analysis
- Complaint Handling
Corrective and Preventive Action
- Corrective Action
- Preventive Action
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President, Ombu Enterprises
Dan O'Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Location: Boston, MA
Hotel: Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States Phone: +1 781-284-7200