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Implementing ISO 13485:2016

GlobalCompliancePanel

Course

In Washington, D. C. ()

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£ 875.29 VAT inc.

*Indicative price

Original amount in USD:

$ 1,095 $ 1,495

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Description

  • Type

    Course

  • Class hours

    9h

  • Duration

    2 Days

Implementing ISO 13485:2016

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.

Important information

Documents

  • Implementing ISO 13485 April 12-13 2018 PDF.pdf

About this course

Workshop Objectives:

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.

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

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.

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Reviews

Subjects

  • Audit
  • Quality
  • ISO
  • Design
  • Planning
  • Systems
  • Medical
  • Medical training
  • Quality Training
  • Regulations

Teachers and trainers (1)

Dan O'Leary

Dan O'Leary

President, Ombu Enterprises

Dan O'Leary is 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 certified by APICS in Resource Management.

Course programme

Day 1 Schedule

Lecture 1:
Overview of ISO 13485:2016

Summary of the differences between ISO 13485:2003 and ISO 13485:2016
High level comparison with FDA QSR
Lecture 2:
Regulatory Framework

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
Lecture 3:
Management Responsibility

Quality Policy and Objectives
Responsibility and Authority
Internal Quality Audits
Management Review
Lecture 4:
Resource Management

Competence and Training
Infrastructure
Work Environment and Contamination Control
Lecture 5:
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

Lecture 1:
Supplier Management

Selection
Purchasing Information
Written Quality Agreements
Purchased Product Verification
Lecture 2:
Production Processes

Production Control
Installation and Servicing
Identification and Traceability
Control of Nonconforming Product
Lecture 3:
Process Validation

When to Validate
Validation Requirements
Software Validation
Lecture 4:
Monitoring and Measuring

Control of Equipment
Processes and Products
Data Analysis
Complaint Handling
Lecture 5:
Corrective and Preventive Action

Corrective Action
Preventive Action

See related categories

Implementing ISO 13485:2016

£ 875.29 VAT inc.

*Indicative price

Original amount in USD:

$ 1,095 $ 1,495

The best Quality Control courses

See all

See all