Quality Management System ISO 13485- 2017

Quality Management System ISO 13485- 2017
Event on 2017-08-17 09:00:00
Course "Implementing ISO 13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


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.

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.

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

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

Dan O'Leary
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: Chicago, IL Date: August 17th & 18th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Four Points by Sheraton Chicago O'Hare 10249 W Irving Park Road, Schiller Park, IL 60176, United States


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at Four Points by Sheraton Chicago O’Hare
10249 W Irving Park Road, Schiller Park, IL 60176, United States
Schiller Park, United States

Moravia Achieves ISO 13485 Certification

Brno, Czech Republic (PRWEB) January 10, 2013

Moravia, a worldwide leader in advanced translation and globalization solutions, has earned CSN EN ISO 13485 certification for its Life Sciences Practice.

This achievement represents a major commitment to excellence in Moravias translation and globalization services as well as to the companys medical device and life sciences customers, according to Renato Beninatto, Moravias Chief Marketing Officer.

ISO 13485 defines international standards for quality management and quality assurance within the design, development, production, installation and servicing of medical and in-vitro diagnostic devices. To market medical device equipment internationally, every piece must comply with each countrys regulations, along with certain manufacturing standards.

ISO 13485 also establishes standards for regulatory compliance, which is critical for medical device manufacturers. In most cases, regulatory compliance mandates that specific content, such as instructions, training, service manuals or software, be available in the native language of the device users in any given market. Moravias Life Sciences unit provides documentation and content translation services for medical and in-vitro diagnostic equipment makers, as well as for the pharmaceutical and biotech industries.

Errors in translationsin addition to generating extra costsmay result in product delays, product recalls, and in some cases, can even lead to product liability lawsuits, Beninatto said.

We hold our employees to the highest standards, he said. ISO 13485 certification complements our existing ISO 9001:2009 certification and reassures our clients that Moravias work meets or exceeds internationally recognized quality benchmarks in one of the most highly regulated industries in the world.

About Moravia

Moravia Worldwide is a leading globalization solution provider, enabling companies in the information technology, e-learning, and life sciences industries to enter global markets with high quality multilingual products. Moravia’s solutions include localization, product testing, internationalization, multilingual publishing, technical translation, content creation, machine translation, and workflow consulting. Our dedicated testing and engineering solutions help companies succeed with their software and hardware products globally through services including test development, linguistic and functional testing, test automation and software engineering. Moravia Worldwide maintains global headquarters in the Czech Republic and North American headquarters in California, with local offices and production centers in Japan, China, Latin America, Ireland, USA and throughout Europe. To learn more, please visit http://www.moravia.com.