Course Description:

A medical device quality management system (QMS) can present a challenge to manufacturers. The contrast between a system that is easy to use and stands up to regulatory scrutiny presents a test. In addition, most manufacturers maintain a dual system to satisfy both FDA QSR and ISO 13485:2003. The requirements are similar, but not identical; they have about 80% overlap. The recent harmonization of EN ISO 13485:2012 raises some additional issues.

The solution, as explained in the course, is to build an integrated system that incorporates both requirements. The course uses two approaches in parallel. The first is the process approach, used in ISO 13485:2003, but introduced after FDA QSR. The second is ISO/TR 10013:2001Guidelines for quality management system documentation.

The process approach identifies the processes necessary in the QMS and prepares process maps to show the steps. The maps also show how the process interacts with other QMS processes. Process identification leads directly to questions of applicability, appropriateness, and exclusion, so the course explains them and provides examples.

The process approach implements the document hierarchy. The course explains the standard method that includes the quality manual, procedures, work instructions, forms, and records. The course examines each of these elements and explains the best practices for developing each one.

There are a number of approaches to preparing these documents, but considerations must include ease of use. To illustrate these methods, the course covers readability indices and flowchart methods to limit the amount of text.

In addition, the course explains best practices for other required documents. This includes the quality policy and objectives, quality plans, and specifications. The course describes how to develop these documents and include them in the QMS.

Process and QMS effectiveness includes measurements. The course explains how to develop metrics and apply them. In particular, metrics are an integral part of quality objectives and quality plans.The course includes many examples and exercises to help participants understand the principles and apply the methods.

Learning Objectives:

  • Understand the process approach and how to apply it to a device QMS.
  • Learn the similarities and differences between ISO 13485:2003 and FDA QSR.
  • Understand the rules to exclude processes from a device QMS.
  • Learn how to define and map QMS processes.
  • Learn the standard hierarchy of QMS documents:
    • Quality manual
    • Procedures
    • Work instructions
    • Forms
    • Records
  • Understand readability indices and how to apply them to your QMS documents.
  • Learn documentation methods that include flowcharts to reduce the amount of text.
  • Learn documentation methods for the quality policy and objectives.
  • Learn how to document quality plans.
  • Learn considerations for specifications.
  • Learn how to develop process metrics and apply them to quality objectives and quality plans.

Who will Benefit:

All medical device manufacturers that apply FDA QSR or ISO 13485:2003.

  • Quality Managers
  • Quality Engineers
  • Quality Assurance and Quality Control
  • Documentation Specialists
  • Regulatory Affairs Managers
  • R&D Managers
  • Operations Managers
  • Production Managers and Supervisors
  • Manufacturing Engineers

Course Outline:

Day One (8.00AM – 4.00PM) Day Two (8.30AM – 4.30PM)

  • Understanding the QMS for medical devices
    • Analysis of FDA QSR
    • Analysis of ISO 13485:2003
  • Developing process maps
  • Understanding what can excluded from a device QMS
  • The role of ISO/TR 10013:2001 in the quality management documentation
  • The quality manual
  • The quality procedure
  • The work instruction
  • The form
  • The record

  • Readability Indices
  • Using flowcharts to reduce text
  • The quality policy and objectives
  • Documenting quality plans
  • The role of specifications
  • Measurements and metrics
  • Process effectiveness
  • Measurable quality objectives

Meet Your Instructor

Dan O'Leary
President at Ombu Enterprises, LLC

Dan O'Leary 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, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.

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What past attendees say

Dan O’Leary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.
- Quality Manager, Parker Hannifin Corp

I enjoyed Dan's course very much. The Instructor and materials were excellent and the information he taught will be very helpful to my Company.
- Compliance Coordinator, Diagnostica Stago, Inc.

I have attended webinars from ComplianceOnline but this "Live" one was incredible. This seminar was excellent.
- Quality Engineering Manager, ConvaTec Inc.

TIt was well organized event by ComplianceOnline. Communication was good. Presenter was very knowledgeable. Practical application of directives, standards, regulations are very helpful.
- Manager, Quality Assurance, Instrumentation Laboratory

It was well organized event by ComplianceOnline with good subject matter and knowledgeable instructor.
- Director of Operations and Quality, NDI Medical LLC.

I appreciate the knowledge given at this seminar. Speaker is very experienced and I found good talent here. I am very happy with first class reference sheet.
- Sr. CAPA Specialist, Johnson & Johnson Vision Care Inc

Knowledgeable speaker with great real life examples and discussions.
- Quality Director, Lifecore Biomedical

It was a well organized seminar. It provides trainees a good understanding about the CA-PA process that complies with regulatory standards.
- QA/RA Representative, ResMed Corp

It was my first conference with ComplianceOnline and experience was good. Love the reference material and flash key.
- Quality Assurance, Beckman Coulter

I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
- Director of Regulatory Affairs, Nickell Physician & Pharmacy Services

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Temporary exhibits are the rule at the Minnesota Museum of American Art, which overlooks the Mississippi River. Expect edgy, contemporary installation pieces, as well as paintings, fiber art, ceramics, works on paper, and works created from found objects.

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Located inside the entrance to the Science Museum of Minnesota , the Mississippi River Visitor Center is operated by the National Park Service and designed to educate visitors about the Mississippi National River & Recreation Area. Park rangers can assist travelers with planning outdoor excursions, including canoe and riverboat trips, hiking, biking, and birding. If you're at all outdoorsy, it's worth a stop.

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One of the Midwest's oldest (1851) and most important universities, with 50,000 students on the Twin Cities campus, the UMN offers three significant museums -- the James Ford Bell Museum of Natural History, the University Art Gallery, and the Frederick R. Weisman Art Museum .The 4,800-seat Northrop Auditorium has been a home for distinguished performances since 1929, and the University Theatre has four separate stages.

The Walker Art Center is as well known for its striking architectural features as for the edgy, contemporary art inside: paintings, sculptures, drawings, photographs, and multimedia installations. A fine-dining restaurant and cafe, both by Wolfgang Puck, and gift shop are also new. Across the street is the Minneapolis Sculpture Garden, the largest urban sculpture garden in the country. A variety of 20th-century sculpture shares space with horticultural plantings, including the famous "Spoonbridge and Cherry" sculpture.

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