Please register (it's free!) or login to view the remaining preview.

If you are logged in, your referral link [?] is automatically included below.

EMBED CODE (Copy and Paste)

BENEFITS OF DOCUMENT

Provides a framework for managing and improving the quality management system based on the ISO 13485:2016 standard for the medical devices industry.
Provides a tool for creating awareness of the ISO 13485:2016 standard.
Provides guidelines and practical tips for handling an audit session.

DOCUMENT DESCRIPTION

ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.

This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.

It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.

LEARNING OBJECTIVES

1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session

CONTENTS

1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001

2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement

3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process

4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings

5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts

Got a question about the product? Email us at [email protected] or ask the author directly by using the form to the right. If you cannot view the preview above this document description, go here to view the large preview instead.

Source: ISO 13485:2016 (Medical Devices - QMS) Awareness PowerPoint document

Top Flevy Author [?]

ISO 13485:2016 (Medical Devices - QMS) Awareness

Sold by Operational Excellence Consulting (this author has 161 documents)

$69.00

ALL FEES INCLUDED

Add to Cart

This business document is categorized under the function(s):

Operations Governance, Risk, & Compliance

It applies to All Industries

File Type: PowerPoint (pptx)

File Size: 9.7 MB

Number of Slides: 72 (includes cover, transition slides)

Related Topic(s): Quality Management & Assurance Healthcare

Purchase includes lifetime product updates. After your purchase, you will receive an email to download this document.

Terms of usage (for all documents from Operational Excellence Consulting)

Initial upload date (first version): Jan 13, 2021
Most recent version published: Jan 13, 2021

Ask the Author a Question

Must be logged in Click here to log in

CUSTOMER TESTIMONIALS

"As a consultant requiring up to date and professional material that will be of value and use to my clients, I find Flevy a very reliable resource.

The variety and quality of material available through Flevy offers a very useful and commanding source for information. Using Flevy saves me time, enhances my expertise and ends up being a good decision."

– Dennis Gershowitz, Principal at DG Associates

"My FlevyPro subscription provides me with the most popular frameworks and decks in demand in today’s market. They not only augment my existing consulting and coaching offerings and delivery, but also keep me abreast of the latest trends, inspire new products and service offerings for my practice, and educate me in a fraction of the time and money of other solutions. I strongly recommend FlevyPro to any consultant serious about success."

– Bill Branson, Founder at Strategic Business Architects

"The wide selection of frameworks is very useful to me as an independent consultant. In fact, it rivals what I had at my disposal at Big 4 Consulting firms in terms of efficacy and organization."

– Julia T., Consulting Firm Owner (Former Manager at Deloitte and Capgemini)

"I have used FlevyPro for several business applications. It is a great complement to working with expensive consultants. The quality and effectiveness of the tools are of the highest standards."

– Moritz Bernhoerster, Global Sourcing Director at Fortune 500

"As a consulting firm, we had been creating subject matter training materials for our people and found the excellent materials on Flevy, which saved us 100's of hours of re-creating what already exists on the Flevy materials we purchased."

– Michael Evans, Managing Director at Newport LLC

"One of the great discoveries that I have made for my business is the Flevy library of training materials.

As a Lean Transformation Expert, I am always making presentations to clients on a variety of topics: Training, Transformation, Total Productive Maintenance, Culture, Coaching, Tools, Leadership Behavior, etc. Flevy usually has just what I need to make my point.

It is well worth the money to purchase these presentations. Sure, I have the knowledge and information to make my point. It is another thing to create a presentation that captures what I want to say. Flevy has saved me countless hours of preparation time that is much better spent with implementation that will actually save money for my clients."

– Ed Kemmerling, Senior Lean Transformation Expert at PMG

"As an Independent Management Consultant, I find Flevy to add great value as a source of best practices, templates and information on new trends. Flevy has matured and the quality and quantity of the library is excellent. Lastly the price charged is reasonable, creating a win-win value for the customer, Flevy and the various authors. This is truly a service that benefits the consulting industry and associated clients. Thanks for providing this service. "

– Jim Schoen, Principal at FRC Group

"As a small business owner, the resource material available from FlevyPro has proven to be invaluable. The ability to search for material on demand based our project events and client requirements was great for me and proved very beneficial to my clients. Importantly, being able to easily edit and tailor the material for specific purposes helped us to make presentations, knowledge sharing, and toolkit development, which formed part of the overall program collateral. While FlevyPro contains resource material that any consultancy, project or delivery firm must have, it is an essential part of a small firm or independent consultant's toolbox."

– Michael Duff, Managing Director at Change Strategy (UK)

"Flevy is now a part of my business routine. I visit Flevy at least 3 times each month.

Flevy has become my preferred learning source, because what it provides is practical, current, and useful in this era where the business world is being rewritten.

In today's environment where there are so many challenges and there is the need to make the right decisions in a short time, with so much scattered information, we are fortunate to have Flevy. Flevy investigates, selects, and puts at our disposal the best of the best to help us be successful in our work."

– Omar Hernán Montes Parra, CEO at Quantum SFE

"I like your product. I'm frequently designing PowerPoint presentations for my company and your product has given me so many great ideas on the use of charts, layouts, tools, and frameworks. I really think the templates are a valuable asset to the job."

– Roberto Fuentes Martinez, Manager at Technology Transformation Advisory

SELECT CUSTOMERS

Since 2012, we have provided best practices to over 5,000 businesses and organizations of all sizes across the world—in over 130 countries. Below is just a very small sample of our customer base.

Did you know?

The average daily rate of a McKinsey consultant is $6,625 (not including expenses). The average price of a Flevy document is $65.

CUSTOMERS ALSO BOUGHT THESE DOCUMENTS

Healthcare Business Capability Model 1-page PDF document $30.00 Author: R Bradley Consulting Healthcare	ISO 9001:2015 (QMS) Awareness Training 83-slide PowerPoint deck and supporting PDF $69.00 Author: Operational Excellence Consulting Quality Management & Assurance ISO 9001	Reducing the Cost of Quality 131-slide PowerPoint deck $79.00 Author: Operational Excellence Consulting Cost Reduction Assessment Quality Management & Assurance Cost of Quality	Pharma Launch Plan 2020 57-slide PowerPoint deck $99.00 Author: BigPharma2000 Healthcare
Total Quality Management (TQM) 181-slide PowerPoint deck $79.00 Author: Operational Excellence Consulting Total Quality Management Continuous Improvement Quality Management & Assurance	Lean Healthcare 180-slide PowerPoint deck $79.00 Author: Operational Excellence Consulting Healthcare	Healthcare Go-to-Market Strategy 65-slide PowerPoint deck $49.00 Author: PPT Lab Healthcare	Overview of Baldrige Excellence Framework 85-slide PowerPoint deck and supporting Word $49.00 Author: Operational Excellence Consulting Performance Management Quality Management & Assurance Malcolm Baldrige
Pharma Field Force Effectiveness Guide 211-slide PowerPoint deck $99.00 Author: BigPharma2000 Healthcare	Pharma Marketing Plan 2.0 277-slide PowerPoint deck $199.00 Author: BigPharma2000 Healthcare	Project Quality Management v1 121-slide PowerPoint deck $180.00 Author: Adaptive US Inc. Quality Management & Assurance	Total Quality Process (TQP) 100-slide PowerPoint deck $69.00 Author: Operational Excellence Consulting Total Quality Management Quality Management & Assurance