ISO 13485 2016
        Internal Audit Program for Medical Devices

This page will describe and explain our new ISO 13485 2016 Internal Audit Program.
However, it will not present the entire program. Instead, it will explain our approach
and it will show you detailed samples of our work (see PDFs). Once you've studied
our audit approach, we hope you'll purchase our complete internal audit program.

ISO 13485 2016 is a new quality management standard for medical devices.

ISO 13485 section 8.2.4 expects you to "conduct internal audits at planned
intervals to determine whether the quality management system conforms
to the requirements of this International Standard
".

The first part of our ISO audit program will help you to meet this requirement.
It will show you how to determine whether or not your QMS “conforms to the
requirements of this International Standard”
. The second part, on the other
hand, will use ISO's internal auditing standard to help you improve the
effectiveness of your internal audit practices and processes.

Use the first section (A) to identify the gaps that exist between ISO's standard
and your quality management practices and processes. Once you've filled all
the gaps, you can be sure that you conform to the new ISO 13485 standard.

And use the second section (B) to pinpoint the gaps that exist between ISO's
internal auditing standard and your internal auditing practices and processes.
Once you've filled all the gaps, you can be sure that you've done all you can
to improve the effectiveness of your auditing practices and processes.


ISO 13485 INTERNAL AUDIT PROGRAM

TABLE OF CONTENTS (TITLE 47)

A

ISO 13485 CONFORMANCE AUDIT TOOL

4

AA

OVERVIEW OF OUR CONFORMANCE AUDIT PROCESS

4

1

Introduction to our ISO 13485 conformance audit tool

4

2

Profile of your ISO 13485 conformance audit project

7

3

Summary of your ISO 13485 conformance audit results

8

AB

ISO 9001 CONFORMANCE AUDIT QUESTIONNAIRES

9

4

Assess how well you conform to ISO's systemic requirements

9

5

Assess how well you conform to ISO's management requirements

20

6

Assess how well you conform to ISO's resource requirements

27

7

Assess how well you conform to ISO's realization requirements

32

8

Assess how well you conform to ISO's remedial requirements

PDF

B

HOW TO AUDIT AN INTERNAL AUDIT PROCESS

78

BA

OVERVIEW OF INTERNAL AUDIT ASSESSMENT PROCESS

78

1

Introduction to our ISO 19011 internal audit assessment tool

78

2

Profile of your ISO 19011 internal audit assessment project

81

3

Summary of your ISO 19011 internal audit assessment results

82

 BB

INTERNAL AUDIT ASSESSMENT QUESTIONNAIRES

83

4

Assess how well you comply with ISO's internal audit principles

83

5

Assess how well you comply with ISO's audit management proposals

87

6

Assess how well you comply with ISO's audit performance expectations

PDF

7

Assess how well you comply with ISO's auditor evaluation recommendations

150

 


 

Since ISO 13485 has five main sections, our conformance audit tool (AB) has
five questionnaires. Similarly, our audit assessment tool (BB) has four sets of
questions because the ISO 19011 auditing standard has four main sections.

For each question, three answers are possible: YES, NO, or N/A. A YES answer
means you’re in compliance with the standard, a NO answer means you’re not in
compliance, while an N/A answer means that a question is not applicable in your
situation. NO answers identify gaps that exist between each standard and your
organization's practices and processes while N/A answers point to items
that aren’t applicable in your case.

All ISO 13485 2016 gaps must be filled and all N/A answers must be justified
and explained before you can say that your organization’s quality management
system complies with the new ISO 13485 2016 standard. You may exclude any
requirement in sections 6, 7, or 8 if you can justify doing so because of the
nature of your activities or products and if doing so does not undermine
regulatory compliance.

Once you’ve completed all five questionnaires, study your NO answers,
your own comments and observations, and our questions and then use this
information to formulate actions or steps that need to be taken in order to bring
your practices and processes into compliance with the new standard. Use this
information to develop your own unique ISO 13485 2016 Quality Management
Conformance Plan
.

You can also summarize your internal audit results quantitatively if you wish.
The idea here is to measure how compliant your quality management practices
and processes actually are. If you carry out regular audits, you can also use our
approach to measure whether or not your quality management practices and
processes are improving over time.

Our ISO 19011 audit assessment tool works much the same way. A YES answer
means you’re in compliance with the standard, a NO answer means you’re not in
compliance, while an N/A answer means that a question is not applicable in your
circumstances. NO answers reveal gaps that exist between the ISO 19011 2011
standard and your organization's internal audit practices and processes.

Once you’ve completed our ISO 19011 audit assessment questionnaires, study
your NO answers and use the associated questions to formulate remedial actions.
Once you've done this for all gaps, you will have four detailed plans which, taken
together, will make up a complete Internal Audit Improvement Plan. And once all
plans have been implemented and all remedial actions have been taken, you
will have improved the overall effectiveness of your organization's internal
audit practices and processes.


Attention

Now that you understand our approach, please consider
purchasing Title 47: ISO 13485 2016 Internal Audit Program.

If you purchase our ISO 13485 2016 Internal Audit Program, you'll
find that it's integrated, detailed, exhaustive, and easy to understand.
You'll find that we've worked hard to create a high quality product.
In fact, we
guarantee the quality of our quality management audit tool.
Title 47 is 172 pages long and comes in pdf and MS doc file formats.

See ISO 13485 Audit Sample.     See ISO 19011 Audit Sample.

Place an Order 

Check our Prices

See our License


MORE ISO 13485 PAGES

Introduction to ISO 13485 2016

Outline of ISO 13485 2016 Standard

ISO 13485 2016 versus ISO 13485 2003

Plain English ISO 13485 2016 Definitions

Overview of the ISO 13485 2016 Standard

ISO 13485 2016 Translated into Plain English

Plain English ISO 13485 2016 Gap Analysis Tool

Skills Quality Management Auditors Should Have


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Updated on May 15, 2016. First published on May 6, 2016.

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