ISO 13485 2003INTERNAL AUDIT PROGRAM
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| Introduction to ISO 13485 Audit Program |
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Our Audit Program is made up of five programs:
Each of these five programs will be discussed below. We begin with a table of contents.
It shows how we've organized our ISO 13485 Internal Audit Program.
While the content of each program |
This
web page will
introduce our ISO 13485 2003 Internal Audit Program.
However,
it will not present the complete program. Instead, it will show you
how our
Audit Program is organized and it will explain how it works. Once
you've examined our approach, we hope you'll consider purchasing
our
complete ISO 13485 2003 Internal Audit Program.
Our ISO 13485 Internal Audit Program (Title 47) is 189 pages
long, and is available in both pdf and MS doc file formats.
ISO 13485 2003 INTERNAL AUDIT PROGRAM |
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| TABLE OF CONTENTS | ||
| PART | INTRODUCTION | PAGE |
| 1 | Introduction to ISO 13485 | 2 |
| 2 | Introduction to Audit Program | 4 |
| A | ISO 13485 COMPLIANCE AUDIT PROGRAM | 13 |
| 1 | Compliance Audit Procedure | 13 |
| 2 | Compliance Audit Profile | 14 |
| 3 | Compliance Audit Questions |
SAMPLE HTML |
| 4 | Compliance Audit Scores | 89 |
| 5 | Compliance Audit Summary | 90 |
| 6 | Compliance Audit Conclusions | 91 |
| 7 | Compliance Audit Recommendations | 92 |
| 8 | Compliance Audit Implementation Record | 93 |
| B | ISO 13485 POLICY AUDIT PROGRAM | 94 |
| 1 | Policy Audit Procedure | 94 |
| 2 | Policy Audit Profile | 95 |
| 3 | Policy Audit Questions | 96 |
| 4 | Policy Audit Scores | 99 |
| 5 | Policy Audit Summary | 101 |
| 6 | Policy Audit Conclusions | 102 |
| 7 | Policy Audit Recommendations | 103 |
| 8 | Policy Audit Implementation Record | 104 |
| C | ISO 13485 PROCEDURES AUDIT PROGRAM | 105 |
| 1 | Procedures Audit Procedure | 105 |
| 2 | Procedures Audit Profile | 106 |
| 3 | Procedures Audit Questions | 107 |
| 4 | Procedures Audit Scores | 113 |
| 5 | Procedures Audit Summary | 115 |
| 6 | Procedures Audit Conclusions | 116 |
| 7 | Procedures Audit Recommendations | 117 |
| 8 | Procedures Audit Implementation Record | 118 |
| D | ISO 13485 PROCESS AUDIT PROGRAM | 119 |
| 1 | Process Audit Procedure | 119 |
| 2 | Process Audit Profile | 120 |
| 3 | Process Audit Questions | SAMPLE PDF |
| 4 | Process Audit Scores | 164 |
| 5 | Process Audit Summary | 166 |
| 6 | Process Audit Conclusions | 167 |
| 7 | Process Audit Recommendations | 168 |
| 8 | Process Audit Implementation Record | 169 |
| E | ISO 13485 RECORDS AUDIT PROGRAM | 170 |
| 1 | Records Audit Procedure | 170 |
| 2 | Records Audit Profile | 171 |
| 3 | Records Audit Questions | 172 |
| 4 | Records Audit Scores | 180 |
| 5 | Records Audit Summary | 182 |
| 6 | Records Audit Conclusions | 183 |
| 7 | Records Audit Recommendations | 184 |
| 8 | Records Audit Implementation Record | 185 |
| F | ADMINISTRATIVE INFORMATION | 186 |
| MAY 2007 | COPYRIGHT Ó 2007 BY PRAXIOM RESEARCH GROUP LIMITED | VER 1.0 |
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If you purchase our ISO 13485
2003 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 program. In fact, we guarantee the quality! |
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| Overview of Compliance Audit Program |
Our Compliance Audit Program uses questions to list the ISO 13485 quality
management system requirements. Like ISO’s five sets of requirements, our
Audit Program consists of five separate questionnaires (which start with
the number 4 because ISO’s requirements start in section 4):
ISO 13485:2003 is based on the ISO 9001:2000 quality management standard. Both standards are organized in the same way and use basically the same numbering system. In addition, most of the ISO 13485 requirements are taken directly from ISO 9001 without modification. In order to distinguish between ISO 9001 and the new ISO 13485 requirements we use two different fonts and colors. A black font will be used to present ISO 9001 audit questions, while a blue font will be used to present audit questions that are unique to ISO 13485. In general, our Compliance Audit Program asks two types of questions: questions that specify ISO 13485 mandatory quality management system requirements and questions that specify requirements that may be excluded or ignored under some circumstances. Questions that point to mandatory requirements allow two response options: YES or NO, while questions that specify requirements that may be excluded offer three response options: YES, NO, or N/A. An N/A response option is provided because you may exclude or ignore some requirements if you can justify doing so. You can exclude ISO 13485 section 7 product realization requirements if you cannot apply them because of the nature of your organization and its products. Similarly, ISO 13485 says that you can exclude section 7 requirements if they are not applicable in your situation because of the nature of your medical devices. You can also exclude subsection 7.3 design and development if official regulations allow you to do so and if you have made alternative arrangements that comply with these regulations. In addition, ISO 13485 occasionally uses the phrase “if appropriate” or “where appropriate”. When a requirement uses this phrase, you may ignore it if you can justify doing so. In all of these cases all three YES, NO, and N/A response options will be available. YES answers mean you’re in compliance with the standard, NO answers mean you’re not in compliance, and N/A answers mean that a question is not applicable in your case. NO answers to Compliance Audit questions point to compliance problems (also known as nonconformities or noncompliances). Once you’ve answered all the Compliance Audit Questions, you’re ready to summarize your audit, calculate compliance scores, draw general audit conclusions, and make and implement recommendations to address your compliance problems. |
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| Overview of Policy Audit Program |
Our Policy Audit covers the following topics:
Start by selecting a policy that you want to audit. Then prepare your Policy Audit Profile. Before you begin answering policy audit questions, please record the name of this policy at the top of the Policy Audit questionnaire. This will help to maintain the focus of your audit. Three response options are provided: YES,
NO, and N/A. NO answers point to policy
performance problems, YES answers identify positive areas,
while Once you’ve answered all the audit questions, you’re ready to summarize your internal audit, calculate policy performance scores, draw general audit conclusions, and make and implement recommendations to address your policy performance problems. |
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| Overview of Procedures Audit Program |
Our Procedures Audit covers the following topics:
Start by selecting a procedure that you want to audit. Then prepare your Procedures Audit Profile. Define the scope of your audit, identify the participants, and prepare a brief audit plan. Before you begin answering procedures audit questions, please record the name of this procedure at the top of the Audit questionnaire. This will help auditors to maintain the focus of their audit. Three response options are provided: YES, NO, and N/A. NO answers point to procedural performance problems, YES answers identify positive areas, while N/A responses identify questions that are not applicable in your situation. Once you’ve answered all the audit questions, you’re ready to summarize your audit, calculate procedural performance scores, draw general audit conclusions, and make and implement recommendations to address your procedural performance problems. |
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| Overview of Process Audit Program |
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Our Process Audit covers the following topics:
Clause 4.1 of ISO 13485 makes it clear that organizations must identify and manage the processes that make up their quality management systems. Therefore, the process approach is now a requirement. The process approach is a management strategy. When managers use a process approach, it means that they manage the processes that make up their organization, the interaction between these processes, and the inputs and outputs that “glue” these processes together. But, what’s a process, and what are inputs and outputs? Briefly put, a process uses inputs to generate outputs. Or, more precisely, a process is an integrated set of activities that uses resources to transform inputs into outputs. A system exists whenever several processes are interconnected using such input-output relationships. Processes are interconnected because the output from one process becomes the input for another process. In effect, processes are “glued” together by means of such input-output relationships. And because the output of one process becomes the input of another process, inputs and outputs are really the same thing. In general, there are three basic types of inputs/outputs: products, services, and information. Below you will find a list of some of the
processes that can
Of course, this does not exhaust the list of possible processes that could be audited using our approach. Your organization’s processes will certainly include many more processes that we have failed to mention. Start your audit by selecting a process. Then prepare your Process Audit Profile. Define the scope of your audit, prepare a brief audit plan, and identify the inputs that are used by this process and the outputs that are generated. Before you begin answering process audit questions, please enter the name of your process at the top of the Process Audit questionnaire. Three response options are provided: YES, NO, and N/A. NO answers point to process performance problems, YES answers identify positive areas, while N/A responses identify questions that are not applicable in your situation. Once you’ve answered all the audit questions, you’re ready to summarize your audit, calculate process performance scores, draw general audit conclusions, and make and implement recommendations to address your process performance problems. |
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| Overview of Records Audit Program |
Our Records Audit Program is partly based on the ISO 15489-1
records management standard and covers the following topics:
Start by selecting a set of records. Our Audit Program can be used to audit virtually any type of record keeping system. Examples that you may wish to consider include the following: training records, design records, production records, service delivery records, measurement records, product traceability records, audit records, manufacturing records, management review records, and calibration records. Once you’ve chosen which records to audit, you’re ready to prepare your Records Audit Profile. Specify the scope of your audit, its location, the participants, and prepare a brief audit plan. Before you begin answering record keeping audit questions, please enter the name of the records being audited at the top of the audit questionnaire. This will help to ensure that the focus of the internal audit is maintained. Three response options are provided: YES, NO, and N/A. NO answers point to record keeping performance problems, YES answers identify positive areas, while N/A responses identify questions that are not applicable. Once you’ve answered all the audit questions, you’re ready to summarize your audit, calculate record keeping performance scores, draw general audit conclusions, and make and implement recommendations to address your record keeping performance problems. |
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| SAMPLE AUDIT QUESTIONS |
A. COMPLIANCE AUDIT PROGRAM3. COMPLIANCE AUDIT QUESTIONS |
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8. REMEDIAL AUDIT QUESTIONS |
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8.5 TAKE REMEDIAL ACTION |
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8.5.1 MAINTAIN QUALITY MANAGEMENT SYSTEM |
NOTES |
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| 164 | Do you maintain the effectiveness of your quality management system? | YES | NO | |||
| 165 | Do you maintain the suitability of your quality management system? | YES | NO | |||
| 166 | Do you use your quality data to maintain the effectiveness and suitability of your quality management system? | YES | NO | |||
| 167 | Do you use your quality policy to maintain the effectiveness and suitability of your quality management system? | YES | NO | |||
| 168 | Do you use your quality objectives to maintain the effectiveness and suitability of your quality management system? | YES | NO | |||
| 169 | Do you use your quality audits to maintain the effectiveness and suitability of your quality management system? | YES | NO | |||
| 170 | Do you use your management reviews to maintain the effectiveness and suitability of your quality management system? | YES | NO | |||
| 171 | Do you use your corrective actions to maintain the effectiveness and suitability of your quality management system? | YES | NO | |||
| 172 | Do you use your preventive actions to maintain the effectiveness and suitability of your quality management system? | YES | NO | |||
| 173 | Have you established procedures that you can use to implement advisory notices? | YES | NO | |||
| 174 |
Have you documented your advisory notice procedures? |
YES | NO | |||
| 175 | Do you use your procedures whenever an advisory notice must be issued? | YES | NO | |||
| 176 | Do you maintain your organization's advisory notice procedures? | YES | NO | |||
| 177 | Do you maintain a record of your customer complaint investigations? | YES | NO | |||
| 178 | Do you exchange information with external organizations whenever an investigation shows that the activities of those organizations have contributed to the receipt of a customer complaint? | YES | NO | |||
| 179 | Do you formally authorize decisions not to take corrective or preventive actions in response to customer complaints? | YES | NO | |||
| 180 | Do you record all decisions not to take corrective or preventive actions in response to customer complaints? | YES | NO | |||
| 181 | Do you record why you chose not to take corrective or preventive actions in response to a customer complaint? | YES | NO | |||
| 182 | Have you established procedures to notify regulatory authorities about adverse events if national or regional regulations require special reporting rules to be followed? | YES | NO | N/A | ||
| 183 |
Have you documented your notification procedures? |
YES | NO | N/A | ||
| 184 | Do you use your notification procedures whenever adverse events must be reported to regulatory authorities? | YES | NO | N/A | ||
| 185 |
Do you maintain your notification procedures? |
YES | NO | N/A | ||
| Etcetera ... | ||||||
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Now
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OTHER AUDIT TOOLS Plain English Process Audit Program ISO 9001 2000 Internal Audit Program ISO 14001 2004 Internal Audit Program ISO 22000 Food Safety Audit Program |
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On the Web since May 25, 1997. This web page was
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