1. © 2003 – 2004 Practical PerspectivesTM
Getting Started
A Brief Look at Using
This Audit System
ISO 9001:2000
Revision: 2/20/2004
© 2003 – 2004 Practical Perspectives
PRACTICAL
PERSPECTIVES
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2. © 2003 – 2004 Practical Perspectives
The Audit Process
Audit Schedule(s)
Opening Meeting Materials
Audit Summary and Audit Report
Additional Questions
A Completed Audit Report
Management Summary
Closing Meeting
The Rest of the Story (Audit Procedure)
© 2003 – 2004 Practical Perspectives

3. Examples and/or Explanations are in Blue
An annual audit schedule based upon audit reports, which are in support of ISO 9001:2000.
Basis for number of audits per year.
Audit Schedule – Annual Plan
(frequency and planned intervals of the audit program per ISO 9001:2000)
Audits are spread out to balance the work load. May be subdivided by process(es) for audits covering more than one area (i.e., Production and Service Provision may involve multiple processes).
© 2003 – 2004 Practical Perspectives

4. Examples and/or Explanations are in Blue
An event-based schedule, using a team of auditors to audit the entire system. This schedule tends only to be used when a team is involved or when we are auditing a large portion of the system all at once.
Examples and/or Explanations are in Blue
Fill in the amount of time (hours & minutes) and the hours per day calculate automatically.
Once you know how much time to designate for each, it’s just a matter of setting the time slots and getting the client (person requesting the audit) to tell you who the guide will be.
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5. OPENING MEETING CHEAT SHEET
Opening Meeting Materials
(when we decide we need an opening meeting)
When should we conduct an opening meeting?
An opening meeting is typically done when the audit involves a large group, more than one area or process, and/or when an external party (customer, registrar, etc.) is involved, but can be done for any audit. It’s really up to you.
Lets us keep track of who attended, so we can prove management was aware, when necessary.
Opening Meeting
Sign-In
Date:
______________
NAME
TITLE
What an opening meeting should cover.
OPENING MEETING
CHEAT SHEET
PRACTICAL
PERSPECTIVES
Greeting
Thank them for the invitation & provide a brief introduction of audit team.
Pass around attendance log
Printed names & date.
Defer questions to the end
Questions may be answered in the information provided.
Purpose of audit & scope
Verify compliance with the ________ standard & conformance of effective practices to documented system Note: This is where you normally describe the process (desktop review, audit, & report/conclusion), with the scope being to verify effectiveness of the system to the applicable standard.
Audit process disclaimer
Random sample.
Verify availability of facilities & guides
Set time for Closing Meeting
Auditor Confidentiality
Auditor code of ethics requires confidentiality.
Open up for questions
(applicable)
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6. “I” is done at the beginning, “II” & “III” are done during the audit, and “IV” & “V” are done at the end.
ONE GETS FILLED OUT FOR EVERY AUDIT (in essence, this is the cover sheet for each audit and is filled out along the way)
On this page:
Blue = tutorial
Dark Red = example
Title of the applicable audit report goes here.
The auditor is either happy with what was seen or sad they found something.
© 2003 – 2004 Practical Perspectives
This section tends to get filled out from notes from the audit report and with area management near the end of the audit.
The number corresponding to the finding on this summary or the individual audit report used. The examples shown are write-ups from “General Issues” (line II) and from section “2” of the “Training” audit report. Simply put, the “Line Number” represents the location where the finding came from, so we can have traceability to the issue at hand.

7. Examples and/or Explanations are in Blue
Audit Reports (like this one) have been developed to cover all of the requirements, in a process-oriented manner. Each one includes a flowchart (an overview of the audit being performed) and lays out the series of events, including the evidence and conclusions reached. In other words, the flowchart is fulfilled simply by answering the questions.
Audit Report – Training 5.3d, 5.5.1, & 6.2.2
The numbers over each question relate to the flowchart and allow for traceability when a finding or improvement opportunity is identified.
Questions include the clause(s) in ISO 9001:2000 so you can fall back on the standard if needed.
© 2003 – 2004 Practical Perspectives
The auditor is either happy with what was seen or sad they found something.
Directions provide a starting point and suggested sample sizes.
May be a definition, examples of what to look for, or scenarios to consider.
Additional questions can and should be added where procedures call for requirements greater than those in ISO 9001:2000 (regulatory, customer, legal, those the organization imposes on itself, etc.).

8. A Completed Audit Report
On this page:
Blue = tutorial
Dark Red = example
Audit Report – Training 5.3d, 5.5.1, & 6.2.2
© 2003 – 2004 Practical Perspectives
It is possible to have J and L or more than one J or L on any given question, when the evidence tells you some of the item is done correctly (i.e., happy some are right, but sad to say it is not enough) or a question has more than one piece of evidence collected.

9. ONE GETS FILLED OUT FOR EVERY AUDIT (here is the completed summary for the completed audit report on the previous slide)
On this page:
Blue = tutorial
Dark Red = example
“IV” & “V” are done at the end.
Don’t forget to score the audit.
© 2003 – 2004 Practical Perspectives
The Audit Report should be attached and this record filed per records control procedures.
When everything is dealt with and verified as being effective, the audit coordinator closes out the audit.

10. CLOSING MEETING CHEAT SHEET
Closing Meeting Materials
(when we decide we need a closing meeting, especially if we already had an opening meeting)
When should we conduct a closing meeting?
A closing meeting is typically done when the audit involves a large group, more than one area or process, and/or when an external party (customer, registrar, etc.) is involved, but can be done for any audit. It’s really up to you.
Lets us keep track of who attended, so we can prove management was aware, when necessary.
Closing Meeting
Sign-In
Date:
______________
NAME
TITLE
What a closing meeting should cover.
CLOSING MEETING
CHEAT SHEET
PRACTICAL
PERSPECTIVES
Greeting
Thank them for the audit opportunity & the guides for participating in audit.
Pass around attendance log
Printed names & date.
Defer questions to the end
Questions may be answered in the information provided & allows those needing detail to stay while the others are free to leave.
Purpose of audit & scope
Verify compliance with the _________ standard & conformance of effective practices to documented system Note: This is where you normally describe the process (desktop review, audit, & report/conclusion), with the scope being to verify effectiveness of the system to the applicable standard.
Audit process disclaimer
Random sample.
Auditor Confidentiality
Confidentiality due to auditor ethics.
Report on results of audit
Provide a conclusion
Open up for questions
Provide client with audit summary
(applicable)
© 2003 – 2004 Practical Perspectives
Reporting on the results and providing a conclusion can be accomplished with the Management Summary! (see next slide)

11. Management Summary (page 1) Explanations are in Blue
(can be used to report the results of audits over the year and/or as the summary for any audit involving multiple areas)
Explanations are in Blue
Instructions are embedded as comments in the MS Excel file “Management Summary”
These are the totals from the Audit Summary for each audit. The “Accept. Rate” calculates automatically.
Each finding, noted in the “Issue needing attention…” section of the Audit Summary for each audit is acknowledged as a Major (system-wide breakdown or missing ISO 9001:2000 requirement), Minor (issue needing to be resolved, but not a Major), or Comment (positive or negative feedback that could be acted on to make things better or to prevent potential problems).
This is where you note the significant issues (typically in a bulleted fashion) and let management know whether the system is conforming with requirements based upon a score of 80%+ on each checklist and no Major nonconformances.
© 2003 – 2004 Practical Perspectives

12. Management Summary (page 2) Explanations are in Blue
(can be used to report the results of audits over the year and/or as the summary for any audit involving multiple areas)
Explanations are in Blue
Instructions are embedded as comments in the MS Excel file “Management Summary”
OBSERVATIONS & ACTIONS TAKEN, WHERE KNOWN
Reference to what is not being lived up to.
Each finding, noted in the “Issue needing attention…” section of the Audit Summary for each audit is documented in this section to provide management with an overall ‘laundry list.’ The FINDING forms the basis upon which the MAJOR/MINOR/COMMENT conclusion is made on page one of this summary. REPORT & SECTION OR LINE # is how we tie the finding back to the actual audit. The OBSERVATIONS & ACTIONS TAKEN, WHERE KNOWN is where we quote the requirement(s) not lived up to (paraphrased as much as possible) and a summary of the evidence supporting the finding. The action taken, including evidence of effectiveness would also be helpful.
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13. © 2003 – 2004 Practical Perspectives
The Rest of the Story While this tutorial provides a nice overview, the procedure (including supporting notes) covers the process in detail!
© 2003 – 2004 Practical Perspectives

14. If additional assistance is needed:
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