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© 2003 – 2004 Practical Perspectives Getting Started A Brief Look at Using This Audit System ISO 9001:2000 Revision: 2/20/2004 PRACTICALPERSPECTIVES Brought.

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Presentation on theme: "© 2003 – 2004 Practical Perspectives Getting Started A Brief Look at Using This Audit System ISO 9001:2000 Revision: 2/20/2004 PRACTICALPERSPECTIVES Brought."— Presentation transcript:

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2 © 2003 – 2004 Practical Perspectives Getting Started A Brief Look at Using This Audit System ISO 9001:2000 Revision: 2/20/2004 PRACTICALPERSPECTIVES Brought to you by: TM

3 © 2003 – 2004 Practical Perspectives Audit Schedule(s) Opening Meeting Materials Audit Summary and Audit Report Additional Questions A Completed Audit Report Management Summary Closing Meeting T he Rest of the Story (Audit Procedure) The Audit Process

4 © 2003 – 2004 Practical Perspectives Examples and/or Explanations are in Blue Basis for number of audits per year. An annual audit schedule based upon audit reports, which are in support of ISO 9001:2000. 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).

5 © 2003 – 2004 Practical Perspectives 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. 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.

6 © 2003 – 2004 Practical Perspectives 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 Materials (when we decide we need an opening meeting) Opening Meeting Sign-In Date:______________ NAMETITLE What an opening meeting should cover. PRACTICALPERSPECTIVES 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)

7 © 2003 – 2004 Practical Perspectives On this page: Blue = tutorial Dark Red = example Title of the applicable audit report goes here. “I” is done at the beginning, “II” & “III” are done during the audit, and “IV” & “V” are done at the end. 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. The auditor is either happy with what was seen or sad they found something. This section tends to get filled out from notes from the audit report and with area management near the end of the audit. ONE GETS FILLED OUT FOR EVERY AUDIT (in essence, this is the cover sheet for each audit and is filled out along the way)

8 © 2003 – 2004 Practical Perspectives Audit Report – Training 5.3d, 5.5.1, & 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. Directions provide a starting point and suggested sample sizes. Questions include the clause(s) in ISO 9001:2000 so you can fall back on the standard if needed. The numbers over each question relate to the flowchart and allow for traceability when a finding or improvement opportunity is identified. The auditor is either happy with what was seen or sad they found something. May be a definition, examples of what to look for, or scenarios to consider. Examples and/or Explanations are in Blue 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.).

9 © 2003 – 2004 Practical Perspectives Audit Report – Training 5.3d, 5.5.1, & It is possible to have and  or more than one or  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. A Completed Audit Report On this page: Blue = tutorial Dark Red = example

10 © 2003 – 2004 Practical Perspectives When everything is dealt with and verified as being effective, the audit coordinator closes out the audit. On this page: Blue = tutorial Dark Red = example ONE GETS FILLED OUT FOR EVERY AUDIT (here is the completed summary for the completed audit report on the previous slide) The Audit Report should be attached and this record filed per records control procedures. Don’t forget to score the audit. “IV” & “V” are done at the end.

11 © 2003 – 2004 Practical Perspectives 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 Materials (when we decide we need a closing meeting, especially if we already had an opening meeting) Closing Meeting Sign-In Date:______________ NAMETITLE Reporting on the results and providing a conclusion can be accomplished with the Management Summary! (see next slide) What a closing meeting should cover. PRACTICALPERSPECTIVES 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)

12 © 2003 – 2004 Practical Perspectives Management Summary (page 1) (can be used to report the results of audits over the year and/or as the summary for any audit involving multiple areas) These are the totals from the Audit Summary for each audit. The “Accept. Rate” calculates automatically. 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. 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). Explanations are in Blue Instructions are embedded as comments in the MS Excel file “Management Summary”

13 © 2003 – 2004 Practical Perspectives OBSERVATIONS & ACTIONS TAKEN, WHERE KNOWN Management Summary (page 2) (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” 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.

14 © 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!

15 © 2003 – 2004 Practical Perspectives If additional assistance is needed: Business Consulting We provide on-site assistance in quality (ISO 9001:2000, AS9100, ISO/TS 16949:2002, ISO 13485:2003, etc.), environmental (ISO and Texas EMS), and safety (ISO 18001) management systems, transitional management, leadership development, strategic planning, auditing services, and serve as the management representative for some of our clients. For information, visit us at: (website) ( ) (website) ( ) On-line, On-site, In-class Training We provide on-line training in auditing and management system development, for the adventurous at heart, with time to spare, or as a result of a tight budget. These courses provide the same type of information companies receiving on-site assistance are getting, but in a cost-effective, do-it- yourself kind of way. Those successfully completing one of our courses receive a certificate of completion, intended to satisfy requirements for effectiveness of training and/or for continuing professional development (CPD). To see the courses we currently have available, or to be notified of new offerings, visit us at:


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