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Audit Documentation and Administration

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1 Audit Documentation and Administration
PRI Registrar Auditor Training (Pittsburgh) April 23, 2018

2 Introduction As always, we’d like to take this as an opportunity to review some of the persistent issues that we’ve seen in various administration and documentation areas over the past year, and to clarify expectations and get everyone back on the same page.

3 ISO 9001 / ISO / AQMS

4 RF-115 (Audit Document Listing)

5 Don’t forget to refer to the RF-115 (Audit Document Listing form).
ISO 9001 / ISO / AQMS Don’t forget to refer to the RF-115 (Audit Document Listing form). This lists all of the audit documentation required for each type of audit, broken out by standard. Copies of the most up-to-date RF-115 can be downloaded by selecting “Auditor Help” from the RMS Help tab, then clicking on the appropriate link for audit documents.

6 Non-Applicable Clauses

7 ISO 9001 / ISO / AQMS As of the 2015 revisions of 9001 and 14001, and the 2016 revisions of the AQMS standards, non-applicable clauses are not to be listed in the scope of certification. When updating the scope, please remove any reference to exclusions of they are still there. The non-applicable clauses will be documented in the justification boxes provided by both RMS and OASIS.

8 RF-12 (Audit Plan)

9 ISO 9001 / ISO / AQMS Audit plans are to be completed on the RF-12 forms for all audit types. Please note that there are template versions of the RF-12 for Stage 1 and Transfer audits. All the auditor needs to do is indicate the start and end times of the audits. These templates still need to be sent to the client. For all other ISO 9001/14001 audits, the functionality for entering the audit plan in RMS is still present, but must not be used as the official audit plan, as does not contain all of the requirements for an audit plan. To avoid double work, do not enter the audit plan in RMS. The “Submit” button must still be clicked in order to progress the audit to the next status and generate forms.

10 ISO 9001 / ISO / AQMS Whenever possible, the audit plan shall be ed to the client 30 days in advance of the audit start date. In cases where the audit is scheduled fewer than 30 days in advance, the plan must still be sent prior to the start of the audit. Please complete and send the plan as quickly as possible. Remember that a full audit day is eight hours, and that all audit time must be accounted for in the audit plan. The number of audit days allocated shall not be reduced at the planning stages by programming longer hours per working day. Consideration can be made to allow efficient auditing of shift activities which may require additional hours in a working day. This applies to ISO 9001/14001 only.

11 Audit Documentation Time

12 ISO 9001 / ISO / AQMS Recall that no audit documentation (including entering NCRs into RMS or OASIS) can be completed during audit time. The only documentation that can be completed on-site is objective evidence. If you need to complete NCRs, PEARs, or Audit Reports to leave with the client, be sure to list non-audit time on the audit plan.

13 Audit Program (RMS or RF-117)

14 ISO 9001 / ISO / AQMS Remember that for all clients, an audit program must be completed at the time of the Stage 2 or Recertification audit for the full 3-year cycle. A new program must be completed for every cycle, and may be revised within the cycle, as necessary. AS9100/9110/9120: The audit program is completed on the RF-117 (Audit Program Detail Form), available on the Plan tab of the audit in RMS. ISO 9001 / ISO / OHSAS 18001: The audit program is completed directly in RMS on the Site Audit Program page. The Site Audit Program can be reached via a link near the top of the page in the RMS audit.

15 NCRs

16 Requirements for closing NCRs:
ISO 9001 / ISO / AQMS Requirements for closing NCRs: AQMS: Initial/Recert/Upgrade: All NCRs must be verifiably closed prior to registration decision (i.e., audit cannot be closed until NCRs are closed). Surveillance/Special: All major NCRs must be verifiably closed before the audit can be closed. All minor NCRs must be at last accepted, and may be verified at the next audit. ISO 9001/ISO 14001/OHSAS 18001: Initial/Recert/Upgrade: All major NCRs must be verifiably closed before the audit can be closed. All minor NCRs must be at last accepted, and may be verified at the next audit. Surveillance/Special: All NCRs must be at last accepted, and may be verified at the next audit.

17 ISO 9001 / ISO / AQMS If verifying and NCR for closure at the following audit, the NCR must be closed out in the appropriate audit system. AQMS: The office must initiate a modification in OASIS to open the previous audit record. Once the verification statement has been entered, the audit will be submitted in the same way that a new audit would be submitted. ISO 9001/ISO 14001/OHSAS 18001: Navigate to the previous audit in RMS; the previous NCRs will open automatically to allow verification to be performed. In some older audits, the auditor may have to manually navigate to the previous audit via the Site Audit Program page. In newer audits, there will be a table in the current audit with links to the previous NCRs. If the NCR cannot be verified as effective, the previous NCR must still be closed in the appropriate system, with a reference to the rewritten NCR at the current audit. In most cases, the rewritten NCR should be raised to a major. If already a major, the auditor should contact the office to discuss suspension.

18 RF-76 (Expert Review Checklist)

19 ISO 9001 / ISO / AQMS When completing audit documentation, remember to refer to the RF-76/76AS (Expert Review Checklist) for the requirements and expectations of the registration decision process. Any audit document packages that do not conform to the items in the RF-76/76AS will be rejected back to the auditor for correction, so save yourself some time! AQMS only: Please note that the requirement to address the effectiveness of internal audits and management review in the QMS Matrix is being removed from the RF-76 AS, as this is already expected to be addressed in the Form 5 Audit Report.

20 ISO 9001 / ISO 14001

21 RF-129/129a (QMS/EMS Matrix)

22 ISO 9001 / ISO 14001 The RF-129/129a (QMS/EMS Matrix) has, over the course of the transition to the 2015 standards, been used as a transition document. As the transition concludes, the RF-129/129a will continue to be used for new clients. The matrix will be completed by the client (with help/guidance from the auditor) as an output of a Stage 1 audit. The matrix will then be reviewed at each audit, and modified as necessary. If no modifications are necessary, the matrix will simply be pulled forward from the previous audit.

23 ISO 9001 / ISO 14001 ISO 9001 only: Ensure that, on the RF-129 (QMS Matrix), at least one process has been identified as “critical”. Organizations are expected to measuring and monitoring processes, although they do have the right to choose for themselves what they will measure. Auditors may encourage organizations to identify their Section 8 process(es) as critical, but we cannot require it. A “critical process” is merely the process(es) that the organization has chosen to measure/monitor.

24 Processes in RMS

25 ISO 9001 / ISO 14001 By this point, in most cases, client processes are already entered in RMS, and should only need to be entered for new clients. For existing clients, ensure that any updated processes are added to RMS, and that the new process names match those in the RF-129/129a (QMS/EMS Matrix). If there are any changes, the previous processes cannot be deleted, as that will alter the previous audit record(s). Edit the previous process to add “Obsolete” to the name. An RMS enhancement has been submitted to address this.

26 AS9100/9110/9120

27 Data Entry in OASIS

28 AQMS When entering objective evidence in OASIS, please note that tables cannot and shall not be pasted into the text fields. The formatting of the pasted tables makes the data extremely difficult to understand. If your personal process for collecting objective evidence includes completing tables, please do one of the following: Summarize the data from the table. Attach a Word document containing the table to the QMS or PEAR, and refer to the attachment in the text field. If attaching the tables, be sure that the files are clearly labeled, and that text references clearly indicate those file names.

29 AQMS PEAR QMS Matrix


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