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Audit Documentation and Administration. PRI Registrar Auditor Training (Pittsburgh) 2018 Updated July 09, 2019. Introduction.
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Audit Documentation and Administration PRI Registrar Auditor Training (Pittsburgh) 2018 Updated July 09, 2019
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.
ISO 9001 / ISO 14001 / 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.
ISO 9001 / ISO 14001 / AQMS • Non-applicable clauses are not to be listed in the scope of certification. • When updating the scope, please remove any reference to exclusions if they are still there. • The non-applicable clauses will be documented in the justification boxes provided by both RMS and OASIS.
ISO 9001 / ISO 14001 / 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. • A separate template is available for transfers that will be followed by a recertification audit, which combines a Stage 1 and Transfer. • 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.
ISO 9001 / ISO 14001 / AQMS • Whenever possible, the audit plan shall be emailed 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.
ISO 9001 / ISO 14001 / 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.
ISO 9001 / ISO 14001 / 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. • The audit program is completed directly in RMS within the audit on the Audit Program tab. • See the RMS Guide for additional details. • See Auditor Advisory 109 for information on the use of activities within the audit program.
ISO 9001 / ISO 14001 / 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.
ISO 9001 / ISO 14001 / 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 accompanied by a major NCR against the client’s corrective action process. • If the original NCR was already a major, the auditor should contact the office to discuss suspension.
ISO 9001 / ISO 14001 / 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! • Copies of the RF-76/76AS can be downloaded from the Auditor Reference Materials page, which can be accessed via: • RMS -> Help tab -> Auditor Help -> Auditor Reference Materials
ISO 9001 / ISO 14001 • While the Matrices were originally used as a transition document to the 2015/2016 revisions of the standards, they will continue to be used for new clients. • A 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.
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.
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). • Please see the RMS Guides for details on changing processes in RMS.
AQMS • When entering objective evidence in OASIS, please note that tables cannot 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: • Manually format the tables in the text boxes so that they are clearly understandable. • Summarize the data from the table. • Attach a Word document containing the table to the QMS Matrix 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.
AQMS • PEAR • QMS Matrix
