PRI Registrar ISO Process Summary

1. PRI RegistrarISO Process Summary Last Revised: 17-Oct-2019

2. Table of Contents Click link to jump to slide • Glossary of Terms • Client Manager • RF-### • RMS • Expert Reviewer • Accepted NCR • Closed NCR

3. Table of Contents Click link to jump to slide • Process Flow • Accept audit dates in RMS • Refer to client’s RF-129 series MS Matrix • Create audit plan • Conduct audit page 1andpage 2 • Manage NCRs • Complete and submit audit documentation • Expert Review • Expenses/receipts entered in RMS

4. Glossary of Terms

5. Glossary of Terms • Client Manager: • Also known as the Account Specialist. • Assigned to a particular client on an ongoing basis. • First point of contact for questions regarding an audit (for both auditor and client). • Liaison between auditor and client, when necessary. • Resource for the auditor in dealing with difficult clients. • The name and contact information of the client manager for an audit can be found on the Master Audit Program page (see RMS Auditor Guide – General Functionality)

6. Glossary of Terms • RF-###: • Regulated Form controlled by PRI Registrar. • See the RF-115 (Audit Document Listing) for a cross-reference of RF numbers and form names. • Templates for audit documents (including the RF-115) are available on the following pages: • ISO 9001:2015 Audit Documents • ISO 14001:2015 Audit Documents • ISO 45001:2018 Audit Documents

7. Glossary of Terms • RMS: • Registrar Management System • Internal PRI Registrar audit management system. • Web-based. • Used for availability calendar, audit assignment, audit reporting, NCR management, and expense reports. • Each RMS user has their own task dashboard and is notified of assigned tasks via email. • Tasks on dashboard are color coded per due date: • green (upcoming) • yellow (2 days out) • red (past due) • Refer to Help tab for documents, RMS guides and audit information. • See RMS User Glossary on the Help tab for RMS terms. • NOTE: Ignore the “Type” in the middle of the screen in an audit record – the audit type is in the top left.

8. Glossary of Terms • Expert Reviewer: • An auditor trained to PRI Registrar’s registration decision process. • Remains anonymous through review process to prevent hard feelings if assigned as a teammate for an audit.

9. Glossary of Terms • Accepted NCR: • NCR where the auditor has accepted the client’s plan for corrective action and will verify implementation of the plan at the following audit. • Allowed but discouraged for all NCR’s, with some exceptions. • Major NCRs at initial, recertification, or upgrade audits must be closed. • Accepted majors at surveillances will trigger an expert review of the audit. • Requires additional on-site time for verification at the next audit. • Additional time for verification is not considered audit time. • This time is not subject to the 8-hour days requirement, and may be used to extend the audit day. • This activity must appear on the audit plan, as non-audit time. • See the RMS Auditor Guide – ISO Process for details on accepting an NCR in RMS.

10. Glossary of Terms • Closed NCR: • NCR where the auditor has verified that the client’s corrective action has been implemented. • May require additional time at the next audit for review of effectiveness. • If the NCR was written against a process that is scheduled to be assessed at the next regular audit, the review may be included as part of the audit of that process. • If the review of the NCR will be complicated and/or time-consuming, such that it would detract from the quality of the audit, additional time should be requested. • If the NCR was written against a process that is not scheduled to be assessed at the next regular audit, then additional time must be requested. • See the RMS Auditor Guide – ISO Process for details on closing an NCR in RMS.

11. Process Flow

12. Process Flow • Accept audit dates in RMS • See RMS Auditor Guide – ISO Process. • Refer to client’s RF-129 series Management System Matrix • Matrices are designed to allow clients and auditors to cross-reference the client’s defined processes with the requirements of the standard. • The matrix must reference the client processes, as they are designated by the client as part of their interaction of processes. • Refer to the November 17, 2018 quarterly training for details on process names and how client processes must relate to standard requirements. • For QMS only, all clients must list at least one of their processes as “critical.” • A critical process is monitored and measured, and KPI’s are maintained. • Failure to maintain KPI’s results in a nonconformance. • Existing PRI clients should already have a matrix established. • For new (initial) clients, or for transfer clients, a matrix is sent to the client for completion when their contract is signed, and it is to be done and submitted to the auditor (via email) prior to the start of the audit. • Auditors may need to assist clients on-site to ensure that the matrix is completed correctly. • Matrices are created once, and then merely maintained and updated with process changes.

13. Process Flow • Create audit plan • Use the PRI Registrar RF-12 Audit Plan form. • The form is downloaded from the Plan tab of the RMS audit record. • Audit plans must reference the client processes, as they are designated by the client as part of their interaction of processes. • Due to be sent to the client (via email) at least 30 days prior to the audit, if possible. • If audit is scheduled in less than 30 days, send as soon as possible. • The plan must be uploaded on the Plan page of the RMS audit when submitted to the client; if the plan is revised later, it does not need to be uploaded into RMS again. • Note that working lunches are not acceptable – the plan must account for eight hours of auditing above and beyond any time designated for lunch.

14. Process Flow • Conduct audit • Reference the RF-115 Audit Document Listing for PRI Registrar documents. • Available on the following pages: • ISO 9001:2015 Audit Documents • ISO 14001:2015 Audit Documents • ISO 45001:2018 Audit Documents • The audit document listing will provide guidance on where to acquire, and where to submit required documentation.

15. Process Flow • Conduct audit (cont’d) • Audits are primarily conducted in two places: • RMS Audit Report • This report is completed directly within the RMS audit record. • Please note that Opportunities for Improvement (a.k.a., continuous improvement opportunities) are discouraged, as they run the risk of being considered either consultation or a soft-graded NCR. • RF-26 series Process Audit Form • This form is to be used in conjunction with the RF-129 series Management System Matrix. • A review of the RF-26’s across a client’s 3-year certification cycle, in combination with the RF-129, should show that all standard clauses have been reviewed during the certification cycle. • Refer to the RF-26 Process Audit Form Introduction presentation.

16. Process Flow • Manage NCRs • All NCRs are managed exclusively through RMS. • Client responses and auditor acceptance/rejection shall not be handled outside of the system. • Once an NCR is submitted by the auditor, the client is notified and assigned a task to complete all sections of the NCR form. As the client completes each section of NCR form, the auditor is notified and assigned a task to review each. Once all sections are accepted, the auditor submits the final NCR closure. • See RMS Auditor Guide – ISO Process for details on NCR management in RMS. • See the March 29, 2019 Quarterly Training for PRI Registrar expectations on NCRs, including writing, managing, and closing. • Audit Program • Completed for the three-year cycle directly in RMS at the time of the Stage 2 or Recertification audit. • All processes (as defined by the client) must be assessed at the Stage 2 or Recertification audit, and at least once more during the surveillances. • Refer to Auditor Advisory #115 for details on how the Activities section is to be completed.

17. Process Flow • Complete and submit audit documentation in RMS • Note that all audit documentation is due within 5 business days. • The Report, NCR, Audit Program, and Documents sections in the Report tab are required to be completed before submitting. • See RMS Auditor Guide – ISO Process for details on the online report. • The client manager is notified when an audit is submitted by the auditor. • Documentation is reviewed and either rejected back to the auditor for revision or accepted. • As needed, the audit will be forwarded to expert review/registration decision.

18. Process Flow • Expert Review • Audits requiring a registration decision will be assigned for expert review in RMS once the audit is accepted by the client manager and NCRs are closed/accepted. • Audits requiring registration decision include, but are not limited to: • initial, recert, transfer and upgrade audits • audits that result in suspension • audits that involve an expansion or reduction of scope • audits that have major NCRs or a significant increase in the number of NCRs • Expert review will be conducted anonymously, and reviewer comments and auditor responses will be communicated through RMS. • Note that auditors are encouraged to review the following forms, all available at this link, so as to be familiar with expert review criteria: • RF-76 (Registration Decision Report) • RF-142 (Audit Documentation Expectations) • RF-143 (Objective Evidence and Documentation Requirements)

19. Process Flow • Expenses/receipts entered in RMS • Expenses are due within 7 calendar days. • See RMS Auditor Guide – ISO Process for details on submitting expense reports in RMS.

20. Questions • If you have any questions, please do not hesitate to contact your client manager, or: Pete Kucan (Technical Support Engineer) Samantha Brock (Quality Specialist)