PRI Registrar November 2, 2018 Process Audit Form PRI Registrar November 2, 2018

Introduction Following the ISO 9001:2015 transition, process auditing is being emphasized both by industry, and by the new standard. PRI Registrar began the move to process auditing by introducing the RF-129 QMS Matrix making the RF-25 Audit Checklist an optional form. However, as we continue with this change in perspective from elemental auditing (the checklist) to process auditing, we are going a step further. Starting November 15, 2018, PRI Registrar will no longer be using the RF-25 Audit Checklist for ISO 9001 audits. A new tool has been developed in its place: The RF-26 QMS Process Audit Form.

RF-26 QMS An RF-26 QMS Process Audit Form is to be the record for each process audit conducted during a site visit. For a full-system audit, a separate RF-26 QMS form is to be completed for each process the client has identified on the RF-129 QMS Matrix. For a surveillance, a separate RF-26 QMS form is to be completed for each process identified on the Audit Program as being assessed during that audit.

RF-26 QMS The RF-26 QMS is divided into two sections. The first section is to be completed every time a form is generated.

Section 1 Box 1: Process Name Process names must match the process names identified by the client on the RF-129 QMS Matrix. A process must exist to cover all requirements of the standard. If clients leave any of the requirements of the standard outside of a process (e.g., QMS requirements), a nonconformance must be written against section 4.4.1. Box 2: Individual(s) / Position with authority for process Identify the individual(s) with authority and responsibility for the results of the audit.

Section 1 Box 3: All clauses associated with this process in the RF-129 have been included in this audit All clauses associated with a process shall be audited during Stage 2 and Recert audits. It is understood and permissible that sometimes a process is not audited in its entirety during a surveillance. However, we must be able to track which requirements have or have not been audited, to ensure that they are seen at least once during the two (or five) surveillances. When justifying clauses that are not reviewed during a given surveillance, “it was seen last year” or “it will be seen next year” are perfectly valid justifications. Just make sure they’re true. Box 4: Summary of audit trails and objective evidence This is where the objective evidence of the audit is documented. General statements are discouraged; please provide specifics (e.g., names, dates, document numbers, specific results). For the sake of legibility, this information is to be typed.

RF-26 QMS The second section is to be completed only for processes that the client identifies as “critical” on the RF-129 QMS Matrix.

Section 2 Box 1: N/A – This is not a critical process Box 2: Inputs If the process is not critical, mark this box and leave everything below blank. Box 2: Inputs List the inputs to the process here. Examples are listed. Box 3: Outputs List the out puts from the process here. Examples are listed. Box 4: Process Effectiveness Assessment This is the same table currently found in the RF-22 Audit Report List: The Metric of Performance – what’s being measured The Objective – the goal the organization is trying to achieve The Actual – the actual result of the measurement The Action if not accepted – if the actual does not meet the goal, is the client taking action to address the shortfall? Did you write a nonconformance? Be sure that all measurements have a unit of measure Box 5: Narrative of Effectiveness of Process General commentary on the effectiveness of the process Include a discussion of any risk-based thinking associated with the process

RF-26 QMS The RF-26 QMS is to be the record of the objective evidence and audit trails for ISO 9001 audits for PRI Registrar. The RF-25 Audit Checklist will still be available for download in the RMS Help tab, for those who find it helpful, but as of November 15, 2018 it will no longer be accepted as an audit document. In order to be effective, the process names on the RF-26 QMS forms completed for any given audit must match with the: RF-129 QMS Matrix RF-12 Audit Plan Audit Program in RMS When completed, upload all RF-26 QMS forms into the audit record in RMS in the “Audit Process Form” slot.

Questions If you have any questions, please do not hesitate to contact: Pete Kucan or Samantha Brock