Wiki source code of How to prepare for a CQM Audit by TruCert?
Version 2.1 by SuperUwe Trueggelmann on 2024-09-02
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1.1 | 1 | = Introduction = |
| 2 | |||
| 3 | TruCert provides CQM Auditing services. | ||
| 4 | |||
| 5 | This page describes how a Vendor (the auditee of the CQM audit) should prepare for being CQM Audited by TruCert. | ||
| 6 | |||
| 7 | The main points are: | ||
| 8 | |||
| 9 | * For on-site audits: | ||
| 10 | ** cqmAP form | ||
| 11 | ** Organisational Diagrams | ||
| 12 | ** Corrective Action Plan from the previous CQM audit | ||
| 13 | ** Presentations | ||
| |
2.1 | 14 | ** Audit Plan |
| |
1.1 | 15 | * In addition, for remote audits: |
| 16 | ** cqmGIAP | ||
| 17 | ** CQM Remote Audit - Information Exchange Agreement between Vendor and Auditor | ||
| 18 | |||
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2.1 | 19 | The sections below explain each item. |
| 20 | |||
| 21 | = On-Site Audits = | ||
| 22 | |||
| 23 | == cqmAP Form == | ||
| 24 | |||
| 25 | The cqmAP form is the main operational document for a CQM Audit. | ||
| 26 | |||
| 27 | It contains: | ||
| 28 | |||
| 29 | * Administrative information about the Vendor, the audit, and the auditor | ||
| 30 | * Means of defining the scope of the audit | ||
| 31 | * Lists of applicable requirements for QMS and each CQM product | ||
| 32 | * Sections for the Vendor to declare their compliance and list their main evidences for the audit | ||
| 33 | * Sections for the auditor to record their notes and findings | ||
| 34 | * Forms for the corrective action plan, listing the auditors finding, the Vendor's corresponding corrective action, status report and list of evidences for completion by the Vendor, and the assessment of completion by the auditor | ||
| 35 | * A Report form that serves as the audit report and the status report for the corrective action plan | ||
| 36 | |||
| 37 | Prior to the audit the Vendor needs to complete the following worksheets in the cqmAP: | ||
| 38 | |||
| 39 | * Coverpage - Section 1 | ||
| 40 | * Audit Scope and Compliance - Column C | ||
| 41 | * applicable QMS worksheet - blue sections (columns G to I) | ||
| 42 | * Each applicable product worksheet, blue sections (columns J to V) | ||
| 43 | |||
| 44 | == Organisational Diagrams == | ||
| 45 | |||
| 46 | Prior to the audit, the Vendor shall provide one or multiple organisational diagrams providing the following information: | ||
| 47 | |||
| 48 | * Corporate organisation, showing the top level management functions, identifying the name of the function (eg: CFO) and the name of the current responsible for the function (eg: Peter Parker) | ||
| 49 | * Site organisation, showing the management functions of the site, identifying the name of the function (eg: Production Manager) and the name of the current responsible for the function (eg: Mary Jane Watson) | ||
| 50 | * Quality Management organisation within the site, identifying the name of the function (eg: Quality Manager) and the name of the current responsible for the function (eg: Gwen Stacy) | ||
| 51 | |||
| 52 | == Corrective Action Plan from the previous CQM audit == | ||
| 53 | |||
| 54 | (% class="box infomessage" %) | ||
| 55 | ((( | ||
| 56 | If this is the first CQM audit of the site, this section does not apply. | ||
| 57 | ))) | ||
| 58 | |||
| 59 | If the corrective action plan from the previous audit was already in the CAP worksheet of the cqmAP, then simply copy and paste the corrective action plan (from row 13 onwards), including all notes by the auditor, into the "CAP previous" worksheet. | ||
| 60 | |||
| 61 | Otherwise, please enter the respective data into the "CAP previous" worksheet manually. | ||
| 62 | |||
| 63 | == Presentations == | ||
| 64 | |||
| 65 | Presentations are no longer required. All required information to be provided is entered into the cqmAP Coversheet. | ||
| 66 | |||
| 67 | If you want to provide additional information about your company, for example a company introduction, or a list of developments since the previous audit, then you are free to do so, but this is not required. | ||
| 68 | |||
| 69 | == Audit Plan == | ||
| 70 | |||
| 71 | The audit plan will be defined by the auditor in the Audit Schedule worksheet in the cqmAP. | ||
| 72 | |||
| 73 | = Remote Audits = | ||
| 74 | |||
| 75 | == Introduction == | ||
| 76 | |||
| 77 | For remote audits, all the items for On-Site Audits apply. | ||
| 78 | |||
| 79 | In addition the Vendor must provide prior to the audit: | ||
| 80 | |||
| 81 | * cqmGIAP | ||
| 82 | * CQM Remote Audit - Information Exchange Agreement between Vendor and Auditor | ||
| 83 | |||
| 84 | This section describes the additional items for Remote Audits | ||
| 85 | |||
| 86 | == cqmGIAP == | ||
| 87 | |||
| 88 | == CQM Remote Audit - Information Exchange Agreement between Vendor and Auditor == |