MRF Name – Business Records Table

Below are listed required / suggested management system records that can be used to demonstrate the effective operation of the QMS and/or provide objective evidence of process effectiveness. The ISO references shown in bold* indicate compulsory ISO 9001 records.

Process / Record / ISO Ref / Retention / Location /
Document Control / Issue and Change Control (front sheet approvals and document index QF01) / 4.2.3 / Ongoing / Master File and Document Index
Management Review / Management Review Minutes / 5.6* / 3 yrs / Quality Records File
Competence and Training / Recruitment (application forms, competency requirements, CVs etc) / 6.2.2* / Employment + 6 months / Personnel Files
Job Descriptions (A/R) / 6.2.2* / Employment + 6 months / Personnel Files
Induction Records (QFn2) / 6.2.2* / Employment + 6 months / Personnel Files
Training Records (QFn3) / 6.2.2* / Employment + 6 months / Personnel Files
Appraisal Records (QFn4) / 6.2.2* / Employment + 6 months / Personnel Files
Customer Related Processes / Enquiries and Quotations / 7.2.1 / 5 yrs / Production Pack and Customer Files
Requirements Specifications / Confirmation of Receipt of Order (QFn5) / 7.2.1 / Life of product + 2 yrs / Customer Files
Contracts and Orders (indicating review) / 7.2.2* / 5 yrs / Customer Files
Customer Complaints (QFn6 - QR) / 7.2.3 / 8.5.2 / 3 yrs / Quality Records File
Design and Development
Note: This will generally be an exclusion for a MRF unless activities include MRF design / Design and Development Planning (e.g. project plans, initiation) / 7.3.1 / Life of project + 2 yrs / Project Files
Design Inputs (specifications etc) / 7.3.2* / Life of project + 2 yrs / Project Files
Design Outputs (handbooks, purchase info, performance specs, data sheets) / 7.3.3 / Life of product + 2 yrs / Project Files
Design Review Minutes / 7.3.4* / 2 yrs after equip release / Project Files
Design and Development Verification (test results, final design reviews etc) / 7.3.5* / Life of product + 2 yrs / Database?
Design and Development Validation (e.g. site trials, customer acceptance tests) / 7.3.6* / Life of product + 2 yrs / Project Files / Database?
Design Change Control (ECN) / 7.3.7* / 3 yrs / Change File / Quality File
Purchasing / Evaluation and Selection of Suppliers (questionnaires, AVL etc) / 7.4.1* / 3 yrs / Approved Vendor List AVL
Purchasing Information (approved POs, adequate purchasing information) / 7.4.2 / 2 yrs / PO File / system
Verification of Purchased Product (e.g. GRN / delivery note / invoice) / 7.4.3 / 2 yrs
7 yrs / PO File
(Invoices re: VAT)
Production Provision / Control of Production (production pack information) / 7.5.1 / Ongoing / Customer Files
Validation of Processes / 7.5.2* / Ongoing / Production Files
Identification and Trace-ability (e.g. WO, picking and packing list) / 7.5.3* / 5 yrs / Customer Files
Customer Property – Documents/ Free issue material – issues recorded by QR / 7.5.4* / 3 yrs / Quality Records File
Control of Monitoring and Measuring Devices / Control and Calibration of Measuring Equipment (calibration and maintenance records, cal spreadsheet) / 7.6* / 3 yrs / Equipment Calibration File
Customer Satisfaction / Records of Customer Reviews, Surveys and Feedback / 8.2.1 / 3 yrs / Quality Records/ Customer Files
Internal Auditing / Audit Schedule / 8.2.2* / 3 yrs / Quality Records File
Audit Reports / 8.2.2* / 3 yrs / Quality Records File
Audit Corrective Actions (cross ref to quality reports A/R) / 8.2.2* / 3 yrs / Quality Records File
Monitoring and Measurement of Processes / Quality System Performance Feedback / 8.2.3 / Ongoing / Quality Records File
Internal Process Monitoring Records / 8.2.3 / 3 yrs / Quality Records File (MRM etc)
Monitoring and Measurement of Product / Evidence of Conformity Against Acceptance Criteria (including person(s) authorising release of product), e.g. Sign-off Sheets / Acceptance Records / 8.2.4* / 3 yrs / Customer Files
Monitoring and Measurement of Service / Conformity of Service / Support Activities Against Acceptance Criteria (SLAs, surveys, support information) / 8.2.4* / 3 yrs / Customer Files
Control of NC Product/Service / Records of Non-conforming Products/ Service and any Associated Actions / 8.3* / 3 yrs / Quality Records File
Concessions (if any – QR) / 8.3* / 3 yrs / Quality Records File
NC Product Supplied to Customer (QR inc. S/N, product identification, recipients and actions) / 8.3* / 10 yrs / Quality Records File
Analysis of Data / Evidence of Analysis of Data from CSAT, Product Conformance, Process/ Service Trends and Supplier Performance / 8.4 / 3 yrs / Quality Records File
Continual Improvement / Evidence of QMS Continual Improvement (Q. objective trend, audit results, management review data etc and QRs) / 8.5.1 / 3 yrs / Quality Records File
Corrective Action / Records of Corrective Actions Taken (includes customer complaints - (QR)) / 8.5.2* / 3 yrs / Quality Records File / Database
Preventive Action / Records of Preventive Actions Identified, Risk Mitigation and any Actions Taken (QR). / 8.5.3* / 3 yrs / Quality Records File

Notes

1.  The retention period specified should be the minimum required for contractual, legal, customer or trend analysis reasons.

2.  The Location / Holder needs to be considered from an accessibility and retrieve-ability point of view.

3.  Records and evidence that indicate appropriate control and monitoring of any outsourced processes may also need consideration.

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Business Records Table