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Business Records Table

This document lists management system records that can demonstrate effective operation of the quality management system and provide evidence of process effectiveness. It includes records for processes such as document control, management review, competence and training, customer processes, design and development, purchasing, production, monitoring and measurement, customer satisfaction, nonconforming products, data analysis, continual improvement, and corrective and preventive action. For each record, it specifies the relevant ISO reference, required retention time, and suggested location.

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45 views2 pages

Business Records Table

This document lists management system records that can demonstrate effective operation of the quality management system and provide evidence of process effectiveness. It includes records for processes such as document control, management review, competence and training, customer processes, design and development, purchasing, production, monitoring and measurement, customer satisfaction, nonconforming products, data analysis, continual improvement, and corrective and preventive action. For each record, it specifies the relevant ISO reference, required retention time, and suggested location.

Uploaded by

fee
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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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 Issue and Change Control (front sheet 4.2.3 Ongoing Master File and
Control approvals and document index QF01) Document Index
Management Management Review Minutes 5.6* 3 yrs Quality Records File
Review
Competence and Recruitment (application forms, competency 6.2.2* Employment +6 Personnel Files
Training requirements, CVs etc) months
Job Descriptions (A/R) 6.2.2* Employment +6 Personnel Files
months
Induction Records (QFn2) 6.2.2* Employment +6 Personnel Files
months
Training Records (QFn3) 6.2.2* Employment +6 Personnel Files
months
Appraisal Records (QFn4) 6.2.2* Employment +6 Personnel Files
months
Customer Related Enquiries and Quotations 7.2.1 5 yrs Production Pack and
Processes Customer Files
Requirements Specifications / Confirmation 7.2.1 Life of product Customer Files
of Receipt of Order (QFn5) + 2 yrs
Contracts and Orders (indicating review) 7.2.2* 5 yrs Customer Files

Customer Complaints (QFn6 - QR) 7.2.3 / 3 yrs Quality Records File


8.5.2
Design and Design and Development Planning (e.g. 7.3.1 Life of project + Project Files
Development project plans, initiation) 2 yrs
Design Inputs (specifications etc) 7.3.2* Life of project + Project Files
Note: This will 2 yrs
generally be an Design Outputs (handbooks, purchase info, 7.3.3 Life of product Project Files
exclusion for a performance specs, data sheets) + 2 yrs
MRF unless Design Review Minutes 7.3.4* 2 yrs after equip Project Files
activities include release
MRF design Design and Development Verification (test 7.3.5* Life of product Database?
results, final design reviews etc) + 2 yrs
Design and Development Validation (e.g. 7.3.6* Life of product Project Files /
site trials, customer acceptance tests) + 2 yrs Database?
Design Change Control (ECN) 7.3.7* 3 yrs Change File / Quality
File
Purchasing Evaluation and Selection of Suppliers 7.4.1* 3 yrs Approved Vendor
(questionnaires, AVL etc) List AVL

Purchasing Information (approved POs, 7.4.2 2 yrs PO File / system


adequate purchasing information)
Verification of Purchased Product (e.g. 7.4.3 2 yrs PO File
GRN / delivery note / invoice) 7 yrs (Invoices re: VAT)

Production Control of Production (production pack 7.5.1 Ongoing Customer Files


Provision information)
Validation of Processes 7.5.2* Ongoing Production Files

Identification and Trace-ability (e.g. WO, 7.5.3* 5 yrs Customer Files


picking and packing list)
Customer Property – Documents/ Free issue 7.5.4* 3 yrs Quality Records File
material – issues recorded by QR

Business Records Table 1


MRF Name – Business Records Table

Process Record ISO Ref Retention Location


Control of Control and Calibration of Measuring 7.6* 3 yrs Equipment
Monitoring and Equipment (calibration and maintenance Calibration File
Measuring records, cal spreadsheet)
Devices

Customer Records of Customer Reviews, Surveys and 8.2.1 3 yrs Quality Records/
Satisfaction Feedback 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 8.2.2* 3 yrs Quality Records File
reports A/R)
Monitoring and Quality System Performance Feedback 8.2.3 Ongoing Quality Records File
Measurement of
Processes Internal Process Monitoring Records 8.2.3 3 yrs Quality Records File
(MRM etc)
Monitoring and Evidence of Conformity Against Acceptance 8.2.4* 3 yrs Customer Files
Measurement of Criteria (including person(s) authorising
Product release of product), e.g. Sign-off Sheets /
Acceptance Records
Monitoring and Conformity of Service / Support Activities 8.2.4* 3 yrs Customer Files
Measurement of Against Acceptance Criteria (SLAs, surveys,
Service support information)
Control of NC Records of Non-conforming Products/ 8.3* 3 yrs Quality Records File
Product/Service Service and any Associated Actions
Concessions (if any – QR) 8.3* 3 yrs Quality Records File

NC Product Supplied to Customer (QR inc. 8.3* 10 yrs Quality Records File
S/N, product identification, recipients and
actions)
Analysis of Data Evidence of Analysis of Data from CSAT, 8.4 3 yrs Quality Records File
Product Conformance, Process/ Service
Trends and Supplier Performance

Continual Evidence of QMS Continual Improvement (Q. 8.5.1 3 yrs Quality Records File
Improvement objective trend, audit results, management
review data etc and QRs)

Corrective Action Records of Corrective Actions Taken 8.5.2* 3 yrs Quality Records
(includes customer complaints - (QR)) File / Database

Preventive Action Records of Preventive Actions Identified, 8.5.3* 3 yrs Quality Records File
Risk Mitigation and any Actions Taken (QR).

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.

Business Records Table 2

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