ISO 9001 Implementation Guide

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4.2.4 Control of Records

Records are a special type of document and therefore have separate control requirements. See ISO 9001:2000 4.2.4. (1994 clause, 4.16) for more information. A written procedure is also required.

Not a lot has changed from the 1994 version of ISO 9000 in this clause. In short, quality records are the evidence that shows you have, in fact, followed your system. Some good examples of records are purchase orders, sales records, contracts, internal audits, meeting minutes, or test data.

Records must be legible and retrievable in a reasonable timeframe. (You decide what is reasonable to your organization.) These records should be thought of as long-term documents and must be stored where they cannot be damaged. It might be a good idea to get your legal and IT departments involved when making decisions about records-what should be kept, how long you should keep them, how they should be stored and how they should be disposed.

There are several places in ISO 9001:2000 that require records. Any time the standards states "See 4.2.4," a record is required. However, other records not specifically mentioned will be necessary to show evidence of conformance with requirements and demonstrate effective operation of the system.

If you're transitioning to the new standard and already have a lot of records to deal with, you may want to consider using your organization's Intranet to post and store records. Today, most companies tend to store their records in one area that has been deemed safe for storage. It's a good idea to have a central, physical area for documentation, whether it's in your building or cyberspace.

Also, if you're going to dispose of records, consider shredding them if it's paper copy. Paper shredders are relatively inexpensive, and the leftover product can be recycled in a number of ways. If you store records electronically, as many organizations now do, consult your technology department to ensure proprietary documents don't fall into the wrong hands.

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QUALITY MANAGEMENT SYSTEMS, GENERAL REQUIREMENTS, DOCUMENTATION REQUIREMENTS, GENERAL, QUALITY MANUAL, CONTROL OF DOCUMENTS, CONTROL OF RECORDS, MANAGEMENT RESPONSIBILITY, MANAGEMENT COMMITMENT, CUSTOMER FOCUS, QUALITY POLICY, PLANNING, QUALITY OBJECTIVES, QUALITY MANAGEMENT SYSTEM PLANNING, RESPONSIBILITY, AUTHORITY AND COMMUNICATION, RESPONSIBILITY AND AUTHORITY, MANAGEMENT REPRESENTATIVE, INTERNAL COMMUNICATION, MANAGEMENT REVIEW, GENERAL MANAGEMENT REVIEW, REVIEW INPUT, REVIEW OUTPUT, RESOURCES MANAGEMENT, PROVISION OF RESOURCES, HUMAN RESOURCES, GENERAL, COMPETENCE, AWARENESS AND TRAINING, INFRASTRUCTURE, WORK ENVIRONMENT, PRODUCT REALIZATION, PLANNING OF PRODUCT REALIZATION, CUSTOMER-RELATED PROCESSES, DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT, REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT, CUSTOMER COMMUNICATION, DESIGN AND DEVELOPMENT, DESIGN AND DEVELOPMENT PLANNING, DESIGN AND DEVELOPMENT INPUTS, DESIGN AND DEVELOPMENT OUTPUTS, DESIGN AND DEVELOPMENT REVIEW, DESIGN AND DEVELOPMENT VERIFICATION, DESIGN AND DEVELOPMENT VALIDATION, CONTROL OF DESIGN AND DEVELOPMENT CHANGES, PURCHASING, PURCHASING PROCESS, PURCHASING INFORMATION, VERIFICATION OF PURCHASED PRODUCT, PRODUCT AND SERVICE PROVISION, CONTROL OF PRODUCTION AND SERVICE PROVISION, VALIDATION PROCESSES FOR PRODUCTION AND SERVICE PROVISION, IDENTIFICATION AND TRACEABILITY, CUSTOMER PROPERTY, PRESERVATION OF PRODUCT, CONTROL OF MONITORING AND MEASURING DEVICES, MEASUREMENT, ANALYSIS AND IMPROVEMENT, GENERAL MEASUREMENT, ANALYSIS AND IMPROVEMENT, MONITORING AND MEASUREMENT, CUSTOMER SATISFACTION, INTERNAL AUDITS, MONITORING AND MEASUREMENT OF PROCESSES, MONITORING AND MEASUREMENT OF PRODUCT, CONTROL OF NONCONFORMING PRODUCT, ANALYSIS OF DATA, IMPROVEMENT, CONTINUAL IMPROVEMENT, CORRECTIVE ACTION, PREVENTIVE ACTION,

ISO 9001 GUIDE

ISO 9001 guide

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