Documentation Requirements in ISO/DIS 9001
Keshav Ram Singhal
Documentation and record keeping have been important aspects of ISO 9001 quality management system. Clause 4.2 of ISO 9001:2008 QMS standard has specifically provides documentation requirements, however, clause 7.5 of ISO/DIS 9001 provides requirements for documentation information. Further the terms 'document' and 'record' used in ISO 9001:2008 QMS standard are changed to 'documentation information' in ISO/DIS 9001. The term 'documentation information' is defined in ISO/DIS 9001. It means meaningful data (information) required to be controlled and maintained by an organization and the medium on which it is contained. No specific source, format or media is specified for documentation information in ISO/DIS 9001. It can be in any format (such as language, software version, graphics etc) and media (such as paper, electronic) and from any source. It has been clarified that documentation information can refer to the quality management system including related processes, meaningful data (information) created for the organization to operate and evidence of results achieved.
ISO/DIS 9001 requires documentation information to be available and maintained/retained for the following:
- scope of the quality management system stating (i) products and services covered, and (ii) justification for any instance where a requirement of ISO/DIS 9001 cannot be applied (clause 4.3)
- to the extent necessary to (i) support the operation of processes, and (ii) have confidence that the processes are being carried out as planned (clause 4.4)
- quality policy (clause 5.2.2)
- quality objectives (clause 6.2.1)
- monitoring and measurement resources as evidence of fitness (clause 7.1.5)
- evidence of competence (clause 7.2)
- documentation information of external origin determined by the organization (clause 7.5.3.2)
- result of the review of requirements related to products and services (clause 8.2.3)
- confirmation that design and development requirements have been met (clause 8.3.2)
- design and development outputs (clause 8.3.5)
- design and development changes (clause 8.3.6)
- results of evaluations, monitoring of the performance and re-evaluations of the external providers (clause 8.4.1)
- traceability (clause 8.5.2)
- results of the review of changes, personnel authorizing the change and any necessary action for production and service provision (clause 8.5.6)
- traceability to the person(s) authorizing release of products and services for delivery to the customer (clause 8.6)
- actions taken on nonconforming process, outputs, products and services including any concessions obtained and person/authority made decision regarding dealing with the nonconformity (clause 8.7)
- evidence of results for monitoring, measurement, analysis and evaluation (clause 9.1.1)
- evidence to implement internal audit programme and the internal audit results (clause 9.2.2)
- results of management review (clause 9.3.2)
- evidence of the nature of nonconformities and any subsequent actions taken and results of any corrective action (clause 10.2.2)
- controlled conditions to control production and service provision to include, as applicable, the availability of documentation information defining the characteristics of the products and services, and the activities to be performed and the results to be achieved (clause 8.5.1)
In addition to the above, organization's quality management system needs to include documentation information determined by the organization as being necessary for the effectiveness of the quality management system (clause 7.5.1 b).
Creating and updating of documented information
Clause 7.5.2 of ISO/DIS 9001 provides requirements for creating and updating of documented information. At the time of creating and updating documented information the organization needs to ensure as appropriate:
- suitable identification and description of documented information by marking a title, date, author or reference number
- format of the documented information, such as language, software version, graphics etc
- media of the documented information, such as paper (hard copy), electronic
- review and approval of the documented information for suitability and adequacy
Control of documented information
Clause 7.5.3 of ISO/DIS 9001 provides requirements to control documentation information. As per requirements of ISO/DIS 9001 documented information required by the quality management system and by ISO/DIS 9001 must be controlled to ensure:
- its availability and suitability for use, where and when it is needed,
- its adequate protection so that there is no (i) loss of confidentiality, (ii) improper use, or (iii) loss of integrity,
The organization needs to address the following activities, as applicable, to control documentation information:
- distribution
- access (that imply a decision regarding permission to view the documented information only, or the permission or authority to view and change the documented information)
- retrieval and use
- storage and preservation, also preservation of legibility
- control of changes, such as version control
- retention and disposition
The organization needs to identify as appropriate, and control the documented information of external origin determined by the organization
Is quality manual required in ISO/DIS 9001?
ISO/DIS 9001 no longer includes the requirement of a documented quality manual, where ISO 9001:2008 QMS standard requires a documented quality manual. Although there is no explicit requirement for the quality manual in ISO/DIS 9001, however its clause 7.5.1 (b) states to include documented information determined by the organization as being necessary for the effectiveness of the quality management system. Accordingly, most organizations would determine a manual (or description book or instruction manual) that may define and provide clear direction to the organization people regarding implementing ISO/DIS 9001 in the organization.
Note: The ISO 9001 revision process moves on to the next stage, as such readers should note that there may be some changes in the requirements in the next stage of revision process. The above article is for academic purpose. Readers' comments are invited. Thanks.
