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- Keshav Ram Singhal
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Monday, June 22, 2015

ISO/DIS 9001 - SUPPORT - Documented information

Keshav Ram Singhal


ISO 9001:2008 QMS standard has its clause 4.2 that describes documentation requirements including general requirements (sub-clause 4.2.1), requirements for quality manual (sub-clause 4.2.2), control of documents (sub-clause 4.2.3) and control of records (sub-clause 4.2.4) and accordingly the standard describes two types of documentation (documents and records). Records are a special types of document and many people confuse between a document and a record. ISO/DIS 9001 attempts to reduce the confusion between a document and a record by introducing a common term 'documented information' and thus the implementation will be more transparent. ISO/DIS 9000:2014 defines documented information as the information (meaningful data) required to be controlled and maintained by an organization and the medium on which it is contained. Documented information can be: (i) in any format, (ii) in any media, and (iii) from any source. Documented information can refer to: (i) the quality management system, (ii) any related processes, (iii) information (meaningful data) relevant for the organization's operation, and (iv) evidence of results achieved.

The terms 'documented procedure' and 'record' (used in ISO 9001:2008 QMS Standard) have both been replaced throughout the requirements text in ISO/DIS 9001 by 'documented information'. Where ISO 9001:2008 QMS standard refers to documented procedure, this now expressed as to maintain documented information in ISO/DIS 9001. Where ISO 9001:2008 QMS standard refers to records, this now expressed as to retain documented information in ISO/DIS 9001.

Clause 7.5 (documented information) of ISO/DIS 9001 has following sub-clauses:
7.5.1 - General
7.5.2 - Creating and updating
7.5.3 - Control of documented information

As per the requirements of ISO/DIS 9001, the quality management system of the organization must include (i) documented information required by ISO/DIS 9001, and (ii) documented information determined by the organization for the organization's effective quality management system.

Documented information required by ISO/DIS 9001

Documented information required by ISO/DIS 9001(with clause number) are given below:

4.3 - Scope of the quality management system mentioning the products and services covered and justification for any instance where any ISO/DIS 9001 requirement cannot be applied

4.4 - (i) Necessary to support the operation of processes, and (ii) to have confidence that the processes are being carried out as planned

5.2 - Quality policy

6.2 - Quality objectives

7.1.5 - (i) Monitoring and measuring resources - evidence of fitness, and (ii) Basis used for calibration or verification where no international or national measurement standard exists

7.2 - Evidence of competence

8.1 - Operation planning and control - (i) Processes are carried out as planned and (ii) Conformity of products and services

8.2.3 - (i) Result of the review of requirements, including any new or changed requirements for the products and services, and (ii) Where requirements for products and services are changed, amendment of relevant document information

8.3.2 - Confirmation that design and development requirements are met

8.3.3 - Design and development inputs

8.3.4 - Design and development control activities

8.3.5 - Results from design and development outputs

8.3.6 - Design and development changes, results of reviews, authorization of changes and the actions taken to prevent adverse effects

8.4.1 - (i) Results of evaluation, (ii) Monitoring of performance, and (iii) Re-evaluation of external providers

8.5.1 - Information that defines the characteristics of the products and services to be produced/provided, activities to be performed, and the results to be achieved

8.5.2 - Necessary to maintain traceability

8.5.6 - (i) Results of the review of changes, (ii) Personnel authorizing the change, and (iii) Any necessary action

8.6 - Traceability to the person(s) authorizing release of products and services for delivering to the customer

8.7 - (i) Action taken on nonconforming process outputs, products and services, (ii) Any concession obtained, and (iii) Person or authority that made the decision regarding dealing with the nonconformity

9.1.1 - Evidence of results in monitoring, measurement, analysis and evaluation

9.2 - (i0 Evidence of the implementation of the internal audit programme, and (ii) Internal audit results

9.3 - Evidence of the results of management review

10.2 - Evidence of (i) nature of nonconformities and subsequent actions , and (ii) Results of any corrective action

Although ISO/DIS 9001 does not mention the requirement to have documented information for the following, however, it would be better in the opinion of the author of this article if the organization determines to have documented information for the following:

5.3 - Organizational roles, responsibilities and authorities

6.1 - Actions to address risks and opportunities

8.3.4 - Clearly defining the results to be achieved by the design and development activities

- To be continued ....

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