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Wednesday, May 24, 2017

ISO 9001:2015 QMS - Creating and updating Documented information - Part 1


ISO 9001:2015 QMS - Creating and updating Documented information - Part 1

Documented information in ISO 9001:2015 QMS


ISO 9001:2015 QMS standard does not specify any particular format or design for documented information to maintain and to retain. Earlier version ISO 9001:2008 QMS standard used the terms 'documents', 'documented procedure', 'quality manual' and 'quality plan', however these terms are not used in the requirements of ISO 9001:2015 QMS standard, instead a new term 'documented information' has been used in ISO 9001:2015 QMS standard requirements. Clause 3.8.6 of ISO 9000:2015, QMS - Fundamentals and vocabulary, defines the term 'documented information' as an information (meaningful data) required to be controlled and maintained by the organization and the medium on which it is contained. Documented information can be in any format. It can be in any media. It can be from any source. However, Annex A of ISO 9001:2015 QMS standard provides freedom to organizations to use terms which suit their operations, such as 'records', 'documentation' or 'protocols' rather than 'documented information'. Accordingly, organizations can use the terms 'documentation', 'quality manual', 'QMS manual', 'documented procedures', 'records', 'quality plan' that suit them.

ISO 9001:2015 QMS standard has used two types of terms: 'maintain documented information' and 'retain documented information'. The term 'maintain documented information' is equivalent to keeping a 'document', or 'documented procedure', 'quality manual' or 'quality plan'. The term 'retain documented information' is equivalent to keeping records. In this connection Para A.6 of Annex a of ISO 9001:2015 QMS standard should be referred to.

As per the provisions of ISO 9001:2015 QMS standard (reference Clause 7.5.1), the organization's quality management system documentation need to include the following:
- Documented information required by ISO 9001:2015 QMS standard, and
- Documented information determined by the organization.

ISO 9001:2015 QMS standard requires: (i) to develop a quality policy, (ii) to establish quality objectives at relevant functions, levels and processes, (iii) to create, update, control and retain documented information (as mentioned in the standard and as determined by the organization as being necessary for the effectiveness of the organization's quality management system, and (iv) to maintain documented information to support the operation of its processes and retain them to have confidence that the processes are carried out as planned.

ISO 9001:2015 QMS standard requires to maintain following documented information:
- Scope of the organization's quality management system (4.3)
- Information to support the operation of organization's processes (4.4.2)
- Quality policy (5.2)
- Quality objectives (6.2.1)
- Operational planning and control (8.1)
- Documented information that defines the characteristics of the products and services to be produced/provided, activities to be performed, and the results to be achieved (8.5.1)
- In addition to the above, the organization should determine documented information (to maintain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)

ISO 9001:2015 QMS standard also requires to retain following documented information:
- Processes carried out as planned (4.4.2)
- Monitoring and measuring resources - evidence of fitness, and basis used for calibration and verification, where no international or national measurement standard exists (7.1.5)
- Evidence of competence (7.2)
- Operation planning and control (8.1)
- Results of the review of requirements, including any new or changed requirements, for the products and services, and where requirements for products and services are changed, amendment of relevant documented information (8.2.3)
- Confirmation that design and development requirements are met (8.3.2)
- Design and development inputs (8.3.3)
- Design and development controls activities (8.3.4)
- Design and development outputs(8.3.5)
- Design and development changes, results of reviews, authorization of changes, and actions taken to prevent adverse impacts (8.3.6)
- Evaluation, selection, monitoring of performance, and re-evaluation activities of external providers and any necessary actions (8.4.1)
- Necessary information to maintain traceability (8.5.2)
- Information regarding property belonging to customers or external provider is lost, damaged or otherwise found to be unsuitable for use and reporting to the customer or external provider (8.5.3)
- Results of the review of changes, personnel authorizing the changes, and any necessary action (8.5.6)
- Evidence of product/service conformity with the accepted criteria (8.6)
- Traceability to the person(s) authorizing release of products and services for delivering to the customer (8.6)
- Release of product/service including evidence of conformity with acceptance criteria, Information that describes nonconformity, the actions taken, any concession obtained, and that identifies the authority deciding the action (8.7.2)
- Evidence of results in monitoring, measurement, analysis and evaluation (9.1.1)
- Evidence of the implementation of the internal audit programme, and internal audit results (9.2)
- Evidence of the results of management review (9.3)
- Evidence of nature of nonconformities and subsequent actions, and results of any corrective action (10.2)
- In addition to the above, the organization should determine documented information (to retain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)

Structure of documented information

QMS documented information is the basis for establishing, implementing and maintaining a quality management system in an organization. ISO 9001:2015 QMS standard does not specify any particular format or design for documented information to maintain and to retain, however most organizations prefer to opt for three-levels documented information, which are as under:

- Level 'A' Documented Information: Consisting of Quality Policy, Quality Objectives and Quality Manual (or QMS Manual).
- Level 'B' Documented Information: Consisting of documented information that are required to maintained, such as documented procedures, work instructions.
- Level 'C' Documented Information: Consisting of documented information that are required to retained by the organization, such as records, and others that are needed by the organization, such as various forms, standards, drawings, specifications, etc.

It is not necessary for an organization to have three levels of documented information separately. An organization can combine Level 'A' and Level 'B' documented information in one manual or can have separate manual for different documented information. QMS documented information of one organization can differ from the other due to the following reasons:
- The size of an organization may differ from the size of other organization.
- The type of activities of an organization may be different from the activities of other organization.
- The products/services of an organization may be different from the products/services of other organization.
- The complexity of processes and their interactions of an organization may be different from the complexity of processes and their interactions of other organization.
- The competence of personnel of an organization may differ from the competence of personnel of other organization.

Purposes and Benefits of Documented Information

There are several purposes and benefits of having documented information in the quality management system. Documented information generally serves the following purposes:
- Documented information in the quality management system establishes that the organization is dependent on the system, and not on person.
- Documented information in the quality management system describes the quality management system of the organization.
- Documented information in the quality management system provides evidence of management commitment to the system.
- Documented information in the quality management system provides an invaluable training aid to its employees. It defines and guides how the quality management system is managed in the organization. It provides a basis for training new employees and periodic re-training of current employees.
- Documented information in the quality management system assists employees to carry out their jobs effectively by removing ambiguities, defining the system, allocating responsibilities and authorities and identifying those responsible for the activities. It helps employees to understand their roles within the organization.
- Documented information in the quality management system provides mutual understanding between employees and management.
- Documented information in the quality management system provides results of periodic audit and management review.
- Documented information in the quality management system provides operational planning and control guidelines.
- Documented information in the quality management system demonstrates to the organization's customers, certification body and interested parties that the quality management system has been systematically planned.
- Documented information in the quality management system defines the characteristics of the products/services to be produced/provided, activities to be performed, and the results to be achieved that form basis for expectation of work performance.

Is quality manual required in ISO 9001:2015 QMS?

ISO 9001:2015 QMS standard 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 9001:2015 QMS standard, 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 Quality manual (or QMS manual, description book or instructions manual) that may define and provide clear direction to the organization's people regarding implementing ISO 9001:2015 QMS in the organization.

- Keshav Ram Singhal

... To be continued


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