ISO/DIS 9001 - SUPPORT

Keshav Ram Singhal

Clause 7 of ISO/DIS 9001 provides requirements related to support. It includes requirements related to resources (including human resources, infrastructure, environment for the operation of processes, monitoring and measurement resources, organizational knowledge), competence, awareness, communication and documented information. More or less similar requirements under the heading 'Resource management' are mentioned in clause 6 of ISO 9001:2008 QMS standard. Documentation requirements of clause 4.2 of ISO 9001:2008 QMS standard are now part of the support requirements in clause 7.5 of ISO/DIS 9001.

Clause 7 of ISO/DIS 9001 now deals with support requirements, whose relevant sub-clauses are as under:

7.1 - Resources
7.1.1 - General
7.1.2 - People
7.1.3 - Infrastructure
7.1.4 - Environment for the operation of processes
7.1.5 - Monitoring and measuring resources
7.1.6 - Organizational knowledge

7.2 - Competence

7.3 - Awareness

7.4 - Documented information
7.4.1 - General
7.4.2 - Creating and updating
7.4.3 - Control of documented information

RESOURCES

Clause7.1 of ISO/DIS 9001 deals with the requirements of resources needed for the quality management system. As per requirements, the organization is required to determine and provide the resources (such as people, infrastructure, environment, monitoring and measuring resources, organizational knowledge) needed for implementing, maintaining and continually improving the quality management system of the organization. The organization needs to consider:
- the capabilities of existing internal resources available in the organization,
- the constraints on existing internal resources, and
- resources needs to be sourced from external providers.

The organization needs to ensure to consistently meet customer and applicable legal (statutory and regulatory) requirements to achieve conformity of products and services for which the organization is required to provide:
(i) competent persons for effective operation of the quality management system including the processes needed for the quality management system,
(ii) infrastructure for the operation of processes,
(iii) environment (including physical, social, psychological, environmental and other factors such as temperature, humidity, ergonomics and cleanliness) necessary for the operation of the processes,
(iv) monitoring and measuring resources to ensure valid and reliable results.

Infrastructure needed may include:
- buildings and associated utilities,
- hardware and software equipments,
- transportation,
- information and communication technology.

Evidence of conformity of products and services to specified requirements are essential for a robust quality management system for which there are instances where monitoring and measuring resources are used for collection the evidence of conformity of products and services to specified requirements. In such instances the organization needs to determine the resources needed (such as monitoring and/or measuring equipments) to ensure valid and reliable monitoring and measuring results. The organization needs to ensure that the monitoring and measuring resources are suitable and fit (useful) for the purpose they are being used and the organization needs to retain appropriate documented information as evidence of fitness of such resources.

There may be instances where measurement traceability (history) may be a legal (statutory or regulatory) requirement, customer expectation, relevant interested party expectation or organization's consideration to be necessary of providing confidence in the measurement results' validity. In such instances the organization must (i) verify or calibrate the measuring instruments at specified intervals or prior to use against national or international measurement standards, or where no national/international standard exists, retain as documented information the basis used for calibration or verification, (ii) identify the measuring instrument in order to determine its calibration status, (iii) safeguard from adjustments, damage or deterioration that may invalidate calibration status or measurement results.

The organization must: (i) determine if the validity of previously measurement results has been adversely affected, (ii) determine when a monitoring/measuring instrument is found to be defective during its planned verification or calibration or during its use, and (iii) take appropriate corrective action as required.

ISO/DIS 9001 has included new requirements related to organizational knowledge. As a resource, organizational knowledge (such as information on intellectual property and lessons learned) may be necessary for the operation of organization's processes and to achieve conformity of products and services to specified requirements, for which the organization is required to: (i) determine the knowledge, (ii) determine ways or methods to acquire or access the necessary additional knowledge, (iii) maintain the knowledge, (iv) make available the knowledge to the extent necessary, and (v) consider its current knowledge when addressing changing needs and trends.

When team knowledge from several subunits, departments or groups of an organization is combined and used to create new knowledge, the resulting knowledge can be called organizational knowledge.

The organization is required to:
- determine the knowledge necessary for the operation of organization's processes and to achieve conformity of products and services to requirements,
- maintain the knowledge, and
- make available the knowledge to the extent necessary.

When addressing changing needs and trends, there is a need to acquire or access the additional knowledge for which the organization needs to consider the organization's current knowledge and determine the ways to acquire or access the necessary additional knowledge. The organization can consider internal and external sources. Internal sources may include learning within the organization from failures and successes, capturing knowledge that is not documented and experience of local experts. External sources may include standards, academic references, conferences, knowledge from customers or others, such as suppliers, providers.

To be continued ....