ISO/DIS 9001 - OPERATION - Operational planning and control
Keshav Ram Singhal
Clause 8 of ISO/DIS 9001 provides requirements related to the operation. All phases, involved in the development of products and services, come under operation.
The relevant sub-clauses are as under:
8.1 - Operation
8.1.1 - Operational planning and control
8.2 - Determination of requirements for products and services
8.2.1 - Customer communication
8.2.2 - Determination of requirements related to products and services
8.2.3 - Review of requirements related to products and services
8.3 - Design and development of products and services
8.3.1 - General
8.3.2 - Design and development planning
8.3.3 - Design and development inputs
8.3.4 - Design and development control
8.3.5 - Design and development outputs
8.3.6 - Design and development changes
8.4 - Control of externally provided products and services
8.4.1 - General
8.4.2 - Type and extent of external provision
8.4.3 - Information for external providers
8.5 - Production and service provision
8.5.1 - Control of production and service provision
8.5.2 - Identification and traceability
8.5.3 - Property belonging to customers or external providers
8.5.4 - Preservation
8.5.5 - Post-delivery activities
8.5.6 - Control of changes
8.6 - Release of products and services
8.7 - Control of nonconforming process outputs, products and services
Operational planning and control
Requirements in this clause are similar to the requirements as mentioned in clause 7.1 of ISO 9001:2008 QMS standard under the heading 'Planning of product realization', however ISO/DIS 9001 requires more emphasis on control of processes. According to the requirements, the organization needs to plan, implement and control all determined processes that are needed to (i) meet requirements for the provision of products and services, and (ii) implement the determined actions to address identified risks and opportunities. For controlling all determined processes, the organization needs to:
- determine requirements for products and service,
- establish criteria for all processes,
- establish criteria for acceptance of products and services,
- determine the resources needed to operate and control processes so as to achieve conformity to products and service requirements, and
- implement control of processes according to the established criteria.
The organization is also required to retain documented information that provides evidence and confidence that (i) processes have been carried out as per planning, and (ii) products and services are as per requirements.
The output of planning must suit to organization's operations.
The organization is also required to control planned changes, review the results or effects of unintended changes and take necessary action to reduce the gravity of any adverse effects.
The organization is also required to control outsourced processes as per requirements mentioned in clause 8.4 of ISO/DIS 9001.
... to be continued
No comments:
Post a Comment