This is the main clause of ISO 9001 Quality management system which relates to the actual production process of a product or service.
Control of Production and Service
The standard requires the organization to undertake production and service under controlled conditions including delivery and post-delivery activities. These controlled conditions shall include:
- Documented information should be made available that define the characteristics of products and services.
- Documented information should be made available that define the activities that are to be performed and results that are to be achieved.
- Undertake monitoring and measuring activities for process and product and ensure acceptance criteria have been met.
- Suitable infrastructure and process environment is used.
- Ensure that suitable monitoring and measuring equipment are available and used.
- Competent and qualified personnel.
- Validation and re-validation of processes where the output that is resulting cannot be verified by subsequent measurement and monitoring.
- Implementation of actions to prevent any human error.
- Implementation of release, delivery and post-delivery activities for products and services.
Identification and Traceability
The organization shall use suitable means to identify process outputs, where necessary so as to ensure conformity of products and services.
It shall identify the current status of process outputs regarding monitoring and measurement requirements throughout the production process.
It shall control the unique identification of process outputs where traceability is required. Keep documented information or records required to maintain traceability.
Process outputs means the results of any activities which are ready for delivery to internal or external customer. They can include products, services, components or intermediate parts.
External Provider Property
External provider property can be equipment, tool, material or drawing etc. The organization shall take care of the external provider property while it is in its care so that there is no damage or deterioration.
The organization shall identify, verify, safeguard and protect external provider property given for incorporation or use in the products or services.
When the external provider property is lost, damaged or found unsuitable for use it shall be reported to the external provider and documented information is retained on what has happened.
The organization shall ensure the preservation of process outputs during the production and service provision up to that extent required to maintain conformity of products and services.
Preservation includes identification, handling, packaging, storage, transmission or transportation and protection.
The organization shall meet the requirements for post-delivery activities required for products and services. The organization shall consider the extent of post-delivery activities required for
- Risks or potential undesired consequences associated with the products or services.
- The nature, the use and the intended lifetime of products and services.
- Customer requirements.
- The customer feedback.
- The legal requirements.
Post-delivery activities can include the following
Actions to be taken under warranty.The contractual obligations e.g. maintenance.The supplementary services e.g. recycling or the final disposal.
Control of Changes
The organization shall review and control changes that are unplanned that are essential for production and service to the level required to ensure conformity with the specified requirements.
The organization shall retain information that describes
- The result of review of changes.
- The person who is authorizing the changes.
- Any necessary action resulting from review.
Organisation are looking to achieve ISO 9001 Certification for several reasons eg: getting pre qualified for tenders, Customer request, etc,. To develop and Implement systems quickly and have systems that add value to your organisation you may need the services of specialist ISO 9001 Consultants who can guide you through the requirements of the ISO 9001 Quality management system in relation to production and service provision.