ISO 9001 Clause 8.5.1, "Control of production and service provision," provides detailed requirements for ensuring that an organization's production and service processes are carried out under controlled conditions to meet specified requirements.
Detailed Breakdown of Clause 8.5.1
a) Availability of Documented Information: The organization must have documented information specifying the characteristics of the products, services, or activities to be performed, and the desired results expected. This documentation serves as a reference for what needs to be achieved.
b) Availability and Use of Monitoring and Measuring Resources: The organization needs to ensure the availability and use of suitable monitoring and measuring resources. This could include tools, measuring equipment, or monitoring systems needed to monitor and measure various aspects of the production and service provision processes.
c) Implementation of Monitoring and Measurement Activities: Monitoring and measurement activities must be implemented at appropriate stages to verify that criteria for controlling processes or outputs and acceptance criteria for products and services have been met. This ensures that the outputs are in line with the desired specifications.
d) Use of Suitable Infrastructure and Environment: There should be suitable infrastructure and environment for the operation of processes. This involves providing the necessary physical and environmental conditions for effective production and service provision.
e) Appointment of Competent Persons: Competent persons, including those with required qualifications, should be appointed. This ensures that individuals involved in the processes have the necessary skills and knowledge to perform their roles effectively.
f) Validation and Revalidation: Validation, and periodic revalidation, of the ability to achieve planned results is required for processes where the resulting output cannot be verified by subsequent monitoring or measurement. This is particularly important when the effectiveness of the process cannot be easily determined through regular monitoring.
g) Prevention of Human Error: Actions should be implemented to prevent human error. This could involve training, procedures, or other measures to minimize the likelihood of errors during production and service provision.
h) Implementation of Release, Delivery, and Post-Delivery Activities: The organization must have processes in place for the release of products, delivery of services, and any post-delivery activities. This ensures that products and services meet requirements not only during production but also during delivery and any subsequent activities.
Example of Clause 8.5.1 in a Manufacturing Company Producing Electronic Devices.
a) Availability of Documented Information: The company maintains detailed documentation specifying the characteristics of each electronic device, including specifications for components, assembly processes, and quality criteria.
b) Availability and Use of Monitoring and Measuring Resources: The company ensures that all necessary tools and equipment for monitoring and measuring are available on the production line. This includes calibrated instruments for measuring components and testing the functionality of devices.
c) Implementation of Monitoring and Measurement Activities: During production, quality control checkpoints are established to measure key characteristics of the electronic devices at various stages. This ensures that the manufacturing process is on track and that each device meets the required specifications.
d) Use of Suitable Infrastructure and Environment: The production area is designed to provide a controlled environment, including temperature and humidity control, to ensure optimal conditions for assembling electronic components.
e) Appointment of Competent Persons: Trained and qualified personnel, including technicians and assembly line workers, are appointed to perform specific tasks in the production process. Training programs ensure that employees have the necessary skills.
f) Validation and Revalidation: For new product lines or significant process changes, the company conducts validation processes to ensure that the production methods achieve the planned results. Periodic revalidation may occur to ensure ongoing effectiveness.
g) Prevention of Human Error: Standard operating procedures and training programs are in place to minimize the potential for human errors during assembly. Automated checks and controls are implemented where possible.
h) Implementation of Release, Delivery, and Post-Delivery Activities: The company has established procedures for the release of finished products, including final quality checks. Delivery processes are in place to ensure products reach customers in good condition. Post-delivery, the company may have mechanisms for customer feedback and product improvement.
This example illustrates how a manufacturing company aligns its processes with the requirements of ISO 9001 Clause 8.5.1 to ensure the effective control of production and service provision.
ISO 9001:2015 Clause 8.5.1 Control of Production and Service Provision
In summary, this clause emphasizes the need for thorough planning, documentation, resource availability, and validation to ensure that production and service provision are carried out effectively and consistently to meet specified criteria and customer requirements.