Clause 8 Operation
8.5.1 Control of product and service provision
Clause Criteria
The organization shall implement production and service provision under controlled conditions.
Controlled conditions shall include, as applicable:
a) the availability of documented information that defines:
1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed;
2) the results to be achieved;
b) the availability and use of suitable monitoring and measuring resources;
c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;
d) the use of suitable infrastructure and environment for the operation of processes;
e) the appointment of competent persons, including any required qualification;
f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
g) the implementation of actions to prevent human error;
h) the implementation of release, delivery and post-delivery activities.
Explanation
This clause of ISO 9001 is specific to controlling the working environment, ensuring that product and service provision is done so under "controlled conditions".
Some questions for any organization:
How does the organization control the conditions required for effective operations?
Are there any unique characteristics relevant to the nature of the work being carried out?
Are monitoring and measurement resources deployed to good effect?
Is monitoring and measurement important?
How are risk treatments monitored and controlled throughout operations?
Including controls for the prevention of human error.
How does the organization control release and post-delivery activities, where applicable?
What documented information is required?
Do persons carrying out the related activities require a particular competency?
Once again, the criteria at this clause provides a very good framework for considering the level of detail needed to provide adequate information to effectively control operations.
It is expected that documented information is available where necessary, at the point of use.
Chief Explainer:
Phil Byrne