ISO 29001:2020 8.5.1: Validate special processes with defined equipment, competence, methods, criteria and revalidation, and document production controls

What does 8.5.1 require?

The methods used to validate and periodically revalidate processes whose output cannot be checked by later monitoring or measurement consider the equipment required, the competence of personnel, the specific methods used with their identified operating parameters, the identification of acceptance criteria, and revalidation. The organisation maintains documented information defining the controls used to meet the production and service provision requirements of 8.5.1 and retains documented information demonstrating their effectiveness.