• There are now three notes. In Note 1, there has been an addition of “analysis and improvement,” and the word “should” has been deleted, making it mandatory for all of these types of processes to be included. Noted 2 and 3 are new.
Note 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.
Note 2: An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
Note 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as
a) The potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements,
b) The degree to which the control for the process is …show more content…
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.
7.5.3 Identification and Traceability
• This clause has been expanded to clarify that the product must be identified by suitable means “throughout product realization.” This applies to received product and in-process product, as well as final product.
The organization shall identify product status with respect to monitoring and measurement requirements throughout product realization.
• The small change of moving the record keeping requirement to the end of the following sentence has changed the intent from recording the product identification to maintaining all records associated with product traceability.
Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).
7.5.4 Customer Property
• The wording has been changed for clarification and the note has been expanded to include personal