EN 13485 - point 4.1.6 vs 7.5.6

[lennsy]

Hello,

I have some troubles in interpretation of two points from EN ISO 13485, as below:

There is point 4.1.6 which says: The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.
And the second one: point 7.5.6, where the following part is included: the organization shall document procedures for the validation of the application of computer software used in production and service provision.

What's actually the difference/corerelation between them? Is point 7.5.6 contained in 4.1.6? Can we cover them by one procedure or separate ones are required?

Thank you in advance.

 

[shimonv]

Section 4.1.6 takes about software used in the quality management system, like software for managing document control, change control, etc.
Section 4.1.6 takes about software used in production and service provision, like software for used in final test procedures.
There is also section 7.6 that talks about software used in monitoring and measurements of requirements, like software for managing equipment calibration and maintenance activities.

Essentially, we are talking about different types of software related to QA activities.
One procedure for computer software validation should suffice to manage the validation of these software tools.

-Shimon

 

[DannyK]

Section 4.1.6 takes about software used in the quality management system, like software for managing document control, change control, etc.
Section 4.1.6 takes about software used in production and service provision, like software for used in final test procedures.
There is also section 7.6 that talks about software used in monitoring and measurements of requirements, like software for managing equipment calibration and maintenance activities.

Essentially, we are talking about different types of software related to QA activities.
One procedure for computer software validation should suffice to manage the validation of these software tools.

-Shimon

Shimon,

I think you mean that section 7.5.6 is for software used in validation of production and service provision.

 

[shimonv]

Thanks @DannyK