Il forum sulla Qualità di QualitiAmo

[Simo]

In rete ho trovato questo elenco delle modifiche principali che verranno apportate alla nuova norma.

Nulla di nuovo rispetto a quanto abbiamo già detto qualche tempo fa ma una rinfrescata non fa mai male, no?


0.2
Process approach
Wording change to emphasise that processes must be capable of achieving desired outputs

1.1
Scope
Wording change to clarify that “product can also mean “intermediate product” and a note to explain that statutory and regulatory requirements may be expressed as legal requirements

4.1
General requirements
Notes will be included to clarify the requirements regarding “outsourcing” and its relationship with “purchasing”

4.2.1
General documentation requirements
Notes will be included to emphasise that “documentation” can also include “records” and that mandatory procedures may be in the form of combined documents, or that requirements may be covered by more than one document

4.2.3
Document control
Note to clarify that only external documents affecting the QMS need to be controlled

5.5.2
Management representative
Clarification that the MR must be a member of the organisation’s OWN management

6.2.1
Human resources
Clarification that competence requirements apply to any personnel whose work affects the QMS

6.3
Infrastructure
Clarifies that this includes Information Systems

6.4
Environment
Clarification of circumstances that are covered by this clause

7.2.1
Customer related processes
Clarification of what may be covered by “post delivery activities”

7.3.1
Design & development planning
Clarification that review, validation and verification all have distinct purposes but may be conducted and recorded either separately or in a combined way if appropriate

7.3.3
Design & development outputs
Clarification that product preservation requirements must be considered

7.5.4
Customer property
Clarification that intellectual property and personal data are covered by the clause

7.6
Control of monitoring & measuring devices
Retitled. Replace “devices” with “equipment”. Explanation of its applicability to software

8.2.1
Customer satisfaction
Note offers examples of how perception data may be captured

8.2.3
Monitoring and measurement of processes
Clarification that identifies that consideration be given to product conformity and QMS effectiveness