July 19, 2021

ISO 13485 QMS Planning vs. Quality Plans

I think it’s important to remember that the general quality management system planning and set-up called for by ISO 13485 clause 5.4.2(a) is fundamentally distinct from clause 7.1’s product/project/object/output-oriented planning.  If they were the same, then ISO TC/210 would not have separated and distinguished clauses 5.4.2(a) and 7.1.

Clause 5.4.2(a) general quality management system planning is aimed at the more fundamental quality management system setup, implementation, and maintenance of clause 4.1.  By contrast, ISO TC/210 has traditionally maintained and currently maintains that a clause 7.1 “quality plan” is instead a product/project/object/output-oriented plan generated to support product realization.  Indeed, the scope and intent of ISO 10005 correlates with clause 7.1 quality plans (i.e., product realization plan, i.e., Widget XYZ realization plan, etc.) rather than clause 5.4.2(a) general quality management system planning.

While an ISO 13485 clause 7.1 / ISO 10005 quality plan may indeed address the need for particular quality management system features specific to the object/output of the quality plan, it is nonetheless important that a clause 7.1 quality plan not be confused or equated with clause 5.4.2(a) general quality system planning.

Another way to explain it is that the organization might have multiple clause 7.1 / ISO 10005 quality plans addressing the product realization requirements for various tangible Widgets, projects, or other product realization outputs, whereas clause 5.4.2(a) quality management system planning is a singular (yet ongoing) planning process.

I simply handle ISO 13485:2016 clause 5.4.2(a) by stating in the Quality Manual that:

1. The organization has determined the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization. [Remember that those roles need to first be specified in an appropriate section of the Quality Manual.]

2. This also includes planning the sequence and interaction of the QMS processes via the Quality Manual and the documented procedures included or referenced therein.

3. Moreover, the organization applies a risk-based approach to the control of the appropriate processes needed for the quality management system as described in the corresponding subsection of the Quality Manual (e.g., see ‘Risk-based approach’ under ‘Scope’).

4. The ultimate output of this planning is the Quality Manual and the procedures included or referenced therein.