ISO 13485 Cl. 5.4.2 - Is Documented Quality Planning required?

#1
5.4.2(a) requires that top management carry out the planning of the quality management system to meet 4.1 requirements and quality objectives. My question is whether this quality planning will need to be documented somewhere. Is quality planning an item just discussed at management review meetings? Alternatively, is it a formally documented plan?

Thank you. :thanx:
 
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John Broomfield

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#2
5.4.2(a) requires that top management carry out the planning of the quality management system to meet 4.1 requirements and quality objectives. My question is whether this quality planning will need to be documented somewhere. Is quality planning an item just discussed at management review meetings? Alternatively, is it a formally documented plan?

Thank you. :thanx:
snoopy,

You may have mixed your quality management system planning (see A below) with your quality planning (see B below).

A. Quality management system planning determines the plan for developing the organizational management system to fulfill the organization's mission (purpose).

As a result of quality management system planning and risk assessment the senior management team agrees on the timeframe, determines the processes and resources required, delegates authorities and assigns responsibilities and may decide which parts of the management system are documented.

B. Quality planning determines the plan to use that management system to fulfill the requirements of the organization's services and products.

The quality plan may already be documented as a result of the organization taking the order thereby invoking the management system of processes (resources, work and controls) and may not need more documentation to manage risk and assure quality (deliver confidence that requirements will be fulfilled).

Opportunities (new markets, new products, new projects) may outstrip the capability of the management system in which case more quality planning is required to determine the need for new processes and changes to established processes, resources and logistics, authorities, responsibilities and scheduling.

For these quality plans to be communicated they are documented to the extent necessary for the quality plan to be effective.

Also:

New opportunities may change the mission of the organization and quality planning may become quality management system planning.

In other words, top management review of the size of the opportunity and the performance of the organization or its management system may decide to bring quality plans into the management system to simplify further exploitation of "new"opportunities and this would be another example of quality management system planning.

John
 
#3
You could argue you don't need to document the plan because 5.4.2 doesn't specifically say to "document" as it does in some other sections (Note: I'm referring to ISO 13485:2016).

You could instead show evidence of how you comply to 5.4.2a. and 5.4.2.b.

However, I would document the plan for two reasons.

1 - First reason is because 5.4.2. states "Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives ..."

It doesn't state "Top management shall ensure that a) the requirements given in 4.1, as well as the quality objectives are being met..."

Therefore, its implied that you need to have evidence the planning is being carried out to meet the requirements and not just that the requirements have been met. Also, note the sentence is present tense implying it's ongoing planning.

2 - It's easier for the Management Rep or other person to support how 5.4.2 is being met when you can show the plan and then the evidence.
 
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