ISO 14969 - Conflict in ISO 13485 - Measureable Objectives

M

mcervantes

#1
Does anyone have a copy of ISO 14969 to share? I am conflicted with a requirement from ISO 13485, section 5.4.1 'Quality Objectives'.
 
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Sidney Vianna

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#2
Re: Iso 14969

Please note that it is against our policies to promote intellectual property piracy. The ISO Standards are protected by copyright and CAN NOT be shared freely.

Ask a specific question about the conflict you are trying to resolve and, most likely, experts will assist you.
 
M

mcervantes

#3
Re: ISO 14969 - Conflict in ISO 13485.

Sorry about that...we have quality objectives in our QM but an auditor challenged them and gave us a finding stating they were not measureable. The auditor wanted specific targets for our objectives. I have never put specific targets in the quality objectives; we have added specific targets when we do our Quality Plan with specifics to each area.
 

Sidney Vianna

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#4
Re: ISO 14969 - Conflict in ISO 13485.

Sorry about that...we have quality objectives in our QM but an auditor challenged them and gave us a finding stating they were not measureable. The auditor wanted specific targets for our objectives. I have never put specific targets in the quality objectives; we have added specific targets when we do our Quality Plan with specifics to each area.
ISO 13485 does NOT require TARGETS, associated with quality objectives. For example, you can set as a quality objective "the improvement of on-time delivery, during FY 2012". That objective is clearly measurable, if you have data to show your OTD performance, over time. There is NO REQUIREMENT that says that you must have a target for your OTD performance or any other quality objective.

The ISO 176 paper on auditing quality objectives stipulate:
Auditing quality objectives
Auditors need to verify that the organization’s overall quality objectives have been defined, that they reflect the quality policy, are substantially coherent, aligned and compatible with the overall business objectives, including customer expectations. If this is not the case, the auditors should further evaluate Top Management commitment to quality.The fulfilment of quality objectives needs to be measurable and documented.
There is no specified way of identifying or documenting quality objectives, as these may appear through business plans, management review outputs, annual budgets, etc. It is up to the auditors to satisfy themselves that the objectives are adequately documented.
The auditors should obtain evidence of the way the quality objectives are suitably cascaded throughout the organization’s structure and processes, linking the general strategic objectives to management objectives and down to specific operational activities.
It is recommended that the documented quality objectives should be examined at the documentation review stage of the audit.
Before the end of the audit, the auditors have to satisfy themselves that the quality objectives are realistic and relevant, and that the organization has assigned to responsible personnel the resources needed to meet their objectives. Evidence of this should be obtained at all levels of the organization.
Quality objectives are not static and need to be updated in the light of the current business climate and the quest for continual improvement. Auditors should verify that the overall performance of the organization reflects the aims of the quality policy and reasonably meets the quality objectives.
Auditors should keep in mind that the fulfilment of objectives can be measured in a quantitative or qualitative manner. They should also remember that there is a clear link between the dynamic aspects of revising the quality policy and the quality objectives and the commitment of the organization to continual improvement.
 

Marcelo

Inactive Registered Visitor
#5
Re: ISO 14969 - Conflict in ISO 13485.

This misinterpretation is problably happening because of the phrase "In setting quality objectives and any associated targets, timeframes for achieving the targets are usually established" in ISO 14969.

The "any" in the phrase means if there's any, not that there's requirement implies that there must be any.

This is a typycal problem with auditors, using ISO 14969 directly as if it's interpretations (it's a guidance document) are requirements. If your auditing is doing this, I suggest pointing out that ISO 14969 is guidance, or change auditors.
 
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