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Audit Non-conforming work

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Guest user Created:   Jan 21, 2020 Last commented:   Jan 22, 2020

Audit Non-conforming work

Asking about ISo17025:2017 clause 8.2.2 how to implement in a laboratory?
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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Jan 22, 2020

I understand from your reference to an audit nonconformance that your laboratory may not have adequately addressed competence, impartiality and consistent operations in the Quality Policy and Objectives; and you are asking how to correct this? 

ISO 17025:2017 clause 8.2.2 requires that the policies and objectives of a laboratory are established to support the scope and purpose of the ISO 17025 standard and the quality management system of a laboratory. The role of the Quality Policy is to bind the management system together in a singular vision of what quality means to the laboratory. It essentially sets the stage for establishing objectives and the design of all laboratory processes to ensure competence, consistent operation and safeguard impartiality. 

When looking at the gaps in the Quality Policy and Objectives, start by reviewing the laboratory’s context, i.e. the circumstances – sector, accreditation, legal entity; scope of work; and identify all interested/involved parties. For example, a parent company or board of directors may have a strategic direction and an ethics policy which the laboratory needs to be in line with. The accreditation body that audited your lab is also an “interested party”; as are regulators in your sector. These parties may have specific requirements to be met. Once you have relooked at these core issues, revise the quality policy and quality objectives to address the gaps. For example, include a statement that “Management is committed to performing activities to ensure impartiality through continual identification of risks to its impartiality and taking appropriate action to mitigate them”.  

Commitment to competence and consistent operation is a thread that must run through all laboratory processes. State and provide evidence of commitment and investment in quality control, personnel training and evaluation; equipment maintenance and calibration. State how the laboratory plans to support these policies and achieve objectives.  Ensure effective planning, doing and checking (monitoring). Lastly, record and act on observed improvement or deviations to drive consistent operation. 

The ISO 17025 Toolkit provides useful guidance and templates to assist with effective implementation. Have a look at:

The following articles could also be helpful:

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