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Quality Manger and Head of Department

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Guest user Created:   Feb 27, 2020 Last commented:   Feb 27, 2020

Quality Manger and Head of Department

How we can implement/ show to the assessors the improvement clause in ISO 17025; 2017 effectively?

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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.

Expert
Tracey Evans Feb 27, 2020

To answer your question, let’s look at what ISO 17025 requires and the intent behind the requirement. A laboratory needs to actively identify and act on opportunities for improvement in order to increase the effectiveness of the management system, its activities, service to customers and the consistent validity of results. The drive for improvement should be integrated with existing management system activities such as trend analysis of primary quality indicators to support policies, internal and external quality control; as well as the review of processes, customer satisfaction, internal audit results, documents and records, corrective actions and risk assessments.

To address the need for improvement effectively, a laboratory should

  1. Establish measurable quality objectives (targets)  which are aligned to the strategic direction and policies of the laboratory or organisation. Examples are a) to achieve a 90% percentage customer satisfaction based on the annual survey (minimum 60% response required) and b) to achieve a turnaround time (time from sample submission to reporting) of not more than 3 days, 90% of the time.
  2. Monitor activities that support the strategic direction, policies and quality objectives of the laboratory. Examples are Proficiency testing performance over time; changes in customer satisfaction.
  3. Create a mechanism to identify opportunities for improvement, for example by applying the PDCA (Plan-Do-Check-Act) Cycle for each activity 
  4. Use an Registry of Key Risks and Opportunities to: 
     a) list proposed opportunities for improvement
     b) perform and record a risk-to-benefit measurement (matrix) to determine the best or most suitable opportunities
         to act on
     c) choose appropriate actions to be taken, and review the progress.

The following articles will provide more guidance:

The relevant ISO 17025 document templates and their related documents are available stand-alone, or part of the toolkit :

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Feb 27, 2020

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