Quality management in Analytical Laboratories: ISO Standards applicability

Since a quality assurance programme involves more work, increased costs and additional paperwork, one may be tempted to ask: What are the benefits?Is it worth the cost?

The main benefit of a quality assurance programme in an XRF Laboratory is that it provides assurance to the laboratory itself, as well as those who rely on its services, that it is operating under control and that it is producing data of consistent and proven quality.

On the question of costs you should consider the following situation. Suppose you are doing an XRF analysis that cost $100 to perform and, for whatever reason, you get a wrong result. This means you have just spent $100 to obtain perfectly useless information. Furthermore, costly decisions may be made on the basis of this erroneous information.

Quality assurance ensures that most results are correct and that incorrect results are detected and corrected so that only useful information is produced.

1. How can we design a QMS aimed to ensure the quality of measurements in analytical laboratories? Which recommendations and instructions shall be taking into account as to make such QMS compliant to ISO 9000 standard series requirements?


• We shall follow the ISO 9000:2005 principles, using this standard terms and definitions.
  
  
• Meeting customer requirements is not an easy task in analytical laboratories, but...



2. ISO 9001:2000 provides recommendations that are extremely useful for the organization of the work, if...


• the services are designed to meet customer needs (customer focus)
  
  
• the work is organized as a process
  
  
• resources are efficiently managed
  
  
• procedures and records are maintained
  
  
• the quality of the work is monitored and
  
  
• actions are addressed to ensure continual improvement



3. ISO/IEC 17025:2005 provides recommendations to ensure the quality and traceability of test and calibrations.