News:

Standards & Audits | About PDCA | PDCA Services | Glossary | Miscellaneous |

ISO 17025 History:
The standard was first published in 2001 and on May 12, 2005 the alignment work of the ISO committee responsible for it was completed with the issuance of the revised standard.

ISO 17025 was developed so that testing and calibration laboratories were recognized for their capabilities and areas of competence.  All measurements and decisions should be based on accurate, repeatable, verifiable, cost effective, timely, and believable measurements, opinions, and recommendations.  ISO 17025 helps assures this happens first time, every time, and on-time.  Without these assurances, the data, opinion, and recommendations are immediately suspect, questionable, risky, and of greatly reduced value and usability.

Customers should ensure that all data and opinions upon which they rely can be traced back through an unbroken chain of data based on ISO 17025.  In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement.  Regular internal audits are expected to indicate opportunities to make the test or calibration better than it was.  Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant areas.


About ISO 17025:
"Management system" refers to the organization´s structure for managing its processes - or activities - that transform inputs of resources into a product or service which meet the organization´s objectives, such as satisfying the customer´s quality requirements, complying with regulations, or meeting environmental objectives.
- There are two main sections in ISO/IEC 17025: Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory.  Technical requirements address the competence of staff, methodology and test/calibration equipment.
- Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results.  It is also the basis for accreditation from an Accreditation Body.  Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence.


Implementing ISO 17025:
ISO 17025 is applicable to testing and calibration laboratories of all sizes, and is a detailed international specification and standard.  By its very nature it is complex.  However, this need not present undue difficulties.


Internal and External Audits:
Internal audits are managed by the quality manager.  They verify conformance with the ISO/IEC 17025 requirements and with company policies, processes and procedures.  They are also quite useful in preparation for external audits. External auditors can come from clients or from accreditation bodies.  They verify that the laboratory is operating in compliance with ISO/IEC 17025.

There should be procedures that clearly outline who is doing what before, during and after internal and external audits.  Overall owners should be defined and all employees who may be affected by the audit should be trained.  To make best use of internal audits they should be designed, executed and followed up very much in the same way as external audits are expected to be.  The recommendations for preparation, conduct, documentation and follow-up are written for the audited departments, not for the auditors.


Advantages and Benefits of ISO 17025:
Accreditation is an effective marketing tool for testing, calibration and measurement organizations, and a passport to submit tenders to contractors that require independently verified laboratories.  Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence.  Many industries, such as the construction materials industry, routinely specify laboratory accreditation for suppliers of testing services.  Laboratory accreditation benefits laboratories by allowing them to determine whether they are performing their work correctly and to appropriate standards, and provides them with a benchmark for maintaining that competence.

- Having ISO/IEC 17025 accreditation status will get direct access to more contracts for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories
- Having ISO/IEC 17025 accreditation status will improve the reputation and image of the laboratory.  This will also help to get more contracts from organizations that don´t mandate accreditation but give preference to accredited laboratories in competitive situations
- When correctly implemented, the quality system can help to continually improve the quality of data and effectiveness of the laboratory

ISO/IEC 17025 is the basis for most other quality systems related to laboratories, for example, Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

 

  web design and development
Consultancy firm that specializes in helping the Food   Packaging industries

Food Safety Auditor Professional Coaching