ISO/ IEC 17025:2005

Laboratory Management System

ISO / IEC 17025:2005

Introduction

SO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.

To obtain ISO 17025 Accreditation, your laboratory must document a quality management system (QMS). The growth in the use of management systems generally has increased the need to ensure that laboratories can operate to a QMS that is compliant with ISO 9001 as well as demonstrate technical competency. When ISO 17025 was developed, it was written to incorporate all the ISO 9001 requirements that are relevant to the scope of testing and calibration services as well as specifying the technical requirements for technical competence.

Key Benefits of the Standard

  • The definition of accreditation according to the ISO 17025 standard is the third party attestation, related to a conformity assessment body, which is a formal recognition of their competence to perform specific activities of conformity assessment,
  • Endorse the cooperation and partnership between laboratories and other institutions  with  the  aim  of  exchanging  information  promoting the harmonization  and  standardization  of  procedures  and  standards,
  • Laboratory accreditation strengthens  the  organization performance  through  a  better  control  of  laboratory  procedures  and  thereby  increases their potential due to the increase customer satisfaction,
  • Accreditation is also  an effective  marketing  tool for  calibration or  for testing, because it is a passport for companies and organizations that requires reliable  and  independent  laboratories,
  • Reduce the number of audits and evaluations by customers, since it is periodically audited by an accreditation body,
  • An important accreditation benefit is that any test or calibration certificate issued by an accredited laboratory that is a signatory of the Mutual Recognition Agreement (MRA), is accepted in any country signatory of the Agreement

Our Role:

RAI will support your organization by:

  • Conducting Gap Analysis,
  • Conducting Awareness Training of the system,
  • Defining the scope of accreditation,
  • Developing and assist implementing a quality manual,
  • Developing and assist implementing a quality policy,
  • Developing and assist implementing laboratory procedures,
  • Developing and assist implementing quality procedures,
  • Developing technically competent employees,
  • Producing records demonstrating conformance with ISO 17025’s requirements,
  • Check (Internal Audit),
  • Assisting with corrective and preventive actions,
  • Assisting with the accreditation process itself.
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