Laboratory

Quality of Laboratory

The quality of a product or service is one of the key success factors in marketing. Expertise in building marketing strategies and being accepted by the market is certainly needed so that sales targets are achieved. In addition, product or service quality assurance should not be excluded. Likewise, laboratories both engaged in testing and calibration.

Calibration or Testing Laboratories must be able to provide quality assurance, accuracy, and accuracy of test sample measurement results. With the assurance of the quality of the test or calibration results, it is not impossible to provide a big boost to marketing. Thus, the quality of testing and/or calibration services absolutely must be met.

Laboratories that wish to meet all service or product quality requirements must be supported by a laboratory operational management system. ISO/IEC 17025:2017 provides guidance in developing a management system to improve the Competence of Testing Laboratories and Calibration Laboratories.


ISO/IEC 17025:2017

General requirements for competency fulfillment:

  • Testing Laboratories.
  • Calibration Laboratories.

ISO 17025:2017 is a requirement as well as a guideline in equipping a testing or calibration laboratory with a management system that supports Good Laboratory Practice (GLP). The standard published in 2017 revises and improves the 2008 version of the standard.

This Standard has 8 Clauses which are divided into:

  • Clauses 1 – 4 are general requirements.
  • Clause 5 is a structural requirement.
  • Clause 6 is a resource requirement.
  • Clause 7 is a process requirement.
  • Clause 8 is a management system requirement.

KAN Accreditation

Certification and accreditation of ISO/IEC 17025:2017 “General requirements for the competence of testing and calibration laboratories” in Indonesia one of the authorities is KAN.

KAN is an acronym for the Komite Akreditasi Nasional, which is an institution under and responsible to the President of the Republic of Indonesia with the main task of providing accreditation to the Lembaga Penilai Kesesuaian (PLK).

Among the examples of LPK are the Testing Laboratory and the Calibration Laboratory. To get the recognition given by KAN, LPK must go through a series of accreditation processes. Accreditation from KAN starts from registration, implementation of assessments, completion of corrective actions until the issuance of a certificate of graduation from KAN.

KAN has obtained regional and international recognition for various accreditation schemes. This proves that the certificate/test result issued by the Conformity Assessment Agency accredited by KAN can be accepted by other countries. This recognition was agreed upon through the signing of a Mutual Recognition Arrangement (MRA) and/or Multilateral Recognition Agreement (MLA) at The Asia Pacific Accreditation Cooperation (APAC) and/or International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC).


Accreditation Mechanism

Preparation for Certification and Accreditation

A Lembaga Penilai Kesesuaian (LPK) in the form of a Calibration or Testing Laboratory that wants to apply for the ISO 17025:2017 certification process, first prepares all the certification requirements. Certification preparation includes:

  • Have manuals, work procedures, work instructions, and records.
  • Have personnel who are trained and competent in the field of calibration or testing.
  • Have resources to support the implementation of the management system.

Testing and Calibration Laboratories that already have the preparations mentioned above can then apply for accreditation which is sent to KAN. Furthermore, they will be directed to fill out several accreditation application forms and the requirements for completeness of documents and technicalities. After the application is sent, there will be an answer from KAN. The next mechanism follows the procedures applicable in KAN.

After all stages of the application are fulfilled, an assessment activity will be scheduled by KAN at the laboratory work location. The assessment is aimed at assessing the fulfillment and implementation of the submitted accreditation application. If the results of the assessment state that all accreditation requirements are met, an ISO 17025:2017 accreditation certificate will be issued. The issuance of the certificate proves that all laboratory operations are in accordance with the ISO 17025:2017 management system guidelines.

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