ISO 17025 Certification

1
ISO 17025 2017 previous revision of ISO
170252012 was updated through collaboration with
the International Electrotechnical Commission
(IEC) and released on November 29, 2017. It is
often used in connection with ISO 15189 Medical
Laboratories Requirements for Quality and
Competence for companies in the medical sector.
https//enhancequality.com/standards/iso-170252017
-quality-management-systems-for-laboratories/
2
ISO 17025 certification Standard is applicable to
all laboratories engaged in Calibration,
Verification, Sampling or Testing and applies to
all small, medium, large, government or
privately-owned Laboratories and other entities
engaged in activities of Testing, and
Calibration. ISO/IEC 17025 has established the
requirements necessary to demonstrate ability to
provide accurate and consistent results of tests
and measurements performed. https//enhancequality
.com/standards/iso-170252017-quality-management-sy
stems-for-laboratories/
3
An experienced / reputable ISO/IEC 17025
consulting company is beneficial in successful
accreditation achievement. Quality System
Enhancement has over 27 years of experience as a
premier consulting company to provide effective
ISO/IEC 17025 training, to meet all requirements
of ISO/IEC 17025 standard through gap analysis,
creation of simplified documentation,
implementation assistance, initial internal audit
of system, corrective action assistance, and
preparation for the ISO 17025 accreditation.
https//enhancequality.com/standards/iso-170252017
-quality-management-systems-for-laboratories/
4
ISO 17025 calibration emphasizes total customer
satisfaction related to laboratory testing
measuring equipment calibration, with accurate
results using competent laboratory technicians.
The ISO/IEC 17025 standard requires laboratory
technicians use appropriate audit checklists to
record test results with for comprehensive
coverage of requirements. It is essential to
conduct internal audits using ISO/IEC 17025 audit
checklists to judge the effectiveness of the
entire ISO/IEC 17025 quality management system in
maintaining and retaining customer satisfaction
related to laboratory testing / measuring
equipment calibration. https//enhancequality.com/
standards/iso-170252017-quality-management-systems
-for-laboratories/
5

• The following are the basic requirements for ISO
  17025 standard for the Competence of Testing and
  Calibration Laboratories
• ISO/IEC 170252017 focuses on safety by
  establishing a Safety Officer with defined
  responsibilities to ensure employees realize
  their responsibility for personal safety and the
  safety of others who can be impacted.
• ISO/IEC 170252017 specifies the general
  requirements for the competence, impartiality and
  consistent operation of laboratories.
• ISO/IEC 170252017 is applicable to all
  organizations performing laboratory activities,
  regardless of the number of personnel.
• Laboratory customers, regulatory authorities,
  organizations, and schemes using peer-assessment,
  accreditation bodies, and others use ISO/IEC
  170252017 in confirming or recognizing the
  competence of laboratories. (Source ANSI)
• Structural Requirements with defined management
  structure roles, responsibilities and range of
  activities
• Resource requirements include personnel,
  facilities, and environmental conditions,
  equipment, metrological traceability, externally
  provided products services.
• Process requirements which include review of
  requests, tendering, controls verification
  validation of methods and sampling.
• Management system requirements include control
  of management system documentation, control of
  records, actions to address risks and
  opportunities, improvement, corrective actions,
  internal audits, and management review. (Source
  ISO/IEC 170252017 standard) https//enhancequalit
  y.com/standards/iso-170252017-quality-management-s
  ystems-for-laboratories/