How can a laboratory get an ISO certificate?
A Laboratory is an organization/facility that provides the following services:
- Testing
- Calibration Services
- Scientific/Technological research
- Experiments
- Inspections related to Testing (or in conjunction with testing)
Laboratories may do
the following certifications:
- ISO 9001:2015 Certification
- ISO 14001:2015 Certification
- ISO 45001:2018 Certification
- ISO 27001:2013 Certification
- ISO 17025:2017 Certification
- ISO 17020:2012 Certification
- Etc.
Process to get
accredited for ISO standards as above:
- Conduct a gap Analysis
- Training for Employees
- Documentation: developing a QMS manual, Procedures, Methods, etc
- Keeping records
- Implementing requirements and compliances
- Doing an Internal Audit
- Doing the External Accreditation Audit
- Maintaining the Certificate, through annual/regular surveillance audits
Implementation of ISO standards and certification provides a system for continuous improvement of daily laboratory practices. Direct benefits include faster identification and resolution of issues, risks, and opportunities, improved customer satisfaction, a meeting of quality requirements of specialized customers, and an overall increase in laboratory business.
Laboratories can also
do the following accreditations:
1) ISO 17025:2017 Certification - General requirements for the competence of testing and calibration laboratories. This ISO 17025 standard applies to all organizations performing laboratory activities, regardless of the number of personnel in the organization and size of the laboratory.
There are basically 2 major requirements- Management requirements and Technical requirements.
Management Requirements are similar to ISO 9001 QMS requirements.
Technical requirements are very critical, as it demonstrates the technical competence of the lab ex.
- Competence & Qualification of Personnel
- Environmental Conditions and validations
- Methods of Testing / Calibration
- Validation of Tests / Calibrations- through Proficiency Testing or Inter-Lab comparison and Z-factor calculation.
- Measurement Traceability
- Calculation of Measurement of Uncertainty
- Writing the correct Test Report
- Review and Approvals
ISO/IEC 17025 accreditation Certification enables laboratories to manifest that they operate competently and generate valid results accepted internationally, thereby promoting confidence among the employees and personnel working both nationally and around the world. It also helps to facilitate cooperation and build trust between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted legally and globally without further testing.
Implementing ISO/IEC 17025 Certification as part of laboratory quality management system provides benefits for both, laboratory and business, such as:
Having access to more contracts and wider markets for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories for certain time limit. Accreditation will also help in getting more contracts in competitive situations to achieve markets.
Improved national and global reputation and image of the laboratory by continual improvements in data quality to end-user and effectiveness of the laboratory.
Having a good foundation for most other quality systems related to laboratories, such as Good Manufacturing Practices and Good Laboratory Practices helps in gaining various benefits globally.
The benefits of these technologies and management quality improvements are seen regularly in the laboratory. Faster identification of errors and resolution of issues/errors regarding methods, personnel, or equipment that improve customer satisfaction, meeting quality requirements of specialized customers, and overall increased laboratory business are all the result of implementing an effective quality system.
A QMS in a testing laboratory is a way of showing that you value to achieve that the quality of the final test results can be relied upon and is legally valid. The presence of quality assurance, through the use of appropriate procedures and management methods, guarantees that the errors are least, providing true results to clients that error-free.
1) Increase in public confidence.
2) Assurance that quality data is being used to establish baselines for key analyses and decisions.
3) Reduced uncertainties that affect the protection of human health and the environment.
4) Improved efficiency of the assessment process.
Process to get accredited
for ISO 17025 Certification:
- Conduct a gap Analysis
- Training for Employees
- Documentation: developing a QMS manual, Procedures, Methods, etc
- Keeping records
- Implementing requirements and compliances
- Participating in Proficiency Testing / Inter-Lab Comparison and calculation of Z-factor
- Calculating Measurement of Uncertainty
- Doing an Internal Audit
- Doing the External Accreditation Audit
- Maintaining the Certificate, through annual/regular surveillance audits
2) ISO 15189:2012 - Medical
laboratories — Requirements for quality and competence
ISO 15189 is a standard specification can be used by medical laboratories in developing their quality management systems QMS and assessing their own competence. It can also be used for confirming or identifying the ability of medical laboratories by laboratory satisfied customers, regulating authorities by the law, and accreditation bodies.
The requirements are more-or-less the same as of ISO 17025:2017- management & technical requirements.
Process to get
accredited for ISO 15189:
- Conduct a gap Analysis
- Training for Employees
- Documentation: developing a QMS manual, Procedures, Methods, etc
- Keeping records
- Implementing requirements and compliances
- Participating in Proficiency Testing / Inter-Lab Comparison and calculation of Z-factor
- Calculating Measurement of Uncertainty
- Doing an Internal Audit
- Doing the External Accreditation Audit
- Maintaining the Certificate, through annual/regular surveillance audits
3) ISO 17020:2012 - Conformity
assessment — Requirements for the operation of various types of bodies
performing the inspection
ISO 17020:2012standard specifies requirements for the inspection and for the impartiality and consistency of their inspection. It applies to any stage of inspection by competence of bodies for conducting inspection bodies of type A, B, or C, as defined in ISO/IEC 17020:2012, and it applies.
Process to get
accredited for ISO 17020
- Conduct a gap Analysis
- Training for Employees
- Documentation: developing a QMS manual, Procedures, Methods, etc
- Keeping records
- Implementing requirements and compliances
- Doing an Internal Audit
- Doing the External Accreditation Audit
- Maintaining the Certificate, through annual/regular surveillance audits
Accreditation towards ISO 17025, ISO 15189, or ISO 17020 is generally done through a National Accreditation Board.
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