Is ISO/IEC 17025 Mandatory for Laboratories?

Is ISO 17025 Mandatory for Laboratories
Laboratory Accreditation

Is ISO/IEC 17025 Mandatory for Laboratories?

ISO 17025 Mandatory

ISO/IEC 17025 is the main ISO standard used by testing and calibration laboratories. Although ISO 17025 accreditation is not mandatory, accreditation has rewards and advantages. The industry deems compliance with ISO 17025 requirements as proof of competence.

Laboratories utilize ISO 17025 to implement a quality system. In effect, they can improve their capacity to constantly produce valid results. Consequently, this serves as a basis for accreditation.

ISO accreditation is voluntary. Yet, laboratories that take the initiative to undergo accreditation know that compliance is not enough.

Putting things into perspective, all accredited laboratories are ISO 17025 compliant. However, not all ISO 17025 compliant laboratories are accredited.

If your laboratory wants formal recognition of testing competence, take your compliance to the next level and obtain ISO 17025 accreditation.

What is ISO 17025?

           ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories is mainly used as a basis for the effective operation of laboratories.

Likewise, it is an internationally recognized standard that determines the competence of testing and calibration laboratories.

According to the International Organization for Standardization (ISO), the ISO/IEC 17025:2017 applies to all organizations conducting laboratory activities, regardless of the company size.

Additionally, industries such as the construction and materials industry, require laboratory accreditation for suppliers of testing and calibration services.

The standard does not impose on how to conduct tests. However, it mandates the implementation of a quality system to guarantee technical competence. Consequently, employees can produce valid results in an accurate, timely, and verifiable manner.

In short, the standard identifies the general requirements for impartiality, competence, and consistent laboratory operations.

Moreover, it was developed to drive confidence in laboratory operations.

As a result, laboratories can prove they perform competently and impartially. Subsequently, they can guarantee their ability to produce valid results.

Accreditation vs Compliance: Is Compliance to ISO/IEC 17025 Mandatory?

Since ISO 17025 is deemed an internationally accepted benchmark for laboratory operations, compliance is highly regarded.

In some cases, compliance will not suffice. Local and international customers, stakeholders, retailers, suppliers, and authorities now use accreditation to ISO 17025 as a form of credibility.

Why? Because there is no definite way to confirm whether a laboratory is ISO 17025 compliant unless a laboratory has undertaken the accreditation process.

The following principles do not necessarily mean that a laboratory’s procedures and processes conform to ISO 17025.

Hence, accreditation is voluntary since laboratories aren’t required to hold ISO/IEC 17025 accreditation to execute calibration testing.

However, formal recognition is a globally accepted proof of conformance to the standard’s requirements.

So, laboratories who claim full compliance with the standard’s requirements, but have no accreditation, won’t get the full benefits.

Note that only an audit can verify a laboratory’s process conformance. Hence, compliance does not equate to accreditation.

In other words, you could be complying, but without proof of compliance, your results may not be deemed credible.

More than that, check whether your country does not accept the internal test report if your laboratory is not certified. Yet, some nations do not require ISO accreditation. This part is more of a choice for laboratories.

ISO/IEC 17025 Accreditation as a Recognition of Global Competence

Laboratories must pass audits to secure ISO 17025 accreditation. Passing the audits equates to proof of an effective Quality Management System (QMS).

Note that laboratories can choose whether to pursue accreditation for all or parts of their testing and calibration services.

Laboratories who want to secure accreditation must complete these processes:

  • Application
  • Document Review
  • Process Audit
  • Accreditation Assessment
  • Accreditation Result
  • Surveillance and Continual Assessment

The good thing about undergoing accreditation is that an independent body can check the following internal processes and controls:

·     Staff’s technical competence

·     Effectiveness and conformance of test methods

·     Suitability of testing environment and sampling

·     Verification of test and calibration data quality

·     Maintenance of test equipment

·     Traceability of measurements and calibration methods to recognized standards

What is Mandatory in ISO 17025?

              In general, documents about procedures are mandatory. Laboratories must prepare these documents for the standard’s implementation.

The documents cover 18 procedures and clauses, as well as the scope, purpose, responsibilities, exhibits, formats, and reference documents.

Other required documents are working processes, contract review, documents and data control, purchasing, internal audit, and complaint hiding.

ISO 17025 has clauses that identify what documents must be prepared. Here are the necessary clauses:

  • Document and Record Control Procedure (Clauses 8.2.1, 8.3 & 8.4)
  • Quality Policy (Clauses 8.2.1 & 8.2.2)
  • Competence, Training and Awareness Procedure (Clause 6.2.5)
  • Addressing Risks and Opportunities Procedure (Clauses 8.5.2 & 8.5.3)
  • Externally Provided Products and Services Procedure (Clause 6.6.2)
  • Facilities and Environment Procedure (Clause 6.3)
  • Equipment and Calibration Procedure (Clauses 6.4.3 & 6.5)
  • Customer Service Procedure (Clauses 7.1.1 & 8.6)
  • Test and Calibration Method Procedure (Clauses 7.2.1 & 7.2.2)
  • Quality Assurance Procedure (Clauses 7.7.1 – 7.7.3)
  • Sampling Procedure (Clauses 7.3, 7.5 & 7.8.5, applicable only to laboratories that do sampling)
  • Handling of Laboratory Test or Calibration Items Procedure (Clause 7.4)
  • The complaint, Nonconformity and Corrective Action Procedure (Clauses 7.9 – 7.10 & 8.7)
  • Testing Report Procedure (Clauses 7.8.2 & 7.8.3, applicable to testing laboratories that write test reports)
  • Calibration Report and Certificate Requirements Procedure (Clauses 7.8.2 and 7.8.4, applicable to calibration laboratories that write calibration certificates)
  • Internal Audit Procedure (Clause 8.8.2)
  • Management Review Procedure (Clause 8.9)

List of ISO 17025 procedures:

  • Document and Data Control
  • Contract Review
  • Control of Records
  • Internal Quality Audit
  • Complaint Handling
  • Corrective and Preventive Action
  • Control of Non-Conforming Work
  • Management Review
  • Personnel and Training
  • Accommodation and Environment
  • Working Procedure
  • Purchasing
  • Measurement Uncertainty
  • Equipment and Reference Materials
  • Measurement Traceability and Calibration
  • Handling of Test Items
  • Quality Control and Verification
  • Preparation, Review, and Issue of Test Certificates and Reports Features

Mandatory or Not, ISO 17025 is Beneficial

The number of procedures to follow may look overwhelming, but QSE Academy has toolkits that will make this process simple.

We have prepared editable templates, forms, and lists to help your laboratory develop complete records and documentation.

Our consultants can also assist your management with training and other preparations.

For now, QSE Academy suggests reading other materials produced on our website. You could also check out our packages for instructions and tips.

Do not settle with trying to follow the general requirements of ISO 17025, secure ISO 17025 accreditation for your laboratory.

Let us help your laboratory commit to achieving ISO 17025 accreditation to give your clients confidence in your service.

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Comment (1)

  1. RMC

    Would you help us setup a company with compliance with ISO 17025 in the middle east

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