How-To: Process Requirements of Clause 7.2 in ISO 17025

Process Requirements of Clause 7.2 in ISO 17025

What are the Process Requirements of Clause 7.2 in ISO 17025? Are the selection, verification and validation of methods in a lab environment significant?

In the main blog of How-To: Process Requirements of Clause 7 in ISO 17025, it is said that a laboratory must have a procedure in place to review requests, tenders, and contracts. The procedure must cover various aspects, such as that the requirements are defined, documented, and understood, that the laboratory has the necessary internal resources to meet customer and regulatory requirements and that the customer’s approval is sought prior to performing activities by an external provider. Moreover, the methods or procedures chosen must be appropriate and capable of meeting the customer’s requirements.

This blog will dive into the Process Requirements of Clause 7.2 in ISO 17025 – Selection, Verification, and Validation of Methods. Here, one will understand the responsibilities that laboratories carry when it comes to selecting and verifying methods work. It is important to note that such a clause is divided in two sub-clauses. Firstly, the standard goes over the selection and verification of methods. Secondly, the methods are validated. Now, let’s dive into the process requirements of Clause 7.2 in ISO 17025.

Clause 7.2.1 | Selection and Verification of Methods

The laboratory must always make use of proper methods and procedures for all laboratory activities, including evaluation of measurement uncertainty and statistical techniques for data analysis. All practices and policies, including supporting documentation, external documents, and instructions or manuals, must be periodically reviewed and made readily available to all personnel.

The laboratory must make it a point to keep in line with all updated methods. A client may not specify a particular method; when this occurs, it is up to the laboratory to select the appropriate procedure. The laboratory must, however, choose a method that is considered best for the client’s situation and is updated to the latest version. In-house methods can be used; however, it is typically recommended to use standards, scientific texts, or journals. The laboratory must communicate its decision to the client upon selecting the method.

All methods are to be verified to ensure that they are fit for purpose. The laboratory must establish that the chosen method has been published internationally, regionally, nationally, or by another reputable technical organization. Additionally, the verification of these methods must also be done within the lab itself to ensure that the laboratory has sufficient means to carry out the method.

Moreover, the process requirements of Clause 7.2 in ISO 17025 dictate that the laboratory must retain all records of such verification and shall be periodically reviewed. If method development is required to be done from scratch, this activity must be assigned to competent personnel with adequate resources. Periodic reviews must take place for all method developments, and any modifications done to the method must be approved and authorized.


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Clause 7.2.2 | Validation of Methods

Process requirements of Clause 7.2 in ISO 17025 also state that laboratories are to perform fitness of purpose (validation) of any methods they use. This covers unconventional techniques as well as conventional and laboratory-developed techniques. The methods must undergo comprehensive validation to satisfy the given application’s requirements. If modifications are made to a method that has been verified, it is essential to comprehend their impact by performing a validation test once again. A homogeneity test (F-test) is generally sufficient to evaluate the extent of such differences.

Prior to validation, performance criteria must be set up. These may be requested by the client, legislation, certification, or standard methods. Examples of such characteristics include:

  • Precision
  •  Bias
  •  Measurement range
  •  Accuracy
  •  Expanded uncertainty
  •  Limit of detection
  •  Limit of quantification
  •  Matrix interferences
  •  Linearity
  •  Spike recovery or percentage recovery

The following validation records are to be kept by the lab:

  • Validation procedure used
  •  Specification of the requirements – The process of writing down the user and system requirements into a document
  •  Performance characteristics of the selected method
  •  Results obtained
  •  A statement of validity/ fit for purpose statement.

Other things that laboratories should include in the process requirements of Clause 7.2 in ISO 17025 are the following:

  • Calibration (when possible) or evaluation of a statistical measure of bias and precision;
  • Identification of sources of error and mitigation of these, or inclusion within uncertainty;
  • Method validation to include proper dispensing volumes and acceptable ranges;
  • Comparison of results with reference material (in-house or bought, but traceable to ISO 17034), including calculation of standard deviations, variances, and limit of detection;
  • Interlaboratory comparison by an ability test; Evaluation of expanded uncertainty budgets


Process requirements of Clause 7.2 in ISO 17025 are then followed by a number of other sub-clauses, namely, Clause 7.3 | Sampling. Whether your organization is starting out or you are a seasoned laboratory, ensure that you are accredited. The benefits are countless, and your organization is more likely to land big jobs. This is only the tip of the iceberg for learning the process requirements of Clause 7.2 in ISO 17025.

EAGER TO LEARN MORE ABOUT The Process Requirements of Clause 7.2 in ISO 17025?

As an ISO management system consultant Luke Desira will go out of his way to ensure that your company gets certified or accredited for the respective ISO standard! Learn more on the laboratory management system that can be achieved through ISO 17025 accreditation through Luke Desira’s videos!

One can further expand their knowledge about the process requirements of Clause 7.2 in ISO 17025by reading about how to validate a laboratory with ISO 17025 Laboratory Management System and understand the 6 Powerful Laboratory Resource Requirements for ISO 17025 – Clause 6 of the ISO 17025 Standard. Such material will surely further your understanding about the process requirements of Clause 7.2 in ISO 17025  and meet the criteria set by other process requirements in Clause 7 of ISO 17025.

All management systems based on ISO Standards that are implemented should pertain directly to the organization’s objectives When it comes to ISO 17025– Laboratories Management System, the same mindset have to be applied. Have a look at the ISO Certification specialised by Industry to understand which ISO certifications and accreditations your laboratory can benefit from.

Luke offers a variety of ISO certification services that puts him as the leading ISO Certification consultant in Malta. He can efficiently help you achieve ISO accreditation. What are you waiting for?! Just call Luke Desira – he’ll be more than happy to lend a helping hand.

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