Understanding Clause 7.2 of ISO 17025: Method Selection, Verification, and Validation

Understanding Clause 7.2 of ISO 17025: Method Selection, Verification, and Validation

Clause 7.2 of ISO 17025 focuses on ensuring that laboratories use appropriate, accurate, and reliable methods for all activities. This clause is critical for maintaining the integrity of test and calibration results, and it’s divided into two main components: Selection and Verification of Methods (7.2.1) and Validation of Methods (7.2.2).

7.2.1 Selection and Verification of Methods

1️⃣ Selection of Methods

Laboratories must use methods and procedures appropriate for the task, including evaluating measurement uncertainty and applying statistical techniques when needed.

Selected methods may include standard methods, laboratory-developed methods, or modified standard methods.

The lab must ensure the latest valid version of the method is used unless otherwise justified.

2️⃣ Verification of Methods

Verification ensures that the lab can perform a selected standard method properly under its specific conditions.

It confirms that the lab can achieve the expected performance before introducing the method.

Verification records must be retained, and if the method is revised by the issuing body, verification must be repeated as needed.

7.2.2 Validation of Methods

1️⃣ Scope of Validation

Validation applies to non-standard methods, laboratory-developed methods, or modified methods used outside their intended scope.

The validation process must demonstrate that the method is fit for its intended purpose.

2️⃣ Key Validation Techniques

Calibration with reference standards or materials

Assessing bias and precision

Testing robustness by varying controlled parameters

Comparing results with other validated methods

Interlaboratory comparisons

Evaluating measurement uncertainty

3️⃣ Re-Validation

If changes are made to a validated method, their impact must be assessed, and re-validation conducted if necessary.

4️⃣ Performance Characteristics

Validated methods must meet customer needs and include characteristics such as accuracy, detection limits, linearity, and robustness.

5️⃣ Validation Records

– The lab must maintain records of:

– Validation procedures

– Performance characteristics

– Results obtained

– A statement confirming the method’s validity

Key Difference: Verification vs. Validation

Verification: Confirms the lab’s ability to perform a standard method correctly under its conditions. It ensures the lab can achieve the expected performance without modifying the method.

Validation: Demonstrates that a non-standard or modified method is fit for its intended purpose. It involves a more in-depth evaluation to confirm the method’s reliability.

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