ISO/IEC 17025:2017 Clauses 7.1.2 and 7.1.3

 

ISO/IEC 17025:2017 establishes guidelines for laboratory competence and reliability. Clauses 7.1.2 and 7.1.3 focus on communication between the laboratory and its customers regarding testing methods and decision rules. Proper implementation of these clauses ensures transparency, accuracy, and customer confidence in the laboratory's results.

 

Clause 7.1.2: Informing Customers About Inappropriate or Outdated Methods

If a customer requests a method that is outdated, inappropriate, or does not meet regulatory standards, the laboratory must inform them and suggest a suitable alternative.

Why is This Important?

• Ensures results are scientifically valid and meet current industry standards.
• Prevents misleading results that could impact food safety or compliance.
• Helps customers make informed decisions about testing methodologies.

A food manufacturer requests a moisture content analysis in flour using an old gravimetric method that is slow and less accurate. However, the lab knows that Karl Fischer titration is a more precise and efficient method.

Laboratory Action:

• The lab informs the customer that the requested gravimetric method is outdated.
• The lab explains the advantages of Karl Fischer titration, such as better accuracy and faster results.
• The customer agrees to use the improved method, ensuring compliance with updated standards.

 

Clause 7.1.3: Statement of Conformity to a Specification or Standard

If a customer requests a statement of conformity (e.g., pass/fail, within tolerance/out of tolerance), the lab must clearly define:

1. The specification or standard used.
2. The decision rule applied (i.e., how results are interpreted in relation to the standard).
3. If the decision rule is not inherent in the specification, the lab must communicate it to the customer and obtain agreement.

Why is This Important?

• Ensures clarity in reporting results.
• Prevents misinterpretation of test findings.
• Helps customers understand whether the sample meets regulatory or safety standards.

A beverage company sends a soft drink sample for pH testing and requests a pass/fail result based on an FSSAI standard (pH range: 3.0–4.0).

Laboratory Action:

• The lab confirms the FSSAI standard (3.0–4.0) as the reference.
• The lab explains the decision rule, such as rounding criteria or measurement uncertainty.
• The customer agrees, and the final report states: "pH = 3.8 (Pass, within standard)."

 

Requirement for Compliance

1. Maintain a Database of Valid Methods:

·       Regularly update testing methods based on ISO, AOAC, or regulatory changes.

·       Train staff to identify outdated or inappropriate methods.

2. Communicate Clearly with Customers:

·       Explain why an alternative method is better.

·       Provide references or regulatory guidelines for suggested methods.

3. Define and Document Decision Rules:

·       Clearly specify the criteria used for pass/fail decisions.

·       Ensure agreement with the customer before finalizing results.

4. Maintain Records of Customer Communication:

·       Document discussions regarding method selection and decision rules.

·       Keep records of customer approvals for transparency and audit purposes.