Establishing the Process Requirements of Clause 7.8 in ISO 17025 – A continuation of the How-To blog series for ISO 17025.

In the main blog of How-To: Process Requirements of Clause 7 in ISO 17025, it is discussed how a laboratory must have a procedure in place to review requests, tenders, and contracts. The procedure must cover a number of elements, including that the requirements are specified, recorded, and understood; that the laboratory has the internal resources required to meet customer and regulatory requirements; and that the customer’s consent is obtained before an external provider performs any activities. Additionally, the methods or procedures picked must be suitable and able to satisfy the client’s expectations.

The How-to series also covers Clause 7.2 | Selection, Verification, and Validation of Methods. The blog covers all details regarding the responsibilities that laboratories carry when it comes to selecting and verifying methods work.

This blog will delve into the details of the process requirements of Clause 7.8 in ISO 17025. Clause 7.8 mainly talks about the reporting of results; however, it does so through several sub-clauses. Let us jump into the process requirements of Clause 7.8 in ISO 17025!

Clause 7.8.1 | General

If your laboratory wants to be ISO 17025 accredited, reporting results is critical and must be done correctly according to the standard. Before being made public, the results need to be approved and reviewed. According to the process requirements of Clause 7.8 in ISO 17025, the results must be reported in a clear, succinct, and accurate manner and must include all information mandated by the methods used as well as any information the lab and the customer determined to be necessary for the results’ interpretation.

Clause 7.8.2 | Common Requirements for Reports

Subclause 7.2 identifies the elements that must be included in the results. Whenever reporting, it is essential to mark down every single detail possible. The following are the elements that must be in the report, as per the process requirements of Clause 7.8 in ISO 17025:

1. Title of report
2.  Name and address of the organization
3.  Location of performance of the activities, including if done at customer, on-site, mobile facilities, etc.
4.  Lab number or unique identification
5.  Name and contact information of the customer
6.  Identification of the method used
7.  Description and condition of the item
8.  Date of receipt, date of sampling
9.  Date of performance of the activity
10.  Date of issue of the report
11.  Reference to sample procedure
12. A statement that the results are only applicable to the items evaluated or calibrated
13.  Results with units
14.  Deviations or exclusions from any method
15.  Identification of the person authorizing the report
16.  Identification when results have been subcontracted

Organizations may also include a statement specifying that the report shall not be reproduced, to ensure that results are not interpreted out of context. The report must also show what information the customer provides or is not under accreditation. This is significant when the provided information may affect the validity of the results.

Clause 7.8.3 | Specific Requirements for Test Reports (For Analysis Organizations)

This sub-clause adds additional requirements to Clause 7.8.2. In particular scenarios, apart from the elements provided in section 7.8.2, test reports may also include the following, as per the process requirements of Clause 7.8 in ISO 17025:

1. Environmental conditions during testing and sampling holding relevant for the testing
2. Statement of conformity with requirements or specifications
3. Measurement uncertainty presented in the same unit of the measurand, or if not possible in a term, compared to the measurements e.g., percentage
4. Opinions and interpretations which would need to be done by authorized personnel

Special conditions for sampling, when conducted by the same organization, must be considered. This will be highlighted in sub-clause 7.8.5.

Clause 7.8.4 Specific Requirements for Calibration Certificates (For Calibration Organizations)

This subclause adds additional requirements to Clause 7.8.2. In particular scenarios, apart from the elements provided in section 7.8.2, test reports may also include the following, as per the process requirements of Clause 7.8 in ISO 17025:

1. Measurement uncertainty presented in the same unit of the measurand, or if not possible in a term, compared to the measurements e.g., percentage
2. Environmental conditions during calibration, influencing the calibration
3. Statement finding how the measurements are metrologically traceable. This may refer to NIST material (refer to Annex A of ISO 17025)
4.  Results before and after any adjustment
5. Statement of conformity with requirements or specifications;
6. Opinions and interpretations which would need to be done by authorized personnel

Clause 7.8.5 Reporting Sampling – Specific Requirements

This subclause adds additional requirements to Clause 7.8.2. In cases where sampling is conducted by the organization, the reports must include the following, if necessary, for the interpretation of results, as per the process requirements of Clause 7.8 in ISO 17025:

1. Date of sampling
2. Unique code of the item or material sampled, where relevant
3. Location of sampling, including site plan, sketches, or photographs
4. Reference to sampling plan and method
5. Information about the environmental conditions during sampling that affects the results
6. Any information which would be required to evaluate the uncertainty of measurement