How-to: Process Requirements of Clause 7.8 in ISO 17025

process requirements of Clause 7.8 in ISO 17025

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

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Clause 7.8.6 Reporting Statements of Conformity

Moving on to the next sub-clause of the process requirements of Clause 7.8 in ISO 17025, the organization shall be dealing with the statements of conformity. Whenever the organization is needed to declare compliance with a standard or legislation, it shall document the decision rule employed, including the level of risk (uncertainty of measurement range and statistical assumptions).

The organization shall then report on its statement, including the identification:

  1. To which results the statement is referring to
  2. To which specifications or standard, the results are met;
  3. The decision rule applied.

Clause 7.8.7 Reporting Opinions and Interpretations

Opinions and interpretations differ from statements of inspection and product certification, and as such, these must be distinguished.

These may be subjective; thus, when expressed, the organization must ensure that they are done by authorized personnel and based on results obtained, and clearly identified as such.

A record must be kept when such opinions and interpretations are directly communicated by word of mouth with the customer.

Clause 7.8.8 Amendments to Reports

This sub-clause of the process requirements of Clause 7.8 in ISO 17025 state that if a published report needs to be revised, updated, or republished, the changes must be made apparent. The statement “Amendment to Report, serial number (or other identifying method)” must be included in the amendments, whether they are issued as a new document, data transfer, or both. Labs must make sure that revisions adhere to the rules. One must also  make reference to the previous report that it replaces if an entirely new report needs to be issued.

Conclusion

Overall, this blog gives us an insight into the process requirements of Clause 7.8 in ISO 17025. In the following sub-clauses, organizations will undergo a process to set up procedures for receiving, evaluating, and deciding on complaints, as well as methods for recording and acting on any aspect of the organization’s activities or results that deviate from its own procedures or the agreed-upon customer requirements, and finally, how to control data and information management.

EAGER TO LEARN MORE ABOUT The Process Requirements of Clause 7.8 in ISO 17025?

As an ISO management system consultant Luke Desira does his best 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! One can further expand their knowledge about the process requirements of Clause 7.8 in ISO 17025 by reading about the process to validate a laboratory with ISO 17025 Laboratory Management System and understand the means to enhance the lab environment through Software Validation in ISO 17025 that will help an organization meet the criteria set by the process requirements of Clause 7.8 in ISO 17025, and other subsequent clauses.

All management systems based on ISO Standards that are implemented should be in line with the organization’s objectives. When it comes to ISO 17025– Laboratories Management System, the same applies. Have a look at the ISO Certification specialised by Industry to understand which ISO standards 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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