How-to: Process Requirements of Clause 7 in ISO 17025

Process Requirements of Clause 7 in ISO 17025

Tackling each of the Process Requirements of Clause 7 in ISO 17025 to claim your Accreditation without a hitch!

The international standard, ISO 17025 outlines the fundamental criteria for laboratory testing and calibration proficiency. The requirements for the laboratory’s procedures, such as sample handling, sampling, and testing, are covered in Clause 7 of this standard.

Process requirements of Clause 7 in ISO 17025 generally include corporate processes, expectations, goals, and specifications. They may be gathered from a variety of stakeholders, including business divisions, customers, internal customers, users, and subject matter experts.

Clause 7.1 | Review of Requests, Tenders, and Contracts

Your laboratory is required by ISO 17025 to have a process in place for reviewing requests, tenders, and contracts. This process must guarantee that:

  • The requirements are defined, documented, and understood;
  • The laboratory has the required internal resources to meet customer and regulatory requirements;
  • If external providers are used, the laboratory must meet the needs of Clause 6.6;
  • The methods or procedures selected must be proper and can meet the customers’ requirements.

In cases where the method requested by the customer is unsuitable, the laboratory shall inform the customer that the method needs to be revised or updated. Furthermore, the laboratory must clearly define the decision rule whenever a customer requests a statement of conformity to a specification or standard. If outside the standard, it should be communicated and agreed upon in writing by the customer.

Any deviations between the request or tender and the contract shall be communicated to the customer and resolved before the commencement of the activities. When the customer requests a variation to the agreement, these should not affect the integrity of the organization or the results. All changes, communication, and reviews must be retained, including significant changes to the contract and/or results.

Clause 7.2 | Selection, Verification, and Validation of Methods

Clause 7 also states that the laboratory must have a procedure for handling nonconforming test findings. This procedure must contain a method for finding, analyzing, and documenting nonconformities as well as steps to rectify and prevent them.

To further read about Clause 7.2 of the ISO 17025 standard, please click here.

Clause 7.3 | Sampling

ISO 17025 requires all laboratories and organizations to have a sampling plan backed with proper statistical methods to ensure a good representative sample for testing and calibration. To ensure the validity of subsequent testing, the laboratory must assess the sampling procedures, address the factors that need to be controlled, and confirm that the sampling plan and method are available at the location where sampling is being done. It is essential to sample only by utilizing proper statistical techniques.

The sampling methods should include:

  • Factors to be controlled, such as temperature or time to ensure the validity of testing;
  • Selection of samples or sites;
  • Sampling plan and any specific requirements for collection;
  • Preparation and treatment if samples, e.g. preservation requirements or samples container.

When the laboratory is sampling, appropriate records of samples must be kept at all times. These records must include:

  • Reference to the sampling procedure
  • Date and time of sampling
  • Information to find and describe the sample (e.g. sample point)
  • Name of personnel doing the sampling
  • Reference to any equipment used (e.g. thermometer, chlorine comparator, on-site test kits)
  • Environmental or transport conditions (temperature and time)
  • Site plan to find sampling point if applicable
  • Comments for deviations

Clause 7.4 | Handling of Test or Calibration Items

The laboratory shall document a procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return of the sample.

The laboratory also needs to have a procedure to identify and trace test and calibration items throughout the laboratory process, including during storage and transportation. Suppose the laboratory is unable to perform the test or calibration as requested. In that case, they must notify the client and take appropriate action to ensure that the test or calibration item is returned in a suitable condition. This is needed to ensure that the integrity of the test or calibration item is maintained and that the test or calibration results are accurate and reliable.

The crucial aspect is the storage of samples. Although traceability plays a key role, one must attest that the samples, under storage, are not being degraded from the original form, thus affecting the analysis needed. If any sample is to deviate from specified conditions, records shall be kept, and the customer informed.

Clause 7.5 | Technical Records

Clause 7.5 of ISO 17025 states the requirements for all technical records.

In order to facilitate, if at all feasible, the identification of components affecting the results and its associated measurement uncertainty, it is the laboratory’s duty to make sure that technical records for every one of the lab’s activities include results, a report, and information. The organization must also make it possible for laboratory activities to be repeated under circumstances that are as similar to the original as possible.

The date and the names of the people in charge of lab activities must be listed in your records. Records should be kept in their original form, contain the original observations, data, and calculations, and be kept contemporaneously. If adjustments are made, it is necessary to compare them to earlier iterations or the initial observations.

Clause 7.6 | Evaluation of Measurement Uncertainty

Measurement uncertainty exists in every measurement, and as an ISO 17025 accredited laboratory, it is your job to understand where this comes from and what its repercussions are. Measurement uncertainty needs to be taken into consideration during the validation of processes. When dealing with uncertainty, all significant contributions must be considered, e.g., sampling, sample measurement, and equipment uncertainty.

Any calibration being done in-house on any equipment must have its measurement uncertainty evaluated. Standard methods may include measurement uncertainty, and organizations may not need to re-calculate the uncertainty, provided that the organization can prove that the identified critical influencing factors are under control, e.g., the temperature during a reaction or pressure during balance calibration.


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Clause 7.7 | Ensuring the Validity of Results

Organizations must have a well-established quality control system to find trends. These shall include:

    • Use of reference materials or in-house prepare quality control materials;
    • Use of reference instrumentation, which may have been calibrated externally;
    • Operational checks of measuring and testing equipment, e.g. using weights to ensure reading is within error or autoclave tape to check the operation of the autoclave;
    • Working standards with control charts (Shewhart type);
    • Performance checks on measuring equipment e.g., monthly Geobacillus strips to ensure that the autoclave is functioning well.
    • Replicate tests using the same or different methods;
    • Retesting of stored items;
    • Correlation of results for different criteria of an item;
    • Review of results, preferably by a different competent person;
    • Interlaboratory or ability testing;
    • Testing of blind samples, which may include unknown replicates.

All of the above must be separate from comparative analysis with other organizations through ability testing, which falls under the umbrella of ISO 17043 or interlaboratory comparisons with other ISO 17025 organizations or in-house.

The laboratory should be able to find deviations or improvements to the organization’s activities. Moreover, records must be kept and retained.

Clause 7.8 | Reporting of Results

If your lab wants to achieve ISO 17025 accreditation, reporting results is crucial and must be done properly in accordance with the requirements of the standard. To learn more click here.

Clause 7.9 | Complaints

If your laboratory wants to be ISO 17025 accredited, managing customer complaints must become a priority. The organization must have a process of receiving, evaluating, and deciding on complaints.

This process shall be made available on request, and on receipt of a complaint, the organization must confirm if this is related to its own activities and, if so, deal with it accordingly.

The process shall have at least the following elements:

    • Description of process for receiving, confirming, investigating, and deciding what actions are to be taken;
    • Tracking and recording of complaints, including mitigation measures;
    • Ensuring any proper action is taken.

Upon receiving a complaint, the organization will need to investigate to confirm it. Moreover, the organization must identify whether or not the complaint relates to an activity within the laboratory or due to other non-conforming work and/or miscommunication.

The complaint must always be tracked when possible, and a response must be given to the complainant by an individual not involved in the original activity in question.

Once the review has been finalized, the organization shall inform the completion of the review to the complainant.

Clause 7.10 | Non-conforming Work

Clause 7.10 states that an organization must stick to a procedure whenever laboratory activities and/or results do not conform to the routine processes or to whatever has been agreed with the client.

The laboratory must keep a record of such non-conforming work, including all investigation details, including the root cause analysis, risk analysis, and any corrective measures needed, especially when such non-conforming work might recur.

The procedure shall include:

    • Levels of responsibility and authority for the management of non-conforming work are defined;
    • Actions based on the risk levels set up by the organization – This may include any activity ranging from a repeat of analysis, withholding reporting, and halting research.
    • Impact analysis on the significance of the non-conforming work – usually defined as root cause analysis;
    • Decision rules on the criteria of acceptance for the non-conforming work;
    • Notification of customer to recall work, if considered necessary;
    • The responsibility of authorization for the resumption of work.

Clause 7.11 | Control of Data and Information Management

To be able to accomplish their tasks, laboratories need to have control over their data and information. Labs must confirm that they have access to the data and information required to carry out all of their tasks. The lab must make sure that the functionality of the information management system used for data collecting, processing, recording, reporting, storing, and/or retrieval has been verified. 

This includes the appropriate operation of interfaces inside the laboratory information management system. This is used within the organization’s quality management system for collecting, processing, recording, reporting, storage, or retrieving data that need to be confirmed for its functionality, including the proper interfaces within the management system before introduction.

Commercial off-the-shelf software in widespread use, with no different configuration or customizable features, can be sufficiently confirmed but would still need verification within the quality procedures of the organization.

Any such configurations or customizations need to be documented, authorized and validated before use.

Laboratory Information Management System shall:

    1. Be protected from unauthorized access;
    2. Have proper security levels, with user passwords in place to protect from tampering and loss;
    3. Be used in an environment that follows the organization’s specifications, including backups. In cases of non-computerized systems, checks must be in place to ensure the accuracy of manual recording and transcription;
    4. Through maintenance, the LIMS will ensure consistent integrity of the data;
    5. Include recording system failures and the proper corrective actions.

Any calculations and/or data transfers, shall be checked in a proper and systematic manner.


Following these steps, a process-driven organization can be more adaptable than a hierarchical organization. People’s interrelationships increase because procedures are transversal and touch different organizational units. Each procedure is given to an individual or individuals who oversee it.

EAGER TO LEARN MORE ABOUT Process Requirements of Clause 7 in ISO 17025?

As an ISO management system consultant Luke Desira always works his magic to get your company 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 by reading about how to validate a laboratory with ISO 17025 Laboratory Management System and understand the ISO 17025 Laboratory Sampling Requirements that will help an organization meet the criteria set by the process requirements of Clause 7 in 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. When ready, just call Luke Desira – he’ll be more than happy to lend a helping hand.

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