How-To: Clause 8 Management System Options in ISO 17025

Clause 8 Management System Options in ISO 17025

The Continuation of the ISO 17025 How-To Series… How-To: Clause 8 Management System Options in ISO 17025 – Why are we given such options?

For Clause 8 of ISO 17025, the organization has to choose from either Option A or Option B. But what are these options, and why are there even options in the first place? This article will help you better understand what each option consists of and what ae the expectations that have to be met by the organizations

To start with, we have to look at what Clause 8 primarily focuses on. Clause 8 of ISO 17025 mandates that the laboratory must develop, document, put into place, and keep up a management system that can support and show adherence to the requirements. Laboratories shall establish a management system in line with Option A or B in addition to the requirements of Clauses 4–7.

Let us dive into the detail of Options A and B regarding the maintenance of the management system.

Clause 8 Management System Options in ISO 17025 | Option A

As a minimum, the organization must address the following:

  • Management system documentation as per Clause 8.2
  • Control of management system documents as per Clause 8.3
  • Control of records as per Clause 8.4
  • Actions to address risks and opportunities as per Clause 8.5
  • Improvement as per Clause 8.6
  • Corrective actions as per Clause 8.7
  • Internal audits as per Clause 8.8
  • Management reviews as per Clause 8.9

Clause 8.2 | Management System Documentation

The organization must set up, document, and maintain policies and objectives to be implemented throughout the entire organization.

The procedure shall address the competence and impartiality of all personnel while checking consistent operations of all activities.

Supply enough evidence of commitment to the development and implementation of the system while continually improving its effectiveness. This can include audits, feedback and improvement actions, training records etc.

Overview of documents to ensure traceability of all documentation, processes, systems, and records related to the requirements of ISO 17025 while ensuring that all personnel have access to such documentation.

Clause 8.3 | Control of Management System Documents

Overview of internal and external documents for easier control. Such control includes:

  • All documents must be authorized by competent personnel to ensure adequacy to QMS;
  • Documents need to be kept, reviewed, and updated as necessary;
  • Changes within documents are highlighted;
  • Relevant version distributions are controlled and made available to end users;
  • Documents are uniquely found, and relevant issues are marked and dated;
  • Destruction of obsolete documents is well documented, and suitable identification is applied if retention is needed.

Clause 8.4 | Control of Records

All policies shall decide the retention period of different procedures or policies. Legible records are to be kept for audit and investigative purposes.

Controls for the identification, storage, protection, backup, archival, retrieval, retention and disposal of records are to be implemented. Access control must be documented and consistent with the confidentiality requirements.

Clause 8.5 | Actions to Address Risks and Opportunities

Additionally, Option A of Clause 8 management system options in ISO 17025 must also take into account all risks and opportunities. Such risks and opportunities must be addressed by taking the necessary actions, such as the following:

  • Assert that QMS achieves its intended results and planning mitigation measures;
  • Enhance the purpose and aims;
  • Reduce nonconformities and potential failures by ensuring proper risk analysis;
  • Achieve improvement actions.

The organization shall then address such risks and opportunities to ensure that action is proportional to the potential impact while evaluating the effectiveness of these actions. Although no recommendations or further notes are mentioned in the ISO 17025 document, one should consider ISO 31000 case the main basis of risk assessments and analysis.


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Clause 8.6 | Improvement

A document must be in place to find and select opportunities for improvement and record the implementation of necessary action. These opportunities could be found in the several processes included in the QMS. Such processes include, but are not limited to, feedback (positive or negative), complaints, audit results, corrective measures, management reviews, risk analysis, ability results etc.

Clause 8.7 | Corrective Actions

Corrective actions shall allow the organization to check and record nonconformities. When a non-conformity is found, the procedure should allow a proper action to control and correct it while also addressing the consequences, such as informing the customers or withdrawing reports, if necessary.

The non-conformity shall be evaluated to eliminate or at least mitigate the cause, to reduce or preferably cut the recurrence. This is normally set up by studying the root cause analysis of the non-conformity, i.e., reviewing and deciding the cause and then deciding if similar nonconformities exist.

Implement actions and periodically review the effectiveness of such actions. This will generally lead organizations to make the necessary changes to documents, competences and training methods to be in line.

It is vital to keep in mind that all changes are to be kept, with the necessary evidence for traceability and review purposes.

Clause 8.8 | Internal Audits

Internal audits are to be planned at intervals by an audit planner to supply information on the conformity of the activities within the organization and that they are effectively implemented.

Audit planners shall set up the frequency of such audits and the method used (vertical, horizontal or method seeing) and will record any non-conformities which may be raised.

Such audits should have well-established criteria and scopes to ensure that the results are reported to management and proper measures are implemented for corrective or improvement actions without delay.

Clause 8.9 | Management Reviews

Management of organizations must review the QMS at planned intervals to ensure continual improvement and improve the efficiency and adequacy of current policies.

Management reviews shall include the following:

  • Changes within the internal (or external) structures that may be relevant to the ongoing activities;
  • Fulfilment of aims and key performance indicators;
  • Adequacy and efficiency of current policies or procedures, and if any changes are needed;
  • Status of earlier minutes;
  • Outcome of internal audits;
  • Corrective actions raised between reviews of relevance;
  • Assessments by external bodies;
  • Review of workloads or change in scope of activities;
  • Customer and personnel feedback;
  • Complaints received, its investigation and implementation measures;
  • Effectiveness of improvements measures;
  • Current resources;
  • Risk matrix analysis;
  • Ability testing results and other quality control measures;
  • Training and other monitoring activities;

Outputs of such meetings shall be recorded, and all decisions written as minutes and passed for approval. These should at least include the following:

  • Effectiveness of QMS and all its processes;
  • Improvement actions of the activities related to ISO 17025;
  • Required resources to ensure effectiveness;
  • Need of changes for continual improvement.

Clause 8 Management System Options in ISO 17025 | Option B

In accordance with Option B, your laboratory is compliant if

  • The laboratory has created and maintained a management system in line with ISO 9001:2015’s criteria.
  • You have the ability to support and demonstrate that ISO 17025:2017’s clauses 4–7 are consistently met.
  • You have complied with the demands for management system documentation and management review (clauses 8.2 and 8.9 of ISO17025:2017).

In essence, if your laboratory has ISO 9001:2015 certification, you can select Option B. This gives you more freedom as you apply 17025:2017.


ISO management system standards (MSS) assist organizations in improving resource utilization and financial performance, risk management and protection of people and the environment, increasing the capability to deliver consistent and improved services and products, and thus increasing value to customers and all other stakeholders. One should evaluate carefully both options before reaching a conclusion. When it comes to Clause 8 management system options in ISO 17025, organizations must be aware of what awaits them when they choose one option or the other, the decision must not be rushed.

EAGER TO LEARN MORE ABOUT Clause 8 Management System Options in ISO 17025?

As an ISO management system consultant Luke Desira is all about making your company the best version of itself by getting 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 Youtube channel! One can further enhance their knowledge on Clause 8 management system options in ISO 17025 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 requirements of Clause 8 management system options in ISO 17025.

All management systems based on ISO Standards that are implemented should be directly in line with 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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