Section 4: General Requirements – Impartiality and Confidentiality

Impartiality – Implies that the labs will not allow outside influence on the quality of test results. Examples of outside influences can be commercial, financial, governmental or any other agency having a gainful advantage to influencing test results in nature. This also accounts for any internal issues, personal influences, relationships or conflicts in general that would need to be addressed and resolved. 

Confidentiality – the requirement here is that all information, including test results remain private. 

Section 5: Structural Requirements – Organizational components of a laboratory

This section deals with a lab’s commitment to a professional functioning management system and its range of activities as an accredited laboratory. In order for a laboratory to receive accreditation, it can only be a standalone legal entity or a part of an existing legal entity, who would be responsible for the activities centered around the lab’s testing and calibration. Section 5 defines management’s responsibilities in the laboratory, and the responsibilities of management to regulatory authorities, organizations, and customers. Additionally, this section sets a basic overview requirement for personnel and what authority they would have and insight to the resources they require to perform their duties. 

Section 6: Resource Requirements – the laboratory must have 6 clauses available

This section will address the six clauses mandated for a lab pertaining to personnel, equipment, support services, facilities, and systems required to carry out it’s lab activities. 

Section 7: Process Requirements – 11 core processes to improve efficiency

A critical section, this one begins with: Review of Requests, Contracts and Tenders.  

One of the most technical and important parts of Section 7 deals with Selection, Verification and Validation Methods. This section covers handling of test items, sampling and technical record keeping. The validity of results is vital here as is the control and quality monitoring in place at the laboratory. The requirements (and explanations) for testing proficiency is here along with several tools listed available for monitoring. 

There is a great deal of detail in this standard related to results reporting. Requirements for dealing with non-conforming work and complaints are also listed here. This section was updated to reflect technologies impact on privacy in the Control of Data and Information Management sub-section. 

Section 8: Management Systems Requirements – option A or B, eight activities, and internal audit

Option A – If a laboratory’s QMS (Quality Management System) runs independent of any other management system, it must comply with all Section 8 requirements of the ISO/IEC 17025 standard. 

Option B – If the laboratory is part of a larger legal entity, or if it’s management system currently used is within compliance of ISO 9001:2015, then the Section 8 requirements would be met by the ISO 9001:2015 standard provided the labs activities are included and they can demonstrate fulfillment of this standard in compliance with ISO/IEC 17025 clauses 4 to 7. 

Eight Activities – Included in this section are policies and their objectives, QMS documentation, addressing risks and opportunities, control of documentation, improvement, and corrective action. 

Internal Audit – This gives general requirements for the internal audit and management review. Since it is only general input, compliance with ISO 19011 would be best used here to fill in the details (Guidelines for auditing management systems).