Issued first in 1999 by the International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC), the ISO 17025 2005 standard is the single most crucial standard certification for calibration and testing laboratories around the globe.
The newest and revised version of this standard which is ISO 17025: 2017 was launched in 12-10-2017 and many businesses are still unaware of the newest additions to this global standard which may result in discontinuation of their previously acquired ISO 17025 standard.
Here we will completely describe all the management requirements of ISO 17025:2005 for your acknowledgment. As this will not be a brief presentation of ISO 17025:2005 management requirements, we will describe the whole scenario in a few parts for your reading convenience. So, let’s start with our list.
Management Requirements for ISO 17025:2005
The primary clause of ISO 17025:2005 is divided into fifteen chapters here, which are described below thoroughly.
The roles and responsibilities of the laboratory, key personnel associated with it, and the complete management are defined in this section.
The key points of this section will be as followed:
- An organizational structure, as well as the tasks and responsibilities of staff and management, should be defined.
- An appointment of a quality assurance manager will be needed.
- The organizational structure should be such that departments having conflicting interests do not adversely influence the laboratory’s work quality.
- All personnel associated with the laboratory should be free from financial and commercial pressure that could impact the quality of test and calibration results.
The proper implementation of a management system, its maintenance, and continual improvement will be defined here.
- The implementation of policies, work instructions, and standard procedures is needed to ensure the quality of results.
- The management system’s effectiveness should be continually improved.
- Implementation of quality manual with policy statements issued and communicated by top-level management should be in place.
The unique identification, creation, approval, issue, and changes needed to the management system documents are described here.
- Controlled and authorized documentation.
- Regular review and updating of documents if needed. The frequency of reviews depends on documents.
- Any changes to documents should be followed with the same review process as for the development of initial documents.
Review of Request, Tenders, and Contracts
The following chapter will describe how to ensure the requirements of requests, tenders, and contracts are properly defined, reviewed, documented and understood.
The key points will indicate:
- The technical capability and resources of the laboratory should meet the requirements which will be ensured by the laboratory supervisor’s review.
- Any change in the contract should follow the same process as the initial contract.
Subcontracting of Tests and Calibrations
This phase describes how the quality standards performed by subcontracted third parties must stay the same in the subcontracting laboratory.
- A documented quality system must be performed to check the competence of the subcontracted party.
- The subcontracting laboratory is responsible to the customer for the subcontractor’s work.