The International Standards Organization has outlined a series of qualifications that pertain to quality assurance of products and services. ISO 17025 deals specifically with Laboratory Management Systems. If a company is seeking ISO 17025 accreditation, they need to conform to the rules set forward by the ISO committee. Before a business can determine whether it should start on the path of accreditation or not, however, the structure of the ISO program should be evaluated.
Structure of ISO 17025
There are a series of headings to review for ISO 17025. Among these are:
- Scope: This heading covers the requirements (both scientific and technical) that a lab must display to demonstrate that it operates at the quality standards set forth by accreditation.
- Normative References: Outlines a non-ambiguous framework for discussion of ISO 17025.
- Terminologies and Definitions: The specific phrases and words that will be used to discuss laboratory Management Systems.
- General Requirements: Requirements that the management system must have that encompass standard operating procedures and interface.
- Structural Requirements: Infrastructure necessary to attain ISO 17025 accreditation.
- Resource Requirements: Resources that a laboratory seeking ISO 17025 accreditation should have access to.
- Process Requirements: Internal lab procedures should follow the guidelines set forward in this section.
- Management Requirements: The management and running of the lab should use this section as a general guideline.
In addition to these clauses, two Annexes are also attached, viz.:
- Annex A: Metrological Traceability (Informative)
- Annex B: Management System (Informative)
To ensure that results delivered are accurate and precise, testing and calibration labs work within strictly defined guidelines for these specific tasks:
- Documentation of results into a readable format
- Sample analysis
- Sample testing
- Sample labeling
- Sample identification
ISO 17025 requires a continuous review of processes. This review happens both during the audit process as well as after accreditation. The ISO 17025 methodology comes with a clause that focuses on corrective and preventative actions. The clause in detail states:
Clause 8.7 “Corrective Action” 8.7.1: Procedure for implementing Corrective Action: Selection and implementation of Corrective Action Selection and implementation of the most suitable Corrective Action. Document and implement any changes as a result of Corrective Action 8.7.2: Effectively addressing Nonconformities, Cause Analysis – Investigation of the root cause 8.7.3: Recording and Monitoring, Monitoring of Corrective Action
Steps in Addressing Corrective Actions
When corrective actions are prescribed to a laboratory, implementation of these corrective actions is done as follows:
- Root Cause Analysis: A problem can’t be solved unless the root cause of the issue is located. A cross-functional team is best suited to examining every aspect of the matter in detail to determine where the problem exists within the procedure.
- Examination of non-conformity: Non-conformity is a precursor to a problem arising within a process. The Corrective Actions unit should address any non-conformity that has occurred or has the possibility of re-occurring.
- Determining Corrective Actions and Implementation: The most suitable corrective actions that will ensure the quality of the process would be selected from the potential actions, under the supervision of management. The chosen works will then be implemented to bring about change.
- Monitoring of Actions: The team is required to observe and record what happens after the measures have been applied. If the discrepancy re-occurs, the process must be redone.
- Additional Auditing: Determine whether internal audits are higher in quantity, or create any further non-conformity.
- Record-Keeping: Meticulous recording of problems and actions taken to alleviate them allows for analysis of the methods undertaken both quantitatively and qualitatively. A review of records will make it easier to determine whether suggested activities are likely to work or not based on previous implementations.
- Evaluation of Corrective Actions: Quality assurance departments are required to revisit the activities performed periodically to determine their long-term success. Management teams can use these periodic reports in the future for both internal and external audits.
The Vital Role of Continuous Improvement
ISO 17025 is an iterative process seeking to ensure that a laboratory raises the quality of methods with each audit. Daily improvement is facilitated by embedding a continuous improvement cycle and using Six Sigma Quality Management within the institution. Additionally, the current level of the institution’s Quality Management Service can be referenced. Additional benefits of a continuous improvement cycle include:
- Reduction in customer complaints due to a higher quality of service, which leads to better customer response times.
- Making it easier to gain ISO accreditation or re-accreditation.
- Reduction in non-conformities that impact the efficiency and effectiveness of the system.
- Delivering continual betterment through corrective actions.
- Overview and verification of how effective the implemented corrective actions have been in both the short and long term.
- Examining other opportunities the business has for improvement.
- Checks on the efficiency of the company’s QMS.
- Be updated with the current advances and changes to the company’s processes to match those developments.
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