Learn from Experts About the Five Requirements of The ISO 17025?
The ISO 17025 is the ideal quality/service management standard for testing/calibration laboratory industries. To implement this standard and ensure 100% compliance, a company must understand all objectives and requirements of each. There is a set of clauses, which defines the precise requirements for meeting compliance. Small and medium companies often ask, “what are the five requirements of the ISO 17025?” To ensure a laboratory is fully prepared to become accredited an authoritative body will conduct evaluations like an internal audit and a readiness review. These two evaluations of the system highlight the areas that require immediate attention. A readiness review and analyses will determine whether your management team took enough responsibility for the service improvements or not. Also, before implementing any ISO clauses, you must conduct a gap analysis to better understand your current situation and if any existing flaws must be remedied.
This blog will discuss the five requirements in more detail. Also, it will highlight the beneficial side of having the ISO 17025 certification.
What are the five requirements of the ISO 17025?
1.Structural Requirements – This clause ask you to define organizational structure, roles, and responsibilities within the lab. According to these demands, laboratories must have an identifiable structure, showing how roles and responsibilities are assigned. Additionally, Management must support the lab’s activities and ensure that roles are clearly defined. Laboratories should be accountable for their activities and have processes in place for the management team and outline the process for decision-making.
2.Requirement of resources – The objective here is to establish the technical processes involved in testing, calibration, and reporting. It says that the laboratories must have protocols for receiving, storing, and tracking samples to avoid contamination or loss. Testing and calibration methods must be validated and documented to ensure they are suitable and accurate. All measurements should be traceable to national or international standards. There must be procedures for identifying, documenting, and addressing nonconformities in testing or calibration work. Also, all the results should be reported clearly and accurately, including any factors that might affect the test or calibration outcome.
3.The general requirements – It aims to establish a foundation of impartiality and confidentiality in lab operations. The key points include laboratories must ensure impartiality in their testing and calibration activities, avoiding conflicts of interest. Also, it asks for a high level of data management. Under the general requirements, a company must consider that confidentiality of client data and information must be maintained. Labs must have policies to protect sensitive information.
4.The process requirements – The objective here is to establish the technical processes involved in testing, calibration, and reporting. It says that all laboratories must have protocols for receiving, storing, and tracking samples to avoid contamination or loss. Testing and calibration methods must be validated and documented to ensure they are suitable and accurate. Also, all measurements should be traceable to national or international standards. There must be procedures for identifying, documenting, and addressing nonconformities in testing or calibration work. Results should be reported clearly and accurately, including any factors that might affect the test or calibration outcome.
5.The management requirements – The final one in the top five requirements list is your management’s responsibility. The objective is to provide a quality management system framework that supports continuous improvement. Under management accountability, the laboratories can choose the ISO 9001 or other QMS standards, or they can implement the specific management system outlined in the ISO 17025. They must maintain records of procedures, results, and quality measures. Periodic internal audits help identify areas for improvement. Therefore, leaders must monitor and organize evaluations from time to time. Regular reviews by management ensure the lab meets its quality objectives and complies with the ISO 17025. Also, the laboratories have procedures for addressing issues identified through audits or management reviews to continuously improve operations. The management personnel must take complete responsibility to implement effective strategies and mobilize relevant resources.
What benefits can a laboratory yield from having the ISO 17025 certification?
The ISO 17025 is the accreditation that helps to improve the service delivery system for laboratories. It means a plethora of benefits can be enjoyed from time to time. To start with, you can achieve a loyal customer segment. That will gradually stabilize your income margin. Moreover, with loyal and satisfied customers, your laboratory establishes a strong brand name that can approach the international markets. Therefore, market exposure and subsequent sustainability are achieved. Since the ISO 17025 focuses on management responsibility and resource management, employee competence is accomplished as well. They become more concerned about quality management. Individual stakeholders take responsibility as they are aware of the service’s reliability needs. Also, the ISO 17025 offers a great competitive edge that helps with cost management too.
To learn more about the ISO 17025 management certification costs and other significant aspects related to varied business management for individual industries, hire professional assistance. We at Compliancehelp Consulting LLC offer several services for how to conduct internal audits, gap analysis, and readiness reviews. Besides having a comprehensive set of guidelines, you will be given the opportunity to customize a package according to your needs. Your overall costs might be reduced after a consultant assesses and evaluate your exact requirements.