ISO/IEC 17025 Assessor Training Course
The ISO/IEC 17025 Assessor Training Course (ATC) was designed to not only introduce participants to the techniques to be employed in the assessment of testing laboratories to ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories but will also include the principles of Internal Auditing.
This course was developed to train persons interested in becoming assessors of laboratory management systems. This is done by a familiarization of participants with the requirements of ISO/IEC 17025 standard and techniques for assessing fulfillment of these requirements. The course also provides guidance to managers of laboratories preparing for accreditation to ISO/IEC 17025 and persons involved in internal auditing of laboratories.
This course also aims to provide participants with an understanding of the importance of accreditation to the growth and development of national economies.
ISO 15189 Assessor Training Course
ISO 15189 Medical laboratories – Particular requirements for quality and competence is an international standard which describes those requirements that must be fulfilled by medical laboratories seeking to demonstrate quality and competence in their operations.
This Assessor Course aims to provide an understanding of the importance of accreditation to laboratories, familiarize participants with the ISO 15189 standard and with the techniques for assessing fulfillment of the requirements.
This course was developed to train persons interested in becoming assessors of laboratory management systems, it will also provide guidance to managers of laboratories preparing for accreditation to ISO 15189 and persons involved in internal auditing of laboratories
Assessor Conclave (I & II) (Conclaves Are Held In June And December)
JANAAC’s Assessor Conclaves are designed and conducted in adherence with stipulations of the International Laboratory Accreditation Cooperation (ILAC), which requires that National Accreditation Bodies continually update their assessor pool concerning international accreditation issues and also continually provide opportunities for their development. The Conclave is therefore arranged to equip assessors with the knowledge and technical tools that will allow them to maintain a high standard of performance and work well to conduct the required assessments to aid national and international trade.
ISO/IEC 17025 & Accreditation
ISO/IEC 17025 & Accreditation seminar was designed to give participants a better understanding of the requirements of the international standard ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories and other accreditation requirements. In addition to gaining knowledge on the requirements of this standard, participants will be provided with general knowledge on the design and development of laboratory documents including the quality manuals. Participants will also be introduced to the requirements of an internal quality audit program, a key element of the ISO/IEC 17025 Standard.
The seminar serves to assist the building of capacity and competence of potential assessors as well as other personnel from testing labs, such as the individual who has responsibility for the lab’s technical management or for the lab’s quality management system development in the requirements of ISO/IEC 17025.
ISO 15189 & Accreditation
The ISO 15189 Medical laboratories – particular requirements for quality and competence, is an international standard which details the requirements to be fulfilled by medical labs, in order to attain quality and competence in their testing and other operations. Accreditation to this standard will therefore recognize the competence of the medical lab and provides confidence in its ability to meet the needs of all patients and the clinical personnel responsible for their care.
The seminar serves to assist potential assessors as well as other personnel from medical labs, such as the individual who has responsibility for the lab’s technical management or for the lab’s quality management system development. It will enable persons to understand the requirements of the ISO 15189:2012 standard, enabling them to effectively adjust aspects of their operation and documentation, facilitating their smooth transition towards fulfilling the standard’s requirements.
Taking Effective Corrective Actions
Labs that want to ensure they take effective steps to eliminate errors and nonconformities have guidance for this assurance, described in the requirements of both international accreditation standards - ISO 15189 – Medical Laboratories – particular requirements for Quality and Competence and the ISO/IEC 17025 - General requirements for the Competence of Testing and Calibration Laboratories. Both standards require a lab to have an established corrective action programme that effectively deals with any nonconformity identified within the lab’s management or technical operations.
An effective programme must see the lab’s implementation of actions that prevent the recurrence of the nonconformity or error, instead of just correcting the problem. This is often a very challenging accomplishment for labs and has been identified as a key issue that must be resolved.
Our Corrective actions seminar provides participants with a range of tools which can be utilized by CABs in the identification of non-conformities and further identification of root causes and the development of appropriate corrections and corrective actions to effectively address these non-conformities.
Internal Auditing & Risk Management
Internal Auditing is a critical requirement of all management systems and is a very reliable tool for CABs to identify opportunities for improvement in their organizations by conducting “self-assessment” on the implementation of their management systems to the relevant international standard. The effectiveness of these internal audits is dependent on the quality of the internal audit process developed and implemented by the CABs, including the competence and independence of internal auditors.
JANAAC provides general guidance through our seminars on the requirements of the standard along with the personality traits and competences which provides the basis for a good internal auditor.
Risk Management on the other hand (which is also increasingly a requirement of conformity assessment standards), is the systematic application of management policies, procedures, and practices to the tasks of identifying, analyzing, evaluating, controlling and monitoring risk (the effect of uncertainty on objectives). Both Clinical & Testing laboratories conduct a number of activities that have associated risks. These include; verification of performance of new tests, troubleshooting instrument problems and responding to physician complaints. Our risk management seminar is designed to provide a wide range of tools available to the CAB in the identifying and addressing these risks.
Method Validation /Verification
Verification is intended to check that a product, service, or system meets a set of design specifications. In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service or system, then performing a review or analysis of the modeling results. In the post-development phase, verification procedures involve regularly repeating tests devised specifically to ensure that the product, service, or system continues to meet the initial design requirements, specifications, and regulations as time progresses. It is a process that is used to evaluate whether a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase.
Method validation is an essential part of establishing and ensuring the quality of analytical data. It cannot be guaranteed that data will be fit for purpose unless the performance of the test method has been studied and demonstrated to be adequate. Method validation is the process that provides evidence that a test method is capable of providing data that are suitable for a particular application. It is a requirement of the ISO/IEC 17025 laboratory accreditation standard and many other sectorial regulations and directives. Method validation should always be a planned activity.
This course introduces the statistics required for interpreting validation data and provides the tools to plan and carry out effective validation studies.