15189 – Short QMS Courses

These free webinars are provided to help overcome some of the difficulties many labs have in appreciating what our standard is asking of us.  They have been scheduled on our schedule page (https://www.iasonline.org/training/ias-training-schedule/) and the links will automatically register a person for the training.

ISO 15189 – MEDICAL LABORATORIES-REQUIREMENTS FOR QUALITY AND COMPETENCE

MODULE 1.  Resource and infrastructure requirements for competence in a medical/clinical laboratory.

Course Objectives

This module covers clauses 5.1 to 5.3 of the standard.

Medical laboratory infrastructure and resources are within eight broad classes covering competent personal, quality material, the testing environment, the testing equipment and all types of supplies used to support competent testing. This is in addition to requirements for metrological traceability of clinical measurements and the measurement equipment that is used to produce results and control the testing environment.

Accreditation of medical/clinical laboratories by ILAC-recognised accreditation bodies includes examination of these resources. 

Associated policies, procedures and records are discussed in this Module with examples.  This session is 90 minutes in duration and is delivered in two Parts:

• Part 1:  Resource procurement, management and continual improvement
• Part 2:  Policies processes and records requirements for conformity assessment bodies (in this case medical testing laboratories)

MODULE 2.  Method and Processes requirements for competence in a medical/clinical laboratory.

Course Objectives

This module covers clauses 5.4, 5.5 and 5.7 of the standard and will take up to 3 hours to complete.

Once the resources and infrastructure are in place, medical/clinical laboratory staff are required to develop, validate and implement the processes to be used in the laboratory under controlled conditions so as to produce technically valid results that will affect patient outcomes.   

Both pre-analytical (pre-examination) and post-analytical (post examination) sets of processes are examined in this Module.  Exercises are designed to help participants understand their roles and responsibilities in the lab. The focus is on assuring the quality of examination results and this is covered in significant depth in Module 3 which follows, on Clause 5.6-Ensuring the quality of examination results.

Module 2 also introduces the concepts and disciplines of evidence-based medicine.

MODULE 3.  Process Management – Outcomes – Technical Requirements

Course Objectives

Clinical laboratory processes and process management are discussed. Examples of all relevant documents and records for this will be highlighted including the importance of process flow charts.

The focus in Module 3 is on developing the process tools needed to properly manage laboratory processes and create expected outcomes.

Module 3 is divided into the following Parts:

• Part 1:  Understanding of the requirements contained in 15189
• Part 2:  Process Flow tools for clinical laboratories.

MODULE 4.  System Management Policies – What is required?

Course Objectives 

This Module examines ISO 15189 system management requirements in developing and implementing the laboratory system policies. Examples of a quality policy and other policy documents are discussed as well as the the importance of understanding and implementation of policies across the laboratory operations.

This module covers the requirements contained in ISO 15189 Clauses 4.1 to 4.1.5.

Module 4 is divided into the following Parts:

• Part 1:  Understanding of the requirements contained in 15189
• Part 2:  Samples of requisite laboratory system policies.

MODULE 5.  Requirements and Procedures for Records

MODULE  V.  Procedures and records requirements from all parts of 15189

Course Objectives 

This Module examines ISO 15189 records requirements, from all relevant Clauses including 4.13.

The clinical laboratory is required to exercise good control of the records it generates, and this module examines this concept as described throughout the standard.  Examples of record control processes are discussed.

Control of records is explicitly or implicitly stated throughout all parts of 15189 and there are no requirements that do not imply sufficient control of the records that demonstrate fulfillment of requirements.

Module 5 is divided into the following Parts:

• Part 1:  Understanding of the requirements contained in 15189
• Part 2:  Samples of requisite laboratory control of records.

MODULE 6.  Quality assurance and quality control – Requirements and Importance 

Course Objectives

In Module 6, Quality assurance and Quality control requirements for ensuring the quality of examination results are discussed. Examples of various quality tools will be highlighted including the importance of appropriate action to be taken when a quality control result or the results in quality assurance are questionable.

The focus is on assuring the quality of examination results and this is covered in Clause 5.6 – Ensuring the quality of examination results.

Module 6 is divided into the following Parts:

• Part 1:  Understanding of the requirements contained in 15189
• Part 2:  Quality control approaches used in clinical laboratories.

MODULE 7.  Auditing Clinical Lab Processes – Techniques, Documentation and Evaluation

Course Objectives

In Module 7, the importance of both audits and evaluation are discussed, with emphasis on the importance of continual improvement.  This Module is based primarily on Clauses 4.12 and 4.14 which demonstrates the link between continual improvement and the internal audit tool used to help implement it.

Examples of various QMS tools are highlighted and the importance of taking appropriate action following both evaluation and audit are demonstrated. Module 6 is divided into the following Parts:

• Part 1:  Understanding of the requirements contained in 15189
• Part 2:  Audit and evaluation tools and techniques in the clinical lab.

MODULE 8.  Measurement Traceability of all Laboratory Measurements

Course Objectives

In Module 8, the importance of measurement (metrological) traceability of all laboratory measurements is highlighted.  The desired outcome is that laboratory measurements are both traceable and precise, within an acceptable level of accuracy.

Traceability of all laboratory measurements to the international system of units (SI) is discussed along with the contribution of reference materials used in both chemistry and biological test measurements.  Standard Reference Materials and Certified Reference Materials will be discussed.

Uncertainty of Measurement, a tool to ensure metrological traceability, will also be discussed.

• Part 1:  Understanding of the requirements contained in 15189
• Part 2:  Audit and evaluation tools and techniques in the clinical lab.