Clinical and Laboratory Standards Institute guideline QMS03—Training and Competence Assessment provides the necessary background information and processes to develop training and competence assessment programs that meet regulatory and accreditation requirements and help ensure knowledgeable and competent personnel in all laboratory disciplines. An effective training program sets the expectation that personnel need to learn and apply the laboratory and organization’s processes and procedures. A competence assessment program ensures that personnel continue to perform the learned processes and procedures correctly so that the laboratory’s quality goals and objectives can be achieved. Training and competence assessment programs are important components of a QMS.

This guideline replaces the previous edition of the approved guideline, QMS03, published in 2009. Several changes were made in this edition, including: ? Development of a process flow for training and competence assessment ? Expansion of the competence assessment processes ? Addition of examples for test systems for competence assessment ? Information related to potential actions when performance is unacceptable

QMS03 provides the necessary background information and processes to develop training and competence assessment programs that meet regulatory and accreditation requirements and help ensure knowledgeable and competent personnel in all laboratory disciplines. 

QMS03 is intended for use by: 

- Administrative and technical personnel who develop and deliver laboratory training and competence assessment programs 

- Pathologists and laboratory medical directors

- Regulatory and accreditation organizations 

- Educators 

This guideline is designed primarily for use in medical laboratories; however, the concepts are generic and can be applied in point-of-care testing, as well as research, public health, and veterinary laboratories.