This can –but does not have to- be the quality focal person identified at phase 1. This task should be carried out by the laboratory supervisor.
Since the implementation of ISO 15189 requirements is increasingly demanding time and efforts, it will be necessary to establish a coordinating position within the laboratory to effectively coordinate efficient implementation of the requirements. A quality officer is an advisory position without subordinates. This means that the quality officer has no authority to function as a manager: he/she merely observes the functioning of the quality management system and advises the management on activities that need to be carried out to continuously improve the system.
Bilateral discussions will be organized at least twice per month between the laboratory manager and the quality officer.
The laboratory manager or director has the authority to assign tasks to personnel members that are most appropriate for carrying out these tasks.
Activities related to Phase 2 - Personnel
The laboratory manager/director must be trained in change management and appropriate communication skills.
Implementing a quality management system is a process of change. Change management is therefore highly important to keep as many staff as possible involved. The laboratory manager and director need to obtain the right competences to direct and guide the implementation of a quality management system through courses, if they don’t have these competencies already (ISO 15189:2007 article 5.1.4 sums up the different responsibilities of the laboratory management).
The course list (earlier provided in phase 1) contains a course specifically for laboratory managers to learn to implement a quality management system in diagnostic laboratories according to ISO 15189. Besides this course, a more general management course with emphasis on change management could be followed in combination with a quality management course not specific for laboratory managers.
The laboratory manager/director must assess and document that all staff members perform their tasks properly. In this assessment the laboratory manager investigates if the competencies shown by a personnel member comply with the required competencies as described in the job description of the personnel member's position. If the personnel member is a laboratory technician, this personnel member should be able to show the competencies as required in the job description of the position "laboratory technician". The job descriptions of each position in the laboratory were already made in phase 1, after the development of the organizational charts. Another important part of the competency assessment is the identification of training needs for each staff member.
The WHO and SLMTA provide more information on what a competency assessment is, how you should do it, and forms that could be used. The SLMTA also provides example competency assessment forms.
During the competency assessment, special emphasis should be put on the educational background of each personnel member to determine if this is adequate for the tasks to be performed. If not, enroll him/her in a training that will satisfy his/her professional development needs. More information on this is also provided by the WHO Training Toolkit (under the same link).
As competency asssessments should be standard practice that is performed annually, an SOP for this activity is needed: write an SOP on Competency Assessment
Note: the competences of the laboratory director him/herself should also be assessed. This should be done by the person higher in the hierarchy than the laboratory director. In the public sector this is often the programme (NTP) director.
To be able to prove that the laboratory staff is competent, and has the right educational background and experience, personnel files need to be made. For a specific overview on which information to include and also to omit from the personnel files, refer to the SLMTA course on assembling personnel files. The WHO LQMS training toolkit also provides background information on personnel files. The following should at least be included in the personnel files:
- Certificates, diplomas, etc.
- Job descriptions belonging to the position of the personnel member, these job descriptions were made in phase 1 and include a description of the responsibilities of the personnel member.
- Records of courses/trainings followed as continuing education.
- List with techniques the personnel member has been made familiar with
- Competency assessment reports.
- Possible reports of accidents that have happend to the personnel member.
- Health record: the vaccination status of the personnel member.
Store the files in a locked cabinet to prevent unauthorized access to the documents.
Nb: As the laboratory should be directed by a competent laboratory manager, this should be demonstrable throught the personnel file of the laboratory manager, containing his/her CV and certificates of training. Hence, don't forget to also make a file for the laboratory manager. ISO 15189:2007 article 5.1.4 provides a list of (competency-) requirements to the laboratory manager.
An induction (not introduction) program is necessary for familiarizing new personnel with the organization. A checklist could be used to guide the new employee through the program. This way the new employee can most quickly start working in an efficient manner suiting the culture of the laboratory.