Marouane Nasser1*, Tijane M’hamed1, Narjis Badrane2, Rachida Soulaymani Bencheikh2, Omaima El Bouazzi2
1Laboratory of Biochemistry and Immunology, Faculty of Sciences, Mohammed-V University, Morocco
2Laboratory of Toxicology and Pharmacology, Centre of Poison Control and Pharmacovigilance of Morocco, Street lamfadel cherkaoui Madinat al Irfane Rabat, Morocco
*Corresponding author: Marouane Nasser, Laboratory of Biochemistry and Immunology, Faculty of Sciences, Mohammed-V University, Morocco. Email: email@example.com
Received Date : 12 March, 2018 ; Accepted Date : 02 April, 2018 ; Published Date : 11 April, 2018
The quality manual is a quality guideline which is imposed to all medical laboratories which are ISO 15189 certified.
In order to meet the standard requirements, we have elaborated a quality
manual. This approach will enable the mastery of all LAB-CAPM (laboratory of
toxicology and Pharmacology of the Center of Poison Control and
Pharmacovigilance of Morocco) specific activities and as well optimize their
This article describes the methodology, the means used and the advantages of elaborating a quality manual in the context of an ISO 15189 accreditation procedure.
In order to ensure this, we have developed several points in this article, starting with the presentation of the ISO 15189 standard, its requirements and topics, in the second chapter we described the standards used in the accreditation of ISO 15189. The quality manual: imposed by ISO 15189 describe the content of a quality manual according to the ISO15189 standard. In results and discussion, we presented the quality manual that we realized within the LAB-CAPM.
2. Keywords: Accreditation; ISO 15189; Quality Assurance; Quality Manual
This competence recognition is intended to guarantee to the accredited bodies clients, that the deliveries of these accredited bodies, under cover their accreditation, are trustworthy .
Accreditation might be as a part of a voluntary initiative, today it’s the case for LAB-CAPM that’s committed to obtain ISO 15189 accreditation.
Traceability is the key to quality. If their actions and reactions become quality related, then expensive failures and the accumulation of hidden costs may be reduced to an acceptable minimum or even prevented altogether. Quality folder is a holistic concept, which requires quality motivation of all people in an organization towards a common quality goal.
2. Materials and Methods
We used ISO 15189
The methods followed in the drafting of our quality manual are as follows:
-Preparing laboratory for accreditation with the ISO 15189 standard.
-Following chapter 4.2.2 of ISO 15189 which describes the structure of the manual documentation.
-Writing the processes used in the laboratory.
2.1. NF EN ISO 15189 Standard
It’s a more specific standard as its title indicates: Medical laboratories - Requirements for quality and competence.
This standard combines EN ISO 9001: 2000 standard quality system requirements and the technical requirements proper to medical laboratories. Part on Management requirements and a part on Technical requirements which takes into account the overall analysis including both pre-analytical and post-analytical phases; its summary is close to NF EN ISO/CEI 17025 standard.
The topics addressed on the part Management requirements are already mentioned
in NF EN ISO 9001 standard (preventive actions, corrective actions, management
review, audits, etc.). In contrast, chapters Examination by referral
laboratories, External services and supplies and Advisory services are
Technical requirements concern pre-analytical, analytical and post-analytical procedures, and as well results reporting, staff, facilities, environmental conditions and laboratory equipments.
This is the first specific standard that covers the entire activities of medical laboratories .
2.2. Preparation for Accreditation
Medical laboratory quality systems can be based on different standards or protocols, such as ISO 15189, ISO 17025, ISO9001, JCI, EFQM Model, and WHO Health Promoting Hospitals. The laboratory has to decide to which system it should apply .
The most recent, internationally accepted Accreditation System is the ISO 15189 Standard .
Previously, medical laboratories were accredited according to ISO/EN 45001, ISO/IEC 17025 standards.
Top management of the candidate laboratory has to be committed to accreditation and fully support the team in every aspect. Large spectrum servicing laboratories have to establish an accreditation team. Coordination of these activities may be too large and detailed task for one manager. One person should be devoted and responsible for the development and maintenance of the Quality System Documents.
Candidate laboratory has to obtain an official copy of ISO 15189: 2007.
Content of the standard should be understood very well.
Criteria should be discussed by the maximum possible number of related staff. Weak and strong points of the existing practice should be identified. Weaknesses must be revised.
Organizational arrangements, practices and procedures have to be examined to see whether they meet the requirements of the standard. Improvements have to be made on the basis of evaluation, if necessary. This stage is the most critical issue of preparation for accreditation. You have to evaluate your system.
Decide on the correction. Document it and follow it up in a sufficient period of time. Then, you can decide whether your laboratory is ready for accreditation application or not. It may take more time, effort and money than you expect, to adopt the existing practice to the requirements of the standard.
2.3. The Quality Manual: Imposed by ISO 15189
The quality manual is on the documents required by ISO 15189. It’s defined by ISO 9000 as a document which specifies the quality management system of an organization.
The quality manual is a Framework document of the documentary structure. This documentary structure is often presented in the form of a pyramid (see below) where in the top of the pyramid there’s the quality manual and in its base there’s the records.
Documents types, their designation, and as well the quality manual form are left up to every organization so it elaborates its own adapted document structure. Therefore, a small size organization might find it appropriate to include a complete description of its quality system in the quality manual, including all the documented procedures required by the standard. In the opposite, big size organizations might need a more important number of documentary levels, for example national procedures, local procedures, sectorial methods of operation, and perhaps even many quality manuals (group quality manual, site quality manual…)
According to chapter 4.2.2 of the ISO 15189 standard, a quality manual should describe the quality management system and its documentation structure. The quality manual should include or make reference to supporting procedures, including technical procedures
It should highlight the documentation structure of the quality management system. The role and the responsibilities of the technical direction and the quality manager, including their responsibilities concerning the compliance to this international standard, should be included to the quality manual as well.
The whole staff should be trained to the use and application of the quality manual, the referenced documents and all the relating requirements for their implementation. The quality manual should be kept up-to-date under the authority and the responsibility of a quality manager designated by the laboratory direction.
The table of contents of a medical laboratory quality manual might, for example, be presented as follow:
b) Laboratory description, its legal status, resources and main activities.
c) Quality policy.
d) Qualification and staff training.
e) Quality assurance.
f) Documents control.
g) Records, conservation and archiving.
h) Facilities and environment.
i) Instruments control reagents and/or appropriate consumables.
j) Analytical procedures validation.
l) Environmental aspects [For example conveyance, consumables, waste disposal, in addition and independently to bullets h) and i)].
m) Research and development.
n) Procedures and analytical methods list.
o) Prescription protocols, primary samples removal, samples collection and processing.
p) Results validation.
q) Quality controls (including inter-laboratory comparison).
r) Laboratory’s information system.
s) Results review.
t) Remedial actions and processing of complaints.
u) Communication and other relations with clients, health professionals, subcontracting laboratories and suppliers.
v) Internal audits.
w) Ethics .
3. Results and Discussion
We developed a quality manual which presents the general provisions adopted and executed by the laboratory in order to guarantee the quality of its provided services in compliance with the current regulations and the NF EN ISO 15189 version August 2007 standard.
This manual includes as well the laboratory structure, its different provided services and the measures implemented systematically in terms of quality assurance.
It refers to the common horizontal procedures which precise operational, organizational and managerial dispositions. This manual presents the elements which, by implementing the described dispositions, demonstrate the laboratory’s ability to deliver services in compliance with the regulatory requirements and clients requirements, in order to increase their satisfaction. Modifications might be carried out during the annual review or in case of important changes in the organization or the quality system.
The quality manual of LAB-CAPM is a part of the laboratory’s quality system documentation. It’s subject to control procedures requirements notably with regard to distribution and archiving.
We produced 10 processes containing all the activities of the laboratory:
a) Laboratory general organization process
b) Quality system follow-up process
c) Pre-analytic process
d) Analytics process
e) Post-analytic process
f) Staff process
g) Information management process
h) Equipments maintenance process
i) Purchasing process
j) Hygiene, security and environment process
Many procedures (more than twenty) were elaborated; this will enable a quality increase in the whole laboratory.
These procedures are documents which tackle operatory modes.
* Internal audits procedure.
* Non-compliance management procedure.
*Corrective actions procedure.
* Preventive actions procedure.
There are other procedures identified in the procedures and instructions list, which area applicable depending on the identified risk areas.
The quality manual is a document which contains a set of clear and precise instructions regarding all the ongoing operations of LAB-CAPM.
For the laboratory, it constitutes a memory capitalizing the individual and collective expertise.
It’s a reference used by the entire laboratory staff. It indicates operations processing flow, while specifying:
- The task to do (what)
- The responsibility level (who)
- Different processing steps (when)
- Premises of establishment (where)
- Execution mode (how)
The main objective of the quality manual is to express in an accessible direct language, who is doing what, where, how and for what reason?
The major objectives of the quality manual are in the context of internal control, amongst others, ensure the sustainability of the laboratory.
Just like an internal control it allows the following:
- Explain the operating mode of different procedures according to LAB-CAPM activities;
- Safeguard the laboratory’s assets by using permanent internal control procedures;
- Promote the harmonization of tasks execution modes by formalizing it. Which excludes differences on the manner operations are treated, more often in the absence of quality manual this will depend on style, acquired personal experience and as well the nature of operations;
- Train staff.
3.1. Quality Manual Functions
The functions assigned to the quality manual are enumerated as follow:
- Management tool: The quality manual defines activities execution modalities by entrusting acts and tasks to every procedures interveners.
- Communication tool: The manual creates conditions for different interveners to act in cooperation, following standards and common codes.
- Management information tool: The manual is a management information tool because it enables to directors and services managers to better analyze the information and results which are given to them in a standardized format.
3.2. Structure and Presentation of the Quality Manual
The quality manual presentation must match content and form criterions, but also the diffusion support must be defined.
The Manual is almost like all other data in the system, a reflection of
- a result: being a descriptive of the organization as a structure committed to a process of customer satisfaction and continuous improvement of its organization.
- a reflection: the norm attributes to it minimal characteristics (which monopolize in all that 4 lines in the chapter) .
Everybody knows that non-quality is expensive. Quality as well especially COFRAC (French Accreditation Committee) quality .
Quality approach offer greater rigor in work methods and in the organization, a better definition of functions and responsibilities, a practices harmonization. Tracking non- compliance and dysfunction is always a priority. In this level, quality management meets risks management and prevention. It’s the main purpose of quality. Likewise, in every standard, writing internal quality document is inescapable and imposes to shift from an oral tradition to a written one. These necessary documents are a warranty of all actions traceability, but are not the essential .
Preparation-implementation period for accreditation
may require 2 years of tedious and frustrating work. Getting accreditation is
feeling of satisfaction to people who participated in the process.
Post-accreditation settlement period may also take 2 years. The staff will have
much better understanding after this period.
Accreditation means that the serving laboratory has been successful at meeting the requirements of international accreditation standards. The patient reduces the risk of selecting an incompetent laboratory .
The quality folder becomes a communication medium:
· Internal: it can be used to sensitize new entrants on the organization of the laboratory
· External: for clients and auditors to present the general organization and give confidence to the control of the activities .
Figure 1: The ISO 15189 documentation pyramid.
Figure 2: Quality manual cover.
7. Mallet G, Dugay A, Leroy M, Gray C, Basuyau JP, et al. (2005) Cofrac accreditation procedure in a multipurpose hospital laboratory. Establishment and daily management. Immunoanalysis and Specialized Biology 239-244.
Citation: Nasser M, M’hamed T, Badrane N, Soulaymani-Bencheikh R, Bouazzi OE (2018) Preparation for the Accreditation According to ISO 15189: A Quality Folder Realization. Arch Anal Bioanal Sep Tech: IJABT-104. DOI: 10.29011/AABST-104.100004