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5.1 The
laboratory shall be a legal entity, or a defined part of a legal entity, that
is legally responsible for its laboratory activities.
NOTE For the purposes of this document, a governmental laboratory is deemed to be a legal entity
on the basis of its governmental status.
5.2 The laboratory shall identify management that has overall
responsibility for the laboratory.
5.3 The laboratory
shall define and document the range of laboratory activities for which it
conforms with this document. The laboratory shall only claim conformity with
this document for this range of laboratory activities, which excludes
externally provided laboratory activities on an ongoing basis.
5.4 Laboratory
activities shall be carried out in such a way as to meet the requirements of
this document, the laboratory’s customers, regulatory authorities and
organizations providing recognition. This shall include laboratory activities
performed in all its permanent facilities, at sites away from its permanent
facilities, in associated temporary or mobile facilities or at a customer's
facility.
The laboratory is part of the organization or body and was established
pursuant to Decree No. ............... Date …………….. Although the laboratory is
under the direct supervision of the organization's or agency's senior
leadership, it has a management team that oversees all its activities.
Laboratory staff are affiliated with… [Write the affiliated organization]… and
specify the agency or organization to which the laboratory staff are
administratively and financially affiliated. The laboratory's management system
covers activities at its headquarters. The areas of activity include… [Specify
the areas of activity in detail]. The testing services offered by the
laboratory are listed in Appendix 6. The laboratory is organized to meet the
needs of clients and regulatory authorities; it complies with ISO 17025 and ISO
9001. The laboratory consists of the following units: [Specify the different
units of the laboratory].The laboratory shall:
5.5 The laboratory must:
a)
define the organization and management structure of the
laboratory, its place in any parent organization, and the relationships between
management, technical operations and support services;
b)
specify the responsibility, authority and interrelationship
of all personnel who manage, perform or verify work affecting the results of
laboratory activities;
c)
document its procedures to the extent necessary to ensure
the consistent application of its laboratory activities and the validity of the
results.
a) Attach an organizational chart for both the organization or body to
which the laboratory belongs and a detailed layout of the laboratory. Figure 1
shows the organizational structure of the organization or body. Figure 2 shows
the organizational structure of the laboratory.
The laboratory was established in …… [insert year here] ……, pursuant
to Decree No. ………, dated ……., issued by the senior leadership of the
organization or body (Appendix 7: Establishment Decision issued by the highest
official of the organization or body).
The laboratory provides its services to ……. [insert clients here] ...
and is staffed by qualified and experienced personnel. The laboratory is
located at …. [insert laboratory location here]… .. (Appendix 1: Laboratory Layout)
For further information, contact:..............
Telephone: ……. Fax: …….
Location: ………………………………………………….
Figure 1. Organizational Structure of the Body
or Organization to Which the Laboratory Belongs
b) Responsibilities, Authorities, Duties, and Interrelationships Among
All Staff Who Manage, Perform, or Verify Work Affecting the Results of
Laboratory Activities:
Laboratory Supervisory Committee
Generally, the Laboratory Supervisory Committee is responsible for the
following:
-
Defining the strategic and operational objectives of the laboratory.
-
Developing the quality policy for the laboratory.
-
Ensuring that the organizational structure of the laboratory is
appropriate.
-
Nominating the technical managers and the quality control manager.
-
Evaluating the laboratory supervisor, technical managers, and quality
control manager.
-
Approving budgets and work plans.
-
Reviewing and approving financial statements.
-
Approving bonuses within the framework of the approved regulations and
systems.
Figure 2. Organizational Structure of the
Laboratory
Laboratory Supervisor
The laboratory supervisor is the representative of senior management
and has the primary role in approving all protocols, forms, and all documents.
The laboratory, in addition to the following responsibilities and authorities:
-
Developing the laboratory's initial objectives, operating plans,
policies, and short- and long-term goals; and implementing them after approval
by the supervisory committee.
-
Directing and coordinating activities to achieve profitability and
return on investment.
-
Designing and building the organizational structure and delegating
authority to subordinates.
-
Leading the laboratory towards its objectives, meeting and advising
other executives, and reviewing the results of business operations.
Technical Director
The laboratory consists of... [insert
number of units here], and each unit has a Technical Director (the Technical Directors' appointment letters are included
in Appendix 8). The Technical Director is fully responsible for the
laboratory's technical operations, including protocols, forms, and all related
documentation. He is also responsible for defining the responsibilities and
authorities of employees and providing them with the necessary facilities to
deliver their assigned services, in addition to the following responsibilities
and authorities:
- Being familiar with all operations carried out
under his supervision.
- Providing the necessary resources (personnel,
equipment, and supplies) for the quality assurance program to ensure confidence
in the laboratory's results.
- Ensuring the maintenance and calibration of
equipment and reporting all deficiencies (e.g., equipment malfunctions)
appropriately.
- Ensuring that employees are trained in their
duties, including providing substitutes when essential staff are absent.
- Maintaining records and managing all aspects
of testing activities.
- Ensuring the laboratory's compliance with ISO
17025 and ISO 9001 standards.
- Responding to customer inquiries and providing
professional advice.
- Orienting new employees.
- Identifying the technical training needs of
individuals.
- Evaluating employee performance.
- Scheduling employee leave.
- Determines who will perform the duties of
those on leave.
- Ensures compliance with all health and safety
regulations.
- Oversees quality, standard pricing, custom
quotes, and invoicing for tests performed (purchasing department duty).
- Defines operational priorities or workloads.
- Resolves any operational issues within the
scope of work.
- Ensures accurate and consistent testing
procedures by validating all existing procedures and by developing, validating,
and implementing new protocols.
- Coordinates purchase orders.
- Ensures operational needs are within budget
and advises management on any discrepancies.
Technicians
The
laboratory consists of... [insert number of laboratory units here]... each
laboratory has one or more technicians. Each technician has established
procedures and policies that they must adhere to in order to avoid engaging in
activities that could diminish confidence in their competence. In general, the
technician is responsible for the following:
- Maintaining records of all quality activities
as documented in the Standard Operating Procedures (SOPs) and Test Methods
(TMTs).
- Handling samples and performing analyses
according to the SOPs and TMTs.
- Writing the SOPs and TMTs.
- Signing reports issued by the laboratory or
unit where they work.
- Maintaining and calibrating equipment.
- Reporting deficiencies or malfunctions to the
supervisor.
- Identifying and recording nonconformities in
corrective action requests.
- Identifying and recording potential
nonconformities in preventive action requests.
- Correcting existing and potential
nonconformities.
- Continuously improving the laboratory and/or
quality activities.
Customer
Office Manager
The laboratory has a Customer Office responsible for communicating
with clients about the services offered, answering client questions, assisting
in resolving issues, processing refunds, and addressing client complaints. Or
their concerns, working to resolve their problems, and obtaining customer feedback
on service quality. Generally, the Customer Service Office in laboratories is
responsible for the following:
- Receiving samples from customers.
- Distributing samples to the relevant units.
- Collecting and delivering test data to
customers.
- Maintaining records of test data performed in
the laboratory.
- Receiving, evaluating, and resolving customer
complaints.
- Distributing and collecting performance
satisfaction questionnaires.
- Recording all complaints and following up
until the customer receives a response. These records include details of the
complaints, the investigations, and the corrective actions taken.
- Receiving payment for the analysis from the
customer.
5.6 Quality Manager
The laboratory shall have personnel who, irrespective of other responsibilities, have the authority and resources needed to carry
out their duties, including:
a)
implementation, maintenance and improvement of the management system;
b)
identification of deviations from the management system or
from the procedures for performing laboratory activities;
c)
initiation of actions to prevent or minimize
such deviations;
d)
reporting to laboratory management on the performance of
the management system and any need for improvement;
e)
ensuring the effectiveness of laboratory activities.
The laboratory has a Quality Control Manager
appointed by the organization, agency, or laboratory (see Appendix 8: Letter of
Appointment of Quality Control Manager). This Quality Control Manager is fully
responsible for implementing a quality management system that meets the requirements
of ISO 17025 and oversees all laboratory-related functions. The Quality Control
Manager has the authority to communicate directly with senior officials and
technical managers within the organization. The Quality Control Manager is
responsible for the following:
- Ensuring the
establishment, implementation, and maintenance of a quality management system
in accordance with ISO 17025 and ISO 9001 standards.
- Managing the internal
audit program.
- Coordinating laboratory
accreditation activities.
- Maintaining and
distributing the quality manual and related documents.
- Maintaining a master list
of current versions of quality documents.
- Training staff on quality
management system activities.
- Monitoring the quality
management system.
- Reporting on the
performance of the quality management system to senior management for review
and use as a basis for improving the quality management system.
- Overseeing the
proficiency testing program between the laboratory and other laboratories.
- Maintaining the current
job description.
- Developing and
documenting safety procedures that address hazards associated with laboratory
operations.
- Communicating hazard
information and safe work practices to laboratory visitors.
- Ensuring the availability
of laboratory safety equipment and personal protective equipment, including
Suitable for ongoing laboratory work.
- Implementing preventive
measures to control hazardous materials and minimize risks, complying with
safety management regulations and policies, and adhering to sound laboratory
safety practices.
- Following environmental
regulations and guidelines for the proper management of hazardous waste.
- Taking effective steps to
identify and address deficiencies in laboratory safety
5.7 Laboratory management shall
ensure that:
a)
communication takes place
regarding the effectiveness of the management system and the importance of meeting customers' and
other requirements;
b)
the integrity of the management system is maintained when changes to the management system are planned and implemented.
Laboratory management ensures a suitable
communication system within the laboratory, enhancing the effectiveness and
efficiency of the management system. This includes effective communication
among all relevant staff, as well as between the laboratory and other laboratories
and clients. Client communication is maintained through reviewing test reports
and conducting customer satisfaction surveys to improve the quality management
system, testing activities, and customer service. The management system is
further improved through customer satisfaction surveys and other customer
feedback, including complaints and suggestions; market research and analysis;
employee, supplier, and other stakeholder opinions; internal and external
audits of the management system; non-conformity records; and data on process
and service characteristics and trends. The laboratory ensures that these
improvement efforts do not compromise the integrity of the management system.
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