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6.1 General
The laboratory shall have available the personnel,
facilities, equipment, systems and support services necessary to manage and perform its laboratory activities.
In
a laboratory, several factors influence the validity and reliability of the
tests performed. These factors include: (1) human factors (see paragraph 6.2);
(2) environmental and spatial conditions (see section 6.3); (3) testing and calibration
methods and verification procedures (see sections 7.2.2 and 7.8.2); (4)
equipment (see section 6.4); (5) traceability of measurements (see section
6.5); (6) sampling procedures (see section 7.3); and (7) handling of testing
and calibration materials (see section 7.4). The laboratory considers all of
these factors when developing protocols, training and qualifying staff, and
selecting equipment. Furthermore, they are taken into account when determining
the overall uncertainty in the measurement.
6.2
Personnel
6.2.1 All personnel
of the laboratory, either internal
or external, that could influence
the laboratory activities shall act impartially, be competent and work
in accordance with the laboratory's management system.
The laboratory management ensures that laboratory staff are qualified
to conduct tests and/or calibrations, evaluate results, and sign test reports.
Staff files contain documentation of staff qualifications, experience, skills,
and training for their assigned job duties (see Appendix 9: Training File).
Individuals undergoing training are subject to appropriate supervision. The
laboratory qualifies individuals conducting tests and/or calibrations through
appropriate education and training, as well as through on-the-job experience.
Furthermore, these individuals are fully aware of the general requirements
stipulated in legislation and standards (regulations in general and those
specific to the organization or agency), and they understand and are cognizant
of any malfunctions or distortions that may occur in relation to the normal use
of materials or products that they handle within the scope of their duties.
6.2.2 The
laboratory shall document the competence requirements for each function
influencing the results of laboratory activities, including requirements for
education, qualification, training, technical knowledge, skills and experience.
The staff responsible for evaluating the results in test reports have
relevant knowledge of the technology used to manufacture the materials or
products tested, how they are used or intended to be used, and the defects or
deterioration that may occur during or in service.
6.2.3 The
laboratory shall ensure that the personnel have the competence to perform
laboratory activities for which they are responsible and to evaluate the
significance of deviations.
Staff and management formulate learning objectives and training skills
for laboratory personnel (see Appendix 9: Training File - Training Program).
The training program is linked to the current and anticipated tasks of laboratory
personnel. Procedure FT.10.0 is used to identify staff training needs and to
evaluate the effectiveness of the required training annually. When identifying
training needs, management compares the job description for each position (item
5.5) with the skills and knowledge of the new job holder to determine the
training requirements. In the laboratory, training should cover all or part of
the methods and techniques performed by specific staff members. To ensure a
technician's competence, management, at a minimum, observes their work or
examines samples of their work. For technicians performing only parts of a
laboratory method, the laboratory assesses their competence through observation
only. All staff members undergo a competency check at least once a year to
ensure their proficiency in performing methods and using techniques relevant to
their job descriptions (see Appendix 9: Staff File - Employee Evaluation).
6.2.4 The management of the laboratory shall
communicate to personnel their duties, responsibilities and authorities.
The laboratory appoints qualified permanent staff, and the Quality
Manager informs them of their duties, responsibilities, and authorities. The
Quality Manager also supervises the technical and key support staff, monitoring
their work in accordance with the policies and procedures outlined in the
Quality Manual (see Appendix 2: Responsibilities and Authorities).
6.2.5 The laboratory shall have procedure(s) and retain records
for:
a)
determining the competence requirements;
b)
selection of personnel;
c)
training of personnel;
d)
supervision of personnel;
e)
authorization of personnel;
f)
monitoring competence of
personnel.
Laboratory staff report to [a laboratory, organization, or agency].
The Human Resources (HRD) department maintains records for each individual, including
competency requirements for: selection, training, supervision, delegation, and
monitoring competence.
6.2.6 The laboratory shall authorize personnel
to perform specific
laboratory activities, including
but
not limited to, the following:
a)
development, modification, verification and validation of methods;
b)
analysis of results,
including statements of conformity or opinions and interpretations;
c)
report, review and authorization of results.
The laboratory management authorizes specific staff members to conduct
tests and issue test reports. The laboratory manually maintains records of the
authorization, relevant competence, educational and professional
qualifications, training, skills, and experience of all technicians (see
Appendix 9: Training File). Authorization and/or competence information
includes the date the authorization and/or competence was confirmed and the
criteria upon which the authorization and/or competence is based.
6.3 Facilities and environmental conditions
6.3.1 The
facilities and environmental conditions shall be suitable for the laboratory
activities and shall not adversely affect the validity of results.
NOTE Influences that can adversely affect
the validity of results can include, but are not limited to, microbial
contamination, dust, electromagnetic disturbances, radiation, humidity,
electrical supply, temperature, sound and vibration.
The
laboratory is located in [City Name] and [Laboratory Address], and its area is
[Square Meters]. The laboratory's supplies and services (water purification
systems, air supply, vacuum system, sample storage, etc.) are suitable for the
proper and high-quality conduct of the tests performed. Only authorized
personnel (individuals affiliated with the organization or holding a valid
laboratory access card) are permitted entry. They are informed of the purpose
of restricted access to certain areas of the laboratory, the limitations on
work within these areas, and the reasons for these limitations. The
laboratory's environmental conditions are designed to ensure the proper
performance of the tests. The test protocols used by the laboratory include
instructions regarding the appropriate environmental conditions for conducting
these tests (see Appendix 10: Protocols File - Environmental Conditions
Protocol). These instructions cover power sources, lighting, heating,
ventilation, dust, humidity, temperature, and any other environmental conditions.
The laboratory takes appropriate measures to ensure that the results and
quality of tests and measurements are not negatively affected or inaccurate.
6.3.2 The
requirements for facilities and environmental conditions necessary for the
performance of the laboratory activities shall be documented.
The laboratory documents the technical requirements of the premises
and the environmental conditions that may affect the results of tests and
calibration (see Appendix 11: Records File - Environmental Conditions Record).
6.3.3 The
laboratory shall monitor, control and record environmental conditions in
accordance with relevant specifications, methods or procedures or where they
influence the validity of the results.
The laboratory monitors, controls, and records critical environmental
conditions that may affect the quality of results (see No. 10: Protocols File -
Environmental Conditions Protocol), particularly dust, air quality and
humidity, electricity supply and temperature, and sound and vibration levels,
in accordance with its technical activities. When environmental conditions are
unsuitable, the laboratory immediately suspends testing. The laboratory marks
its environmental conditions records with a distinctive label (see Appendix No.
11: Records File - Environmental Conditions Record).
6.3.4 Measures to control facilities shall be implemented, monitored and periodically reviewed and shall
include, but not be limited
to:
a)
access to and use of areas affecting
laboratory activities;
b)
prevention of contamination, interference or adverse influences
on laboratory activities;
c)
effective separation between areas with incompatible laboratory activities.
The
laboratory is constantly ventilated to minimize contamination levels, reduce
humidity, and control temperature. All testing areas are air-conditioned, and
some may be heated as needed to maintain suitable humidity and temperature
levels for specific tests. All laboratory walls and ceilings are made of
smooth, easy-to-clean materials. Work surfaces and floors are made of
non-permeable, easy-to-clean materials. The laboratory provides at least two
linear meters of workspace for each technician. The laboratory effectively
separates adjacent areas where activities are incompatible and takes measures
to prevent cross-contamination. Reference and approved reference materials are
kept separate from sample storage areas. Access to reference and approved
reference materials and sample storage areas are kept separate within the
laboratory and away from sewage to prevent cross-contamination. The separation
of activities is achieved through spatial and temporal separation. Cleaning and
pest control materials are used under strict control and in accordance with
local health and safety requirements (Appendix 10: Protocols File - Laboratory
Waste Disposal Protocol).
6.3.5 When the
laboratory performs laboratory activities at sites or facilities outside its
permanent control, it shall ensure that the requirements related to facilities
and environmental conditions of this document are met.
The laboratory takes additional precautions when using reference
standards and reference materials outside the permanent laboratory premises for
testing, calibration, or sampling. The laboratory establishes appropriate
conditions for the storage, handling, and care of reference standards and
reference materials. Regarding test subjects, the laboratory ensures they have
acclimatized to the test environment for a sufficient period before the test
begins. It also ensures that all necessary information is clearly labeled on
the reference standards and the containers holding the reference materials.
6.4
Equipment
6.4.1 The
laboratory shall have access to equipment (including, but not limited to,
measuring instruments, software, measurement standards, reference materials,
reference data, reagents, consumables or auxiliary
apparatus) that is required for the correct
performance of laboratory activities and that can influence the results.
NOTE 1 A multitude
of names exist
for reference materials and certified reference materials, including reference standards, calibration
standards, standard reference materials and quality control materials. ISO
17034 contains additional information on reference material producers (RMPs).
RMPs that meet the requirements of ISO 17034 are considered to be competent.
Reference materials from RMPs meeting the requirements of ISO 17034 are
provided with a product information sheet/certificate that specifies, amongst
other characteristics, homogeneity and stability for specified properties and,
for certified reference materials, specified properties with certified values,
their associated measurement uncertainty and metrological traceability.
NOTE 2 ISO Guide 33 provides
guidance on the selection and use of reference materials. ISO Guide 80 provides guidance to produce in-house
quality control materials.
The laboratory is equipped with all the sampling,
measurement, and testing equipment required for the correct performance of
tests and/or calibrations (including sampling, test and/or calibration material
preparation, test and/or calibration data processing and analysis), all from
approved reference material manufacturers and reference materials.
6.4.2 When the laboratory uses equipment outside
its permanent control,
it shall ensure
that the requirements for equipment
of this document
are met.
When a laboratory uses equipment at a location outside its permanent
premises, it ensures compliance with the requirements of this Quality Manual.
It also ensures that the equipment is used in an environment suitable for its
proper functioning. All equipment for a given test is specified in the test
procedure (including the allowable tolerances for equipment located outside the
laboratory's permanent premises), ensuring compliance with the requirements of
this Quality Manual and that the equipment is used in an environment suitable
for its proper functioning. All equipment required for each test is described
in each procedure, including its load capacity.
6.4.3 The
laboratory shall have a procedure for handling, transport, storage, use and
planned maintenance of equipment in order to ensure proper functioning and to
prevent contamination or deterioration.
The laboratory uses a secure protocol for handling, transporting,
storing, and using equipment. The laboratory also has plans for maintaining equipment
and preventing contamination or deterioration in order to ensure its proper
functioning (see Appendix 10: Protocols File - Equipment Protocol).
6.4.4 The laboratory shall verify that equipment conforms
to specified requirements before being placed or returned into
service.
When laboratory equipment is out of direct control for a period of
time, the procedures outlined in the equipment manufacturer's manual are used
to verify and ensure that the performance and calibration status of the
equipment is satisfactory before it is returned to service again (see Appendix
12: Procedures and Forms Manual - Procedures and Form for Receiving Equipment
After Exit), in addition to re-examining it by quality control to ensure that
it has become usable and suitable for any testing.
6.4.5 The
equipment used for measurement shall be capable of achieving the measurement
accuracy and/or measurement uncertainty required to provide a valid result.
— Measuring equipment shall be calibrated when: the measurement accuracy or measurement uncertainty affects the validity of the reported
results, and/or
— calibration of the equipment
is required to establish the metrological traceability of the reported
results.
NOTE Types of equipment having an effect on the validity of the reported results can include:
— those used for the direct measurement of the measurand, e.g. use of a balance
to perform a mass measurement;
— those used to make corrections to the measured value, e.g. temperature measurements;
— those used to obtain a measurement result calculated from multiple quantities.
The instruments used for measurement in the laboratory
are capable of achieving the measurement accuracy and/or measurement
uncertainty required to obtain valid results (see Appendix 12: Procedures and
Forms Guide).
Since measurement uncertainty affects the accuracy of recorded
results, the laboratory contracts with accredited companies possessing
technical expertise in calibrating its instruments. These contracts not only
cover the calibration of laboratory equipment but also include the calibration
of metrological traceability devices to meet the requirements of ISO 17025 (see
No. 11: Records File - Calibration Certificates and Records).
6.4.6 The laboratory shall establish a calibration programme, which shall be reviewed and adjusted as necessary in order to maintain
confidence in the status of calibration.
The laboratory has a calibration program, which is reviewed and
modified annually in cooperation with the companies responsible for measuring
and calibrating the instruments in order to maintain confidence in the
calibration status (see Appendix No. 11: Records File - Calibration
Certificates and Records).
6.4.7 All
equipment requiring calibration or which has a defined period of validity shall
be labelled, coded or otherwise identified to allow the user of the equipment
to readily identify the status of calibration or period of validity.
The laboratory affixes a label to instruments requiring calibration to
indicate the calibration status and/or operating status, and the date for which
recalibration is appropriate. Calibration labels have a writable top surface
and a pressure-sensitive adhesive underside (see Appendix 12: Procedures and
Forms Manual - Calibration Label Form FT.22.0). The calibration label can be
obtained from the calibration company or designed in-house. It includes the
calibration personnel's information, the date of calibration, the date of
subsequent calibration, and the instrument's identification number. The
laboratory marks instruments that have failed calibration or are considered out
of service, indicating which part of the instrument was not calibrated.
6.4.8 Equipment that has been subjected to overloading or mishandling, gives questionable results,
or has been shown
to be defective or outside
specified requirements, shall be taken out of service. It shall be isolated to prevent its use or clearly
labelled or marked as being out of service until it has been verified to
perform correctly. The laboratory shall examine the effect of the defect or
deviation from specified requirements and shall initiate the management of
nonconforming work procedure (see 7.10).
Equipment that has been overloaded, misused,
gives inaccurate results, is found to be faulty, or operates outside its
specified limits shall be taken out of service, clearly marked, and properly
stored until it has been repaired, calibrated, and tested to ensure that all
tests performed on it are conducted correctly. Out-of-service equipment shall
be marked with distinctive signs as described in section 6.4.8.
6.4.9 When intermediate checks are necessary
to maintain confidence in the performance of the equipment, these checks shall be carried
out according to a procedure.
Form
FT.20.0 outlines the preventive maintenance plan for the instruments and includes
various tests (see Appendix 12: Procedures and Forms Manual). Internal quality
control tests are specified for each testing method (see Appendix 10: Protocol
File). When intermediate tests are required to maintain confidence in the
instrument calibration status, the laboratory performs them periodically
according to the Calibration and Maintenance Request Procedure (see Appendix
12: Procedures and Forms Manual).
6.4.10
When calibration and reference
material data include reference values or correction factors, the laboratory shall ensure the reference
values and correction factors are updated and implemented, as appropriate, to
meet specified requirements.
The
laboratory updates the reference values and correction coefficients as
appropriate to meet the specified requirements.
6.4.11
The laboratory shall take practicable measures
to prevent unintended adjustments of equipment
from invalidating results.
The
laboratory protects its testing equipment, including hardware and software,
from modifications that would invalidate results-based testing and calibration
protocols and the manufacturer's operating instructions. It also protects the
equipment by implementing policies that allow only trained and qualified
personnel to operate it, and access to the laboratory is restricted to
authorized personnel. Computer software protection includes password protection
for critical files and programs, restricting access to these to authorized
personnel only.
6.4.12
Records shall be retained
for equipment which can influence
laboratory activities. The records shall include the following, where applicable:
a)
the identity of equipment, including
software and firmware
version;
b)
the manufacturer's name, type identification, and serial number or other unique identification;
c)
evidence of verification that equipment conforms
with specified requirements;
d)
the current location;
e)
calibration dates, results of calibrations, adjustments,
acceptance criteria, and the due date of the
next calibration or the calibration interval;
f)
documentation of reference
materials, results, acceptance criteria, relevant dates and the period of validity;
g)
the maintenance plan and maintenance carried out to date, where relevant to the performance of the equipment;
h)
details of any damage, malfunction, modification to, or repair of, the equipment.
The
laboratory maintains a database (records) for each instrument component
relevant to the tests performed in the laboratory (see Appendix 13: Instrument
Instruction Protocol). The records include: the identity of the instrument
components (and their software); the manufacturer's name, type identifier,
serial number, and/or other distinguishing identifier; verification that the
instruments conform to the required specifications (see subsection 6.4.4); the
current location, where applicable; the manufacturer's instructions, if
available, or a reference to their location; calibration dates and results,
copies of reports, certificates of all calibrations and modifications,
acceptance criteria, and the due date for the next calibration; maintenance
performed to date and the maintenance plan (including calibration); and any
damage, malfunctions, modifications, or repairs to the instrument (see Appendix
14: Maintenance and Calibration File).
6.5
Metrological traceability
6.5.1 The
laboratory shall establish and maintain metrological traceability of its
measurement results by means of a documented unbroken chain of calibrations,
each contributing to the measurement uncertainty, linking them to an
appropriate reference.
NOTE 1 In ISO/IEC Guide 99, metrological traceability is defined as the
“property of a measurement result whereby the result can be related to a
reference through a documented unbroken chain of calibrations, each
contributing to the measurement uncertainty”.
NOTE 2 See Annex A for additional information on metrological traceability.
The
laboratory calibrates testing equipment for sub-measurements or auxiliary
measurements (e.g., environmental conditions) that significantly affect the
accuracy or validity of test results before putting it into service. It also
calibrates and/or verifies all measuring and testing equipment that affects
test accuracy or validity before putting it into service. As stated in section
6.4, the calibration procedure establishes a specific equipment maintenance
program and ensures that calibration is carried out according to the required
specifications. The calibration program includes a system for selecting, using,
calibrating, inspecting, monitoring, and maintaining: measurement standards; reference
standards used as industry measurement standards; and the equipment used for
testing and calibration (see Appendix 14: Maintenance and Calibration File).
The laboratory maintains records for each standard, including: supplier, purity
grade, batch or paste; preparation or verification dates; measurements of
weights, volumes, time intervals, temperatures, pressures, and related
calculations; and related processes (e.g., pH adjustment and sterilization).
The results of the verification process and the identification of the
individuals involved are documented. The laboratory affixes a label to the
reagents prepared within its premises, including the following information:
substance, strength, solvents, any special precautions or hazards, restrictions
on use, and the preparation and expiration dates. The person responsible for
preparing the reagent is identified either from the label or from the records.
6.5.2 The laboratory
shall ensure that measurement results
are traceable to the International System of Units (SI) through:
a)
calibration provided by a competent
laboratory; or
NOTE 1 Laboratories fulfilling the requirements of this document
are considered to be competent.
b)
certified values of certified reference materials provided
by a competent producer with stated metrological traceability to the SI; or
NOTE 2 Reference material producers fulfilling the requirements of ISO 17034
are considered to be competent.
c)
direct realization of the SI units ensured
by comparison, directly
or indirectly, with national or international standards.
NOTE 3 Details of practical realization of the definitions of some important
units are given in the SI brochure.
The laboratory designed and implemented an instrument
calibration program to ensure the traceability of calibration measurements
relative to International System of Units (SI). The laboratory guarantees
traceability by utilizing calibration services from reputable laboratories with
proven measurement and traceability capabilities. Calibration certificates
issued by these laboratories demonstrate a correlation to a primary or constant
standard that achieves an SI unit through a continuous series of calibrations.
Calibration certificates issued by these laboratories contain the measurement
results, including measurement uncertainty and a statement of conformity to the
specified metrological standard (see also subsection 7.8.4).
ISO 17025 certified calibration laboratories are
competent to provide appropriate calibration services. Traceability to SI units
can be achieved by reference to a suitable primary standard or to a natural
constant whose value is known, in terms of the relevant SI unit. The term
"specified metrological standard" means that the calibration
certificate must clearly state the standard against which the measurements were
compared, either by including the standard or by giving an unambiguous
reference to it. When the terms "international standard" or
"national standard" are used in relation to traceability, these
standards are assumed to meet the characteristics of primary standards for
achieving SI units. The laboratory maintains certificates for all approved
reference standards, measuring equipment, or reference materials used to ensure
traceability (see Annex 10: Protocol File - Traceability Protocol). (Metrologist).
6.5.3 When
metrological traceability to the SI units is not technically possible, the
laboratory shall demonstrate metrological traceability to an appropriate
reference, e.g.:
a)
certified values of certified reference
materials provided by a competent
producer;
b)
results of reference measurement procedures, specified
methods or consensus standards that are clearly described and accepted as
providing measurement results fit for their intended use and ensured by
suitable comparison.
If
national measurement standards cannot be applied, the laboratory provides
satisfactory evidence of the correlation of results, for example, through
participation in an appropriate interlaboratory comparison program, proficiency
testing, or through the manufacturer's regional representative. The laboratory
adheres to reference standards, such as those for thermometers and weights, in
accordance with national or international standards (e.g., CDC and NIST).
6.6
Externally provided products and services
6.6.1 The
laboratory shall ensure that only suitable externally provided products and
services that affect laboratory activities are used, when such products and
services:
a)
are intended for incorporation into the laboratory’s own activities;
b)
are provided, in part or in full, directly to the customer by
the laboratory, as received from the external provider;
c)
are used to support the operation of the laboratory.
NOTE
Products can include, for example, measurement standards and equipment,
auxiliary equipment, consumable materials and reference materials. Services can
include, for example, calibration services, sampling services, testing
services, facility and equipment maintenance services, proficiency testing
services and assessment and auditing
services.
The
laboratory ensures that the services (calibration services, sampling services,
testing services, facility and equipment maintenance services, proficiency
testing services, and evaluation and auditing services) and products (measuring
standards and equipment, auxiliary devices, consumables, materials, and
reference materials) provided by external service providers are suitable and
support the operation of the laboratory (see Appendix 14: Maintenance and
Calibration File) and (see Appendix 10: Protocol File - External Protocol
Products and Services Provided)
6.6.2
The laboratory shall have a procedure
and retain records
for:
a)
defining, reviewing and approving the laboratory’s
requirements for externally provided products and services;
b)
defining the criteria for evaluation, selection, monitoring
of performance and re-evaluation of the external providers;
c)
ensuring that externally provided products and services
conform to the laboratory’s established requirements, or when applicable, to
the relevant requirements of this document, before they are used or directly
provided to the customer;
d)
taking any actions
arising from evaluations, monitoring of performance and re-evaluations of the external providers.
The laboratory uses the Externally Provided Products and Services
Protocol (see Appendix 10: Protocol File) to define, review, and approve the
laboratory's requirements for externally provided products and services;
establish evaluation and selection criteria; monitor performance; reassess
external service providers; ensure that externally provided products and
services comply with the laboratory's defined requirements; and take corrective
action for any deviations arising from the evaluation, performance monitoring,
and reassessment processes of external service providers.
6.6.3 The laboratory shall communicate its requirements to external providers
for:
a)
the products and services to be provided;
b)
the acceptance criteria;
c)
competence, including any required qualification of personnel;
d)
activities that the laboratory, or its customer,
intends to perform
at the external provider's premises.
The laboratory communicates its requests for products and services to
external service providers annually or as needed, including the criteria for
acceptance, the required qualifications of the staff performing the work, and
the activities that the laboratory or its client intends to carry out at the
external provider's premises.
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