TRAC 2572 2-9-99

for the Monitoring of Foodstuffs Intended for Human

Consumption, O.J. L372 of 31.12.1985.
[ 2] Precision of Test Methods, Geneva, 1994, ISO5725 ( pre-
vious editions were issued in 1981 and 1986).
[ 3] M. Thompson, R. Wood ( Editors), The International
Harmonised Protocol for the Prociency Testing of
( Chemical ) Analytical Laboratories, Pure Appl. Chem.
65 ( 1993) 2123 ( also published in J. AOAC Int. 76
( 1993) 926).
[ 4] M. Thompson, R. Wood ( Editors ), Guidelines on internal
quality control in analytical chemistry laboratories, Pure
Appl. Chem. 67 ( 1995) 649.
[ 5] Report of the 21st Session of the Codex Committee on
Methods of Analysis and Sampling, FAO, Rome, 1997,
ALINORM 97/ 23A.
[ 6] Council Directive 93/ 99EEC on the Subject of Addi-
tional Measures Concerning the Ofcial Control of Food-
stuffs, O.J. L290 of 24.11.1993.
[ 7] Procedural Manual of the Codex Alimentarius Commis-
sion, 10th Edition, FAO, Rome, 1997.
[ 8] W. Horwitz ( Editor ), Protocol for the design, conduct and
interpretation of method performance studies, Pure Appl.
Chem. 70 ( 1998) 855.
[ 9] W. Horwitz ( Editor ), Protocol for the design, conduct and
interpretation of method performance studies, Pure Appl.
Chem. 67 ( 1995) 331.
[ 10] MAFF Validated Methods for the Analysis of Foodstuffs:
VOA^ Introduction, General Considerations and Analyt-
ical Quality Control, J. Assoc. Publ. Anal. ( in prepara-
tion).
[ 11] W. Horwitz, Evaluation of analytical methods used for
regulation of foods and drugs, Anal. Chem. 54 ( 1982)
67A.
[ 12] Report of the 22nd Session of the Codex Alimentarius
Commission, FAO, Rome, 1997, ALINORM 97/ 37.
[ 13] S. Ellison, M. Thompson, P. Willetts, R. Wood ( Editors),
Harmonised Guidelines for the Use of Recovery Informa-
tion in Analytical Measurement, Pure Appl. Chem. ( in
press).
[ 14] Validation of Chemical Analytical Methods, NMKL Sec-
retariat, Helsinki, 1996, NMKL Procedure No. 4.
[ 15] Method Validation ^ A Laboratory Guide, EURACHEM
Secretariat, Laboratory of the Government Chemist, Ted-
dington, 1996.
[ 16] An Interlaboratory Analytical Method Validation Short
Course developed by the AOAC INTERNATIONAL,
AOAC INTERNATIONAL, Gaithersburg, MD, 1996.
[ 17] Validation of Methods, Inspectorate for Health Protec-
tion, Rijswijk, Report 95-001.
[ 18] A Protocol for Analytical Quality Assurance in Public
Analysts' Laboratories, Assoc. Publ. Anal., Shefeld,
1986.
Step-by-step implementation of a quality
system in the laboratory
Maria Joa o Benoliel
Empresa Portuguesa das Aguas Livres S.A., Laboratorio Central da EPAL, Rua do Alviela 12,
P-1170-012 Lisboa codex, Portugal
In recent years laboratories have undergone
huge transformations due to the technologi-
cal development of inspection and testing
equipment; the introduction of computerised
and automated systems; keen competitive-
ness between companies/ laboratories as a
result of demand within Europe and on the
international market; and greater consumer
awareness of the quality of the products avail-
able. Laboratory accreditation, though a vol-
untary process, is formal recognition by an
accreditation body of the laboratory's compe-
tence to carry out certain tests. This article
presents those aspects which should be
taken into account in the step-by-step imple-
mentation of a quality system and also makes
reference to the requirements for the opera-
tion of accredited laboratories in accordance
with European Standard EN 45001. z1999
Elsevier Science B.V. All rights reserved.
Keywords: Accreditation; Quality assurance system;
Validation
1. Introduction
Quality is a daily, on-going challenge contributing
to technological and scientic development. Quality
has also become a factor of competitiveness between
laboratories and companies. In recent years there has
been growing concern about quality-related aspects as
a result of the creation of the internal European market
accompanied by the trend toward globalisation of the
0165-9936/99/$ ^ see front matter 1999 Elsevier Science B.V. All rights reserved.
PII: S 0 1 6 5 - 9 9 3 6 ( 9 9 ) 0 0 1 6 8 - 5
632 trends in analytical chemistry, vol. 18, nos. 9+10, 1999
TRAC 2588 2-9-99
economy and free trade and, at the same time, by
greater consumer awareness.
Implementation of a quality system enables compa-
nies to be better organised and to introduce more
efcient work methods, thereby leading to higher
protability. Accreditation is the best way of demon-
strating or proving that the laboratory is properly oper-
ated and constitutes formal recognition by an ofcial
accreditation body of the laboratory's competence to
undertake certain tests.
The general and specic requirements for proper
operation of an accredited laboratory are described
in Standard EN45001 [ 1]. There are additional stand-
ards, legislation and specic Guides for each of the
aspects whose implementation has to be documented
and validated, such as, for example, EN 45002, EN
30011, ISO/ IEC Guide 25, 30 and 31, WELAC p
EUROCHEM [ 2,3,5^7].
The requirements for obtaining accreditation are
assessed by means of quality audits which, in accord-
ance with ISO 8402 [ 8], are dened as ``a systematic
and independent exam to determine whether quality-
related activities and results satisfy pre-established
provisions and whether those are being applied effec-
tively and are adequate to attain the desired objec-
tives''.
Implementation of a quality assurance system in a
laboratory is a slow and costly process but has innu-
merable advantages not only internally within the lab-
oratory but also externally. Some of those advantages
are:

Better internal organisation through the formalisa-

tion and application of procedures, leading to
process optimisation;

Denition of duties and responsibilities of all key

staff;

Detection and correction of errors;

Proof of the competence and quality of the work;

Better image of the laboratory vis-a-vis the

customer;

Easier handling of customers' complaints.

2. Implementation of the quality system
Planning objectives and actions is deemed to be of
enormous importance when implementing the quality
system in the laboratory to be accredited. In this con-
text, and in accordance with the tests for which accred-
itation is sought, adequacy of the premises as well as of
available human and technical resources will have to
be assessed. As this process will necessarily entail
expenditure, a cost estimate should be drawn up, bear-
ing in mind, however, the advantages of accreditation
both for the laboratory and/ or the company and the
need to explain this to, and involve, the company's or
the laboratory's board of management.
The main phases of the quality system implementa-
tion process may be dened as follows:

Planning;

Responsibility of the management of the labora-

tory/company;

Training of key staff involved in the accreditation

process;

Preparation of the documentation system;

Preparation of the quality manual (QM) on the

basis of the criteria laid down in Standard EN
45001 [1]. QM will dene the laboratory's quality
policy and objectives and outline the quality system
framework. In the QM reference must be made to
all of the quality system documentation and care
must be taken to ensure all of the information is
correctly inter-linked;

Preparation and implementation of procedures, i.e.

Administrative,
General and calibration techniques,
Operation of the equipment;

Testing methods whenever these differ from

standardised methods;

Validation of analytical methods and implementa-

tion of the analytical quality control system;

Conducting internal audits to assess whether the

quality guarantee system complies with Standard
EN 45001 [1].
2.1. Planning
The establishment of a plan, an activity schedule
and a deadline for formalising the accreditation appli-
cation will ensure the accreditation process is con-
ducted more efciently and consequently with greater
staff support. It is of the utmost importance to involve
all staff members, each of whom should be given
clearly dened duties and deadlines.
All action should be co-ordinated and stimulated
by the laboratory representative in charge of qual-
ity.
trends in analytical chemistry, vol. 18, nos. 9+10, 1999 633
TRAC 2588 2-9-99
2.2. Management responsibility
The most senior management body in the laboratory
or in the company to which the laboratory belongs has
a fundamental role to play in the quality system. That
body is responsible for dening quality policy laying
down a set of objectives aimed at satisfying the cus-
tomer and the internal requirements of the company.
That body should also be responsible for the follow-
ing:

Divulging the quality policy to the whole of the

organisation;

Appointing a representative vested with the re-

sponsibility and authority necessary to ensure that
the system is implemented and maintained;

Ensuring the necessary conditions are available to

achieve the stated objectives, particularly in terms
of human and technical resources and installations;

Making known the QM as this is the document

which explains the quality policy and objectives
based on the provisions of the Standard being
applied.
2.3. Training on quality assurance in laboratories
Professional training on the subject of quality and
particularly on accreditation is of fundamental impor-
tance. Background training focussed on aspects such
as basic concepts, objectives and advantages of quality
assurance and an analytical quality control system, as
well as on the requirements laid down in the Standards,
helps develop skills, attitudes and performance and is
therefore instrumental in the success of the action plan
leading up to the laboratory's accreditation.
In addition to focusing on quality aspects, it is nec-
essary to identify what background training is required
by different staff members in technical aspects which
have to be implemented within the scope of the accred-
itation process, such as instrument calibration, method
validation, calculation of uncertainties, etc.
2.4. Documentation
The QM is the basic document for laboratory
accreditation and its purpose is to describe the quality
system being developed and implemented as well as
methods adopted to ensure its fullment on the basis of
the provisions of the reference standard.
All or any documentation needed for a full under-
standing of the QM should be attached to it, such as
forms, test methods, general technical and calibration
procedures, administrative procedures, equipment
operating procedures, etc.
Standards, Directives, Regulations, quality records,
test reports, etc. are also part of the quality system
documentation.
The QM should be drawn up or co-ordinated by the
person in charge of quality and it is that person who,
for each requirement, should determine what docu-
mentation is needed and create work groups for the
purpose.
The documentation, i.e. the QMand its attachments,
should be easy to consult, control and/ or le.
2.5. Validation of analytical methods and
implementation of the analytical quality control
system
The purpose of a testing laboratory is to measure,
examine, test, calibrate or generally determine the
characteristics or behaviour of materials or products.
For this purpose the laboratory may have standardised
methods or develop in-house methods suitable for the
test that is to be conducted.
Whenever the laboratory utilises in-house methods
it will have to undertake a validation process in order
to demonstrate that in the conditions under which the
laboratory is operating the results will be credible and
suitable for the intended quality. Thus, a laboratory
will have to dene the degree of renement that is
required for a specic test and carry out validation
studies such as:

Range of work/linearity;

Detection and quantication limits;

Repeatability and accuracy;

Sensitivity;

Acceptance criteria.
Considering that the purpose of the laboratory is to
prevent analytical errors as well as to control their
occurrence, it is fundamental to implement analytical
quality control measures both internally ( e.g. control
charts ) and externally ( e.g. certied reference materi-
als, participation in intercalibration tests).
This work should be conducted by the professional
staff who undertake the analyses and by their superi-
ors, in accordance with the methodologies existing in
Standards. All of the ndings should be recorded and
led so as to validate the studies and respective con-
clusions. Those technical procedures deemed to be
essential will be drawn up on the basis of this technical
634 trends in analytical chemistry, vol. 18, nos. 9+10, 1999
TRAC 2588 2-9-99
work but always bearing in mind that a quality system
should comply with the rule that it is `documented and
is demonstrable'.
This phase will have to be conducted in parallel
with preparation of the documentation and with imple-
mentation of the laboratory's quality assurance system
and all of the work should be completed simultane-
ously.
2.6. Internal audits
Before formally applying to the ofcial national
body for accreditation, the laboratory should conduct
an internal audit of the quality system being imple-
mented and this should cover management and organ-
isation as well as technical aspects.
The purpose of this audit is to assess quality oper-
ations, detect the real situation and take corrective
action in the event of detecting situations of non-com-
pliance.
It is deemed advisable to have the in-house audit
conducted by professional external auditors with
experience in laboratory accreditation and in the
type of tests for which accreditation is sought. This
methodology will allow for total impartiality of the
assessment process.
3. General criteria for the operation of
the laboratory
The general criteria governing the operation of an
accredited laboratory are established at an European
level in Standard EN45001 [ 1] and at an international
level in Guide ISO/ IEC 25 [ 4].
It behoves each laboratory to demonstrate and prove
that its activity is conducted in accordance with the
criteria described in the Standard so as to have its
technical competence recognised, through accredita-
tion, to carry out tests in a specic eld. The quality
system should be documented in the QM. Under these
circumstances, in the preparation of the QM, it is
deemed to be more efcient to group together the var-
ious criteria for the attainment of common objectives,
without prejudice to being organised in accordance
with the provisions laid down in the Standards
which are being followed:

Quality of the test/result;

Efciency of the organisation;

Maintenance of the quality system.

3.1. Factors having a direct inuence on the result
3.1.1. Staff
The laboratory should have staff in a sufcient num-
ber to ensure normal conduct of business and staff
should have the necessary academic qualications,
technical training and experience for the duties allo-
cated to them within the scope of the quality system.
The laboratory should:

Dene the minimum qualications and minimum

number of years of experience required for each job
and demonstrate that staff meet those requirements;

Describe the main duties of the various members of

the professional laboratory staff engaged in activ-
ities related with the accreditation process;

Dene each staff member's area of responsibility as

well as the academic qualications required to
assume that responsibility;

Maintain up-to-date staff records containing curri-

cula vitae and all or any relevant information about
their professional or vocational training;

Demonstrate that staff are conscientious and have

been informed of the need to guarantee professional
secrecy in the conduct of their duties, it being
advisable to obtain from them signed statements of
condentiality;

Carry out an annual survey of staff training

requirements and draw up a staff re-training plan.
A record must be kept of all training, indicating the
contents of the training programme, its duration,
names of the monitor and staff involved;

Keep a list of the signatures and initials of the

persons with responsibilities within the scope of the
quality system;

Keep a training requirement plan and an up-to-date

training plan.
3.1.2. Environment and premises
The workplace should have adequate environmen-
tal and safety conditions to ensure good working con-
ditions and the conduct of tests with the required pre-
cision. The areas of the laboratory and of the premises
where the tests to be accredited are to be conducted
should be properly identied. The following aspects
are deemed to be particularly important:

Access to the premises should be out of bounds to

anyone not working in the laboratory and all or any
measures required to guarantee complete conden-
tiality of the tests should be authorised and taken;
trends in analytical chemistry, vol. 18, nos. 9+10, 1999 635
TRAC 2588 2-9-99

The laboratory should have safety devices ready to

hand at clearly indicated locations, such as eye-
washes; showers; emergency exits opening in-
wards; individual protective devices; emergency
telephones, re detectors, re extinguishers, etc.

Adequate ventilation and extraction equipment,

care to be taken to have it located so as not to
interfere with the operation of certain equipment
such as scales;

Lighting located so as to adequately illuminate each

work area and a source of power matching the
characteristics of the equipment to be installed.
More sensitive equipment should be provided with
tension stabilisers and be earth wired;

The materials used to line walls, ceilings and oors

should be easy to clean and disinfect and should be
suitably resistant to chemicals;

Dene and control environmental conditions and

record them whenever testing methods so demand.
For example, installation of thermohydrographs in
areas where temperature and humidity control is
required;

Toxic and dangerous products should be handled in

laminar ow systems;

Dene and guarantee hygiene and safety measures

and ensure all members of staff are aware of them;

Provide separate areas for storing reagents, sam-

ples, calibration standards and certied reference
materials, and for washing and decontaminating
material, preparing samples and reagents, under-
taking analyses, etc.;

In the case of microbiological laboratories the

following aspects are particularly important: rooms
with rounded corners; protection of piping and
pipes in appropriate channels; no plants, posters or
interior blinds; clean material never overlapping
with the path of contaminated materials (`marching
ahead' principle) [9].
3.1.3. Sample handling
This can include questions like:

Procedure for taking, preserving and/or storing

samples;

Procedure for receiving samples and moving them

around;

Samples tagging system to guarantee control and

condentiality.
3.1.4. Testing methods
The choice of testing method is a fundamental factor
to obtain results. When making that choice the follow-
ing are some of the aspects that need to be taken into
consideration: type of sample; parameters to be deter-
mined; range of concentration, quality requirements
and available nancial, material and human resources.
Test laboratories need to be able to guarantee they
have at least the following technical prerequisites:

Identify the tests to be accredited and the products

to be subjected to testing;

Identify the standardised methods and describe in-

house methods;

Ensure the most up-to-date version is used;

Procedures for washing material;

Validate in-house methods and ensure standardised

methods are fully followed to the letter;

Analytical calibration standards, calculus function,

blanks, analytical quality control, recoveries;

Repeatability and accuracy control;

Acceptance/rejection criteria;

Validation of results;

Uncertainties;

Validation of software.
3.1.5. Equipment
The laboratory should be provided with all of the
inspection, measurement and test equipment neces-
sary and suitable for the tests to be conducted and
up-to-date records of all equipment should be main-
tained. The operating condition of the equipment
should be veriable from maintenance records. The
laboratory should have an annual calibration plan for
all of the inspection, measuring and testing equipment
and that plan should indicate the following:

Identication of the equipment;

Interval between calibrations and date of the last

and of the next calibration;

Reference to the calibration certicate and respec-

tive acceptance criteria;

Proof of acceptance of the calibration certicates.

Responsibility should be assigned for drawing up
and approving the calibration plan, for accepting the
respective certicates on the basis of previously
dened acceptance / rejection criteria, and for monitor-
ing fullment of the calibration plan.
636 trends in analytical chemistry, vol. 18, nos. 9+10, 1999
TRAC 2588 2-9-99
3.1.6. Test reports
Test results should be recorded in a test report which
should set out in a clear, precise form all the informa-
tion stipulated in Standard EN45001 [ 1] as well as all
or any information which make it easier for the cus-
tomer to interpret and understand the results. The
report should not contain any appraisal or recommen-
dation of a subjective nature based on the results.
3.2. Efciency of the organisation
3.2.1. Management and organisation

Proof of legal existence;

Proof of impartiality, independence and integrity,

the rendering of consultancy services on the basis
of tests conducted by the laboratory to be strictly
forbidden;

Denition of individual duties and responsibilities;

Presentation of the organisation chart of the

laboratory or of the company to which the
laboratory belongs;

Assignment of responsibilities;

Minimum requirements to head teams and mini-

mum academic qualications and experience for
each job.
3.2.2. Document control

Denition of documentation and responsibilities;

Identication of documents in an unambiguous

manner;

Preparation, verication and approval by qualied

personnel;

Updating and distributing documentation to ensure

obsolete or annulled documents are replaced;

Filing.
3.2.3. Quality records
All of the documents relating to the conduct of qual-
ity system activities are deemed to be quality records
including training and calibration plans, laboratory
control charts, computerised records of laboratory
equipment, records of environmental conditions, etc.
A system of identication, compilation, indexing, and
place and time of ling should be put in place.
3.2.4. Complaints
A complaints book relating to tests results and/ or
laboratory services should be available such as a pro-
cedure describing how to handling of complaints and
response period to the customer.
3.2.5. Subcontracting

Dene the conditions for subcontracting;

Identify subcontracted tests in the report.

3.2.6. Co-operation

Arrangements allowing for customers to watch the

tests;

Mechanisms for the return of samples;

Participation in interlaboratory tests.

3.3. Maintenance and improvement of the quality
system
3.3.1. Internal quality audits
Maintenance of the whole of the quality system is
guaranteed by means of internal quality audits which,
by sampling, identify deviations from what has been
established. In this connection we would stress:

Preparation and approval of an annual audit plan;

Denition of the requirements for auditors;

Preparation of audit report;

Implementation of corrective action whenever

noncompliance is detected;

Termination of quality audit.

3.3.2. Review of the quality system
The quality system should be reviewed periodically
on the basis of a report drawn up by the person in
charge of quality, proposing measures for improve-
ment of the system. An improvement plan should
then be drawn up, dening action to be taken, the
persons to be in charge and deadlines.
4. Conclusions
Quality management in a laboratory should be con-
sidered to be part of overall management and should
be clearly dened and monitored. Aspects to which the
laboratory must pay special attention, not only during
implementation of the quality system but particularly
after accreditation, include the following: training
staff in methods to improve quality; promoting
adequate modernisation of equipment and methods;
and guaranteeing reliability of results.
The quality system in an accredited laboratory, and
therefore all of the documentation, has to be imple-
mented so as to comply with Standard EN 45001
trends in analytical chemistry, vol. 18, nos. 9+10, 1999 637
TRAC 2588 2-9-99
[ 1]. It must also be kept very straightforward so as to
be easily understood by all staff and easy to monitor. A
quality management system aims at satisfying the lab-
oratory's interests but also the customer's needs and
expectations.
All costs arising from laboratory accreditation have
to be seen as costs which would otherwise have had to
be borne as a result of utilising incorrect testing meth-
ods and the ensuing commercial and legal consequen-
ces of that practice. Quality improvement programmes
should therefore include a cost reduction component
arising from making the staff more aware of the need
for quality and the desire to resolve problems. Take
corrective action and follow through results.
References
[ 1] EN 45001, General Criteria for the Operation of Testing
Laboratories, European Standardisation Committee,
Brussels, 1989.
[ 2] EN45002, General Criteria for the Assessment of Testing
Laboratories, European Standardisation Committee,
Brussels, 1989.
[ 3] EN 30011, Guidelines for Auditing Quality Systems,
European Standardisation Committee, Brussels, 1989.
[ 4] ISO/ IEC Guide 25, General Requirements for the Com-
petence of Calibration and Testing Laboratories, Interna-
tional Organization for Standardization, Geneva, 1990.
[ 5] ISO/ IEC Guide 30, Terms and Denitions Used in Con-
nection with Reference Materials, International Organi-
zation for Standardization, Geneva, 1992.
[ 6] ISO/ IEC Guide 31, Contents of Certicates of Reference
Materials, International Organization for Standardiza-
tion, Geneva, 1981.
[ 7] WELAC and EURACHEM, Accreditation for Chemical
Laboratories: Guidance on the Interpretation of the EN
45000 Series of Standards and ISO Guide 25, WELAC
Guidance Document No. 2 and EURACHEM Guidance
Document No. 1, Teddington, 1993.
[ 8] ISO 8402, Quality Management and Quality Assurance ^
Vocabulary, International Organization for Standardiza-
tion, Geneva, 1994.
[ 9] EAL-918, Accreditation for Laboratories Performing
Microbiological Testing, 1995.
The implementation of accreditation in a
chemical laboratory
L. Cortez
Instituto Portugue s da Qualidade, Rua Anto nio Gia o 2, 2829-513 Caparica, Portugal
This article describes the current state of the
art in the accreditation of chemical laborato-
ries, both in Europe and world-wide, empha-
sising the most common discussion topics.
The results of recent prociency testing in
chemical laboratories are summarised to
draw conclusions on the performance of
accredited laboratories. z1999 Elsevier Sci-
ence B.V. All rights reserved.
Keywords: Accreditation; Chemical laboratory;
Quality assurance; Prociency testing
1. Introduction
Although accreditation has only become a familiar
word for the scientic community and society in
recent years, its beginnings go back to the 1970s
( and before that, in Australia). One of the starting
points was the problem faced by some National Met-
rology Institutes (NMIs) with growing requests from
industry to continue providing them with reliable cal-
ibration services, while the NMIs needed time to
devote themselves to scientic investigations. This
led to a compromise in which they recognised some
laboratories competent enough to performcalibrations
on their behalf, through an assessment of their capa-
bility to provide reliable and traceable services.
In Europe, the New Approach and the Global
Approach Directives were responsible for the gener-
alised development of accreditation systems, based on
the EN 45001 standard [ 1], derived from the existing
ISO/ IEC Guide 25 [ 2], which had been used until
then.
Laboratory accreditation can be dened [ 3] as a
formal recognition by an authoritative body of the
technical competence of a laboratory to perform tests
or calibrations. This recognition is given by an accred-
itation body, which acts as a third party between the
638 trends in analytical chemistry, vol. 18, nos. 9+10, 1999