An analysis of the competence,
qualifications, responsibilities and
authorisations of personnel involved in
testing, investigations and expert
judgement.
Technical Secretariat
BAM; Unter den Eichen 87; D-12205 Berlin; Germany
Phone: +(49 30) 81 04 37 62; Fax: +(49 30) 81 04 46 28
No 2/99
Chapters
0. Foreword
1.
2.
3.
4.
5.
6.
7.
Introduction
Review of the existing documents and current practice
Description of the qualification of personnel
Personnel carrying out expert judgement
Personnel working in the fields of R&D and other non routine activities
Follow-up of personnel qualifications
Competence, qualifications, responsibilities and authorisation
Annex 1 Job description
Annex 2 Bibliography
Annex 3 Quotations
0. Foreword
Laboratories have been confronted with an increasing number of additional requirements
since accreditation has come into force as means to prove competence. Laboratories
have worked successfully for nearly one century without accreditation and without a
quality system according to new quality standards and quality guidelines on the basis of
competent and well trained personnel. Adequate instrumentation, well trained personnel
in combination with a responsible management are fundamental to a sound laboratory.
Impartiality and independence in combination with competence have been the
requirement for a recognized laboratory.
Experience with the accreditation process gained in a number of laboratories led to the
idea to investigate the role of personnel in relation to the „Quality of a laboratories’ work“.
Accreditation as means for recognition of competence has been focusing more on
paperwork than on management abilities and human properties. But after having gained
some experience in accreditation it has developed a general awareness of the importance
of personnel qualifications beside quality management. Assessment of technical
competence in connection with accreditation were introduced in laboratory activities. A
demand arose for a systematic way or a tool in order to tackle this subject. This document
deals with many aspects of technical competence as far as laboratory activities including
R&D are concerned.
This document is not at all a compilation of requirements on personnel. Furthermore, it is
the intention to give ideas and hints for the improvement of the human factors. In many
cases a single person is not required as the problems are too complex so that teamwork
is more efficient. And big laboratories also have other requirements than small
laboratories and multidiscipline laboratories cannot be compared with R&D laboratories
with respect to the qualification of their staff.
The terminology related to the personnel is different in different countries. The reader
should focus the interest more on the content of the descriptions given than on the terms
used.
1
1 Introduction
It is generally agreed that personnel performing specific tasks in laboratories shall be
qualified on the basis of appropriate education, training, experience and/or skills, as required
by the management or as resulting from the duties. In this context there are several
„problems“.
The first problem arises when relating this demand to Europe as an area that should have
a harmonized approach in the field of services offered to clients. When talking in Europe
about a professional or academic level of education or about degrees and titles it becomes
evident that in the European countries there are different philosophies and systems of
education and vocational training. The level after having finished an educational path and the
meaning of a title connected with this education differs from country to country. They are not
directly comparable and additional clarifications are needed in order to achieve
comparability. In practice this situation may call for some kind of up/or down grading of titles
or degrees, which is not a simple task and obviously a delicate matter.( Conclusion of
Council 1996 - 05 - 06 ( 96/C 195/02))
The second problem arises from the following situation: the absence of harmonized
European criteria necessary to assess the titles and degrees coming from different schools
and countries in Europe. There is a need for criteria that take into account the level of the
theoretical and practical competence of a person who has completed a particular education.
The third problem is connected with the acceptance and rejection of degrees and diplomas
in the European countries.
The forth problem relates to the training of personnel in a way that is appropriate for the
current and future operations in the laboratory and takes also into account e.g. modification
of existing as well as the development and implementation of new technologies.
The envisaged solution to this problem is dependent on the management of the laboratory.
There should be a clear statement in standards or other basic documents formulating the
tasks of the management. One of the management’s duties is to define the quality goals with
respect to the education and the skills of the personnel. The resulting training program must
be directed towards the major recent and future tasks of the whole laboratory as well as to
the specific needs of each employee of the laboratory. The laboratory should have a policy
and procedures for identifying training needs and providing training of personnel.
The fifth problem relates to the different philosophies as to how to connect real
assignments presented by the clients of a laboratory with the services and activities of the
laboratory. The difference between the laboratories lies in the manner in which a laboratory
seriously tries to understand and solve the client’s problem and to formulate the task to be
performed by the laboratory, i.e. to do the work in such a way that the results of the test
and/or investigation are the ones most suitable for solving the actual problem of the client or
for providing support in the form of professional advice based on these results.
The sixth problem has to do with the description of the test or investigation methods by the
laboratory that is to say how it proceeds when assessing the performance of the method on
one hand and how it decides whether they are appropriate for the task to be performed (for
the needs of the laboratory’s client) on the other. In other words, the laboratory has to decide
how serious and how cost-relevant the validation of the laboratory should be.
The seventh problem lies in the field of expert services, i.e. professional judgement ( e.g.:
opinions, interpretations, predictions, simulations and models etc.) and professional advice.
The client must be sure that in the field of his interest he can rely on the expert’s technical
competence and skills. One of the measures to be taken to improve the existing situation is
to improve the job descriptions of the experts offering professional judgement or giving
advice to the client. At present too many job descriptions are too formalistic and often they
2
do not define the expert’s responsibilities and do not give any information about his
theoretical and practical background or his recent experience, nor do they in a reliable way
specify the expert’s integrity and reputation. - An example of an extended job description is
given in annex 1 to this document.
In the following the discussion is limited to those problems which can be influenced by the
laboratory directly, using for example the QM system as a tool.
2 Review of the existing documents and current practice
Hardly any regulation or written documentation exists in the field of personnel qualification in
testing with the exception of the field Non Destructive Testing and Destructive Testing
(NDT and DT) where certification of personnel has been a tradition for many years. Some
laboratories have developed their own schemes of personnel qualification and put them
into force by laying down relevant requirements in the quality manual.
The following documents were reviewed by the writing group:
EN 45001 General Criteria for the Operation of Testing Laboratories, 1 June 1990
ISO/IEC Guide 25, General requirements for the competence of calibration and testing
laboratories. 1990
ANSI/ ASQC Q2-1991, Quality Management and Quality System, Elements for LaboratoriesGuidelines, 1990 (USA)
ANSI/NCSL Z540-1-1994 Calibration Laboratories and Measuring and Test Equipment,
General Requirements, 1994 (USA)
NATA General requirements for registration (Australia)
TELARC New Zealand Code of laboratory management practice,1993 ( New Zealand)
EN 473, Qualification and certification of NDT personnel, General principles, 1993
ASTM, E 548-94, Standard Guide for General Criteria Used for Evaluating Laboratory
Competence (USA)
GLP The OECD principles of good laboratory practice, 1992
CITAC Guide 1, International guide to quality in analytical chemistry, 1995
EAL Guide 8, Guidelines for selection of participants to courses for the training of assessors
involved in assessments of laboratories applying for accreditation.
ISO 10011-2, Guidelines for auditing quality systems. Qualification criteria for quality system
auditors
Remark:
The EN 45000 series does not deal with personnel requirements in sufficient detail; in
particular EN45001 which applies to laboratories where competence of personnel is one
of the most important factors.
3
Like EN45001, ISO/ IEC Guide 25 focuses more on the organisational part than on the
human resources. The draft of ISO/IEC Guide 25 tries to improve this situation.
In the field of non destructive testing a number of national standards have existed. EN 473
„Qualification and certification of NDT personnel” has now replaced these national
documents although interpretation documents are needed. This standard clearly specifies
all requirements on personnel as well as the certifications process. The NDT field largely
depends on satisfying qualification requirements of personnel. That is the reason for the
tradition of certification in this field.
GLP (The OECD Principles of Good Laboratory Practice) has a special view on the
personnel matter which is related to specific requirements (e.g. personal safety; integrity
of the study and traceability).
3 Description of the qualification of personnel
In this chapter the attempt is made to find out general classifications of personnel in different
laboratories. It turned out that nowadays the level of training and education differs from
country to country, from working field to working field, from small to big laboratories.
Nevertheless a rough analyse was made.
3.1 General observation
Personnel in a laboratory has to fulfil a number of tasks depending e.g. on the scope of the
activities, the size of the laboratory, and the status of the laboratory with respect to its
degree of independence and impartiality. In addition, the tests also depend on the individual
responsibilities of the staff members.
When analysing the requirements a laboratory imposes on individual employees a certain
pattern emerges. They must know something about the technical field (field competence),
methods to be used (method competence) as well as co-operate and communicate (social
competence).
These competence areas have been analysed in some more detail and they encompass e.g.
the following:
Field competence
- basic knowledge
- knowledge of a special field
- interdisciplinary knowledge
Method competence
- ability to use, to combine or to create knowledge of a special field
- development of the ability of abstraction,
- readiness to learn thinking systematically,
- planning, solving problems and correct decision making
Social competence
- ability for teamwork
- ability to cooperate
- ability to communicate
4
- tolerance
- sense of responsibility
- solidarity
- ability to set up an understandable description or presentation verbally or in writing
- ethical behaviour in the profession
In the following an attempt is made to relate competence and responsibilities for laboratory
staff members and laboratory managers, respectively.
3.2.Laboratory staff
Competence and responsibility of staff members in a laboratory are often divided in several
categories e.g.into 4 categories as follows. They refer to different levels of responsibilities. It
is quite clear that in a small laboratory the number of categories is diminished and tasks are
combined. In each category the experience is also considered resulting in three levels called
„basic“, „experienced“. and „advanced“. The proposed number of years in the following
chapters are only a hint and can differ from laboratory to laboratory but also depend on other
circumstances.
A. Managerial level
a. „Basic“( acceptable)
The prerequisite should generally be a university degree or a comparable level. The training
should cover the specific technical field. In addition, sound training is required in quality
management and basic economic issues and general principles of testing i.e. traceability,
calibration, uncertainty, comparability, etc. Training in the production and usage of relevant
products is also of benefit for better understanding of the product and the feasibility of the
laboratory operations in the relevant field. Training in interdisciplinary fields is important for
the general overview. Good knowledge of foreign language(s) is also a prerequisite.
b. „Advanced“
About two years of practical experience in several areas of the field for which the person is
responsible. Training in communication is needed.
c. „Experienced“
About five years of practical experience in several areas of the field for which the person is
responsible. Training in communication and training in practical economic issues as well as
in a foreign language is needed. The person should have the ability to solve technical,
logistic and managerial problems.
Relevant publications and active work in national and/or international standardisation as well
as lectures at e.g. conferences and training courses are expected. Project management skill
is also needed.
B. Technical specialist level
a. „Basic“ (acceptable)
Certificate from a technical school shall be the minimum requirement. Additional training in
quality management and statistics and in general principles of testing is a prerequisite. Basic
knowledge in production methods of the relevant goods is necessary.
b. „Experienced“
5
About two years of practical experience in the fields for which were the person is
responsible.
c. „Advanced“
About five years of practical experience in the fields for which the person is responsible.
Additional theoretical background knowledge of comparable measurement methods for
which the person is not directly responsible. Ability to solve technical and logistic problems is
needed.
C. Skilled worker level (laboratory techichan)
a. „Basic“
A certificate of training as a technician or a skilled worker is necessary. Training in quality
management and in an appropriate range of relevant test methods is needed.
b. „Experienced“
About two years of practical experience in the fields for which the person is responsible.
Ability to carry out tests without assistance and to cope with problems arising from test
items, testing instruments etc. is needed.
c. „Advanced“
About five years of practical experience in the fields for which the person is responsible.
Ability to carry out tests, even difficult ones without assistance and to cope with problems
arising from test items, testing instruments etc. is needed.
D. Assistant level
a. „Basic“
Certificate as an assistant (laboratory support staff) or an adequate level of school education
is a prerequisite. Training in the specific methods, standards and SOPs within the person’s
working field is needed together with basic training in quality management.
b. „Experienced“
About two years of practical experience in the fields in which the person is working. Ability to
carry out tests under supervision is the prerequisite.
c. „Advanced“
About five years of practical experience in the fields in which the person is working. Ability to
carry out tests under supervision is the prerequisite.
In the Table in annex 4 there is an attempt to correlate the necessary educational level and
job experience with certain tasks and duties in the laboratory. The Table is made for staff
having a high school degree and is mainly indicative of the way „requirements“ should be
set.
6
3.3 The technical laboratory manager
Mainly in big laboratories a technical laboratory manager is necessary in order to manage
the co-operation between different departments and to take the overall technical
responsibility.
The laboratory manager should have in addition to applicable managerial level requirements
training in the following subjects:
- leadership
- business administration
- project management
- quality management
- communication
- labour legislation
The laboratory manager shall assure that the laboratory has rational exchange of experience
with peers. This can take place on an international and domestic level (especially for small
laboratories). Participation in laboratory comparisons and bench-making exercises is
considered valuable.
The leadership role is important as it can contribute to an improved motivation within the
staff. In order to systematically cover all issues related to the employment and further
education and training it is recommended that the superior and the subordinate should at
least annually meet in development discussions including also achieved results.
4. Personnel carrying out expert judgement
Expert judgement is mainly related to inspection activities (EN 45004) and research activities
in the sense of giving opinion on test results and interpretation . It is also required in projects
where a detailed planning of a measurement programme. Expert judgement must not at all
be confused with evaluation in certification activities.
Experts and their activities have a different legal status in different EU and EFTA member
countries. Experts play an important role in many fields in legal and commercial areas.
Therefore, they have to fulfil a number of expectations e.g. such as:
•
•
•
•
•
Independence
Integrity
Impartiality
Active in a relevant international and /or national field
Experience ( provable ) in testing, inspection and production of relevant goods etc.
The technical expert can in principle be an individual or an employee. However, in many
cases more credit is given if the expert belongs to a third party testing laboratory or
inspection body as the expert can call on the collective knowledge of the whole organisation.
An expert should almost by definition belong to the highest category (level) of staff.
When trying to analyse the situation in more detail this means that the expert should
correspond to the following competence profile:
1. Education and knowledge:
• Sound education, preferably a degree or equivalent qualifications in a relevant
7
scientific or technological discipline
• Theoretical knowledge as well as basic knowledge of mathematics, simulation and
modelling methods, prediction methods, and reliability techniques
• Knowledge of recent literature
Self proclaimed experts may damage the reputation of this group of personnel.
2. Experience:
• Vocational activity of at least four years, including at least two years performing tests
in technical fields covered by the activities of the laboratory
• Professional experience in outlining, design, planning, calculation, construction,
development and research related to the activities
• Professional experience in cases of failure and damage, in a wide range including
border zones of application and in case study exercises
• Knowledge of e.g. testing, measurement and inspection techniques as well as estimating
applicability of methods and procedures
• Recent experience in expert judgement activities
In certain cases the person can be certified by a third party organisation.
3. Management abilities:
• Knowledge of quality systems to be used in calibration or testing laboratories,
gained through practical experience and/or attending relevant training course
• Experience in managerial duties preferred
4. Communication skills:
• Ability to negotiate skilfully
• General aptitude for describing complex connections of facts in an understandable way,
verbally and/or in writing
• Ability to communicate and cooperate in teamwork (acceptable from the view of human
aspects)
• General aptitude for the generalisation of coherent facts in the field of testing, ability to
create new ideas
5. Personal qualities:
• Perseverance and persistence
• Capability to observe, analyse, recognise and arrive at conclusions without delay
8
• Self-control
• Good ethical behaviour in the profession
5 Personnel working in the fields of R&D and other non-routine
activities
Personnel involved in the management of R & D and other non-routine activities in the
laboratory should have a broad experience. The competence profile may comprise the
following:
1. Education and experience:
• Academic education in the same technical discipline in which the work is performed. An
other possibility is an education in a closely related field or equivalent work experience
and technical activity in a related discipline
• Established record of proposing and solving engineering, experimental or theoretical
problems that are recognised as valid by the community of technical peers
• Experience of different materials, matrices or groups of products
• Experience of applications in borderline cases
• Experience of R & D, ability to refer to recently completed findings and projects
• Experience of handling information systems, for example data bases in bibliography,
ability to put up key words for bibliographical search
• Proof of further education and training
• Knowledge and experience of different research methods
2. Leadership qualification:
• Leadership qualification, especially in managing laboratory or research activities. Ability to
take overall responsibility for performing or supervising the research activities
• Experience of observing time-limits (scheduling)
• Ability to make a team cooperate
• Communication skills
• Ability to cope with the difficulties of administrative conditions of the surroundings
• Focused on objectives and aims of the research
3. Ability to assess risks and consequences:
• Mastery of the subject or field which is the topic of a research activity
• Knowledge of the confines and complexities of a scientific or technical area
• Experience to solve peripheral problems of a scientific or practical field
4. Creativity and initiative:
•
•
•
•
Ingenuity and imagination
Creativity
Interdisciplinary thinking
Publishing research results in the proceedings of scientific meetings or in professional
journals
• Participation in expert groups in technical and standardization activities (national or
international TCs or WGs etc.)
9
For the handling of R&D and other non-routine activities there are several steps and
measures that should be taken in order to handle the projects as effectively as possible:
•
•
•
•
•
•
•
•
Nomination of a research project manager
Nomination of a deputy for the research project manager
The type of research, such as contract research, applied research, exploratory research,
fundamental studies, institutional projects etc., has to be precisely defined
The aims of the research activity must be defined as clearly as possible
The responsibilities of personnel involved in R&D must be clearly defined, especially the
approval and authorisation of the research plan, the changing of it, the reporting of
results and other documentation
The research organisation should be committed to managing its technical work in
accordance with accepted principles of project management and ensure that all in house and subcontracted research projects meet the requirements defined in research
plans with respect to the quality of scientific results, costs and schedule as well as
environmental, safety and health aspects
Interdisciplinary R&D needs defined interfaces and responsibilities
Initial and updating research reviews by independent experts to assess the technical
competence, the current relevance of technical knowledge and the management of the
projects with the aim to demonstrate the appropriate level of the R& D activity
corresponding with the goal.
6 Follow-up of personnel qualification
6.1 Supervising the competence and skills of personnel
To determine whether or not a staff member fulfils all necessary requirements,
different tools and methods are used. The most usual ones are mentioned here:
6.1.1 Evaluation of the needs of training
At regular intervals or as required, internal audits are performed with the purpose of
showing deficiencies, if any, between the needed and present capabilities of a staff
member. In addition to the qualification files the fulfilment of the training plans are
audited. Also the frequency of performing a specific task by a certain person is also
subjected to audits. The staff member will also be interviewed and his/her performance
in a specific task will be supervised (witness auditing).
6.1.2 Management review
The result of internal audits will be part of the input to the management review which is
also to be performed at regular intervals (minimum: once a year). An output of a
management review is the decision whether the qualifications of the staff are
adequate.
6.1.3 Publications and participation in professional committees
Another means to „measure“ qualifications is the number and quality of publications
and participation in professional committees, development of standards and guidelines
in this particular field of activity.
10
6.1.4 Certificate
Holding a certificate from a recognised certification body for special ability is another
measure of qualification.
6.2
Documentation of qualification data
6.2.1 Files and activities
It is necessary to establish a file for each staff member containing the experience,
skills, personal attributes and increments of knowledge and newly acquired know how,
needed for maintaining the ability to do the particular job properly. These needs may
change as time goes by and depend on the present tasks and the planned or
foreseeable tasks to be performed.
The files are continuously updated and kept for a specified time in a safe place
(archive) by a responsible person. The archive can be computerized.
6.2.2 Qualification plan
It is in the responsibility of the superior to discuss the needs for further qualification
with each staff member and to make a qualification plan for the coming working period
within the allocated funds. The discussion should take place at regular intervals
(usually yearly). This plan shall contain all training aspects with regard to technical, QM
and managerial issues. The plan shall be used at the end of a period to compare the
results achieved.
7 Competence, qualifications, responsibilities and authorisation
7.1. Quality standards
A testing laboratory shall, according to the quality standards, maintain a quality assurance
system documented in a quality manual. The manual must contain documents or procedures
relating amongst others to the following matters:
Competence
The competence of the personnel in laboratory shall be defined on the basis of the tasks of
the laboratory and the jobs/positions in the laboratory. The laboratory shall have documents
to verify this.
Qualification
Qualification systems and programmes shall be defined and documented to ensure the
achievement of the required competence levels.
Training plans shall cover the gaps between the competence needed and actual skills of the
personnel. Individual training plans shall be updated regularly. Documents shall be
maintained to verify the completed training.
Responsibilities
Written job descriptions (see Annex 1 ) are usually needed to demonstrate that the person is
competent enough. Job descriptions shall be reviewed sufficiently often to correspond to the
11
needs and changes in the laboratory’s operations and to the external requirements, for
example set by an accreditation body.
Procedures for assessing and nominating personnel and the delegation of responsibilities
may require written documentation complemented by organisation charts and job
descriptions.
Job descriptions should be made so flexible that the laboratory has the possibility to make
necessary adjustments if and when the tasks in the laboratory are changing in time. It is to
be noted that job descriptions may be correlated to certain employment agreements and
salary classifications. Great care must be observed by the laboratory in defining the job.
Supervision of personnel qualification
Regular reviews of job requirements compared with the competence of the person carrying
the job are necessary. It is recommended that the adequacy of the competence be
documented in personnel files. A Curriculum Vitae (CV) document is often needed for
responsible persons to prove the competence to clients or external assessors. In some
cases a valid certificate from an accepted certification body is an adequate proof of the
competence of the person.
Authorisation
Procedures for nominations of project managers and deputies are needed and the
nominations shall be documented.
The management must be able to demonstrate that the persons authorised to sign
documents are sufficiently reliable and competent. The rules for the authorisation to sign
documents, the procedure for authorisation and the lists of persons authorised to sign and to
be responsible for the contents of the documents should be specified in the quality manual.
For the laboratory, the competence of signatories is imperative for the liability of the
laboratory. In most cases the laboratory will be liable for the activities carried out by the
signatories. In general, one has two signatories, one for the document such and one for the
technical content. He/she has to be sufficiently competent to fully understand the technical
aspects mentioned in the report as well as the requirements in standards or other normative
documents on which the report is based.
7.2. Independance
Management and personnel in an independent 3rd party laboratory must be free of any
undue influence. The management shall be able to demonstrate the independence.
12
Annex 1
AN EXAMPLE OF A JOB DESCRIPTION
to be revised each year
Position in the organisation: Group leader in the Mechanical Testing Section
Parameter
Requirement
Current Status
Holder of the position
Task of the mechanical testing section
NN
Requirements are fully met with the
exception of fatigue testing. Training shall
be finalised by end of the year
Requirement are fulfilled with the
exception of identifying clients needs in
forecasting lifetime of large structures.
Subject to be supported by head of
laboratory.
Reports to
Male/female
Carrying out fatigue, fracture, mechanical
and impact testing of metallic samples
also in customers’ laboratories
Identifying clients needs and formulating
tasks; arrangement and surveillance of
maintenance and calibration of the
testing equipment;
control of tests carried out, development
of work processes;
surveillance of housekeeping in the
laboratory
The head of the laboratory
Substitute for
In tension testing
SS
Substitute for
In hardness testing
RR
Responsibilities of the group leader
Own substitute
Education
Complementary courses
MM
HH
Basic school (9 years), skilled worker (3
years), school for technicians (2 years),
vocational education
Participation in a course dealing with the
calibration of testing equipment
13
Basic school (9 years), skilled worker (5
years), school for technicians (2 years),
vocational education (two-day course)
Participation in a course dealing with the
calibration of
testing equipment (5 days), two courses
dealing with fatigue testing (2 weeks) and
impact testing (5days)
Professional experience
Experience in quality management
Experience in leadership
Languages
Special requirements
At least 2 years as testing operator with
an electronically controlled servohydraulic testing system in the field of
fatigue tensile testing up to 5 Hz.
No specific requirement
4 years as testing operator with an
electronically controlled servo-hydraulic
testing system in the field of fatigue
tensile testing up to 5 Hz.
Profound knowledge of ISO 9002
Must be suitable for management tasks
Ability to read and to understand English
documents containing technical terms
(basic English)
Health (must not suffer from vertigo)
PC-skills (knowledge of Microsoft-Excel)
Group leader for 1 year in this laboratory
Good knowledge of written and spoken
English, little knowledge of written
German.
Health requirement is fulfilled
Good knowledge of all Microsoft and
Lotus Programmes
Driving licence (class XYZ)
Special qualifications
Driving licence (class XY)
Personal attributes
Ability to contribute to the goals of the
laboratory and comply with it culture.
NN is capable of observing, analysing,
recognising and arriving at conclusions
without any delay.
NN has the ability to negotiate skilfully
NN has the ability to negotiate skilfully.
NN is self-controlled and has
perseverance and persistence
Place , Date
Approved by
Vienna, 22 June 1997
Head of laboratory MM
14
Signature
Annex 2
Bibliography
Änkö, S., Job descriptions in testing laboratories, Espoo 1993. Nordtest, NT Techn Report
196.15 p.
Elo, N., Kujala, S., Lindroos, V. and Tiittanen, K., Report Format and Signing of Documents,
Espoo 1996. Nordtest, NT Techn Report 323.21 p.
EN 45001 General Criteria for the Operation of Testing Laboratories, 1 June 1990
ISO/IEC Guide 25, General requirements for the competence of calibration and testing
laboratories. 1990
ANSI/ ASQC Q2-1991, Quality Management and Quality System, Elements for LaboratoriesGuidelines, 1990
ANSI/NCSL Z540-1-1994 Calibration Laboratories and Measuring and Test Equipment,
General Requirements, 1994
NATA General requirements for registration
TELARC New Zealand Code of laboratory management practice,1993
EN473, Qualification and certification of NDT personnel- General principles, 1993
ASTM, E 548-94, Standard Guide for General Criteria Used for Evaluating Laboratory
Competence
CITAC Guide 1, International guide to quality in analytical chemistry, 1995
EAL Guide 8
ISO 9712
ISO 10011-1, Guidelines for auditing quality systems-Auditing
ISO 10011-2, Guidelines for auditing quality systems-Qualification criteria for quality system
auditors
ISO 10011-3, Guidelines for auditing quality systems-Management of audit programs
ISO 10012-1
Dutch Standard NEN 3417: Feb 1992, first edition
American National Standard ANSI Z 1.13, Quality Systems Guidelines Research, Draft one
The German Accreditation System for Testing DAP Ltd., Temporary Guidance
for assessment and accreditation of a flexible scope of accreditation, 1996-03-27
Morkowski, J.: Accreditation applying well defined degrees of freedom,
18th Nordic Conference: Measurement and Calibration, Lillehammer, Norway, 1996
15
Annex 3
Quotations
Competence
ISO9004-1: ”Management should identify resource requirements, and provide sufficient and appropriate resources essential to the
implementation of the quality policy and the achievement of quality objectives.
For example, these resources can include:
a) Human resources and specialised skills
...
Management should determine the level of competence, experience and training necessary to ensure the capability of personnel.”
EN45001: ”5.2 Personnel: The testing laboratory shall have sufficient personnel, having the necessary education, training, technical
knowledge and experience for their assigned functions. The testing laboratory shall ensure that the training of its personnel is kept
up-to-date. Information on the relevant qualifications, training and experience of the technical personnel shall be maintained by the
laboratory.”
Qualification
ISO 9004-1:
”Qualification: The need to require and document qualifications of personnel performing certain specialised operations, processes,
tests or inspections should be evaluated and implemented where necessary, in particular for safety related work. The need to
assess periodically and/or require demonstrations of skills and/or capability should be addressed. Consideration should also be
given to appropriate education, training and experience.”
Responsibilities
EN45001:”The testing laboratory shall be organised in such a way that each member of personnel is aware of both the extent and
the limitation of his area of responsibility. The organisation shall provide supervision of the test and the assessment of the test
results. The proportion of supervisory to non-supervisory personnel shall be such as to ensure adequate supervision. The testing
laboratory shall have a technical manager who has overall responsibility for the technical operations of the laboratory. A document
showing the organisation and distribution of responsibilities of the testing laboratory shall be available and kept up-to-date.”
ISO9004-1:”Functions related to the quality system should be clearly established within the overall organisational structure. The
lines of authority and communication should be defined”.
Training
ISO 9004-1:
”Training”: The need for training of personnel should be identified, and documented procedures for providing that training should be
established and maintained. Appropriate training should be provided to all levels of personnel within the organisation performing
activities affecting quality. Particular attention should be given to the qualifications, selection and training of newly recruited
personnel transferred to new assignments. Appropriate records of training should be maintained.”
”Records on the relevant qualifications, training, skills and experience of the technical personnel shall be maintained (ISO/IEC Guide
25)”
Authorisation
EN45001:”Each test report shall include at least the following information:...l) a signature and title or an equivalent marking of
person(s) accepting technical responsibility for the test report and date of issue;”
According to EN 45004, only authorised staff members may sign or otherwise approve inspection reports or certificates
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