Technical requirements:

general (ISO 17025:2005, 5.1)

personnel (ISO 17025:2005, 5.2)

accommodation and
environment
(ISO 17025:2005, 5.31)
 The Laboratory Process

Report
Laboratory

Sample
 Technical requirements
In general
Factors influencing the
correctness and reliability of the
tests performed

Laboratory ?
Sample
 Factors determine correctness
and reliability of the tests
Human factors
Acomodation and
environmental conditions
Test and calibration
methods, method validation
Equipment
Measurement traceability
Sampling
Handling test items
 Personnel
(ISO 17025:2005, 5.2)
 Management requirements to
personnel -1 (ISO 17025: 2005, 4.1)
Laboratory have managerial and technical
personnel (irrespective of other responsibilities)
who have the authority and resources needed to
carry out their duties and to identify the
occurrence of departures from the quality
system and initiate actions if required

Free from any undue internal and external

pressures and influences
 Management requirements to
personnel -2 (ISO 17025 ; 2005,4.1)
Protection of the customers confidential
information
Specify responsibilities, authority and
interrelations of all personnel which
activities can influence the quality of the
result
Appropropriate supervision of testing staff
and trainees
 Management requirements to
personnel - 3 (ISO 17025:2005, 4.1)
Technical management which has overall
responsibility for operations and provision of
resources needed to ensure required quality of
operations
Quality manager: irrespective of other duties has
defined responsibility and authority ensuring the
management system is implemented and
followed at all times, has direct access to the
highest level of management
 Management requirements to
personnel - 4 (ISO 17025: 2005,4.1)
Appoint deputies for key managerial
personnel
Ensure that personnel is aware of
relevance and importance of their activities
Top management shall ensure proper
communication processes are established
regarding effectiveness of the
management system
 Technical requirements to
personnel -1 (ISO 17025:2005, 5.2)
Laboratory management shall ensure the competence of
personnel for operation specific equipment, perform
tests, evaluate results, sign test reports

Personnel responsible for opinions and interpretation at

reports have relevant knowledge of technology including
legislation, understanding significance of deviations

Training programme: Management formulates goals for

education, training and skills of personnel. Needs are
identified and training programme is evaluated.
 Personnel -2 (ISO 17025:2005, 5.2)
Job descriptions
minimal responsibilities with respect to
performing tests, planning and evaluation
of tests, reporting opinions and
interpretations, method modification and
validation new methods.
Expertise and experience required
Qualification and training programmes
Managerial duties
 Personnel - 3 (ISO 17025:2005, 5.2)
Authorization to perform particular types of
sampling, tests, issuing tests reports, to
give opinions and interpretations,
operation of particularly types of
equipment
Authorization of specified tasks is done
including date on which it is confirmed and
registrated and readily available
Requirements to personnel are registrated
Accommodation and environmental
conditions (ISO17025:2005, 5.3)
Laboratory facilities will facilitate correct
performance of the tests and are documented
Monitor, control and record conditions as
required by relevant specifications (biological
sterility, dust, humidity temperature, electrical
supply etc.)
Attention for access to certain test areas, good
housekeeping and effective separation of
incompatible activities