Planned and systematic action

necessary to provide adequate

confidence that testing or
calibration will satisfy given
requirement for quality.

The operational techniques and

activities that are used to fulfill
requirements for quality
ISO/IEC 17025:2006 - General requirements for the
competence of testing and calibration laboratories
- documents describing the
requirements on how to
achieve quality assurance/
quality control (QA/QC) in
analytical laboratories

•Documentation
•Organization
•Personnel
•Equipment
•Methods
•Traceability
•Sampling
•Reporting
ISO/IEC/EN 17025
5.6.1 General

All equipment used for tests and/or calibrations, including equipment for
subsidiary measurements (e.g. for environmental conditions) having a significant
effect on the accuracy or validity of the result of the test, calibration or sampling
shall be calibrated before being put into service. The laboratory shall have an
established programme and procedure for the calibration of its equipment.

5.9 Assuring the quality of test and calibration results

5.9.1 The laboratory shall have quality control procedures for monitoring the
validity of tests and calibrations undertaken. The resulting data shall be
recorded in such a way that trends are detectable and, where practicable,
statistical techniques shall be applied to the reviewing of the results. This
monitoring shall be planned and reviewed and may include, but not be
limited to, the following:
5.9 Assuring the quality of test and calibration results

a) regular use of certified reference materials and/or internal quality

control using secondary reference materials;
b) participation in interlaboratory comparison or proficiency-testing
programmes;
c) replicate tests or calibrations using the same or different
methods;
d) retesting or recalibration of retained items;
e) correlation of results for different characteristics of an item.

Intercomparison measurements and proficiency tests are the

best mechanisms to show overall performance of the
laboratory work
• SELECTION OF METHODS
• SELECTION OF EQUIPMENT
• METHODS VERIFICATION
• VALIDATION OF METHODS
• TO ENSURE OPERATING CONDITIONS
• SAMPLING, TRANSPORT and SAMPLE STORAGE
• CALIBRATION
• UNCERTAINTY BUDGET
• TRAINING and SUPERVISION OF STUFF
• …
QC must be embedded into an overall systematic approach
to avoid mistakes before they are made, and this is
commonly referred to as QA.

QC ought to be:
planned,
described in the quality documentation,
performed in a systematic manner,
recorded and
reviewed.
PLANNING:
identify (what) and define (how):

– type of quality control

– frequency of quality control (when)
– control limits
– actions if control limits are exceeded
– periodic review of results.
 PROCEDURES/DOCUMENATION

Describe QC and complementary measures

Should be carried out at appropriate interval
Identification of the person responsible for operation and
maintenance of equipment
Use traceable radiation sources
Instrument calibration
Contol limits
Evaluation and review,
Corrective actions.
RECORDING:
results with attributes (date, procedure, material, operator,
instrument, calibration and correction factors, values of relevant
environmental parameter, other experimental parameters)
association to production work
which QC results are relevant for a particular sample
which samples are affected by a particular QC result
quality control charts
corrective actions.
 The accuracy and reproducibility of measurement
systems has to be verified on a periodic basis
The major aim of QA/QC in analytical laboratory
is to address measures used to verify the validity of
the final results.
Laboratory has to participate at PT with good
results. If some result is N, corrective action should
be performed.