ISO/IEC 17025

TECHNICAL REQUIREMENTS

FACTORS DETERMINING
CORRECTNESS AND
RELIABILITY OF TESTS
PERFORMED
 Operate Equipments
Competence Performe Tests
Evaluate Results
Sign Reports
Personnel
Performing
Technical
Work
5.2 Goals Education
ID Training Needs
Training Skills

Training Programmes
 Profiles and Job Descriptions

Diferences Improvements
Personnel in Personnel

Records of
the Reality
Accommodations and • Necessary and sufficient conditions not to
Invalidate or adversely affect results
Environment (permanent /different sites and mobile
Conditions installations)

5.3 • Requirements shall be defined and

documented

• Monitor/Control/Record where results

influenced

• Stop work when results jeopardized

• Effective separation between incompatible

actitivities

• Control access to areas affecting quality

• Measures taken to ensure good

housekeeping

• Special procedures where necessary

Methods and
Methods
Selection of Methods 5.4.2
Validation
5.4
 Meet needs of client
 Technical basis and
consistency
 Appropriate for intended use
 Customer informed about
 Customer informed when
method
proposed by customer is
considered to be inapropriate
 Methods and Methods Validation 5.4

Laboratory
 Validation
Development of
Methods Methods
5.4.3 5.4.5
Non
Standard
Methods
5.4.4
Method planned Evidence that
Assigned to qualified people requirements are fulfilled
Equiped w/adequate resources

Agreement with client

Clear Specifications
VALIDATION OF METHODS (5.4.5)
How to do it
• Evaluation of Prototypes
• Evaluation by Customer
• Interlaboratorial Comparisons
• Evaluation during use
• Evaluation by results
• Evaluation by clear arguments
Known method
Previously used
• Combined evaluation
• Linearity, Repeatability, reproductbility, etc.
METHODS AND METHODS
VALIDATION 5.4
Estimation of uncertainty
of measurements
5.4.6

Identifications of all
Components of
uncertainty

Based on:
Performance of method
Measurement scope
 METHODS AND METHODS
VALIDATION 5.4

Control of Data 5.4.7 Calculations and data

Subjected to systematic check

Data transfer controlled

Software for data treatment validated

Procedure for integrity and

confidenciality of data entry, collection
storage, transmission, processing.

Equipments:
Proper functioning
Maintain integrity of data
 TEST MEASURING EQUIPMENT 5.5

• All equipment (and software) permanently

controlled.
• Capable of achieving accuracy required
• Calibration Programmes
• Standards and valid methods for calibration
• Equipment checked for use.
 TEST AND MEASURING
EQUIPMENTS 5.5
• Operated by authorized personnel
• Using up-to-date instructions (available)
• Each item significant to the result uniquely identified.
• Records maintained for items
 Identity of item and software
 Manufacture name/type/model/s.nr
 Main specification
 Current location where appropriate
 Manufacture instructions
 Date/reports/certificates/adjustements/results/next
calibration
 Damages/malfunctions/repairs
 TEST / MEASURING
EQUIPMENTS 5.5
• Procedures for handling, transport, storage, use and maintain.

• Defective equipment prevent for use up to new calibration.

• Effect of equipment defect on services

• Identify calibration status.

• Intermediate checks to maintain confidence in calibration (procedure)

• Calibration correction factors

• Equipment safeguard from improper adjustment

MEASUREMENT TRACEABILITY
5.6
• Accredited calibration laboratory 
traceability to S.I.
• Chain of comparisons linked to primary
standards.
• Calibration based on accepted methods.
• Participation in a suitable program of inter-
laboratory comparisons
• If S.I. not possible then agreement shall
be performed with client
MEASUREMENT TRACEABILITY
5.6

• Reference standard (Program and

Procedure for Calibration)

• Reference Materials (Traceable to S.I or

certified reference material)
 SAMPLING 5.7

• Sampling plan and procedures

• Based on appropriate methods

• Record of data and operations

 Handling of Service Items 5.8
• Transport/reception/handling/protection/
retention/storage/disposal….

• Identify item for life, not confuse

• Departures recorded

• Avoid deterioration/loss/damage keep integrity.

 ASSURING THE QUALITY OF
TESTS 5.9
• Q.C. Procedures to monitor validity of
results.
• Inter-Laboratory comparisons
• Proficiency testing programmes
• Replications
• Retesting
• Correlation of results,for different item
characteristics.
 REPORTING THE RESULTS 5.10
Accurate clear unambigous objective

• Title
• Name/address laboratory
• Location of work
• Unique identification on each page.
• Name/address of client
• Identification/Description method used for service.
• Clear description of item.
• Date receipt of item.
• Reference to sampling plan if applicable.
• Test results with units of S.I.
• Name/Function person authorizing certificate.
• Deviation of test method such as environmental , etc.
• Estimated measurement uncertainty.
• Statements.
REPORTING THE RESULTS 5.10

• Opinions and interpretations

• Judgments under criteria
• Results form subcontractors
• Electronic transmission of results (control
of data – 5.4.7)
• Amendments to rest report