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Checklist ISO 17025
Checklist ISO 17025
Management requirements
Compliance
The Requirements Remarks
Yes No NA
4.1 Organization
4.1.1 Legally responsible entity
The laboratory's responsibility is to carry out testing
4.1.2
and calibration according to ISO 17025
Permanent and mobile facilities covered by the
4.1.3
laboratory management system
Responsibilities of key personnel if the laboratory is
4.1.4 part of an organization performing other activities than
testing/calibration
The laboratory shall have(requirement to
4.1.5
organization):
Managerial and technical personnel with authority
a and resources to carry out duties and to identify
departures
Management and personnel free from undue internal an
b
external pressure and influences
Policies and procedures to protect the customer
confidential information and proprietary rights,
c
including procedures for electronic storage and
transmission of results
Policies and procedures to avoid the involvement in
d activities that would diminish confidence in the
laboratory's competence, impartiality, independence
Definition of the organization and management
e
structure
Specification of responsibility and authority for all
f
relevant personnel
g Adequate supervision of testing and calibration staff
h Technical management with overall responsibility
Quality manager and reference to management making
i
decisions on the laboratory's policy or resources
j Appointed deputies for key managerial personnel
k Personnel aware of their contribution to objectives
Top management ensures appropriate
4.1.6 communication of management system effectiveness
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Accreditation Unit Checklist against ISO/IEC17025:2005
Note: the paragraphs in bold indicate the new requirements in the ISO/IEC17025:2005
c Immediate correction
Note: the paragraphs in bold indicate the new requirements in the ISO/IEC17025:2005
Note: the paragraphs in bold indicate the new requirements in the ISO/IEC17025:2005
5. Technical requirements
5.2 Personnel
5.2.1 Ensuring of competence of testing/calibrating personnel,
of personnel who operate specific equipment, evaluate
results or sign reports/certificates
Supervision of personnel undergoing training
5.2.2 Policy and procedures for identifying training needs and
providing training. Training effectiveness is evaluated
5.2.3 Personnel employed or under contract personnel under
contract competent, supervised and working in
accordance with the quality system
5.2.4 Job description maintained for managerial, technical and
key support personnel
5.2.5 Authorization of personnel to specific tasks, and
recording of authorizations, including date confirmation
5.3 Accommodations and environmental conditions
5.3.1 Laboratory facilities ensuring correct performance of
tests/calibrations including sampling and onsite
testing/calibration
5.3.2 Monitoring, controlling and recording of environmental
conditions if required biological sterility, dust,
electromagnetic disturbances, radiation, humidity,
electrical supply, temperature, and sound- and vibration
levels
5.3.3 Effective separation between neighboring areas with
incompatible activities
5.3.4 Control of access to and use of laboratory areas
5.3.5 Measures to ensuring good housekeeping
5.4 test and calibration methods and method evaluation
5.4.1 Use of appropriate methods for all tests/calibrations,
including sampling, handling, transport, storage and
preparation of items for estimation of uncertainty and
analysis of testing/calibration data
Note: the paragraphs in bold indicate the new requirements in the ISO/IEC17025:2005
Note: the paragraphs in bold indicate the new requirements in the ISO/IEC17025:2005
5.5 Equipment
5.5.1 The laboratory's disposal equipment necessary for
correct performance of testes/calibrations
Ensuring compliance with ISO 17025 of equipment
outside the laboratory's permanent control
5.5.2 Calibration programs for all relevant equipment
compliance with the specifications/uncertainty
Calibration or check of equipment before use the
laboratory's specification requirements
5.5.3 Operation by authorized personnel instructions
available
5.5.4 Unique identification of each equipment/software
5.5.5 Recording of equipment including:
a Identification of equipment
b Manufacturer, type, and serial number
c Checks of compliance with specifications
d Current location, where appropriate
e Manufacture's instruction, or reference to this
f All information relating to calibration, adjustments,
acceptance criteria, and next calibration
g Maintenance plan, if appropriate, and maintenance
carried out
h Damage, malfunction, modification or repair
5.5.6 Procedure for handling, transport, storage, use, and
planned maintenance prevention of contamination
5.5.7 Labeling or isolation of defective equipment
examination of the effect on previous tests/calibrations
5.5.8 Indication of calibration status date of recalibration
5.5.9 Ensuring correct function and calibration of equipment
gone outside the laboratory's direct control
Note: the paragraphs in bold indicate the new requirements in the ISO/IEC17025:2005
Note: the paragraphs in bold indicate the new requirements in the ISO/IEC17025:2005
Note: the paragraphs in bold indicate the new requirements in the ISO/IEC17025:2005
Note: the paragraphs in bold indicate the new requirements in the ISO/IEC17025:2005