Norsk akkreditering
DoC.ID.: VII.2.1.25
NA-S10: Checklist for laboratories (NS-EN ISO 17025)
Issued by::
Approved by:
SBE
Verson:
ICL
5.01
Form/Skjema
Valid from:
01.10.2005
Page nr.:
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This checklist shall be filled in by laboratories that are applying for, or wish to renew its accreditation. If an accredited laboratory has made big changes in
the management system’s structure, the checklist also shall be filled in.
The paragraphs arranged in the checklist are in the same order as given in NS-EN ISO/IEC 17025 (2005). In some cases they are also referred to other
requirement documents.
The progress in the handling of an application will depend upon how correct this form has been completed and that the sufficient details have been provided.
The application will be returned without handling if this form is not filled in completely.
If the quality documentation provides a clear answer to all points of the checklist, then it is sufficient to give reference to relevant section of the
documentation. Such references shall be given as detailed as possible. For matters where it is needed to provide more information than what has been
provides in the quality documentation, then the remark column shall be filled in.
PS! For those points in the checklist that are not valid for the laboratory’s practice, the remark column shall be filled in with ”not relevant”.
For insufficient place please provide additional information as annex.
To be completed by the
applicant
To be completed by NA
Name of the laboratory:
Accr. no/ Appl. no:
Address:
E-mail:
Evaluated by:
Telephone:
Telefax:
Date:
Case no.:
Dok.id.:
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Side:
Contact person:
Date:
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NA’s technical officer:
Requirement
Explanation
§ 4.1 Organization
Information about type of company, f. example
limited company, association, foundation etc.
Organization chart and description of structure of the
laboratory giving information about activities and
reporting lines (technical and administrative)
Description of responsibility and authority within the
organization’s structure
Description of management personnel and technical
personnel who, independent from other
responsibilities, have the necessary authority and
recourses to conduct their tasks.
Organization chart for the laboratory and if so, a
description of the bigger organisation which that
laboratory is a part of.
Presentation of the laboratory’s key personnel and
quality manager together with their deputies for these
positions.
Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
Remarks
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Requirement
Explanation
A description of that the quality manager has access
to the top management.
Description of key clients covering also internal
customer.
Clarify potential conflicts of interest regarding
impartiality, independence and integrity and how the
laboratory has solved this.
Description of other activities the laboratory is
involved in besides accredited testing and how
these are organised with respect to each other.
Description of how the laboratory ensures sufficient
recourses in order to perform its duties – own book
keeping and budget.
A statement that all activities are conducted
independent to any pressure that may influence the
results of the work.
Information about wage system (salary) for
laboratory personnel.
- the salary of the laboratory’s staff shall be
independent of total number of samples and their
results.
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
Remarks
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Requirement
Explanation
A description of how confidential information from
the clients and their ownership rights are protected,
included procedures to protect electronic storage and
transmission of results.
A description of how the management has established
appropriate communication processes in the laboratory.
§ 4.2 Management
system
An authorised statement about the quality policy included the
objectives for the management system related to quality
A description of establishing of the objectives and
how it is reviewed during the management review.
A description of the management commitment to
work according to the requirements in the standard
an continuously improve the management system.
A description of how the management ensures that
the personnel understand the importance of the
client’s requirements and needs.
A list or similar which gives the information about
all documents that are part of the management
system
Description of structure of the management system.
Clarifying the roles and responsibilities of the
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
Remarks
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Requirement
Explanation
technical management and the management system.
A description how the management ensures that the
integrity in the management system is maintained by
changes of the system.
§ 4.3 Document
control
A description of who has the authority to approve
different types of documents.
Procedure for document control which gives rules for
valid version number and distribution together with
withdrawal and archiving of obsolete documents.
A document register with indication of valid issues
of different documents and working instructions.
Procedure(s) for development and a unique
identification of documents.
Procedure for periodical evaluation and updating of
documents.
Rule for changes in documents (evaluation, approval
etc) including hand made changes if this is
allowable.
A description of identification of changes or new
text.
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
Remarks
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Requirement
Explanation
Procedure for changes of documents in the computer
system.
Procedure for use of copied procedures/routines,
overview of personnel holding copies and total
number of copies.
For electronic systems: Procedures for who can print
out and rules and status for such copies.
How the quality manual and relevant annexes are
made available to laboratory personnel.
Are working instructions available where the work is
conducted.
§ 4.4 Reviews of
requests, tenders and
contracts
Procedure describing how the laboratory handles
requests, tenders and contracts and agreements the
laboratory may have for all types of assignments.
Procedure(s) for handling of changes in the contract
after it has been signed.
Procedure for registrations from contract reviews and
changes in the contracts.
Procedure for information to the client about
deviation from, or changes in the contract/
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
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Requirement
Explanation
agreement.
§ 4.5 Subcontracting
of tests and
calibrations
Procedure for use of subcontractor for accredited
services with the scope of the laboratory’s
accreditation.
Procedures for documentation of the subcontractor’s
competence.
Procedure how the client get information about use
of subcontractors and how to get he client’s
acceptance for using subcontractor.
Cross reference to a register showing all
subcontractors with description of topical
methods/parameters for each subcontractor.
§ 4.6 Purchasing
Policy and procedure for selection and procurement
services and suppliers of services, consumable materials and reagents.
Routines for receiving, control and storage of
material, reagents and consumption material.
Procedure(s) that describe how the laboratory assess
suppliers and surveillance of suppliers.
List of approved suppliers.
§ 4.7 Service to the
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Procedure(s) describing that the laboratory is willing
to cooperate with the customer to clarify their needs
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
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Requirement
Explanation
customer
and to describe how the laboratory ensures
confidential handling regarding other customers.
A description how the laboratory measures customer
satisfaction and how the feedback from customers
are evaluated.
§ 4.8 Complaints
Policy and procedure(s) for registration, handling,
follow up and feedback to customers when receiving
of complaints.
§ 4.9 Control of non-
Policy and procedure(s) for registration and handling
of non-conformities regarding own procedures or
requirements agreed with the customer.
conforming testing
and/or calibration work
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Clarification of responsibility and authority.
§ 4.10 Improvement
A description of how the laboratory continually
improve the effectiveness of its management system
by use of the quality policy, audit results, analysis of
data, corrective and preventive actions and
management review.
§ 4.11 Corrective
action
Description of policy and procedure for appointment
of personnel with authority to carry out corrective
actions.
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
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Requirement
Explanation
Rules for cause analysis.
Rules for selection and implementation of corrective
action.
Rules for monitoring of corrective actions.
Rule for when additional audits shall be performed in
connection with corrective actions.
§ 4.12 Preventive
action
Procedure for how potential source for nonconformities shall be identified. Rule for issuing,
implementation and monitoring of action plans.
§ 4.13 Control of
records
Procedure for identification, collection, recording,
access to, archiving, storage, maintenance and
disposal of records.
Routines for recording of all necessary information
that will be necessary to repeat test/calibration.
Rule for changes in records like raw data.
§ 4.14 Internal audits
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Procedure and distribution of responsibility for
conducting internal audits (both horizontal and
vertical) including audit of quality manager work
related to the management system.
Guidelines for the preparation of plans, reporting,
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
Remarks
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Requirement
Explanation
following up and archiving of results.
An annual plan showing; what shall be audited, when
it shall be performed and by whom.
Information about the qualification requirements for
auditors.
§ 4.15 Management
reviews
Procedure for planning, performing and follow up of
results from management review of the management
system, included a list of subjects that shall be
discussed during the meeting.
Description of how the results shall be implemented
in the laboratory’s system for planning of the coming
years.
Description of reporting and archiving of the minutes
from the management review of the management
system.
§ 5.2 Personnel
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Laboratory goal for education, training and skill.
Policy for identification of need for training and
training programme.
Description of how the effectiveness of training shall
be evaluated.
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
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Requirement
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Explanation
Procedure for training, maintenance and updating of
staff qualification within the management system.
Procedure for training, maintenance and updating of
staff qualifications within the different technical
assignments like:
 Persons who performs testing/calibration
 Sampling
 Responsible for approval of results
 Responsible for preparation of plans for
development and validation of in
house/modified methods
 Those who sign test reports/ calibration
certificates.
Routine(s) for approval of different category of staff
(see above), which competence is required together
with the criteria, which is used for approval.
Overview of responsible person(s) for development
and validation of non-standard methods.
Overview of staff showing who is qualified to
perform the individual methods and the date for the
approval.
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
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Requirement
Explanation
Overview showing who is approved to assume the
technical responsibility for testing/calibration results
from the individual methods.
Cross reference to updated and signed CVs for
laboratory staff.
Job descriptions for each post category/function.
Specification of job assignments, deputies can take
over.
Cross reference to declaration of confidentiality
signed by the staff.
§5.3 Accomodation
and environmental
conditions
Description of the test facility - preferably in form of
a drawing.
Description of the laboratory’s access control.
Description of actions that shall be taken to avoid
any cross contamination.
Specification of requirements for laboratory
environment.
A description and a system how environmental
parameters are recorded.
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
Remarks
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Requirement
Explanation
Description of actions performed when
environmental parameters are not longer in
conformity with the specified requirements.
§ 5.4 Test and
Cross reference to written work
calibration methods
instructions/procedures for all methods in the
and method validation accreditation scope.
Overview of laboratory testing /calibration scope
(including accredited methods).
§ 5.4.2 Selection of
methods
Policy showing how laboratory selects its methods
and procedures for clarifying the method of selection
with the client.
Describing of procedure verifying that the laboratory
is capable of performing standard methods in a
correct way.
Description of routines ensuring that the laboratory
uses the latest version of standard methods (updating
of method collection, subscription of standards).
Cross reference to documentation, which shows that
the laboratory get acceptable results using standard
methods.
§ 5.4.3 / § 5.4.4
Procedure for development of own (in house)
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
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Requirement
Explanation
Laboratory-developed methods / non-standard methods.
methods / non
standard methods
§ 5.4.5 Validation of
methods
Procedure and documentation, including cross
reference to these, for validation of non-standard
methods, modified methods and in-house methods.
Rules for mapping, planning performance and
reporting of validations.
§ 5.4.6 Estimation of
uncertainty of
measurement
Procedure describing how measurement uncertainty
for testing/calibration/possible sampling is estimated
or calculated.
Cross reference to reports or other equivalent
document, which document the estimated or
calculated measurement uncertainty.
When it is not required/used uncertainty budget.
Specify how the important contributors to
measurement uncertainty have been identified.
§ 5.4.7 Control of
data
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Procedure for control of raw data, calculations,
registrations, registration of recorded values.
Procedure for control of calibration / test results.
Procedure(s) and documentation including cross-
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
Remarks
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Requirement
Explanation
reference to these, for validation/control of computer
software that are used for calculation, data transfer or
archiving of data.
§ 5.5 Equipment
Cross reference to a list giving an overview of all
equipment that is used in connection with accredited
testing/calibration (included software). The
equipment outside the laboratory premises and
equipment, which is not directly controlled by the
laboratory, is included in the list.
A description of how equipment is labelled for
example with calibration labels or quarantine labels.
Program and yearly plan with distribution of
responsibility for calibration and control of
equipment (traceability chart).
Cross reference to procedures for handling
laboratory equipment.
A program for maintenance and verification of
equipment.
§ 5.6 Measurement
traceability
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Description of laboratory system for achieving
traceability for testing and calibrations.
Cross reference to procedures for use and storage of
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
Remarks
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Requirement
Explanation
laboratory’s standards and/or reference materials.
§ 5.7 Sampling
(requires a separate
application)
Procedure describing how sampling is planned and
conducted.
Procedure(s) for registration of relevant data in
connection with sampling.
Procedure describing how the laboratory handles in
case of change in the sampling plan and how the
client approves this.
§ 5.8 Handling of test Procedure for receipt and receipt control of test
and calibration items items/ test- and calibration objects, and a system for
making test items/ test objects anonymous in the
laboratory.
Procedure(s) describing how the laboratory takes
care of sampling and calibration items with
irregularity or deviations from normal or specified
conditions, or if the item is not in accordance with its
description.
A system for identification of test and calibration
items either with the help of documents or labelling.
Procedure for handling, storage, transport and
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
Remarks
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Requirement
Explanation
disposal of test and calibration items.
§ 5.9 Assuring the
quality of test and
calibration results
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Procedure describing how the laboratory monitors
the quality of testing (for example control samples,
inter laboratory comparison (ILC), certified
reference material) or calibration. This should also
cover the handling of results.
A description of how trends in quality control data
are detectable and evaluated.
An overview of inter laboratory schemes in which
the laboratory participates and frequency of its
participation.
Procedure describing analysis of quality control data
and actions that has to be taken to avoid reporting of
incorrect results.
§ 5.10. Reporting the Description of the contents of calibration certificates
results
or test reports including system for their
identification and publication.
Description of and cross-reference to, preparation of
calibration certificates or test reports (for example
reference to a template)
If relevant, a procedure for publication of simplified
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Explanation
reports
Description of how non-accredited activities/results
are identified in the report (for example sampling,
opinion and interpretation, results from nonaccredited methods).
Description of how intermediate results are quality
ensured when this is relevant (This can be both in
written or verbal reporting).
Procedure for correction of published
reports/additional reports.
Procedure for referring to possible sub-contractors
that have been used.
NA Dok. 14 and
25/31
Guidelines for referring to accreditation and use of
calibration labels in advertisement and on web site
and in all other situations.
NA Dok. 25/31, pkt.
2, 4, 6 og 7,
Cooperation
Description of co-operation with the accreditation
body.
NA Dok. 25/31
Disclosure
requirements
Guidelines describing how major changes in the
laboratory are communicated to NA.
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Explanation
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Location in the
management system
documentation (chapter,
section, book, procedure,
work instructions etc)
Additional requirements for area P32 ”Opinion and interpretation” (require a separate application)
§4.2 Management
system
Procedure describing the system for opinion and
interpretation including information what is to be
interpreted and limitation of the system.
A detailed description of type of statements
laboratory can make. Possible cross-reference to
literature where this is adequately described. (If it is
referred to literature then this has to be attached with
the application, if not agreed before hand).
§4.1 Organization
Description of responsibility and authority in
connection with opinion and interpretations.
§4.13 Control of
records
Description of how the basis for opinion and
interpretation will be recorded.
§5.2 Personnel
Description of what competence is required from
personnel who shall make statements on opinion and
interpretations. This should also cover the criteria
for approval of these personnel.
Procedure for training, maintenance and updating of
qualifications of the personnel who shall
make/approve opinion and interpretations.
An overview of personnel who can make/approve
Remarks
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Explanation
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Location in the
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work instructions etc)
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opinion and interpretation of test and calibration
results.
§5.10 Reporting the
results
Description of the contents of the report and how
opinion and interpretation are identified. (Relevant
examples of the reports should be attached).
Additional requirement for area P31 “Flexible accreditation” (require a separate application) See also NA Dok 50
§4.2 Management
system
Procedure describing the system for flexible
accreditation including information about what can
be allowed and limitations of the system.
§4.1 Organization
Description of responsibility and authority in
connection with flexible accreditation.
§4.13 Control of
records
Descriptions showing how changes related to
flexibility are recorded.
§5.2 Personnel
Description of what competence is required from
personnel who shall develop and validate plans.
Criteria for approval of these personnel.
Procedure for training, maintenance and updating of
qualifications of the personnel who shall be involved
in the development and validation of plans
An overview of personnel who are responsible for
validation.
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Explanation
§5.4.3 Laboratorydeveloped methods
Procedure for preparation of a plan for development
of methods and how this shall be carried out.
§5.4.4 Non-standard
methods
Procedure for preparation of a validation plan and
how the validation shall be carried out.
References
External References
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Location in the
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work instructions etc)
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