IECEE OPERATIONAL DOCUMENT
IECEE OD-2017
Edition 1.6
2017-05-17
IECEE
OPERATIONAL DOCUMENT
IEC System of Conformity Assessment Schemes for Electrotechnical Equipment
and Components (IECEE System)
IECEE OD-2017:2017(EN)
Check list for Testing and Calibration Laboratories
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–2–
IECEE OD-2006:2017 © IEC 2017
FOREWORD
Document Owner
PAC
History of changes
Date
Brief summary of changes
2017-05-17
The introduction and clause 5.10.5 have been updated.
Effective date
Target revision date
2017-05-17
2020-05-17
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Only the version on the IECEE Website is the current document version
IECEE OD-2006:2017 © IEC 2017
–3–
CHECK LIST FOR TESTING AND CALIBRATION LABORATORIES
This check list is based on INTERNATIONAL STANDARD ISO/IEC 17025: 2005, with equivalent numbering.
The introduction clauses 1, 2 and 3 of this International Standard are left out in this check list.
Laboratory concerned:
(name, address etc.)
Date of completion:
Completed by:
Please specify the language of the following documents:
Document
Language
Quality Manual
Quality procedures
Working Instructions
Please note: If the language of these documents is not English, at least the Index and Headings must be in English
Legend:
Status:
Y = YES
Doc. ref.:
Document reference of the relevant laboratory document
N = NO
N/A = Not applicable
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–4–
4
Management requirements
Item
Status
4.1
4.1.1
Organization and management
Is the laboratory or the organization of which it is a part
an entity that can be held legally responsible?
4.1.2
Does the laboratory feel responsibility to carry out its
testing and calibration activities in such a way as to
meet the requirements of this International Standard and
to satisfy the needs of the customer, the regulatory
authorities or organisations providing recognition?
4.1.3
Does the laboratory management system cover work
carried out in the laboratory’s
4.1.4
IECEE OD-2006:2017 © IEC 2017
•
permanent facilities?
•
at sites away from its permanent facilities?
•
or in associated temporary or mobile facilities?
Doc. ref. / Remarks
If the laboratory is a part of an organization performing
activities other than testing and/or calibration, are the
responsibilities of key personnel in the organization that
have an involvement or influence on the testing and/or
calibration activities of the laboratory defined in order to
identify potential conflicts of interest?
Note 1
Where a laboratory is part of a larger organization, the organisational arrangements should be such that
departments having conflicting interests, such as production, commercial marketing or financing do not adversely
influence the laboratory’s compliance with the requirements of this International Standard.
Note 2
4.1.5
If the laboratory wishes to be recognised as a third-party laboratory, it should be able to demonstrate that it is
impartial and that it and its personnel are free from any undue commercial, financial and other pressures which
might influence their technical judgement. The third-party testing or calibration laboratory should not engage in any
activities that may endanger the trust in its independence of judgement and integrity in relation to its testing or
calibration activities.
Does the laboratory
a)
have managerial and technical personnel with the
authority and resources needed to carry out their
duties and to identify the occurrence of departures
from the quality system or the procedures for
performing tests and/or calibrations, and to initiate
actions to prevent or minimise such departures
(see also 5.2)?
b)
have arrangements to ensure that its management
and personnel are free from any undue internal or
external commercial, financial and other pressures
and influences that may adversely affect the
quality of their work?
c)
have policies and procedures to ensure the
protection
of
its
customers’
confidential
information and proprietary rights, including
procedures for protecting the electronic storage
and transmission of results?
d)
have policies and procedures to avoid involvement
in any activities that would diminish confidence in
its competence, impartiality, judgement or
operational integrity?
e)
define the organization and management structure
of the laboratory, its place in any parent
organization, and the relationships between quality
management, technical operations and support
services?
specify
the
responsibility,
authority
and
interrelationships of all personnel who manage,
perform or verify work affecting the quality of the
tests and/or calibrations?
f)
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Means that the laboratory must have all the necessary
resources for the operation of its management system.
Ensures the implementation, maintenance and
improvement of the management system by the
laboratory managerial and technical personnel.
IECEE OD-2006:2017 © IEC 2017
–5–
Item
Status
g)
provide adequate supervision of testing and
calibration staff, including trainees, by persons
familiar with methods and procedures, and with
the assessment of the test or calibration results?
h)
have the technical management which has overall
responsibility for the technical operations and the
provisions of the resources needed to ensure the
required quality of laboratory operations?
i)
appoint a member of staff as quality manager
(however named) who, irrespective of other duties
and
responsibilities,
shall
have
defined
responsibility and authority for ensuring that the
management system is implemented and followed
at all times?
Doc. ref. / Remarks
does the quality manager have direct assess to
the highest level of management at which
decisions are made on laboratory policy or
resources?
j)
appoint deputies for key managerial personnel
such as the quality manager (see note)?
Note
Individuals may have more than one function and it may be impractical to appoint deputies for every function.
k)
ensure that its personnel are aware of the
The Laboratory must be able to demonstrate how its
relevance and importance of their activities and
personnel contribute to the effectiveness of the
how they contribute to the achievement of the
management system and that each person knows the
objectives of the management system?
value of the contribution that they make.
4.1.6
4.2
4.2.1
Does the Top management ensure that
appropriate communication processes are
established within the laboratory and that
communication takes place regarding the
effectiveness of the management system?
Management system
Has the laboratory established, implemented and
maintained a management system appropriate to the
scope of its activities?
Has the laboratory documented its policies, systems
programs, procedures and instructions to the extent
necessary to enable the laboratory to ensure the quality
of the test and/or calibration results?
4.2.2
Is documentation used in this system communicated to,
understood by, available to, and implemented by the
appropriate personnel?
Are the laboratory's management system policies
related to quality, including a quality policy statement,
defined in a quality manual (however named)?
Are the overall objectives established and reviewed
during management review?
Are the overall objectives documented in a quality policy
statement?
Is the quality policy statement issued under the authority
of the top management?
Does the manual at least include the following:
a)
the laboratory management’s commitment to good
professional practice and to the quality of its
testing and calibration in servicing its customers?
b)
the management’s statement of the laboratory’s
standard of service?
c)
the purpose of the management system related to
quality;?
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The Laboratory must have clearly stated objectives
and ensure they are reviewed during management
review.
–6–
Item
IECEE OD-2006:2017 © IEC 2017
Status
d)
a requirement that all personnel concerned with
testing and calibration activities within the
laboratory familiarise themselves with the quality
documentation and implement the policies and
procedures in their work?
e)
the laboratory management’s commitment to
continually improve the effectiveness of the
management?
Doc. ref. / Remarks
The management’s commitment to continually improve
the effectiveness of the management has to be
demonstrated.
Note
4.2.3
The quality policy statement should be concise and may include the requirement that tests and/or calibrations shall
always be carried out in accordance with stated methods and customers’ requirements. When the test and/or
calibration laboratory is part of a larger organization, some quality policy elements may be in other documents.
Does the Top management provide evidence of
Requires the Laboratory to provide evidence of their
commitment to the development and implementation of
commitment.
the management system and continually improving its
effectiveness?
4.2.4
Does the Top management communicate to the
organization the importance of meeting customer as well
as statutory and regulatory requirements?
4.2.5
Does the quality manual include or make reference to
the supporting procedures including technical
procedures.
Does the quality manual outline the structure of the
documentation used in the management system?
4.2.6
Are the roles and responsibilities of technical
management and the quality manager, including
their responsibility for ensuring compliance with this
International Standard, shall be
defined in the quality manual.
4.2.7
Does the Top management ensure that the integrity of
the management system is maintained when changes to
the management system are planned and implemented?
4.3
4.3.1
Document control
General
Demonstrates the importance of customer
relationships and the need to be aware of statutory
and regulatory requirements and to communicate this
to the Laboratory staff.
Changes to the management system are usually
covered at management review. When changes are
made it is important to verify if these changes have
had the desired effect and not caused other problems.
In this way, the integrity of the system is maintained.
Has the laboratory established and maintained
procedures to control all documents that form part of its
management system (internally generated and from
external sources), such as regulations, standards, other
normative documents, test and/or calibration methods,
as well as drawings, software, specifications,
instructions and manuals?
Note 1
4.3.2
4.3.2.1
4.3.2.2
In his context “document” could be policy statements, procedures, specifications calibration tables, charts, text
books, posters, notices, memoranda, software, drawings, plans, etc. These may be on various media, whether
hard copy or electronic, and they may be digital, analogue, photographic or written.
Note 2 The control of data related to testing and calibration is covered in 5.4.7. The control of records is covered in 4.12
Document approval and issue
Are all documents issued to personnel in the laboratory
as part of the management system reviewed and
approved for use by authorised personnel prior to issue?
Is a master list or an equivalent document control
procedure identifying the current revision status and
distribution of documents in the management system
established and readily available to preclude the use of
invalid and/or obsolete documents?
Do the procedures adapted ensure that:
a)
authorised editions of appropriate documents are
available at all locations where operations
essential to the effective functioning of the
laboratory are performed?
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IECEE OD-2006:2017 © IEC 2017
–7–
Item
Status
b)
documents are periodically reviewed and, where
necessary, revised to ensure continuing suitability
and compliance with applicable requirements?
c)
invalid or obsolete documents are promptly
removed from all points of issue or use, or
otherwise assured against unintended use?
Doc. ref. / Remarks
obsolete documents retained for either legal or
knowledge preservation purposes are suitably
marked?
Are management system documents generated by the
laboratory uniquely identified?
d)
4.3.2.3
4.3.3
4.3.3.1
Does such identification include the date of issue and/or
revision identification, page numbering, the total number
of pages or a mark to signify the end of the document,
and the issuing authority(ies)?
Document changes
Are changes to documents reviewed and approved by
the same function that performed the original review
unless specifically designated otherwise?
Do the designated personnel have access to pertinent
background information upon which to base their review
and approval?
4.3.3.2
Where practicable, is the altered or new text identified in
the document or its appropriate attachments?
4.3.3.3
If the laboratory’s documentation control system allows
for the amendment of documents by hand pending the
re-issue of documents, are the procedures and
authorities for such amendments defined?
Are amendments clearly marked, initialled and dated?
Is a revised document formally re-issued as soon as
practicable?
4.3.3.4
Are procedures established to describe how changes in
documents maintained in computerised systems are
made and controlled?
4.4
4.4.1
Review of Requests, Tenders and Contracts
Has the laboratory established and maintained
procedures for the review of requests, tenders or
contracts?
Do the policies and procedures for these reviews leading
to a contract for testing and/or calibration ensure that:
a)
the requirements, including the methods to be
used are adequately defined, documented and
understood?
(see 5.4.2)
b)
the laboratory has the capability and resources to
meet the requirements?
c)
the appropriate test and/or calibration method is
selected and capable of meeting the customer’s
requirements?
(see 5.4.2)
Are any differences between the request or tender and
the contract resolved before any work commences?
Is each contract acceptable both to the laboratory and
the customer?
Note 1
The request, tender and contract review should be conducted in a practical and efficient manner, and the effect of
financial, legal and time schedule aspects should be taken into account. For internal customers, reviews and
requests, tenders and contracts can be performed in a simplified way.
Note 2
The review of capability should establish that the laboratory possesses the necessary physical, personnel and
information resources, and that the laboratory’s personnel have the skills and expertise necessary for the
performance of the tests and/or calibrations in question. The review may also encompass results of earlier
participation in interlaboratory comparisons or proficiency testing and/or the running of trial test or calibration
programs using samples of items of known value in order to determine uncertainties of measurements, limits of
detection, confidence limits, etc.
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Item
4.4.2
IECEE OD-2006:2017 © IEC 2017
Status
Doc. ref. / Remarks
Note 3 A contract may be any written or oral agreement to provide a customer with testing and/or calibration services.
Are records of such reviews, including any significant
changes, maintained?
Are records maintained of pertinent discussions with a
customer relating to the customer’s requirements or the
results of the work during the period of execution of the
contract?
Note
4.4.3
4.4.4
4.4.5
4.5
4.5.1
4.5.2
4.5.3
4.5.4
4.6
4.6.1
4.6.2
For reviews of routine and other simple tasks, the date and the identification (e.g. the initials) of the person in the
laboratory responsible for carrying out the contracted work are considered adequate. For repetitive routine tasks,
the review need be made only at the initial inquiry stage or on granting of the contract for on-going routine work
performed under a general agreement with the customer, provided that the customer’s requirements remain
unchanged. For new, complex or advanced testing and/or calibration tasks, a more comprehensive record should
be maintained.
Does the review also cover any work that is
subcontracted by the laboratory?
Is the customer informed about any deviation from the
contract?
If a contract needs to be amended after the work has
commenced, is the same contract review repeated and
any amendments communicated to all affected
personnel?
Subcontracting of tests and calibrations
Where a laboratory subcontracts work whether because
of unforeseen reasons (e.g. workload, need for further
expertise or temporary incapacity) or on a continuing
basis ( e.g. through permanent subcontracting, agency
or franchising arrangements), is this work placed with a
competent?
A competent subcontractor is one that, for example,
complies with this International Standard for the work in
question.
Does the laboratory advise the customer of the
arrangement in writing and, when appropriate, gain the
approval of the customer, preferably in writing?
Is the laboratory responsible to the customer for the
subcontractor’s work, except in the case where the
customer or a regulatory authority specifies which
subcontractor is to be used?
Does the laboratory maintain a register of all subcontractors that it uses for tests and/or calibrations and
a record of the evidence of compliance with this
International Standard for the work in question?
Purchasing services and supplies
Does the laboratory have a policy and procedure(s) for
the selection and purchasing of services and supplies it
uses that may affect the quality of the tests and/or
calibrations?
Do procedures exist for the purchase, reception and
storage of reagent and laboratory consumable materials
relevant for the tests and calibrations?
Does the laboratory ensure that purchased supplies and
reagents and consumable materials that may effect the
quality of tests and/or calibrations are not used until they
have been inspected or otherwise verified as complying
with standard specifications or requirements defined in
the methods for the tests and/or calibrations concerned?
Do the services and supplies used comply with specified
requirements?
4.6.3
Are records of actions taken to check compliance
maintained?
Do purchasing documents, for items affecting the quality
of laboratory output, contain data describing the services
and products ordered?
Are these purchasing documents reviewed
approved for technical content prior to release?
Note
and
The description may include type, class, grade, precise identification, specifications, drawings, inspection
instructions, other technical data including approval of test results, the quality required and the management
system standard under which they were made.
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Item
4.6.4
–9–
Status
Does the laboratory maintain records of
evaluations and list those supplier approved?
4.7
4.7.1
Doc. ref. / Remarks
Does the laboratory evaluate suppliers of critical
consumables, supplies and services which may affect
the quality of testing and calibration?
these
Service to the customer
Is the laboratory willing to cooperate with customers or
their representatives in clarifying the customer's request
and in monitoring the laboratory’s performance in
relation to the work performed, provided that the
laboratory ensures confidentiality to other customers?
This implies that it is not mandatory for the Laboratory
to allow customers to verify the customer’s request
and the Laboratory’s performance in relation to the
work performed unless confidentiality to other
customers can be maintained.
Note 1 Such cooperation may include:
a) providing the customer or the customer's representative reasonable access to relevant areas of the laboratory for the
witnessing of tests and/or calibrations performed for the customer;
b) preparation, packaging, and dispatch of test and/or calibration items needed by the customer for verification purposes.
Note 2 Customers value the maintenance of good communication, advice and guidance in technical matters, and
opinions and interpretations based on results. Communication with the customer, especially in large
assignments, should be maintained throughout the work. The laboratory should inform the customer of any
delays or major deviations in the performance of the tests and/or calibrations.
4.7.2
Does the laboratory seek, both positive and negative
feedback from its customers?
Is the feedback used and analysed to improve the
management system, testing and calibration activities
and customer service?
Mandatory requirement. For example, a simple
questionnaire could be used to obtain this feedback
Note Examples of the types of feedback include customer satisfaction surveys and review of test or calibration reports with
customers.
4.8
Complaints
Has the laboratory a policy and procedure for the
resolution of complaints received from customers or
other parties?
Are records maintained of all complaints and of the
investigations and corrective actions taken by the
laboratory?
(see also 4.10)
4.9
4.9.1
Control of nonconforming testing and/or calibration work
Has the laboratory a policy and procedures to be
implemented when any aspect of its testing and/or
calibration work, or the result of this work, do not
conform to its own procedures or the agreed
requirements of the customer?
Do the policy and procedures ensure that:
a)
the responsibilities and authorities for the
management of nonconforming work are
designated and actions (including halting of work
and withholding of test reports and calibration
certificates, as necessary) are defined and taken
when non-conforming work is identified?
b)
an evaluation of the significance of the nonconforming work is made?
c)
remedial actions are taken immediately, together
with any decision about the acceptability of the
nonconforming work?
d)
where necessary, the customer is notified and
work is recalled?
e)
the responsibility for authorising the resumption of
work is defined?
Note
Identification of nonconforming work or problems with the management system or with testing and/or calibration
activities can occur at various places within the management system and technical operations. Examples are
customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations
or supervision, test report and calibration certificate checking, management reviews and internal or external audits.
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– 10 –
Item
4.9.2
IECEE OD-2006:2017 © IEC 2017
Status
4.10
Where the evaluation indicates that the non-conforming
work could recur or that there is doubt about the
compliance of the laboratory’s operations with its own
policies and procedures, are the corrective action
procedures given in 4.10 promptly followed?
Improvement
Does the laboratory continually improve the
effectiveness of its management system through the use
of the quality policy, quality objectives, audit results,
analysis of data, corrective and preventive actions and
management review?
4.11
4.11.1
Corrective action
General
Has the laboratory established a policy and procedures
and designated appropriate authorities for implementing
corrective action when non-conforming work or
departures from the policies and procedures in the
management system or technical operations have been
identified?
Doc. ref. / Remarks
Requires the Laboratory to plan, implement and
monitor its improvement activities and preventive
actions.
Note
4.11.2
A problem with the management system or with the technical operations of the laboratory may be identified
through a variety of activities, such as control of non-conforming work, internal or external audits, management
reviews, feedback from customers or staff observations.
Cause analysis
Does the procedure for corrective action start with an
investigation to determine the root cause(s) of the
problem?
Note
4.11.3
Cause analysis is the key and sometimes the most difficult part in the corrective action procedure. Often the root
cause is not obvious and thus a careful analysis of all potential causes of the problem is required. Potential causes
could include customer requirements, the samples, sample specifications, methods and procedures, staff skills
and training, consumables, or equipment and its calibration.
Selection and implementation of corrective actions
Where corrective action is needed, has the laboratory
identified potential corrective actions?
Does the laboratory select and implement the action(s)
most likely to eliminate the problem and to prevent
recurrence?
Are corrective actions to a degree appropriate to the
magnitude of the risk of the problem?
Does the laboratory document and implement any
required changes resulting from corrective action
investigations?
4.11.4
Monitoring of corrective actions
Does the laboratory monitor the results to ensure that
the actions they have been taken are effective?
4.11.5
Additional audits
Where the identification of non-conformances or
departures casts doubt on the laboratory’s compliance
with its own policies and procedures, or on its
compliance with this International Standard, does the
laboratory ensure that the appropriate areas of activity
are audited in accordance with 4.13 as soon as
possible?
Note
4.12
4.12.1
Such additional audits often follow the implementation of the corrective actions to confirm their effectiveness. An
additional audit should be necessary only when a serious issue or risk to the business is identified.
Preventive action
Are needed improvements and potential sources of nonconformances, either technical or concerning the
management system, identified?
If preventive action is required, are action plans
developed, implemented and monitored, to reduce the
likelihood of occurrence of such non-conformances and
to take advantage of the opportunities for improvement?
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Item
4.12.2
– 11 –
Status
Note 1
Preventive action is a pro-active process to identify opportunities for improvement rather than a reaction to the
identification of problems or complaints.
Note 2
Apart from the review of the operational procedures, the preventive action might involve analysis of data, including
trend and risk analysis and proficiency testing results.
4.13
4.13.1
Control of records
General
4.13.1.1
Has the laboratory established and maintained
procedures for identification, collection, indexing,
access, filing, storage, maintenance and disposal of
quality and technical records?
4.13.1.2
Doc. ref. / Remarks
Do procedures for preventive actions include the
initiation of such actions and application of controls to
ensure that they are effective?
Do quality records include reports from internal audits
and management reviews as well as records of
corrective and preventive actions?
Are all records legible and stored and retained in such a
way that they are readily retrievable in facilities that
provide a suitable environment to prevent damage or
deterioration and to prevent loss?
Are retention times of records established?
4.13.1.3
4.13.1.4
4.13.2
4.13.2.1
Note
Records may be in any media, such as hard copy or electronic media.
Are all records held secure and in confidence?
In some cases access limited electronically
Does the laboratory have procedures to protect and
back-up data records stored electronically and to
prevent unauthorised access to or amendment of these
records?
Technical records
Does the laboratory retain records of original
observations, derived data and sufficient information to
establish an audit trail, calibration records, staff records
and a copy of each test report or calibration certificate
issued, for a defined period?
Do the records for each test or calibration contain
sufficient information to facilitate, if possible,
identification of factors affecting the uncertainty and to
enable the test or calibration to be repeated under
conditions as close as possible to the original?
Do the records include the identity of personnel
responsible for the sampling, performance of each test
and/ or calibration and checking of results?
Note 1
In certain fields it may be impossible or impracticable to retain records of all original observations.
Note 2
4.13.2.2
4.13.2.3
Technical records are accumulations of data (see 5.4.7) and information which result from carrying out tests
and/or calibrations and which indicate whether specified quality or process parameters are achieved. They may
include forms, contracts, work sheets, work books, check sheets, work notes, control graphs, external and internal
test reports and calibration certificates, customers’ notes, papers and feedback.
Are observations, data and calculations recorded at the
time they are made and identifiable to the specific task?
When mistakes occur in the records, is each mistake
crossed out, not erased, made illegible or deleted, and
the correct value entered alongside?
Are all such alterations to records signed or initialled by
the person making the correction?
In case of records stored electronically, are equivalent
measures taken to avoid loss or change of original data?
4.14
4.14.1
Internal audits
Does the laboratory periodically and in accordance with
a predetermined schedule and procedure conduct
internal audits of its activities to verify that its operations
continue to comply with the requirements of the
management system and this International Standard?
Does the internal audit program address all elements of
the management system, including the testing and/or
calibration activities?
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Doc. ref. / Remarks
Is the quality manager responsible to plan and organise
audits as required by the schedule and requested by
management?
Are such audits carried out by trained and qualified
personnel who are, wherever resources permit,
independent of the activity to be audited?
4.14.2
4.14.3
4.14.4
4.15
4.15.1
Note
The cycle for internal auditing should normally be completed in one year.
When audit findings cast doubt on the effectiveness of
the operations or on the correctness or validity of the
laboratory’s test or calibration results, does the
laboratory take timely corrective action and notify
customers in writing if investigations show that the
laboratory results may have been affected?
Are the area of activity, the audit findings and corrective
actions that arise from them recorded?
Do follow-up audit activities verify and record the
implementation and effectiveness of the corrective
action taken?
Management reviews
In accordance with a predetermined schedule and
procedure, does the laboratory’s management conduct a
review of the laboratory’s management system and
testing and/or calibration activities to ensure their
continuing suitability and effectiveness, and to introduce
necessary changes or improvements?
Does the review take account of:
• the suitability of policies and procedures?
• reports from managerial and supervisory personnel?
• the outcome of recent internal audits?
• corrective and preventive actions?
• assessment by external bodies?
• the result of interlaboratory comparisons
or proficiency tests?
• the suitability of policies and procedures?
• customer feedback?
• complaints?
• recommendations for improvement?
• other relevant factors such as quality control
activities, resources and staff training?
4.15.2
Note 1
A typical period for conducting management reviews is once every 12 months.
Note 2
Results should feed into the laboratory planning system and should include the goals, objectives and action plans
for the coming year.
Note 3
A management review includes consideration of related subjects at regular management meetings.
Are findings from management reviews and the action
arising from them recorded?
Does the management ensure that those actions are
discharged within an appropriate and agreed
time scale?
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5.1
5.1.1
General
Many factors determine the correctness and reliability of the tests and/or calibrations performed by a laboratory.
These factors include contributions from:
•
human factors (5.2),
•
accommodation and environmental conditions (5.3),
•
test and calibration methods and method validation (5.4),
•
equipment (5.5),
•
measurement traceability (5.6),
•
sampling (5.7),
•
the handling of test and calibration items (5.8).
5.1.2
The extent to which these factors contribute to the total
measurement uncertainty differs considerably between
(types of) tests and between (types of) calibrations.
Does the laboratory take account of these factors in
developing test and calibration methods and procedures,
in the training and qualification of personnel, and in the
selection and calibration of the equipment it uses?
5.2
5.2.1
Personnel
Does the laboratory management ensure the
competency of all personnel who operate specific
equipment, perform tests and/ or calibrations, evaluate
results, and sign test reports and calibration certificates?
When using staff who are undergoing training, is
appropriate supervision provided?
Are personnel performing specific tasks qualified on the
basis of appropriate education, training, experience
and/or demonstrated skills, as required?
Note 1
In some technical areas (e.g. non-destructive testing) it may be required that the personnel performing certain
tasks hold personnel certification. The laboratory is responsible for fulfilling specified personnel certification
requirements. The requirements for personnel certification might be regulatory, included in the standards for the
specific technical field, or required by the customer.
Note 2
5.2.2
The personnel responsible for the opinions and interpretations included in test reports should, in addition to the
appropriate qualifications, training, experience and satisfactory knowledge of the testing carried out, also have:
•
relevant knowledge of the technology used for the manufacturing of the items, materials, products, etc.
tested, or the way they are used or intended to be used, and the defects or degradations which may occur
during or in service;
•
knowledge of the general requirements expressed in the legislation and standards; and
•
an understanding of the significance of deviations found with regard to the normal use of the items, materials,
products, etc. concerned.
Has the management of the laboratory formulated the
goals with respect to the education, training and skills of
the laboratory personnel?
Does the laboratory have a policy and procedures for
identifying training needs and providing training of
personnel?
Is the training program relevant to the present and
anticipated tasks of the laboratory?
5.2.3
5.2.4
Is the effectiveness of the training actions taken (of the
laboratory personnel) evaluated by the management of
the laboratory
Does the laboratory use personnel who are employed by,
or under contract to, the laboratory?
Where contracted and additional technical and key
support personnel are used, does the laboratory ensure
that such personnel are supervised and that they work in
accordance with the laboratory’s management system?
Does the laboratory maintain current job descriptions for
managerial, technical and key support personnel
involved in tests and/or calibrations?
Note
Job descriptions can be defined in many ways. As a minimum, the following should be defined:
•
•
•
•
•
•
the responsibilities with respect to performing tests and calibrations;
the responsibilities with respect to the planning of tests and/or calibrations and evaluation of results;
the responsibilities for reporting opinions and interpretations;
expertise and experience required;
qualifications and training programs;
managerial duties.
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Does the management authorise specific personnel to
perform particular types of sampling, test and/or
calibration, to issue test reports and calibration
certificates, to give opinions and interpretations and to
operate particular types of equipment?
Does the laboratory maintain records of the relevant
authorisation(s),
competence,
educational
and
professional qualifications, training, skills and experience
of all technical personnel, including contracted
personnel?
Is this information readily available and include the date
the authorisation and/or competence is confirmed?
5.3
5.3.1
Accommodation and environmental conditions
Are the laboratory facilities for testing and/or calibration,
including but not limited to energy sources, lighting and
environmental conditions, such as to facilitate correct
performance of tests and/or calibrations?
Does the laboratory ensure that the environmental
conditions do not invalidate the results or adversely
affect the required quality of any measurement?
Is particular care taken when sampling and tests and/or
calibrations are undertaken at sites other than a
permanent laboratory facility?
5.3.2
Are the technical requirements for accommodation and
environmental conditions that can affect the results of
tests and calibrations documented?
Does the laboratory monitor, control and record
environmental conditions as required by relevant
specifications, methods and procedures or where they
influence the quality of the results?
Is due attention paid, for example, to biological sterility,
dust, electromagnetic disturbances, radiation, humidity,
electrical supply, temperature, and sound and vibration
levels, as appropriate to the technical activities
concerned?
5.3.3
5.3.4
5.3.5
Are tests and calibrations stopped when the
environmental conditions jeopardise the results of the
tests and/or calibrations?
Are there effective separation between neighbouring
areas in which there are incompatible activities?
Are measures taken to prevent cross-contamination?
Is access to and use of areas affecting the quality of
tests and/ or calibrations controlled?
Has the laboratory decided the extent of control based
on its particular circumstances?
Are measures taken to ensure good housekeeping in the
laboratory?
Are special procedures prepared where necessary?
5.4
5.4.1
Test and calibration methods and method validation
General
Does the laboratory use appropriate methods and
procedures for all tests and/or calibrations within its
scope?
Do these include sampling, handling, transport, storage
and preparation of items to be tested and/or calibrated?
Do these, when appropriate, include an estimation of the
measurement uncertainty as well as statistical
techniques for analysis of test and/or calibration data?
Does the laboratory have instructions on the use and
operation of all relevant equipment, and on the handling
and preparation of items for testing and/or calibration, or
both, where the absence of such instructions could
jeopardise the results of tests and/or calibrations?
Are all instructions, standards, manuals and reference
data relevant to the work of the laboratory kept up to date
and made readily available to personnel? (see 4.3)
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Do deviations from test and calibration methods only
occur if the deviations have been documented,
technically justified, authorised and accepted by the
customer?
Note
5.4.2
International, regional or national standards or other recognised specifications that contain sufficient and concise
information on how to perform the tests and/or calibrations do not need to be supplemented or rewritten as internal
procedure if these standards are written in a way that they can be used as published by the operating staff in a
laboratory. It may be necessary to provide additional documentation for optional steps in the method or additional
details.
Selection of methods
Does the laboratory use test and/or calibration methods,
including methods for sampling, which meet the needs of
the customer and which are appropriate for the tests
and/or calibrations it undertakes?
Are the methods published in international, regional or
national standards preferably used?
Does the laboratory ensure that it uses the latest valid
edition of the standards unless it is not appropriate or
possible to do so?
When necessary, is the standard supplemented with
additional details to ensure consistent application?
When the customer does not specify the method to be
used, does the laboratory select appropriate methods
that have been published either in international, regional
or national standards, or by reputable technical
organisations, or in relevant scientific texts or journals, or
as specified by the manufacturer of the equipment?
If laboratory-developed methods or methods adopted by
the laboratory are used, are these appropriate for the
intended use and validated?
Is the customer informed as to the method chosen?
Does the laboratory confirm that it can properly operate
standard methods before introducing the tests or
calibrations?
If the standard method changes, is the confirmation
repeated?
5.4.3
Does the laboratory inform the customer when the
method proposed by the customer is considered to be
inappropriate or out of date?
Laboratory-developed methods
Is the introduction of test and calibration methods
developed by the laboratory for its own use a planned
activity and assigned to qualified personnel equipped
with adequate resources?
5.4.4
Are plans updated as development proceeds and does it
ensure effective communication amongst all personnel
involved?
Non-standardised methods
When it is necessary to employ methods not covered by
standard methods, are these subject to agreement with
the customer and include a clear specification of the
customer’s requirements and the purpose of the test
and/or calibration?
Has the method developed been validated appropriately
before use?
Note
For new test and/or calibration methods, procedures should be developed prior to the tests and/or calibrations
being performed and should contain at least the following information:
a)
appropriate identification;
b)
scope;
c)
description of the type of item to be tested or calibrated;
d)
parameters or quantities and ranges to be determined;
e)
apparatus and equipment, including technical performance requirements;
f)
reference standards and reference materials required;
g)
environmental conditions required and any stabilisation period needed;
h)
description of the procedure, including
•
affixing of identification marks, handling, transporting, storing and preparation of items,
•
checks to be made before the work is started,
•
checks that the equipment is working properly and, when required, calibration and adjustment of the
equipment before each use,
•
the method of recording the observations and results,
•
any safety measures to be observed;
i)
criteria and/or requirements for approval/rejection;
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j)
data to be recorded and method of analysis and presentation;
k)
the uncertainty or procedure for estimating uncertainty.
Validation of methods
5.4.5.1
Validation is the confirmation by examination and the
provision of effective evidence that the particular
requirements for a specific intended use are fulfilled.
5.4.5.2
Does the laboratory validate non-standard methods,
laboratory-designed/developed
methods,
standard
methods used outside their intended scope, and
amplification and modifications of standard methods to
confirm that the methods are fit for the intended use?
Is the validation as extensive as is necessary to meet the
needs of the given application or field of application?
Does the laboratory record the results obtained, the
procedure used for the validation, and a statement as to
whether the method is fit for the intended use?
Note 1
Validation may include procedures for sampling, handling and transportation;
Note 2
The techniques used for the determination of the performance of a method should be one of, or a combination of,
the following:
•
calibration using reference standards or reference materials;
•
comparison of results achieved with other methods;
•
interlaboratory comparisons;
•
systematic assessment of the factors influencing the result;
•
assessment of the uncertainty of the results based on scientific understanding of the theoretical principles of
the method and practical experience.
Note 3
5.4.5.3
When some changes are made in the validated non-standard methods, the influence of such changes should be
documented and, if appropriate, a new validation should be carried out.
Is the range and accuracy of the values obtainable from
validated methods (e.g. the uncertainty of the results,
detection limit, selectivity of the method, linearity, limit of
repeatability and/or reproducibility, robustness against
external influences and/or cross-sensitivity against
interference from the matrix of the sample/test object),
as assessed for the intended use relevant to the
customers’ needs?
Note 1
Validation includes the specification of the requirements, determination of the characteristics of the methods, a
check that the requirements can be fulfilled by using the method, and a statement on the validity.
Note 2
As method-development proceeds, regular reviews should be carried out to verify that the needs of the customer
are still fulfilled. Any changes in requirements requiring modifications to the development plan should be approved
and authorised.
Note 3
5.4.6
5.4.6.1
5.4.6.2
Validation is always a balance between costs, risks and technical possibilities. There are many cases in which the
range and uncertainty of the values (e.g. accuracy, detection limit, selectivity, linearity, repeatability, reproducibility,
robustness and cross-sensitivity) can only be given in a simplified way due to lack of information.
Estimation of uncertainty of measurement
Does a calibration laboratory, or a testing laboratory
performing its own calibration, have procedures and
apply these to estimate the uncertainty of measurement
for all calibrations and types of calibrations?
Do testing laboratories have and also apply procedures
for estimating uncertainties of measurements?
In certain cases the nature of the test method may
preclude rigorous, metrologically and statistically valid
calculations of uncertainty of measurement. In these
cases, does the laboratory at least attempt to identify all
the components of uncertainty and make a reasonable
estimation and ensure that the form of reporting of the
results does not give a wrong impression?
Is the reasonable estimation based on knowledge of the
performance of the method and on the measurement
scope by use of, for example, previous experience and
validation data?
Note 1
The degree of rigor needed in an estimation of uncertainty of measurement depends on factors such as:
•
the requirements of the test method;
•
the requirements of the customer;
•
the existence of narrow limits on which decisions on conformance to a specification are based.
Note 2
In those cases where a well-recognised test method specifies limits to the values of the major sources of
uncertainty of measurement and specifies the form of presentation of calculated results, the laboratory is
considered to have satisfied this clause by following the test method and reporting instructions (see 5.10).
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When estimating the uncertainty of measurement, are all
uncertainty components which are of importance in the
given situation taken into account by using appropriate
methods of analysis?
Note 1
Sources contributing to the uncertainty include, but are necessarily limited to, the reference standards and
reference materials used, methods and equipment used, environmental conditions, properties and condition of the
item being tested or calibrated, and the operator.
Note 2
The predicted long-term behaviour of the tested and/or calibrated item is not normally taken into account when
estimating the measurement uncertainty.
Note 3
5.4.7
5.4.7.1
5.4.7.2
For further information, see ISO 5725 and the Guide to the Expression of Uncertainty in Measurement (see
bibliography).
Control of data
Are calculations and data transfers subject to appropriate
checks in a systematic manner?
When computers or automated equipment are used for
the acquisition, processing, recording, reporting, storage
or retrieval of test or calibration data, does the laboratory
ensure that:
a)
computer software developed by the user is
documented in sufficient detail and is suitable
validated as being adequate for use?
b)
procedures are established and implemented for
protecting the data; such procedures shall include,
but not be limited to, integrity and confidentiality of
data entry or collection, data storage, data
transmission and data processing?
c)
computers and automated equipment are
maintained to ensure proper functioning and are
provided with the environmental conditions
necessary to maintain the integrity of test and
calibration data?
Note
5.5
5.5.1
5.5.2
Commercial off-the-shelf software (e.g. word-processing, database and statistical programs) in general use within
their designed application range may be considered to be sufficiently validated. However, laboratory software
configuration/modifications should be validated as in 5.4.7.2a).
Equipment
Is the laboratory furnished with all items of sampling,
measurement and test equipment required for the correct
performance of the tests and/or calibrations (including
sampling, preparation of test and/or calibration items,
processing and analysis of test and/or calibration data)?
In those cases where the laboratory needs to use
equipment outside its permanent control, does the
laboratory ensure that the requirements of this
International Standard are met?
Is the equipment and its software used for testing,
calibration and sampling capable of achieving the
accuracy required and does it comply with specifications
relevant to the tests and/or calibrations concerned?
Are calibration programs established for key quantities or
values of the instruments where these properties have a
significant effect on the results?
When received, is equipment (including that used for
sampling) calibrated or checked to establish that it meets
the laboratory’s specification requirements and complies
with the relevant standard specifications?
5.5.3
5.5.4
5.5.5
Is it checked and/or calibrated before use?
(see 5.6)
Is equipment operated by authorised personnel?
Are up-to-date instructions on the use and maintenance
of equipment (including any relevant manuals provided
by the manufacturer of the equipment) readily available
for use by the appropriate laboratory personnel?
Is each item of equipment and its software used for
testing and calibration and significant to the test result,
when practicable, uniquely identified?
Are records maintained for each item of equipment and
its software significant to the tests and/or calibrations
performed?
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Do these records include at least the following:
a)
the identity of the item of equipment and its
software?
b)
the manufacturer’s name, type identification and
serial number or other unique identification?
c)
checks that
specification?
d)
the current location, where appropriate?
e)
the manufacturer’s instructions, if available, or
reference to their location?
f)
dates, results and copies of reports and
certificates of all calibrations, adjustments,
acceptance criteria, and due date of next
calibration?
g)
the maintenance plan, where appropriate, and
maintenance carried out to date?
equipment
complies with the
(see 5.5.2)
h)
5.5.6
any damage, malfunction, modification or repair to
the equipment?
Does the laboratory have procedures for safe handling,
transport, storage, use and, planned maintenance of
measuring equipment to ensure proper functioning and in
order to prevent contamination or deterioration?
Note
5.5.7
Additional procedures may be necessary when measuring equipment is used outside the permanent laboratory for
tests, calibrations or sampling.
Is equipment that has either been subjected to overloading or mishandling, gives suspect results, or has
been shown to be defective or outside specified limits,
taken out of service?
Is such equipment isolated to prevent its use or clearly
labelled or marked as being out of service until it has
been repaired and shown by calibration or test to perform
correctly?
5.5.8
5.5.9
5.5.10
5.5.11
5.5.12
5.6
5.6.1
Does the laboratory examine the effect of the defect or
departure from specified limits on previous tests and/or
calibrations and institute the “Control of non-conforming
work” procedure?
(see 4.9)
Whenever practicable, is all equipment under the control
of the laboratory and requiring calibration labelled, coded
or otherwise identified to indicate the status of calibration
and the date or expiring criteria when recalibration is
due?
When, for whatever reason, equipment goes outside the
direct control of the laboratory, does the laboratory
ensure that the function and calibration status of the
equipment are checked and shown to be satisfactory
before the equipment is returned to service?
When intermediate checks are needed to maintain
confidence in the calibration status of the equipment, are
these checks carried out according to a defined
procedure?
Where calibrations give rise to a set of correction factors,
does the laboratory have procedures to ensure that
copies (e.g. computer software) are correctly updated?
Is test and calibration equipment, including both
hardware and software, safeguarded from adjustments
which would invalidate the test and/or calibration results?
Measurement traceability
General
Is 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, calibrated before being put into
service?
Does the laboratory have an established program and
procedure for the calibration of its equipment?
Note
Such a program should include a system for selecting, using, calibrating, checking, controlling and maintaining
measurement standards, reference standards used as measurement standards, and measuring and test
equipment used to perform tests and calibrations.
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5.6.2
Specific requirements
Status
5.6.2.1
Calibration
5.6.2.1.1
For calibration laboratories, is the program for calibration
of equipment designed and operated so as to ensure
that calibrations and measurements made by the
laboratory are traceable to the International System of
Units SI?
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Has the calibration laboratory established traceability of
its own measurement standards and measuring
instruments to the SI by means of an unbroken chain of
calibrations or comparisons linking them to the relevant
primary standards of the SI units of measurement?
Is the link to SI units achieved by reference to national
measurement standards?
Are national measurement standards primary standards
which are primary realisations of the SI units or agreed
representations of SI units based on fundamental
physical constants or secondary standards which are
standards calibrated by another national metrology
institute?
When using external calibration services, is traceability
of measurement assured by the use of calibration
services for laboratories that can demonstrate
competence, measurement capability and traceability?
Do the calibration certificates issued by these
laboratories contain the measurement result, including
the measurement uncertainty and/or a statement of
compliance with an identified metrological specification?
(see also 5.10.4.2).
Is the traceability of measurement assured by the use of
calibration services from laboratories that can
demonstrate competence, measurement capability and
traceability?
Do the calibration certificates issued by these
laboratories show that there is a link to a primary
standard or to a natural constant realising the SI unit by
an unbroken chain of calibrations?
Do the calibration certificates contain the measurement
results including the measurement uncertainty and/or a
statement of compliance with an identified metrological
specification (see also 5.10.4.2)?
Note 1
Note 2
Note 3
Note 4
Note 5
Note 6
Note 7
Note 8
Calibration laboratories fulfilling the requirements of this International Standard are considered to be competent. A
calibration certificate bearing an accreditation body logo from a calibration laboratory accredited to this
International Standard for the calibration concerned, is sufficient evidence of traceability of the calibration data
report.
Traceability to SI units of measurement may be achieved by reference to an appropriate primary standard (see
VIM:1993, 6.4) or by reference to a natural constant, the value of which in terms of the relevant SI unit is known
and recommended by the General Conference of Weights and Measures (CGPM) and the International Committee
for Weights and Measures (CIPM).
Calibration laboratories that maintain their own primary standard or representation of SI units based on
fundamental physical constants can claim traceability to the SI system only after these standards have been
compared , directly or indirectly, with other similar standards of a national metrology institute.
The term “identified metrological specification” means that it must be clear from the calibration certificate which
specification the measurements have been compared with, by including the specification or by giving an
unambiguous reference to the specification.
When the terms “international standard” or “national standard” are used in connection with traceability, it is
assumed that these standards fulfil the properties of primary standards for realisation of SI units.
Traceability to national measurement standards does not necessarily require the use of the national metrology
institute of the country in which the laboratory is located.
If the calibration laboratory wishes or needs to obtain traceability from a national metrology institute other than in
its own country, this laboratory should select a national metrology institute that actively participates in the activities
of BIPM either directly or through regional groups.
The unbroken chain of calibrations or comparisons may be achieved in several steps carried out by different
laboratories that can demonstrate traceability.
5.6.2.2
Testing
5.6.2.2.1
For testing laboratories, the requirements given in
5.6.2.1 apply for measuring and test equipment with
measuring functions used, unless it has been
established that the associated calibration uncertainty
contributes little to the total uncertainty of the test result.
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When this situation arises, does the laboratory ensure
that equipment used can provide the accuracy of
measurement needed?
Note
5.6.3
The extent to which the requirements in 5.6.2.1 should be followed depends on the relative contribution of the
calibration uncertainty to the total uncertainty. If calibration is the dominant factor, the requirement should be
strictly followed.
Where traceability to the SI units of measurement is not
possible and/or not relevant, the same requirements for
traceability to, for example, certified reference materials,
agreed methods and/or consensus standards, are
required as for calibration laboratories (see 5.6.2.1.2).
Reference standards and reference materials
5.6.3.1
Reference standards
5.6.2.2.2
Has the laboratory a program and procedure for the
calibration of its reference standards?
Are reference standards calibrated by a body that can
provide traceability as described in 5.6.2.1?
Are such reference standards of measurement held by
the laboratory used for calibration only and for no other
purposes, unless it can be shown that their performance
as reference standards would not be invalidated?
5.6.3.2
Are reference standards of measurement calibrated
before and after any adjustment?
Reference materials
Are reference materials, where possible, traceable to SI
units of measurement, or to certified reference
materials?
5.6.3.3
Are internal reference materials checked as far as is
technically and economically practicable?
Intermediate checks
5.6.3.4
If checks are needed to maintain confidence in the
calibration status of reference, primary, transfer or
working standards and reference materials, are such
checks carried out according to defined procedures and
schedules?
Transport and storage
Has the laboratory procedures for safe handling,
transport, storage and use of reference standards and
reference materials in order to prevent contamination or
deterioration and in order to protect their integrity?
Note
5.7
5.7.1
Additional procedures may be necessary when reference standards and reference materials are used outside the
permanent laboratory for tests, calibrations or sampling.
Sampling
Does the laboratory have a sampling plan and
procedures for sampling when it carries out sampling of
substances, materials or products for subsequent testing
or calibration?
Is the sampling plan as well as the sampling procedure
available at the location where sampling is undertaken?
Are sampling plans, wherever reasonable, based on
appropriate statistical methods?
Does the sampling process address the factors to be
controlled to ensure the validity of the test and calibration
results?
Note 1
5.7.2
Sampling is a defined procedure whereby a part of a substance, material or product is taken to provide for testing
or calibration a representative sample of the whole. Sampling may also be required by the appropriate
specification for which the substance, material or product is to be tested or calibrated. In certain cases (e.g.
forensic analysis), the sample may not be representative but determined by availability.
Note 2
Sampling procedures should describe the selection, sampling plan, withdrawal and preparation of a sample or
samples from a substance, material or product to yield the required information.
Where the customer requires deviations, additions or
exclusions from the documented sampling procedure,
are these recorded in detail with the appropriate
sampling data and included in all documents containing
test and/or calibration results, and communicated to the
appropriate personnel?
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Does the laboratory have procedures for recording
relevant data and operations relating to sampling that
forms part of the testing or calibration that is under
taken?
Do these records include the sampling procedure used,
the identification of the sampler, environmental
conditions (if relevant) and diagrams or other equivalent
means to identify the sampling location as necessary
and, if appropriate, the statistics the sampling
procedures are based upon?
5.8
5.8.1
5.8.2
Handling of test and calibration items
Does the laboratory have procedures for the
transportation, receipt, handling, protection, storage,
retention and/or disposal of test and/or calibration items,
including all provisions necessary to protect the integrity
of the test or calibration item, and to protect the interests
of the laboratory and the customer?
Does the laboratory have a system for identifying test
and/or calibration items?
Is the identification retained throughout the life of the
item in the laboratory?
Is the system designed and operated so as to ensure
that items cannot be confused physically, or when
referred to in records or other documents?
5.8.3
5.8.4
Does the system, if appropriate, accommodate a
subdivision of groups of items and the transfer of items
within and from the laboratory?
Upon receipt of the test or calibration item, are abnormalities or departures from normal or specified
conditions, as described in the relevant test or
calibration method recorded?
When there is any doubt as to the suitability of an item
for test or calibration, or when an item does not conform
to the description provided, or the test or calibration
required is not specified in sufficient detail, does the
laboratory consult the customer for further instruction
before proceeding and records the discussion?
Does the laboratory have procedures and appropriate
facilities for avoiding deterioration, loss or damage to the
test or calibration item during storage, handling and
preparation?
Are handling instructions provided with the item
followed?
When items have to be stored or conditioned under
specified environmental conditions, are these conditions
maintained, monitored and recorded?
Where a test or calibration item or portion of an item is
to be held secure, does the laboratory have
arrangements for storage and security that protect the
condition and integrity of the secured items or portions
concerned?
Note 1
5.9
5.9.1
Where test items are to be returned into service after testing, special care is required to ensure that they are not
damaged or injured during the handling, testing or storing/waiting process.
Note 2 A sampling procedure and information on storage and transport of samples, including information on sampling
factors influencing the test or calibration result, should be provided to those responsible for taking and transporting
the samples.
Note 3 Reasons for keeping a test or calibration item secure can be for reasons of record, safety of value, or to enable
complementary tests and/or calibrations to be performed later.
Assuring the quality of test and calibration results
Does the laboratory have quality control procedures for
monitoring the validity of tests and calibrations under
taken?
Is the resulting data recorded in such a way that trends
are detectable and, where practicable, statistical
techniques applied to the reviewing of results?
Is this monitoring planned and reviewed and include, but
not limited to, the following:
a)
regular use of certified reference materials and/or
internal quality control using reference materials?
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Status
b)
participation in interlaboratory comparison or
proficiency testing programs?
c)
replicate tests or calibrations using the same or
different methods?
d)
e)
re-testing or re-calibration of retained items?
correlation of results for different characteristics of
an item?
Note
Doc. ref. / Remarks
The selected methods should be appropriate for the type and volume of the work undertaken.
5.9.2
Does the laboratory analyse the quality control data
where they are found to be outside predefined criteria,
and does the laboratory take planned action to correct
the problem and to prevent incorrect results from being
reported?
5.10
5.10.1
Reporting the results
General
Ensures the quality of test and calibration results and
planned action to correct problems if any occur so that
any incorrect results are prevented from being
reported.
Are the results of each test, calibration, or series of tests
or calibrations (see note 1) carried out by the laboratory
reported accurately, clearly, unambiguously and
objectively, and in accordance with any specific
instructions in the test or calibration methods?
Are the results usually reported in a test report or a
calibration certificate (see note 1) and include all the
information requested by the customer and necessary
for the interpretation of the test or calibration results and
all information required by the method used?
Is this information normally that required by 5.10.2,
5.10.3 and 5.10.4?
In the case of tests or calibrations performed for internal
customers, or in the case of a written agreement with the
customer, the results may be reported in a simplified
way.
Is the information listed in 5.10.2 to 5.10.4 which is not
reported to the customer readily available in the
laboratory which carried out the tests and/or
calibrations?
Note 1
Test reports and calibration certificates are sometimes called test certificates and calibration reports, respectively.
Note 2
5.10.2
The test reports or calibration certificates may be issued as hard copy or by electronic data transfer provided that
the requirements of this International Standard are met.
Test reports and calibration certificates
Unless the laboratory has exceptional reasons for not
doing so, does each test report or calibration certificate
include at least the following information:
a)
a title, e.g. “Test Report”/”Calibration Certificate”?
b)
the name and address of laboratory, and location
where the tests and/or calibrations were carried
out, if different from the address of the laboratory?
c)
unique identification of the report or certificate
(such as the serial number), and on each page an
identification in order to ensure that the page is
recognised as a part of the test report or calibration certificate, and a clear identification of the
end of the test report or calibration certificate?
d)
e)
f)
the name and address of the customer?
identification of the method used?
a description of, the conditions of, and
unambiguous identification of the item(s) tested or
calibrated?
g)
date of receipt of test or calibration item(s) where
this is critical to the validity and application of the
results, and the date(s) of performance of the test
or calibration?
h)
reference to the sampling plan and procedures
used by the laboratory or other bodies where these
are relevant to the validity or application of the
results?
the test and calibration results with, where
appropriate, the units of measurement?
i)
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Status
j)
the name(s), function(s) and signature(s) or
equivalent identification of person(s) authorising
the test report or calibration certificate?
k)
where relevant, a statement to the effect that the
results relate only to the items tested or
calibrated?
Note 1
Hard copies of test reports and calibration certificates should also include the page number and total number of
pages.
Note 2
5.10.3
5.10.3.1
It is recommended that laboratories include a statement specifying that the test report or calibration certificate shall
not be reproduced except in full, without written approval of the laboratory.
Test reports
In addition to the requirements listed in 5.10.2, do test
reports, where necessary for the interpretation of the test
results include:
a)
deviations from, additions to or exclusions from the
test method, and information on specific test
conditions, such as environmental conditions?
b)
where relevant, a statement of compliance/noncompliance
with
requirements
and/or
specifications?
c)
where applicable, a statement on the estimated
uncertainty of measurement?
Information on uncertainty is needed in test reports
when it is relevant to the validity or application of
the test results, when a customer’s instruction so
requires, or when uncertainty affects compliance to
a specification limit
d)
where appropriate and needed opinions and
interpretations ?
(see 5.10.5)
e)
5.10.3.2
additional information which may be required by
specific methods, customers or groups of
customers
In addition to the requirements listed in 5.10.2 and
5.10.3.1, do test reports containing the results of
sampling include the following, where necessary for the
interpretation of the test results:
a)
the date of sampling?
b)
unambiguous identification of substance, material
or product sampled (including the name of the
manufacturer, the model or type of designation and
serial numbers as appropriate)?
c)
the location of sampling, including any diagrams,
sketches or photographs?
a reference to the sampling plan and procedure
used?
d)
e)
details of any environmental condition during
sampling that may affect the interpretation of the
test results?
f)
5.10.4
5.10.4.1
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any standard or other specification for the
sampling method or procedure, and deviations,
additions to or exclusions from the specification
concerned?
Calibration certificates
In addition to the requirements listed in 5.10.2, do
calibration certificates include the following, where
necessary for the interpretation of calibration results:
a)
the conditions (e.g. environmental) under which
the calibrations were made that have an influence
on the measurement results?
b)
the uncertainty of measurement and/or a
statement of compliance with an identified
metrological specification or clauses thereof?
c)
evidence that the measurements are traceable?
(see note in 5.6.2.1.1)
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5.10.4.2
5.10.4.3
5.10.4.4
5.10.5
IECEE OD-2006:2017 © IEC 2017
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Does the calibration certificate relate only to quantities
and the results of functional tests?
If a statement of compliance with a specification is
made, does this identify which clauses of the
specification are met or not met?
When a statement of compliance with a specification is
made, omitting the measurement results and associated
uncertainty, does the laboratory record those results and
maintain them for possible future reference?
When statements of compliance are made, is the
uncertainty of measurement taken into account?
When an instrument for calibration has been adjusted or
repaired, are the calibration results before and after
adjustment or repair, if available, reported?
Does a calibration certificate (or calibration label) contain
any recommendation on the recalibration interval except
where this has been agreed with the customer?
This requirement may be superseded by legal
regulations.
Opinions and interpretations
When opinions and interpretations are included, does
the laboratory document the basis upon which the
opinions and interpretations have been made?
Are opinions ad interpretations clearly marked as such in
a test report?
Note 1
5.10.6
Opinions and interpretations should not be confused with inspections and product certifications as intended in
ISO/IEC 17020 and ISO/IEC 17065.
Note 2 Opinions and interpretations included in a test report may comprise, but not be limited, to the following:
•
an opinion on the statement of compliance/non-compliance of the results with requirements;
•
fulfilment
•
of contractual requirements;
•
recommendations on how to use the results;
•
guidance to be used for improvements.
Note 3 In many cases it might be appropriate to communicate the opinions and interpretations by direct dialogue with the
customer. Such dialogue should be written down.
Testing and calibration results obtained from
subcontractors
When the test report contains results of tests performed
by subcontractors, are these results clearly identified?
Does the subcontractor report the results in writing or
electronically?
When a calibration has been subcontracted, has the
laboratory performing the work issued the calibration
certificate to the contracting laboratory?
5.10.7
Electronic transmission of results
In the case of transmission of test or calibration results
by telephone, telex, facsimile or other electronic or
electromagnetic means, are the requirements of this
International Standard met?
(see also 5.4.7)
5.10.8
Format of reports and certificates
Is the format designed to accommodate each type of
test or calibration carried out and to minimise the
possibility of misunderstanding or misuse?
Note 1
5.10.9
Attention should be given to the lay-out of the test report or calibration certificate, especially with regard to the
presentation of the test or calibration data and ease of assimilation by the reader.
Note 2 The headings should be standardised as far as possible.
Amendments to test reports and calibration
certificates
Are material amendments to a test report or calibration
certificate after issue made only in form of a further
document, or data transfer, which includes the statement
“Supplement to Test Report [or Calibration Certificate],
serial number …. [or as otherwise identified]“, or an
equivalent form of wording?
Do such amendments meet all the requirements of this
International Standard?
When it is necessary to issue a complete new test report
or calibration certificate, is this uniquely identified and
contains a reference to the original that it replaces?
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INTERNATIONAL
IEC SYSTEM OF CONFORMITY ASSESSMENT
ELECTROTECHNICAL
SCHEMES FOR ELECTROTECHNICAL
COMMISSION
EQUIPMENT AND COMPONENTS (IECEE)
IECEE Secretariat c/o IEC
3, rue de Varembé
3, rue de Varembé
PO Box 131
PO Box 131
CH-1211 Geneva 20
Switzerland
CH-1211 Geneva 20
Switzerland
Tel: + 41 22 919 02 11
Tel: + 41 22 919 02 11
[email protected]
[email protected]
www.iec.ch
www.iecee.org
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