Indian Standard: Quality Assurance Requirements FOR Measuring Equipment
Indian Standard: Quality Assurance Requirements FOR Measuring Equipment
Indian Standard: Quality Assurance Requirements FOR Measuring Equipment
Part1
):1993
IS0 10012-1
: 1992
Indian
QUALITY
PART 1
Standard
REQUIREMENTS EQUIPMENT
SYSTEM FOR MEASURING
ASSURANCE MEASURING
CONFIRMATION
FOR
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METROLOGICAL
EQUIPMENT
UDC
65856 : 6812
@ BIS 1993
BUREAU
MANAK
OF
BHAVAN,
INDIAN
9 BAHADUR NEW DELHI
STANDARDS
SHAH 110002 Price Group 8 ZAFAR MARG
April 1993
Indian Standard
QUALITY
PART 1
ASSURANCE MEASURING
CONFIRMATION
REQUIREMENTS EQUIPMENT
SYSTEM FOR -MEASURING
-FOR
EGUtPMENT
METROLOGICAL FOREWORD
NP,TlONAL
Standard which is identical with IS0 10012-l : 19% Duality assurance requirements confirmation system for measuring equipment, for measuring equipment - Part 1 : Metrological issued by the International Organization for Standardization ( IS0 ), was adopted by the Bureau of Indian Standards on the recommendations of the Quality Management Sectional Committee ( MSD 2 ), and approval of the Management and Systems Division Council. The text of the IS0 standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Attention is particularly drawn to the Following: Standards.
This
Indian
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Standard
appear
referring
to this standard,
they should
In the adopted standard, normative reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their place are listed below along with their degree of equivalence for the editions indicated: International Standard Corresponding Indian Standard Degree of Equivalence Identical Identical
IS0 IS0
8402 9001
: 1986 : 1987
IS 13999
: 1988 Quality
systems-Vocabulary
IS 14001 : 1988 Quality systems - Model for quality assurance in design/development, production, installation and servicing IS 14002 : 1988 Quality for quality assurance installation IS 14003 : 1988 Quality for quality assurance and test IS 14004 : 1991 Quality quality system elements is also systems - Model in production and systems - Model in final inspection management - Guidelines given to and Guides
Is0
9002
: 1987
Identical
Is0
9003
: 1987
Identical
ISO 9004
: ! 987
In the adopted standard, normative reference publications as per details given below: IS0 Guide 30 : 1981 Terms and-definitions General
ISO/IEC with
used in connection
reference
materials of testing :
requirements vocabulary
International
in metrology and
The concerned sectional committee has decided that they are acceptable
has reviewed the provisions of above publications. to use in conjunction with this standard.
(i)
IS 14012 IS0
( Part
1 ) :I993
100r2-I
: 1992 reference appears to IS0 9000 : 1987 Quality management Guidelines for selection and use, for which IS 14000 : 1988 In addition, informative reference has been given to : 1987. and operation 10, Guidelines used in testing 16, Principles of of laboratory for the laboratories of assurance d contractors used proficiency of testing recalibration
In the adopted standard, informative and quality assurance standards exists and is identical to IS0 9000 ISO/IEC Guide 43 : 1984
Development
OIML International Document No. intervals of measuring equipment OIML International Document ) Guide No.
determination
of metrological measurement
Organization
for quality,
of terms
in the management
The concerned sectional committee has reviewed the provisions of these publications decided that they are also acceptable for use in conjunction with this standard.
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( ii )
IS14012(Part1):1993 Is010012-1:1992
Contents
Page 1 2 3
Scope
.. ....... ........... ...... ... .. ........ ......... .... ..... ...... ....... ... .... ....... ... ... .... ... 1 references ...... .. ...... ....... .... ....... ..... .. ...... ...... ....... ... .. .. 1
Normative Definitions
... ....... ... .... ........ ...... ...... ...... .... .... ....... ...... ........ ... ..... .... 2 ._._.______._.._.._,.........._...____..............__..__,_.................. 4 .. ........ ....... ..... ... . ... .. .... .. ..... .. ......... ....... ........ ...... .. .... ...... 4
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4
4.1
Requirements General Measuring Confirmation Periodic Planning Uncertainiy Documented Records Nonconforming Confirmation Intervals Sealing
4.2 4.3
equipment system
...... ...... ...... ........ ....... ... ...... ...... .. ..... .. ... .. 4 ... ..... .. ...... .. ... ...... ......... .... .. ...... ..... ...... ..... 4 system .._..._.. 5 5 6 .:. 6
. ........... .. ......... ........... ........ ...... ...... ........ .... .. ...... ..... ...... 6 measuring labelling equipment .. ... ...._..._..__..__._.__...__ 7
....... ..... ..... ....__.._..._...................._.___.....7 ... .. ..... ..... ...__..................._..___...._...._.8 .... .... .... ..... ... ..... .. ....... .. .... ......_...__...__..__... 8 and services ...... ..... ... ... ........ ......_.. 9
Use of outside
4.14
4.15 4.16 4.17 4.18
... .... .... ....... ..... ..... ... ..... .... .. ....... ........ .. ..... ......... ..... 9 effect of uncertainties conditions ...... ... ...... ....... . .... ...... ... 10
.. .... ..... ...... ..... .... .... ... .. .... ........ ....... ...... ...... ..... .... .... 10
( iii )
ISl4012(
Isolool2-1:1992
Annexes A Guidelines measuring Introduction Initial choice for the determination of confirmation intervals for . . . . . . . . . . .._..__~.__....................__.........._..____.. 11 equipment . . . . . . . . . . .._................................._._............._____......... of confirmation intervals intervals 11
. . . . . . . . .._._....._____...___...11 ..__.__......____.__ 11 14
Methods ~Bibliography
of reviewing
confirmation.
. . . . . . . . . . . .._...............................__._.............................
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Introduction
This part of IS0 10012 is written in the context of a Purchaser and a Supplier, both terms being interpreted in the broadest sense. The Supplier may be a manufacturer, an installer or a servicing organization responsible for providing a product or a service. The Purchaser may be a procurement authority or a customer using a product or service. Suppliers become Purchasers when procuring supplies and services from vendors or other outside sources. The subject of the negotiations relating to this part of IS0 10012 may be a design, an artefact, a product or a service. This part of IS0 10012 may be applied, by agreement, to other situations. Reference to this part of IS0 when when 10012 may be made: or services or services required; offered; or regulatory
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specifying
products products
specifying
or employee
interests,
or by legislative
and audit
In order to distinguish clearly between requirements and guidance, in clause 4 the latter appears in italic type-face, in a box, after each corresponding paragraph under the heading GUIDANCE. The text under GUIDANCE is for information only and contains no requirements. Statements given there are not to be construed as adding to, limiting or modifying any requirement. NOTE 1 Use of the masculine gender in this part of IS0 10012 is not meant to exclude the feminine gender where applied to persons. Similarly, use of the singular does not exclude the plural (and vice versa) when the sense allows.
(VI
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1 1.1
Scope
This part of IS0 10012 contains quality assurance requirements for a Supplier to ensure that measurements are made with the intended accuracy. It also contains guidance on the implementation of the requirements.
The role of the Purchaser in monitoring a Suppliers compliance with the requirements of this part of IS0 10012 may be fulfilled by a third party, such as an accreditation or certification body.
1.5
Normative
references
1.2 This part of IS0 10012 specifies the main features of the confirmation system to be used for a Suppliers measuring equipment.
This part of IS0 10012 is applicable to measuring equipment used in the demonstration of compliance with a specification: it does not apply to other items of measuring equipment. This part of IS0 10012 does not deal extensively with other elements that ma-y affect measurement results such as methods of -measurement, competence of personnel etc.; these are dealt with more specifically in other International Standards, such as those referred to in 1.4.
1.3
The following standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 10012. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of IS0 10012 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 8402:1986, Quality Vocabulary.
Model for quality production, in-
1.4
This part of IS0 10012 is applicable: to testing laboratories, including those providing a calibration service; this includes laboratories operating a quality system in accordance with ISO/IEC Guide 25; to Suppliers of products or services who~operate a quality system in which measurement results are used to demonstrate compliance with specified requirements; this includes operating systems that meet the requirements of IS0 9001, IS0 9d)2 and IS0 9003. The guidance given in IS0 9004 is also relevant: to other organizations where measurement is used to demonstrate compliance with specified requirements.
for
quality
assurance
IS0 9003:1987, Quality systems - Model in final inspection and test. IS0 9004:1987, Quality
tem elements -
foor quality
management
and quality
sys-
Guidelines.
IS0
Guide
connection
used in
o-f
IS14012(Part1):1993 Is010012-1:1992
Definltlons
For the ~purposes of this part of IS0 10012, the following definitions apply. Most of them are based on the International vocabulary of basic and general terms in metrology (VIM): 1984, but they are not always identical to the definitions given therein. Terms in IS0 8402 are also relevant. Relevant reference numbers are given in brackets following the delinitions. confirmation: required to ensure that an item ment is in a state of compliance for its intended use.
NOTES 2 Metrological confirmation normally includes, inter alia, calibration. any necessary adjustment or repair and subsequent recalibration, as well as any required sealing and labelling. 3 For brevity, in this part of IS0 ferred to as confirmation. 10012, this term is re-
3.6 accuracy of measurement: The closeness of the agreement between the result of a measurement and the (conventional) true value of the measurand.
NOTES 6 Accuracy is a qualitative concept. for accuracy should
precision
[VIM,
3.051
3.1 metrological
3.7 uncertainty of measurement: Result of the evaluation aimed at characterizing the range within which the true value of a measurand is estimated to lie, generally with a given likelihood.
NOTE 8 Uncertainty of measurement comprises, in general, many components. Some of these components may be estimated on the basis of the statistical distribution of the results of series of measurements and can be characterized by experimental standard deviations. Estimates of other components can only be based on experience or other information.
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[VIM, 3.2 measuring equipment: All of the measuring instruments, measurement standards, reference materials, auxiliary apparatus and instructions that are necessary to carry out a measurement. This term includes measuring equipment used in !he course of testing and inspection, as well as that used in calibration. NOTE 4 In the context of this part of IS0 10012, the term measuring equipment is taken to encompass measuring instrum-ents and measurement standards. Morbover. a reference material is considered to be a type of measurement standard. 3.3 measurement: The set of operations having object of determining the value of a quantity. [VIM, 2.011
A quantity
3.091 error of measurement: minus the true The value result of of the
9 See true value (of a quantity) value (of a quantity) in VIM. 10 The term relates equally to
and conventional
true
the
11 The known parts of the error of measurement may be compensated by applying appropriate corrections. The error of the corrected result can only be characterized by an uncertainty.
subjected
to measure-
measured
12 Absolute error, which has a sign, should not be confused with absolute value of an error which is the modulus of an error. [VIM, 3.103
[VIM, .
2.091
3.5 influence quantity: A quantity which is not the subiect of the measurement but which influences the val;e of the measurand or the indication of the measuring instrument. EXAMPLES ambient temperature; measured voltage. [VIM, 2.101 frequency of an alternating
3.9 correction: The value which, added algebraically to the uncorrected result of a measurement, compensates for an assumed systematic error. NOTES 13 The correction is equal error, but of opposite sign. to the assumed systematic
be known exactly,
[VIM,
3.141
3.10
measuring
instrument:
3.16
drift:
3.11
intended to bring a measuring instrument into a state of performance and freedom from bias suitable for its use. [VIM, 4.331
limits of permissible error (of a measuring invalues of an error permitted by specifications, regulations, etc. for a given measuring instrument. [VIM, 5.231
3.12 specified measuring range: The set of values for a measurand for which the error of a measuring instrument is intended to lie within specified limits. NOTES
15 The upper and lower limits of the specified measuring range are sometimes called the maximum capacity and the minimum capacity respectively. 16 In some other fields of knowledge, range is used to mean the difference between the greatest and the smallest values.
3.18 (measurement) standard: A material measure, measuring instrument, reference material or system intended to define, realize, conserve or reproduce a unit or one or more values of a quantity in order to transmit them to other measuring instruments by comparison. EXAMPLES
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4 b) cl
1 kg mass standard; standard gauge block; resistor; cell; frequency standard; serum as a stan-
[VIM, 5.04)
4
3.13 reference conditions: Conditions of use for a measuring instrument prescribed for performance testing, or to ensure valid intercomparison of results of measurements.
NOTE 17 The reference conditions generally specify reference values or reference ranges for the influence quantities affecting the measuring instrument. [VIM, 5.071
4 9
[VIM,
3.19 reference material: A material or substance one or more properties of which are sufficiently well established to he used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials.
NOTE 19 This definition is where it has several notes. taken from IS0 Guide 30,
3.14 resolution (of an indicating device): A quantitative expression of the ability of an indicating device to permit distinguishing meaningfully between immediately adjacent values of the quantity indicated. [VIM, 5.131
6.151
3.15 &ability: The ability of a measuring instrument to maintain constant its metrological characteristics. NOTE 18 It is usual to consider stability with respect to
quantity is
international (measurement) standard: A stanrecognized by an international agreement to internationally as the basis for fixing the value other standards of the quantity concerned.
6.061
time. Where stability with respect to another considered, this should be stated explicitly.
3.21
[VIM,
5.161
national -(measurement) standard: A standard recognized by an official national decision to serve, in a country, as the basis for fixing the value of all other standards of the quantity concerned.
NOT-E 20 primary
standard
in a country
is often
the quality system in relation to quality policy and new objectives resulting from changing circumstances. [ISO 8402. 3.121
[VIM, 6.073 traceability: The property of the result of a measurement whereby it can be related to appropriate measurement standards, generally internatiortal or national standards, through an unbroken chain of comparisons.
NOTES 21 The unbroken .traceability chain. 22 (Applicable chain of comparisons is called a
3.22
4
4.1
Requirements
General
text.)
[VIM,
6.121
3.23 calibration: The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values of a quantity realized by a reference standard.
NOTES 23 The result of a calibration permits the estimation of errors of indication of the measuring instrument, measuring system or material measure, or the assignment of values to marks on arbitrary scales. 24 A calibration properties. may also determine other metrological
The Supplier shall document the methods used to implement the provisions of this part of IS0 10012. This documentation shall be an integral part of the Suppliers quality system. It shall be specific in terms of which items of equipment are subject to the provisions of this part of IS0 10012, in terms of the allocation of responsibilities and in terms ofthe actions to be taken. The Supplier shall make objective evidence available to the Purchaser that the required accuracy is achieved. 4.2 Measuring equipment
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Measuring equipment shall have metrological characteristics as required for the intended use (for example accuracy, stability, range and resolution). Equipment and documentation shall be maintained so as to take account of any corrections, conditions of use (including environmental conditions), etc. that are necessary to achieve the required performance. The required performance shall be documented
25 The result of a calibration may be document, sometimes called a calibration a calibration report. 26 The result as a correction bration curve.
recorded in a certificate or
GUIDANCE The set of mefrological characterisfics (specific requirements) is an essential component of the confirmation system. The Supplier is expected to include in his procedures a list of fhe specified requirements. Usual sources for such requirements include manufacfurers literature, regulations, etc. Wherever the sources are inadequate, the Supplier should himself determine the requirements.
[VIM,
6.131
3.24 (quality) audit: A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
The quality audit typically applies, but is not NOTE 27 limited, to a quality system or elements thereof, to processes, to products, or to services. Such audits are often called quality system audit, process quality audit, product quality audit, service quality audit. [ISO 8402, .3.10]
4.3
Confirmation
system
3.25
(quality
system)
by top
management
The Supplier shall establish and maintain an effective documented system for the managing, confirmation and use of measuring equipment, including measurement standards, used to demonstrate compliance with specified requirements. This system shall be designed to ensure that all such measuring equipment performs as intended. The system shall provide for the prevention of errors outside the specified limits of permissible -error, by prompt detection of deficiencies and by timely action for their correction.
The confirmation system shall take full account of all relevant data, including that available from any statistical process control system operated by or for the Supplier. For each item of measuring equipment, the Supplier shall designate a competent member of his staff as authorized officer to ensure that confirmations are carried out in accordance with the system and that the equipment is in a satisfactory condition. In cases where any or all of a Suppliers confirmation (including calibration) are replaced or supmplemented by services from outside sources, the Supplier shall ensure that these outside sources also comply with the requirements of this part of IS0 10012 to the extent necessary to ensure the Suppliers compliance with the requirements
Some instruments, such as null detectors and coincidence detectors, need periodic calibration and sonfirmation only in the restricted sense of functional checking to assure that they are functioning correctly. A very useful check fhat a measuring instrument continues.to measure correctly is obtained by the use of a checking measurement standard, applied to the instrument by the user. This will demonstrate if, at the value or values checked and under the conditions of the check, the instrument is still functioning correctly. The checking measurement standard itself needs to be calibrated and confirmed and, in order that the results obtained by its use can with confidence be attributed to the instrument and not to changes in the checking measurement standard, it usually has to be simple and robusi. The use of a checking measurement standard is in no way a substitute for regular calibration and confirmation of the instrument, but its use may prevent the use of an instrument which, within the interval between two forma/ confirmations, ceases to conform to specification.
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;UIDANCE rhe intention of a confirmation system is to en;ure that the risk of measuring equipment proresults having unacceptable errors jucing -emains within acceptable bounds. The use of appropriate statistical methods for analysing the -esu/ts of preceding calibrations, for assessing the -esu/ts of calibrations of several similar items of neasuring equipment and for predicting cumuuncertainties is recommended. (See lative SO 9004.,1987, 13.1.) The error attributable to calibration should be as small as possible. In most areas of measurement, it should be no more than one third and preferably one tenth of the permissible error of the confirmed equipment when in use. It is usual to carry out the calibration associated with any confirmation under reference conditions, but where it is known that the operating conditions are significantly different from the reference conditions, calibration under appropriate values of the influence quantities may be carried out. Where this is impractical, due allowance should be made for the difference in the conditions. For a commercial device, it is usual to take the manufacturers claimed performance as the criterion of satisfactory performance and accuracy. It is sometimes necessary to modify the manufacturers claims. no manufacturers claimed performance is criteria for satisfactory performance may have to be determined from experience. Where
4.4
Periodic confirmation
of the
The Supplier shall carry out, or shall arrange to be carried out, periodic and systematic quality auditing of the confirmation system in order to ensure its continuing effective implementation and compliance with the requirements of this pan of IS0 10012. Based on the results of the quality audits and of other.relevant factors, such as feedback from Purchasers, the Supplier shall review and modify the system as necessary. Plans and procedures for the quality audit and review shall be documented. The conduct of the quality audit and review and any subsequent corrective actions shall be recorded.
4.5
Planning
available,
The Supplier shall review any relevant Purchasers and other technical requirements before commencing work on products or services, and shall ensure that the measuring equipment (including measurement standards) needed for the performance of the work aie available and are of the accuracy, stability, range and resolution appropriate for the intended application.
GUIDANCE This review should be carried out at as early so as to permit comprehensive of the Suppliers confir-
GUIDANCE
stage as practical,
4.6
Uncertainty
of measurement
Procedures may be, but are not necessarily, limited to the compilation of published standard measurement practices and a Purchasers or an instrument manufacturers written instructions. The amount of detail in procedures should be commensurate with the complexity of the confirmation process. These methods may techniques of statistical be elaborated using the
In performing measurements and in stating and making use of the results, the Supplier shall take into account all significant identified uncertainties in the measurement process including those that are attributable to measuring equipment (including measurement standards) and those contributed by personnel procedures and environment. In estimating the take account of available from any operated by or for uncertainties, the Supplier shall all relevant data including that statistical process control system the Supplier.
process control, whereby measurement standar-ds and measuring instruments are intercompared in-house, drifts and
faults are determined, and any necessary corrective action is taken. Statistical proress confrol is complementary to regular calibr.afion and reinforces confidence in measurement resulfs during the intervals between confirmations.
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4.6
GUIDANCE When it has been demonstrated by a calibration that measuring equipment is performing correctly (in accordance with its specification), it is usual to assume that the errors produced while the equipment is in use do not exceed its specified limits of permissible error. This is assumed to hold until the equipment is next calibrated and confirmed. This may not be true under the often more arduous conditions of use as compared with the controlled conditions of the calibration. It may therefore be expedient to compensate for fhis by tightening the product acceptance limits. The amount of this tightening depends on the particular circumstances and is a matter for judgement based on experience. (See 4.17.) The use of statistical methods is recommended monitor and control measurement uncertainty a continuing basis. (See IS0 9004:1987, 13. f.) to on
Records
The Supplier shall maintain records of the make, type and serial number (or other identification) of all relevant measuring equipment (incuding measurement standards). These records shall demonstrate the measurement capability of each item of measuring equipment. Any calibration certificates and other relevant information concerning its functioning shall be available
GUIDANCE The records may be in manuscript, typescript or microfilm or may be in an electronic or a magnetic memory or on another data medium. The minimum time lor the refenfion of records is dependent on many factors, such as the Purchasers requirements, regulatory or legal requirements, manufacturers liability, efc. Records concerned with the principal measurement standards may need to be retained indefinitely.
4.7
Documented
confirmation
procedures
The Supplier shall designate and use documented procedures for all confirmations performed. The Supplier shall ensure that all procedures are adequate for their purpose. In particular, procedures shall contain sufficient information to ensure their proper implementation, to ensure consistency of application from one application to another, and to ensure valid measurement results. The procedures shall be available, as necessary, staff involved in performing confirmations. to
The calibration results shall be recorded in sufficient detail so that the traceability of all the measurements can be demonstrated and so that any measurement can be reproduced under conditions close to the original conditions, thereby facilitating the resolution of any anomalies. The recorded information and shall include: unique identification of
4.9
Nonconforming
measuring equipment
equjpment
GUIQANCE In some instances, the calibration result is given as a compliance with or failure to comply with a requirement. that shows any malfunction, whose proper functioning is subject to doubt, that has exceeded interval, or its designated confirmation
interval; -
e) identification of the confirmation procedure; 9 the designated limits of permissible error; 9) the source of the calibration
traceability; used to obtain
by segregation,
Such equipment shall not be returned to service until the reasons for its nonconformity have been eliminated and it is again confirmed. If the results of calibration prior to any adjustment or repair were such as to indicate a risk of significant errors in any of the measurements made with the equipment before the calibration, the Supplier shall take the necessary corrective action.
h) the relevant
9 a statement of the uncertainties involved in calibrating effect; the equipment and of their cumulative
SUIDANCE When measuring equipment is found to be inacsurate or otherwise faulty, it is usual to adjust, overhaul or repair it until it again functions correctly. If this proves to be impractical, consideration should be given to downgrading the equipment or scrapping it. Downgrading should only be used with great care as it may lead to apparent/y identical equipment having different permissible errors, the fact being on& apparent by careful examination of the label referred to in 4.10. Reconfirmation to a relaxed is then necessary. set of requirements
W 9
m) identification of person(s) responsible for ensuring the correctness of the recorded information; n) unique identification (such as serial.numbers) of any calibration certificates and other relevant documents concerned. The Supplier shall maintain clear documented procedures on the retention (including the duration) and safeguarding of records. Records shall be kept until it is no longer probable that they may need to be referred to.
GUIDANCE The Supplier should ensure that records stroyed. take a// reasonable steps to cannot inadvertent/y be de-
In the case of a multi-function or multi-range instrument, where it can be demonstrated that the instrument remains intact on one or more of its functions or ranges, it may continue to be used on the intact functions and/or ranges, provided that it is prominent/y labelled to indicate the restrictions on its use. All reasonable steps should be taken to prevent the use of the instrument on the faulty functions or ranges.
4.10
Confirmation
labelling
The Supplier shall ensure that all measuring equipment is securely and durably labelled, coded or
otherwise identified to indicate its confirmation status. Any limitation on the confirmation, or any restriction of use shall also be indicated on the equipment. When labelling or coding is impractialternative effective procable or inappropriate, cedures shall be established and documented.
The intervals of confirmation shall not be tengthened unless the results of calibrations at preceding confirmations provide definite indications that such action will not adversely affect confidence in the accuracy of the measuring equipment. shall have specific objective criteria on which to base decisions affecting the choice of intervals of confirmation.
In determining whether the changes in the intervals of confirmation are appropriate, the Supplier shall take account of all relevant data including those available from any statistical process control system operated by or for the Supplier.
GUIDANCE The labelling may be by a secure self-adhesive stick-on label or by a tie-on label or by durable marking directly on the measuring equipment.
The Supplier
Any confirmation labelling shall clearly indicate when the equipment is next due for confirmation in accordance with the Suppliers system. The labelling shall also permit ready identification of the authorized officer (see 4.3) responsible for the confirmation in question, and the date of the most recent confirmation. All reasonable the intentional measures shall be taken to prevent or accidental misuse of labels.
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SUIDANCE The purpose of periodically reconfirming measuring equipment is to ensure that the measuring equipment has not suffered a deterioration in aczuracy and to prevent it from being used when !here is a significant possibility of it producing erroneous results. It is impossible -to determine a confirmation interval so short that there is no possibility of measuring equipment becoming faulty ~before the end of the assigned confirmation interval. Frequent confirmation is expensive and takes the equipment out of service, requiring replacement equipment or causing the work on which it was being used to cease. A compromise is therefore necessary. Until sufficient statistical evidence of nonconformity rates has been acquired by a particular organization, confirmation infervals can only be determined from the experience of others (whose circumstances may be different) or by estimaiion. In certain fields of application, the Supplier may have to comply with statutory or technical requirements for confirmation intervals. Advice on the choice given in annex A. of confirmation intervals is
Measuring equipment that is deemed not to require confirmation shall be clearly identified as such, so that it may be distinguished from equipment that requires confirmation but whose label has become mislaid or detached.
by documentation.
Where a significant part of the total capability of an item of measuring equipment is not covered by a confirmation, this shall be indicated on the confirmation label.
confirmed
4.11
Intervals
measurement Measuring equipment (including standards) shall be confirmed at appropriate intervals (usually periodic), established on the basis of their stability, purpose and usage. The intervals shall be such that confirmation is again carried out prior to any probable change in accuracy that is of significance in the use of the equipment. Depending on the results of calibrations at preceding confir-
Access to adjustable devices on measuring equipment, whose setting affects the performance, shall be sealed or otherwise safeguarded at an appropriate stage of the confirmation, in order to prevent tampering by unauthorized ~personnel. Seals shall be.designed so that tampering is clearly apparent.
The Suppliers confirmation system shall provide instructions for the use of such seals and for the disposition of equipment with damaged or broken seals
order to prevent abuse, misuse, damage and changes in dimensional and functional characteristics. Steps shall be taken to prevent confusion between similar items. These steps shall be documented
GUKIANCE The requirement for sealing does not apply to adjustment devices that are intended to be set by the user without the nged for external references; for example, zero adjusters. The decisions about what instruments should be sealed, the dontrols or adjustments which will be sealed and the sealing material such as labels, solder, wire, paint, etc., are normally left to the Supplier. How the Supplier implements a sealing programme in detail should be documented. Not a// measuring equipment /ends itself to sealing. GUIDANCE While the requirements of this part of /SO 10012 apply specifically to measuring equipment forming a part of the Supp!iers own measurement system, it is clear/y good practice to exert care also in dealing with any items of measuring equipment that may belong to a Purchaser, such as measuring equipment received for repair, maintenance or calibra!ion by the Supplier. Requirements concerning the handling of items received for testing or calibration by a laboratory are given in ISOIIEC Guide 25.
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4.13
Use of outside
products
The Supplier shall ensure that products and servicea from outside sources are of the quality level required, where these products and services (including calibration) significantly affect the reliability of the Suppliers measurements.
GUIDANCE The Supplier may ensure the quality of outside products and services by using forma//y accredited sources, where available. (However, the use of such sources does not diminish the Suppliers responsibility to the Purchaser.) Where accredited outside sources are not used and instead the Supplier performs an assessment of the outside source, the Supplier may be called upon to piovide formal evidence of his competence to perform SlJch an assessment.
All measuring equipment shall be calibrated using measurement standards that are traceable to international measurement standards, or to national measurement standards that are consistent with the recommendations of the General Conference on Weights and Measures (CGPM). In cases where such international or national measurement standards do not exist (for example, for hardness), traceability shall be established to other rneasurement standards (for example, suitable reference materials, concensus measurement standards or industry measurement standards) that are internationally accepted in the field concerned. All measurement standards used in the confirmation system shall be supported by certificates. reports or data sheets for the equipment attesting to the source, date, uncertainty, and to the conditions ynder which the results were obtained. Each such document shall be signed by a person attesting to the correctness of the results. The Supplier shall maintain documented evidence that each calibration in the chain of traceability has been carried out.
4.14
Storage
and handling
The Supplier shall establish and maint.ain a system for receiving, handling, transporting, storing and dispatching the Suppliers measuring equipment. in
GUIDANCE
The details of the significant components of the total uncertainty shall be recorded. The method of combining these components ~shall also be recorded.
countries, fhe national measurement rfandards are designated by an official decree in erms of specific arfefact measurement standards or by a group of them), rather than by reference o the technical prescripfions recommended by he CGPM. However, in almost all the situations Nhere this part of IS0 10012 is likely to be used, differences between these two sources of lraceabilify are unlikely to give rise to any problems in practical metrology. Valid traceability may be achieved by the use of sccepfed values of natural physical constants (for example, phase change temperatures), reference materials, ratio-type self-calibration techniques snd build-up scales. The resultant uncertainty may be greater than would be achieved by a direct comparison to an internalional or national measurement standard. An example of a ratio-type self-calibration at a 1:l ratio is the use of the Gauss double weighing mefhod using a nominally equal-arm balance. In the field of electrical measurements, many accurate ratios are obtainable by using properly constructed transformers (inductive voltage dividers) and d.c. current comparators. An example of a build-up scale is the production of an accurate scale of masses by intercomparison of unit-value masses, and then using fhem in appropriate combinations fogive a 1, 2, 3, 4, 5 etc. scale. In practice, for economy, a f-1, 2-2, 5, 10, 20-20, 50 etc. set of masses is offen used. Similar methods are used in other fields of measurement, but care has to be taken that the components are truly additive. The Supplier may provide the documented evidence of traceability by obtaining his calibrations from a formally accredited source.
n some
GUIDANCE A chain of calibrations implies that the value of each measurement standard in the chain has had ifs value determined using another measurement standard, usually having a smaller uncertainty of measurement, up to an international or national measurement standard.
4.17
Environmental
conditions
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Measurement standards and measuring equipment shall be calibrated, adjusted and used in an environment controlled to the extent necessary to ensure valid measurement results. Due consideration shall be given to temperature, rate of change of temperature, humidity, iighting, vibration, dust control, cleanliness, electromagnetic interference and other factors affecting the results of measurements. Where pertinent, these factors shall be continuously monitored and recorded and, when necessary, correcting compensations shall be applied to measurement results. Records shall contain both the original and the corrected data. Corrections, when applied, shall be soundly based.
GUIDANCE The manufacturer of a measurement standard or measuring instrument usually provides a specification giving the ranges and maximum loads, to~gefher with the limiting environmental conditions for the correct use of the device. When this information is available, if should be used for esfablishing the conditions of use and to defermine if any control is necessary to maintain these conditions. If is permissible to narrow the conditions but it is inadvisable to enlarge them.
of use
4.16
Cumulative
effect of uncertainties
The cumulative effect of the uncertainties of each successive stag-e in a chain of calibrations shall be taken into account for each measurement standard and item of equipment that is confirmed. Action shall be taken when the total uncertainty is such that it significantly compromises the ability to make measurements within the limits of permissible error.
The Supplier shall ensure that all confirmations are performed by staff having appropriate qualifications, training, experience, aptitude and supervision.
10
Annex
(informative) Guidelines
NOTE 28 Document
of confirmation
International
intervals
for measuring
equipment
A.1
An
Introduction
important aspect
There are two basic and opposing criteria which are required to be balanced when deciding on the confirmation intervals for each item of m-easuring equipment. These are the following: a) the risk of measuring form to specification small as possible; costs equipment failing to conwhen in use should be as
of the efficient operation of a is the determination of the confirmation system maximum period between successive confirmations of measurement standards and measuring equip*ment. A large number of factors influence the frequency of confirmation. The most important of these factors are the following:
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should
be kept
to a mini-
a) b) C) d) e) 9 3)
type
manufacturers trend data records; recorded extent tendency frequency measuring standard& frequency brations;
Therefore, methods are presented the initial selection of confirmation the readjustment of these intervals experience.
A.2
Initial
choice of confirmation
intervals
and servicing;
.
and iormafity of in-house check cali-
The basis of the initial decision in determining the confirmation interval is invariably the so-called engineering intuition. Someone with experience of measurements in general, or of the measuring equipment to be confirmed in particular, and preferably with knowledge of the intervals used by other laboratories, makes an estimate for each item of equipment or group of items as to the length of time it is likely to remain within tolerance after conftrmation. Factors a) to be taken into account are: recommendation;
h) 9 i) W
the equipment
manufacturers of use;
conditions etc.);
(temperature,
of measurement
sought;
c)
the influence
the penalty of an incorrect measured value being accepted as correct because the measuring equipment has become faulty.
d) the accuracy
The cost of confirmation cannot normally be ignored in determining the confirmation intervals and this may therefore be a limiting factor. It is obvious from all these stated factors that a list of confirmation intervals which can be universally applied cannot be constructed. It is more useful to present guidelines on how confirmation intervals may be established and then reviewed once confirmation on a routine basis is under way.
of reviewing
confirmation
A system which maintains confirmation intervals without review, determined only by so-called engineering intuition, is not considered to be sufficiently reliable. Once confirmation on a routine basis has been established, adjustment of the confirmation intervals should be possible in order to optimize the balance
11
of risks and costs as stated in the Introduction. It will probably be found that the intervals initially selected are not giving the desired optimum results: items of equipment may be less reliable than expected; their usage may not be as expected; it may be sufficient to carry out a limited confirmation of certain items instead of a full confirmation; the drift determined by the regular calibration of the equipment may show that longer confirmation intervals are possible without increasing the risks, and so on. If shortage of money or shortage of staff means that extended confirmation intervals are necessary, it should not be forgotten that the costs of using inaccurate measuring equipment may be significant. If an estimate of these costs is made, it may well be found to be more economical to spend more money on confirmation and to reduce the confirmation intervals. A range of methods 4s available for reviewing confirmation intervals. These differ according whether: the to
ble equipment,
these figures
the drifl over several intervals, From the effective drift may be calculated.
The method is difficult to apply, in fact very difficult in the case of complicated equipment and can virtually only be used with automatic data processing. Before calculations can commence, considerable knowledge of the law of variability of the equipment, or of similar equipment, is required. Again, it is difficult to achieve a balanced work-load. However, considerable variation of the confirmation intervals from those prescribed is permissible without invalidating the calculations; reliability can be calculated and, in theory at least, it gives the efficient confirmation interval. Furthermore, the calculation of the scatter will indicate if the manufacturers specification limits are reasonable and the analysis of the drift which is found may help in indicating the cause of-the drift. A-3.3 Method 3: Calendar time
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items of equipment are treated individually or as groups (for example, by maker or by type); items fail to comply with their specifications to drift with the lapse of time, or by usage; data are available and importance is attached the history of calibration of the equipment. due
Items of measuring equipment are initially arranged into groups on the basis of their similarity of construction and of their expected similar reliability and stability. A confirmation interval is assigned to the group, initially on the basis of engineering intuition. In each group, the quantity of items which return at their assigned confirmation interval and are found to have excessive errors or to be otherwise nonconforming is determined and expressed as a proportion of the total quantity of items in that group which are confirmed during a given period. In determining-the nonconforming items, those which are obviously damaged or which are returned by the user as suspect or faulty, are not included as they are not likely to cause measurement errors. If the proportion of nonconforming items of equipment is excessively high, the confirmation interval should be reduced. If it appears that a particular sub-group of items (such as a particular make or type) does not behave like the other members of the group, this sub-group should be removed to a different group with a different confirmation interval. The period during which the performance is assessed should be as short as possible, compatible with obtaining a statistically meaningful quantity of confirmed items for a given group. If the proportion of nonconforming items of equipment in a given group proves to be very low, it may be economically justifiable to increase the confirmation interval. Other statistical methods may be used. time
to
1: Automatic
or staircase
Each time an item of equipment is confirmed on ~a routine basis, the subsequent interval is extended if it is found to be within tolerance, or reduced if it is found to be outside tolerance. This staircase response may produce a rapid adjustment of intervals and is easily carried out without clerical effort. When records are maintained and used, possible trouble with a group of items, indicating the desirability of a technical modification or preventive maintenance, will become apparent. A disadvantage of systems which treat items individually may be that it is difficult to keep the confirmation work-load smooth and balanced, and that it requires detailed advanced planning. A.3.2 Method 2: Control chart
The same calibration points are chosen from every confirmation and the results are plotted against time. From these plots, both scatter and drift are calculated, the drift being either the mean drift over one confirmation interval or, in the case of very sta-
A.3.4
Method
4: In-use
This is a variation on the foregoing methods. The basic method remains unchanged but tt!? confir-
12
mation interval is expressed in hours of use rather than in calendar months of elapsed time. An item of equipment may be fitted with an elapsed-time indicator, and is returned for confirmation -when this indicator reaches a specified value. The important theoretical advantage of this method is that the number of confirmations performed, and therefore the cost of confirmation, varies directly with the length of time for which the equipment is used. Furthermore, there is an automatic check on equipment utilization. However, the practical include the following: a) disadvantages are many and
the method cannot be used with passive measuring instruments (for example, attenuators) or with passive measurement standards (resistors, capacitors, etc.);
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b) the method should not be used when equipment is known to drift or deteriorate when on the shelf, or when handled, or when subjected to a number of short on/off cycles; it should in any case have a calendar-time back-up; c) the initial cost of the provision and installation of suitable timers is high and, since users may interfere with them, supervision may be required which again will increase costs; it is even more difficult to achieve a smooth flow of work than with the other methods mentioned, since the calibration laboratory has no knowledge of the date when the confirmation interval will terminate.
d)
13
IS14012(Part1):1993 Is010012-1:1992
[I41OIML
ciples
International of assurance
PI
ISO/IEC Guide 43:1984, Development and operation of laboratory proficiency testing. International Document No. 10, Guidelines for the determination of recalibration intervals of measuring equipment used in testing laboratories.
151 AQAP 7 (NATO), Guide for the evaluation contractors measurement and calibration fem. I31
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[I31 OIML
European Organization for Quality, Glossary terms used in the management of quality.
of
14
BIS is a statutory institution established under the Burenu harmonious development of the activities of standardization, and attending to connected matters in the country.
Copyright
of Indian
BIS has the copyright of all its publications. No part of these publications may be reproduced in any form without the prior permission in writing of BIS. This does not preclude the free use, in the course of implementing the standard, of necessary details, such as symbols and sizes, type or grade designations. Enquiries relating to copyright be addressed to~the Director (Publications), BIS.
Review of Indian Standkds
Amendments are issued to standards as the need arises on the basis of comments. Standards are also reviewed periodically; a standard along with amendments is reaffirmed when such review indicates that no changes are needed, if the review indicates that changes are needed, it is taken up for revision. Users of Indian Standards should ascertain that they are in possession of the latest amendments or edition by referring to the latest issue of BIS Handbook and Standards Monthlv A+tions. This Indian Standard has been developed from Dot : No. MSD 2 (-67 )
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Amendments
Amend No.
Date of Issue
Text Affected
BUREAU OF INDIAN STANDARDS Headquarters: Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi 110002 Telephones : 323 0131,323 83 75,323 94 02 Regional Offices : Central
: Manak Bhavan, 9 Bahadur Shah Zafar Marg
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Western
MUMBAI 400093
BHUBANESHWAR. BANGALORE. BHOPAL. Branches : AHMADABAD. COIMBATORE. FARIDABAD. GHAZIABAD. GUWAHATI. HYDERABAD. JAIPUR. KANPUR. LUCKNOW. PATNA. THIRUVANANTHAPURAM.
Printed at Dee Kay Printers, New Delhi, India
NO. 1 JULY 1996 TO IS 14012 ( Part 1) : 1993/ISO 10012-l : 1992 QUALITY ASSURANCE REQUIREMENTS FOR MEASURING EQUIPMENT - PART 1: METROLOGICAL CONFIRMATION SYSTEM FOR MEASURING EQUIPMENT
[ The designation of the standard IS 14012 ( Part 1 ) : 1993/ISO 10012-l : 1992 is replaced by IS/IS0 10012-l : 1992. Wherever the designation IS 14012 ( Part 1 ) : 1993/ISO 10012-l : 1992 is occurring in the standard, it will be read as IS/IS0 10012-l : 1992.1 [ Preliminarypngcs NATIONAL (i) nnd (ii), NotionalForeword ]Substitute the following for the existing:
AMENDMENT
This Indian Standard which is identical with IS0 10012-l : 1992 Quality assurance requirements issued by measuring equipment - Part 1 : Metrological confirmation system for measuring equipment, Internations Organization for Standardization ( IS0 ), was adopted by the Bureau of Indian Standards the recommendation of the Quality Management Sectional Committee ( MSD 2 ), and approval of Managcntcnt and Systems Division Council.
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The text of the IS0 Standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following: Wherever the words International Indian Standard. Standard appear referring to this standard, they should be read as
In the adopted standard, normative references appear to rcrtain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their place are listed below along with their degree of equivalence for the editions indicated: Internntionnl Stnndnrd IS0 8402 : 1994 IS0 9001 : 1994 Corresponding Indian Stnndnrd IS/IS0 8402 : 1994 Quality management assurance - Vocabulary (first revision ) and quality Degree of Eqhulence Identical Identical
IS/IS0 9001 : 1994 Quality systems - Model for quality assurance in design, development, production, installation and servicing (first revision ) IS/IS0 9002 : 1994 Quality systems - Model for quality assurance in production, installation and servicing ( first revision ) IS/IS0 9003 : 1994 Quality systems - Model for quality assurance in final inspection and test (first revision ) IS/IS0 9004-l : 1994 Quality management and quality system elements - Part 1: Guidelines (fourth revision ) reference is also given to ISO/IEC
Identical
In the adopted standard, normative details given below: IS0 Guide 30 : 1981 ISO/IEC Guide 25 : 1990 BIPM/IEC/ ISO/OIML
used in connection
of testing : 1984
vocabulary
The concerned sectional committee has reviewed the provisions they are acceptable to use in conjunction with this standard.
I
: 1993 : 1992
In the adopted standard, inCorn~ative rcfcrcnce appears to IS0 9000 : 1987 which has ken subsequently revised and rcdcsignatcd as IS0 9000-l : 1994 Quality managment and quality assurance standards Part 1 : Guidelines for sclccliou and USC,for which an Indian Standard IS/IS0 9000-l : 1994 exists which is identical to IS0 9000-l : 1994. In addition, informative reference has been made to: IS0 Guide 43 : 1954 Dcvclopmcnt and operation of laboratory proficiency of recalibration testing intervals of
OIML Inkrnational Document No. 10, Guidelines for determination measuring equipment used in testing laboratories OIML AQAP European International 7 ( NATO) Document No. 16, Principles
control system
of a contractors
Organization
The concerned sectional committee has reviewed the provisions of these publications they are also acceptable for use in conjunction with this standard.
( MSD 02)