1、 AMERICAN NATIONAL STANDARD Measurement management systems Requirements for measurement processes and measuring equipment AMERICAN SOCIETY FOR QUALITY P.O. BOX 3005 MILWAUKEE, WI 53201-3005 ANSI/ISO/ASQ Q10012-2003AMERICAN NATIONAL STANDARD Measurement management systems Requirements for measurement
2、 processes and measuring equipment Approved as an American National Standard by: American Society for Quality American National Standards: An American National Standard implies a consensus of those substantially concerned with is scope and provisions. An American National Standard is intended as a g
3、uide to aid the manufacturer, the consumer, and the general public. The existence of an American National Standard does not in any respect preclude anyone, whether he or she has approved the standard or not, from manufacturing, purchasing, or using products, processes, or procedures not conforming t
4、o the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest edition. Caution Notice: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute require that action be
5、 taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Purchasers of American National Standards may receive current information on all standards by calling of writing the American National Standards Institute. An American National Standard Appro
6、ved April 2006ANSI/ISO/ASQ Q10012-2003 2006 by ASQCopyright Protection Notice for the ANSI/ISO/ASQ Q10012-2003 Standard.This standard is subject to copyright claims of ISO, ANSI, and ASQ. Not for resale. No part of this publication may be reproduced in any form, including an electronic retrieval sys
7、tem, without the prior written permission of ASQ. All requests pertaining to the ANSI/ISO/ASQ Q10012-2003 Standard should be submitted to ASQ.Note: As used in this document, the term “International Standard” refers to the American National Standard adoption of this and other International Standards.
8、ASQ will consider requests for change and information on the submittal of such requests regarding this Standard. All requests should be in writing to the attention of the Standards administrator at the address below.ASQ Mission: The American Society for Quality advances individual and organizational
9、 performance excellence worldwide by providing opportunities for learning, quality improvement, and knowledge exchange.Published by:ANSI/ISO/ASQ Q10012-2003Also available from ASQ Quality Press: Concepts for R no measurement process is to be out of control for more than one day without detection; al
10、l metrological confirmations are to be completed by the agreed times; there are to be no illegible metrological confirmation records; all of the technical training programmes are to be completed per the established schedule; the amount of time measuring equipment is out of operation is to be reduced
11、 by a stated percentage. 5.4 Management review Top management of the organization shall ensure the systematic review of the measurement management system at planned intervals to ensure its continual adequacy, effectiveness and suitability. The top management shall ensure that the necessary resources
12、 are available to review the measurement management system. The results of the management review shall be used by the management of the metrological function to modify the system as necessary, including improving measurement processes (see Clause 8) and reviewing quality objectives. The results of a
13、ll reviews and all actions taken shall be recorded. ANSI/ISO/ASQ Q10012-200346 Resource management 6.1 Human resources 6.1.1 Responsibilities of personnel The management of the metrological function shall define and document the responsibilities of all personnel assigned to the measurement managemen
14、t system. Guidance These responsibilities may be defined in organization charts, job descriptions, and work instructions or procedures. This International Standard does not exclude the use of specialist personnel external to the metrological function. 6.1.2 Competence and training The management of
15、the metrological function shall ensure that personnel involved in the measurement management system have demonstrated their ability to perform their assigned tasks. Any specialized skills required shall be specified. The management of the metrological function shall ensure that training is provided
16、to address identified needs, records of training activities are maintained, and that the effectiveness of the training is evaluated and recorded. Personnel shall be made aware of the extent of their responsibilities and accountabilities, and the impact of their activities on the effectiveness of the
17、 measurement management system and product quality. Guidance Competence may be achieved through education, training and experience, and demonstrated by testing or observed performance. When using staff who are undergoing training, adequate supervision shall be provided. 6.2 Information resources 6.2
18、.1 Procedures Measurement management system procedures shall be documented to the extent necessary and validated to ensure the proper implementation, their consistency of application, and the validity of measurement results. New procedures or changes to documented procedures shall be authorized and
19、controlled. Procedures shall be current, available and provided when required. Guidance Technical procedures may be based on published standard measurement practices, or on customers or equipment manufacturers written instructions. 6.2.2 Software Software used in the measurement processes and calcul
20、ations of results shall be documented, identified and controlled to ensure suitability for continued use. Software, and any revisions to it, shall be tested and/or validated prior to initial use, approved for use, and archived. Testing shall be to the extent necessary to ensure valid measurement res
21、ults. ANSI/ISO/ASQ Q10012-20035Guidance Software may be in several forms, such as embedded, programmable, or off-the-shelf packages. Off-the-shelf software might not require testing. Testing may include virus checking, checking of user-programmed algorithms, or a combination thereof as necessary to
22、achieve the required measurement result. Software configuration control can help maintain the integrity and validity of measurement processes using software. Archiving may be accomplished by creating back-up copies, off-site storage, or any other means to safeguard programming, ensure accessibility,
23、 and to provide the level of traceability necessary. 6.2.3 Records Records containing information required for the operation of the measurement management system shall be maintained. Documented procedures shall ensure the identification, storage, protection, retrieval, retention time and disposition
24、 of records. Guidance Examples of records are confirmation results, results of measurement, purchasing, operational data, nonconformance data, customer complaints, training, qualification, or any other historical data supporting the measurement processes. 6.2.4 Identification Measuring equipment and
25、 technical procedures used in the measurement management system shall be clearly identified, individually or collectively. There shall be an identification of the status of the metrological confirmation of equipment. Equipment confirmed for use only in a particular measurement process or processes s
26、hall be clearly identified or otherwise controlled to prevent unauthorized use. Equipment used in the measurement management system shall be distinguishable from other equipment. 6.3 Material resources 6.3.1 Measuring equipment All measuring equipment necessary to satisfy the specified metrological
27、requirements shall be available and identified in the measurement management system. Measuring equipment shall have a valid calibration status prior to being confirmed. Measuring equipment shall be used in an environment that is controlled or known to the extent necessary to ensure valid measurement
28、 results. Measuring equipment used to monitor and record the influencing quantities shall be included in the measurement management system. Guidance Measuring equipment can be confirmed for use for particular measurement processes, and not confirmed for use for other measurement processes because of
29、 differing metrological requirements. Metrological requirements for the measuring equipment are derived from specified requirements for the product or the equipment to be calibrated, verified and confirmed. The maximum permissible error may be designated by reference to the published specification o
30、f the measuring equipment manufacturer, or by the metrological function. Measuring equipment may be calibrated by an organization other than the metrological function performing the metrological confirmation. The characterization of reference materials might meet the requirement for calibration. ANS
31、I/ISO/ASQ Q10012-20036The management of the metrological function shall establish, maintain and use documented procedures for receiving, handling, transporting, storing and dispatching measuring equipment, in order to prevent abuse, misuse, damage and changes to its metrological characteristics. The
32、re shall be procedures for processing measuring equipment introduced into or removed from the measurement management system. 6.3.2 Environment The environmental conditions required for the effective operation of the measurement processes covered by the measurement management system shall be document
33、ed. Environmental conditions affecting measurements shall be monitored and recorded. Corrections based on the environmental conditions shall be recorded and applied to measurement results. Guidance Environmental conditions affecting measurement results can include temperature, rate of change of temp
34、erature, humidity, lighting, vibration, dust control, cleanliness, electromagnetic interference, and other factors. Equipment manufacturers usually provide specifications giving ranges and maximum loads, and limitations of environmental conditions, for correct use of the equipment. 6.4 Outside suppl
35、iers The management of the metrological function shall define and document the requirements for products and services to be provided by outside suppliers for the measurement management system. Outside suppliers shall be evaluated and selected based on their ability to meet the documented requirement
36、s. Criteria for selection, monitoring and evaluation shall be defined and documented, and the results of the evaluation shall be recorded. Records shall be maintained of the products or services provided by outside suppliers. Guidance If an outside supplier is used for testing or calibration, the su
37、pplier should be able to demonstrate technical competence to a laboratory standard such as ISO/IEC 17025. Products and services provided by outside suppliers might require verification to the specified requirements. 7 Metrological confirmation and realization of measurement processes 7.1 Metrologica
38、l confirmation 7.1.1 General Metrological confirmation (see Figure 2 and Annex A) shall be designed and implemented to ensure that the metrological characteristics of the measuring equipment satisfy the metrological requirements for the measurement process. Metrological confirmation comprises measur
39、ing equipment calibration and measuring equipment verification. Guidance Recalibration of the measuring equipment is not necessary if the equipment is already in a valid calibration status. Metrological confirmation procedures should include methods to verify that measurement uncertainties and/or me
40、asuring equipment errors are within permissible limits specified in the metrological requirements. Information relevant to the metrological confirmation status of measuring equipment shall be readily available to the operator, including any limitations or special requirements. The metrological chara
41、cteristics of measuring equipment shall be suitable for its intended use. ANSI/ISO/ASQ Q10012-20037Guidance Examples of characteristics for measuring equipment include: range, bias, repeatability, stability, hysteresis, drift, effects of influencing quantities, resolution, discrimination (threshold)
42、, error, and dead band. Metrological characteristics of measuring equipment are factors contributing to the measurement uncertainty (see 7.3.1) which allows direct comparison with the metrological requirements towards establishing metrological confirmation. Qualitative statements of the metrological
43、 characteristics in terms of, for example, “required accuracy of measuring equipment” should be avoided. 7.1.2 Intervals between metrological confirmation The methods used to determine or change the intervals between metrological confirmation shall be described in documented procedures. These interv
44、als shall be reviewed and adjusted when necessary to ensure continuous compliance with the specified metrological requirements. Guidance Data obtained from calibration and metrological confirmation histories, and advancing knowledge and technology, may be used for determining intervals between metro
45、logical confirmation. Records obtained using statistical process control techniques for measurements can be useful in determining whether or not to modify metrological confirmation intervals. The calibration interval may be equal to the metrological confirmation interval (see OIML D10). Each time no
46、nconforming measuring equipment is repaired, adjusted or modified, the interval for its metrological confirmation shall be reviewed. 7.1.3 Equipment adjustment control Access to adjusting means and devices on confirmed measuring equipment, whose setting affects the performance, shall be sealed or ot
47、herwise safeguarded to prevent unauthorized changes. Seals or safeguards shall be designed and implemented such that tampering will be detected. The metrological confirmation process procedures shall include actions to be taken when seals or safeguards are found damaged, broken, bypassed or missing.
48、 ANSI/ISO/ASQ Q10012-20038Guidance The requirement for sealing does not apply to adjustment means or devices that are intended to be set by the user without the need for external references; for example, zero adjusters. Special attention should be paid to write-protection techniques to prevent unaut
49、horized changes to software and firmware. The decisions about what measuring equipment should be sealed, the controls or adjustments which will be sealed, and the sealing material such as labels, solder, wire, paint, are normally left to the metrological function. Implementation of a sealing programme by the metrological function should be documented. Not all measuring equipment lends itself to sealing. 7.1.4 Records of the metrological confirmation process Records of the metrological confirmation process sha
