DOQ-CGCRE-020 – Revision 06 – Apr/2013 Page 1/12
DEFINITIONS OF TERMS USED IN THE DOCUMENTS RELATED TO THE ACCREDITATION OF LABORATORIES, REFERENCE MATERIAL PRODUCERS AND PROFICIENCY TESTING PROVIDERS
Guidance document
DOQ-CGCRE-020
Revision 06 – APR/2013
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TABLE OF CONTENTS
1Objective
2Application Field
3Responsibility
4Revision background and implementation deadline
5Reference documents
6Acronyms
7General considerations
8Definitions
1 OBJECTIVE
This document aims to present the definitions of terms used in Cgcre documents related to the activity of accreditation of laboratories, reference material producers and proficiency testing providers.
2 APPLICATION FIELD
This document applies to Dicla and to the following conformity assessment bodies, accredited or applying for accreditation:laboratories, proficiency testing providers and reference material producers.
This document also applies to assessors and experts working in the accreditation processes of these conformity assessment bodies and members of the advisory Technical Committees of Cgcre.
3 RESPONSIBILITY
Dicla is responsible for revising this document.
4 REVISION BACKGROUND AND IMPLEMENTATION DEADLINE
4.1 The definition of the term “subcontracting of laboratories” has been changed and the terms "working as an agent” and “outsourcing” have been deleted.These changes have been made with the purpose of eliminating mistaken interpretations about the requirements established in the standards NIE-Cgcre-009 and NIT-Dicla-031.
4.2 The definition of the term “updating the scope” has been changed, so as to clarify the cases in which the updating can be made.A clarification was made about the impossibility of updating scopes to include tests in products, properties or analytes.
4.3 Examples for the term “accreditation extension” have been included so as to clarify the cases in which it is necessary to apply for the accreditation extension.
4.4 Terms whose definitions are mentioned in other documents have been included.
4.5 Small changes have been made so as to improve the definitions of a few terms.
4.6 The definitions from VIM have been updated.
4.7 The most significant changes are marked in yellow.
4.8 This document comes into force on its publication date.
5 REFERENCE DOCUMENTS
ABNT ISO/IEC Guide 2:2006Standardization and related activities – general vocabulary.
ISO/IEC 17025:2005General requirements for the competence of testing and calibration laboratories
ISO/IEC 17000:2005Conformity assessment – Vocabulary and general principles
ISO/IEC 17011:2005Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies
ISO/IEC 17043:2011Conformity assessment -- General requirements for proficiency testing
ISO 15189Medical laboratories - Particular requirements for quality and competence
ILAC P14:11/2010Policy for Uncertainty in Calibration.
ISO Guide 34:2009General requirements for the competence of reference material producers.
VIM: 2012International vocabulary of metrology - Basic and general concepts and associated terms (VIM 2012).
Conmetro Resolution 3, of July 23rd, 2002Approves the terms of reference – Revision of concepts and new guidelines for the organization of metrology activities in the country.
6 ACRONYMS
CgcreGeneral Coordination for Accreditation
DiclaLaboratory Accreditation Division
InmetroBrazilian National Institute of Metrology, Quality and Technology
CABConformity Assessment Body
7 GENERAL CONSIDERATIONS
The definitions that do not refer to the Reference Documents mentioned in item 5 of the summary of this Guidance Document have been established by Cgcre.
This document has definitions of terms widely used in many documents of Cgcre.The terms used only in a specific document of Cgcre are mentioned in this document making reference to the document which mentions its definition.
8 DEFINITIONS
8.1 Warning
Action to notify the CAB about the non compliance with the standard requirements of the accreditation.
Note:
The character of the warning is eminently educative, not configuring a sanction.
8.2 Dicla´s clerical staff
Dicla’s professional responsible for reviewing the application, selecting assessment teams, requesting costs billing and other clerical activities.
Note:
The financial and contractual matters are managed and operated by the Accreditation Support Section - Secre/Cgcre.
8.3 Fortified Sample, Spike Matrix
See NIT-Dicla-057.
8.4 Sampling (ISO/IEC 17025)
Defined procedure whereby a part of a substance, material or product is taken to provide for testing or calibration of 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 is determined by availability.
Note:See also NIT-Dicla-057.
8.5 Appeal (ISO/IEC 17011)
Request by a CAB for reconsideration of any adverse decision made by the accreditation body related to the desired accreditation status.
Note: Adverse decisions include the refusal to accept an accreditation application, the interruption of the assessment process, the request of corrective actions, the changes in the accredited scope, the decisions to refuse, suspend or cancel the accreditation and any other action that prevents obtaining the accreditation.
8.6 Activity Areas:
Area including the economic activities in which testing objects are obtained or produced.
Note:
The activity areas are established in NIT-Dicla-016.
8.7 Filing of the Accreditation Process
Action to definitively terminate an accreditation application, at any time before it is granted, at the request of CAB or by virtue of Cgcre decision.
8.8 Scope Update
8.8.1 For the case of testing and calibration laboratories, as well as for medical testing laboratories, the update scope is a slight modification to the Scope of Accreditation which does not imply the inclusion of:
a)a new service of calibration, testing or examination;
b)new parameters, properties or analytes in calibration or testing services already accredited;
c)a new product for a testing already accredited;
d)a new material for an examination already accredited
e)a new method or technique of examination, calibration, testing or preparation of the item to be examined, calibrated or tested, for an examination, testing or calibration already accredited.
Note 1:Updating the scope shall not require the detailed review of the method, as it shall remain essentially the same.More complex changes in the scope require an application of the accreditation extension.
Note 2:Examples of situations that can lead to updating the scope are:
a)changing the version of the standard and/or procedure without changing the respective method or technique mentioned in the standard or procedure;
b)inclusion of the standard for a testing already accredited that uses method and procedureidentical to the testing already accredited.
c)for a calibration laboratory:small modifications to the calibration and measurement capability derived from the reduction of the contribution to the uncertainty from the calibration of standards or equipment used in calibration;
d)small changes in the measuring range or in the level of quantification that do not come from the introduction of a new measurement method or technique and preparation of the testing or calibration item.
8.8.2 For the case of proficiency testing providers, the updating of scope is a slight modification to the Scope of Accreditation that does not imply the inclusion of:
a)new parameters in the proficiency testing scheme already accredited;
b)new proficiency testing schemes, even for the same activity area, test class and/or service group;
c)new method for the determination of the designated value and of its associated uncertainty for an accredited proficiency testing scheme.
Note 3:Updating the accreditation scope may consist in changing the frequency of the scheme.
8.8.3 For the case of reference material producers, the updating of scope is a slight modification to the Scope of Accreditation that does not imply the inclusion of:
a)new reference materials in the same subcategory of reference materials or in a new subcategory of reference materials;
b)new property in a produced reference material;
c)new characterization technique of the produced reference material.
8.9 Measurement Audit
Interlaboratory comparison performed by the Metrological Reliability Sector (Secme) in order to assess the competence of a calibration laboratory, accredited or applying for accreditation, by Cgcre, to perform a specific calibration.
Note:A measurement audit can be performed for calibration and testing laboratories that perform internal calibration.
8.10 Authentication
See NIT-Dicla-061.
8.11 Follow-up assessment
Assessment carried out at the facilities of CABs or their clients with the purpose of assessing the effectiveness of the implementation of corrective actions taken by the CAB.
Note:A follow-up assessment is performed when the analysis of the documentary evidences of corrective actions implemented by the CAB is not enough to assess this effectiveness.
8.12 Extraordinary Assessment
Assessment carried out in order to:investigate complaints, evaluate changes in CABs, supplement the plan of a regular assessment or monitor CAB´s performance.
8.13 Assessor (ISO/IEC 17011)
Person assigned by an accreditation body to perform, alone or as part of an assessment team, an assessment of a CAB.
Cgcre´s note:The term "technical assessor" can also be used to name an assessor who is qualified to assess specific scopes of accreditation.
8.14 Lead assessor (ISO/IEC 17011)
Assessor who is given the overall responsibility for specified assessment activities.
8.15 Senior assessor
Assessor who, in particular situations, is authorized to perform some of the lead assessor functions in the assessment process.
Note:The functions that a senior assessor can perform are defined in NIT-Dicla-005.
8.16 Biosecurity
See NIT-Dicla-061.
8.17 Biosafety
See NIT-Dicla-061.
8.18 Method Blank or Reagent Blank
See NIT-Dicla-057.
8.19 Travel blank
See NIT-Dicla-057.
8.20 Spike Blank
See NIT-Dicla-057.
8.21 Calibration (VIM)
Operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Note 1:A calibration may be expressed by a statement, calibration function, calibration diagram, calibration curve, or calibration table.In some cases, it may consist of an additive or multiplicative correction of the indication with associated measurement uncertainty.
Note 2:Calibration should not be confused with adjustment of a measuring system, often mistakenly called “self-calibration”, nor with verification of calibration.
Note 3:Often, the first step alone in the above definition is perceived as being calibration.
8.22 Internal Calibration
Calibration performed by calibration or testing laboratory, accredited or undergoing accreditation, in their working standards and measuring instruments, belonging to calibration service groups that are not part of the scope of the accredited laboratory or the scope requested by the applicant.
8.23 Withdrawing Accreditation (ISO/IEC 17011)
Process of terminating accreditation in full.
8.24 Calibration and Measurement Capability (CMC) (based in ILAC P14)
Lowest uncertainty of measurement that a laboratory can achieve when performing calibrations or measurements within the scope of its accreditation.
Note 1:This term replaces the term "best measurement capability".
Note 2:The CMC is published in the scope of accreditation of the calibration laboratory.
Note 3:If the calibration laboratory uses more than one method to perform a given calibration or measurement, in a specific range, the respective CMC will refer to the method by which the laboratory obtains the lowest measurement uncertainty in this range.
8.25 Biological Resource Centers (BRC)
See NIT-Dicla-061.
8.26 Testing class:
Set of tests related to one or more quantities.
Note:testing classes are established in NIT-Dicla-016.
8.27 Technical Committee (for advising Cgcre on accreditation activities)
Advisory committee, composed of technical experts in one or more calibration service groups, testing classes, activity areas, or categories of reference material, linked to Cgcre and operating under the supervision of Dicla/Cgcre, whose function is to assist it in matters related to accreditation of CABs, within one or more fields of operation.
8.28 Interlaboratory Comparison (ISO/IEC 17043)
Organization, performance and assessment of measurements or tests in same or similar items by two or more laboratories in accordance with predetermined conditions.
8.29 Granting of Accreditation
Act to grant an accreditation from a formal application, comprising the steps of the application review, documentation review, measurement audit/proficiency testing, initial assessment, decision on accreditation and formalization of accreditation.
8.30 Sample set from the same site
See NIT-Dicla-057.
8.31 Whistleblowing
Manifestation expressed by a person or organization, reporting actions, performed by Cgcre or organizations which Cgcre holds a formal agreement, which may be illegal.
8.32 Normative Document (ISO/IEC Guide 2)
Document that provides rules, guidelines or characteristics for activities or their results.
8.33 Guidance Document
Document intended to guide and advise on the application of a standard or the performance of a specific activity of conformity assessment.
8.34 Testing (ISO/IEC 17000)
Determination of one or more characteristics of an object of conformity assessment, according to a procedure.
8.35 Duplicate
See NIT-Dicla-057.
8.36 Fortified Sample Duplicate, Spike Matrix Duplicate
See NIT-Dicla-057.
8.37 Proficiency Tests (ISO/IEC 17043)
Determination of laboratory performance by means of interlaboratory comparisons.
8.38 Accreditation Scope (ISO/IEC 17011)
Specific conformity assessment services for which accreditation is sought or has been granted.
Cgcre´s note:
The detailed scope of accreditation may vary depending on the modality of accreditation or technical field of CAB´s activity.Generally, the following information is included:
-For calibration laboratories:calibration service group, accredited services, calibrated standard or instrument (e.g.:liquid in glass thermometer, standard weight, laboratory glassware etc.); range of service, calibration and measurement capability.
-For testing laboratories:activity area, testing class, testing description, tested product (for example:concrete, steel bars, food, fabrics, etc.), standard or procedure.
-For medical laboratories:description of the examination, the methodology, the examined material and the used standard operating procedure.
-For proficiency testing providers:activity area or calibration group,name of the scheme established by the proficiency testing provider, frequency and description of the proficiency testing item, method used for the determination of the designated value and of its associated uncertainty.
-For reference material producers:category, sub-category and the matrix of the reference material, the property, including ranges and uncertainties associated with the property value, in addition to the characterization technique of the reference material.
8.39 Expert (ISO/IEC 17011)
Person designated by an accreditation body to provide specific or specialized knowledge regarding the scope of accreditation to be assessed.
Cgcre´s note:Experts are qualified in levels, according to the functions that they can carry out in the assessment process, as established in NIT-Dicla-005.
8.40 Examination (ISO 15189)
Set of operations having the object of determining the value or the characteristics of a property.
8.41 Extending Accreditation (ISO/IEC 17011)
Process of enlarging the scope of accreditation.
Note:examples of situations that can lead to extension are:
a)In the accreditation of testing and calibration laboratories:
–include a new calibration service group, new activity area or new testing class;
–include service items in calibration service group, activity area or testing class already accredited and in facilities for which they are already accredited;
–include tests for a new product, even if the laboratory is already accredited for this testing in another product;
–include new types of facilities;
–improve the calibration and measurement capability of the calibration services and/or expand the measuring range, in the case it causes the inclusion of new methods or changing in a method already accredited or that needs a detailed review of the procedure by the assessment team;
–new parameters, properties or analytes in calibration or testing services already accredited;
–include or update the standard and/or method developed by the laboratory, in the case of significant changes which require a detailed analysis.
b)In the accreditation of medical testing laboratories:
–enlarge the number of associated facilities;
–enlarge examination or materials items;
–include or change methods and/or standard operating procedure, in the case of significant changes which require a detailed analysis.
c)In the accreditation of reference material producers:
–include new subcategories of reference materials;
–include new reference materials in the same subcategory of reference materials or in a new subcategory of reference materials;
–include new property in a produced reference material;
–include new characterization technique of the produced reference material.
d)In the accreditation of proficiency testing providers:
–include new parameters in the proficiency testing scheme already accredited;
–include new proficiency testing schemes in different activity areas, testing class or service group.
–include new proficiency testing schemes in a activity area, testing class and/or service group already accredited;
–include new method for the determination of the designated value and of its associated uncertainty for an accredited proficiency testing scheme.
8.42 Supplier of Assessors/Experts
Organization that provides its professionals to act as assessors and/or experts in the assessments performed by Cgcre.
8.43 Accreditation Manager (AM)
Dicla’s professional in charge of managing initial, extension and maintenance accreditation processes for accreditation of CABs and of providing technical support to the assessment team.
Note:Financial and contractual matters are managed and operated by the Accreditation Support Section - Secre/Cgcre and are not the responsibility of the Accreditation Manager (AM).
8.44 Quantity (VIM)
Property of a phenomenon, body or substance, where the property has a magnitude that can be expressed as a number and a reference.
Examples:mass, length, volume, electrical resistance etc.
8.45 Calibration service group
Set of calibration services related to one or more quantities of the International System of Units (SI).
Note:Calibration service groups are established in NIT-DICLA-012.
8.46 Associated Facility
Facility off-site the CAB permanent and mobile facilities where CAB support activities are performed.
Notes:
a)Associated facilities shall be necessarily subordinated to a CAB that performs services in permanent, customers and/or mobile facilities.
b)The following examples are considered associated facilities:(i) departments of the organization to which the CAB is linked, that perform clerical and support activities to the CAB, (ii) sampling collection sites, (iii) place of custody of equipment, (iv) vehicle for transportation of a sample or equipment and (v) office where technicians are allocated.