ICS 11.100.99   
 
Reference number  
DRS 438: 2020  
© RSB 2020  
  
 RWANDA 
STANDARD  DRS 438: 
2020  
 
First edition  
2020 -mm-dd 
 
General requirements for the competence 
of verification laboratories  
   
DRS 438: 2020   
©RSB 2020 - All rights reserved                  ii 
 In order to match with technological development and to keep continuous progress in industries, 
standards are subject to periodic review. Users shall ascertain that they are in possession of the latest 
edition  
 
 
 
 
 
 
 
 
© RSB 2020  
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized 
in any form or by any means, electronic or mechanical, including photocopying and microfilm, without 
prior written permission from R SB. 
Requests for permission to reprodu ce this document should be addressed to : 
Rwanda Standards  Board  
P.O Box 7099 Kigali -Rwanda  
KK 15 Rd, 49  
Tel. +250 788303492  
Toll Free: 3250  
E-mail: info@rsb.gov.rw  
Website: www.rsb.gov.rw  
ePortal: www.portal.rsb.gov.rw   DRS 438: 2020  
iii                ©RSB 2020  - All rights reserved  
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ .............................  v 
1 Scope  ................................ ................................ ................................ ................................ ......................  1 
2 Normative references  ................................ ................................ ................................ ............................  1 
3 Definition s ................................ ................................ ................................ ................................ ..............  1 
4 General requirements  ................................ ................................ ................................ ...........................  3 
4.1 Impartiality  ................................ ................................ ................................ ................................ .............  3 
4.2 Confidentiality  ................................ ................................ ................................ ................................ ........  4 
4.3 Independence  ................................ ................................ ................................ ................................ ........  4 
5 Structural requirements  ................................ ................................ ................................ ........................  4 
6 Resource requirements  ................................ ................................ ................................ ........................  6 
6.1 General  ................................ ................................ ................................ ................................ ...................  6 
6.2 Personnel  ................................ ................................ ................................ ................................ ...............  6 
6.3 Facilities and environmental conditions  ................................ ................................ .............................  6 
6.4 Standard Equipment  ................................ ................................ ................................ .............................  7 
6.5 Metrological traceability  ................................ ................................ ................................ .......................  9 
6.6 Externally provided products and services or supplies  ................................ ................................ . 10 
7 Process requirements  ................................ ................................ ................................ .........................  10 
7.1 Review of requests, tenders and contracts  ................................ ................................ ......................  10 
7.2 Subcontracting of verification work  ................................ ................................ ................................ .. 12 
7.3 Purchasing, services and supplies  ................................ ................................ ................................ ... 12 
7.4 Verification methods  ................................ ................................ ................................ ...........................  12 
7.4.1  General  ................................ ................................ ................................ ................................ .................  12 
7.4.2  Selection of methods  ................................ ................................ ................................ ..........................  13 
7.5 Sampling  ................................ ................................ ................................ ................................ ..............  13 
7.6 Handling of verification items  ................................ ................................ ................................ ............  14 
7.7 Technical records  ................................ ................................ ................................ ................................  15 
7.8 Assuring  the validity of verification results  ................................ ................................ .....................  15 
7.9 Reporting of verification results  ................................ ................................ ................................ ........  16 
7.9.1  General  ................................ ................................ ................................ ................................ .................  16 
7.9.2  Verification certificate  ................................ ................................ ................................ .........................  16 
7.9.3 Rejection certificates  ................................ ................................ ................................ ..........................  18 
7.9.4  Amendments to reports  ................................ ................................ ................................ ......................  19 
7.9.5  Electronic transmission of results  ................................ ................................ ................................ .... 19 
7.9.6  Format of reports and certificates  ................................ ................................ ................................ ..... 19 
7.10  Complaints and appeals  ................................ ................................ ................................ .....................  19 
7.11  Nonconforming work  ................................ ................................ ................................ ..........................  20 
7.12  Contr ol of data and information management  ................................ ................................ .................  21 
8 Management system requirements.  ................................ ................................ ................................ .. 22 
8.1 Options  ................................ ................................ ................................ ................................ .................  22 
8.1.1  General  ................................ ................................ ................................ ................................ .................  22 
8.1.2  Option A  ................................ ................................ ................................ ................................ ...............  22 
8.1.3  Option B  ................................ ................................ ................................ ................................ ...............  22 
8.2 Management system documentation (Option A)  ................................ ................................ .............  22 
8.3 Control of management system documents (Option A)  ................................ ................................ .. 23 
8.4 Control of records (Option A)  ................................ ................................ ................................ ............  23 
8.5 Actions to address risks and opportunities (Option A)  ................................ ................................ .. 24 DRS 438: 2020   
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 8.6 Improvement (Option A)  ................................ ................................ ................................ .....................  24 
8.7 Corrective actions (Option A)  ................................ ................................ ................................ ............  25 
8.8 Internal audits (Option A)  ................................ ................................ ................................ ...................  26 
8.9 Management reviews (Option A)  ................................ ................................ ................................ ....... 26 
Annex  A (Normative) Independence requirements for verification laboratories  ................................ ...... 28 
A.1 Requirements for verification laboratories (Type A ) ................................ ................................ ....... 28 
A.2 Requirements for verification laboratories (Type B)  ................................ ................................ ....... 29 
A.3 Requirements for verification laboratories (Type C)  ................................ ................................ ....... 29 
 DRS 438: 2020  
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 Forewo rd  
Rwanda Standard s are prepared  by Technical Committees and approved by R wanda Standards Board (RSB) 
Board  of Directors in  accordance with the procedures of RSB, in compliance with Annex 3 of the WTO/TBT 
agreement on the preparation, adoption and application of standards.  
The main task of technical committees is to prepare national standards.  Final Draft Rwanda S tandards 
adopted by Technical committ ees are ratifie d by me mbers of RSB Board of Director s for publication and 
gazettment as Rwanda Standards.  
DRS 438 was prepared by Technical Committee s RSB/TC 014, Quality management and quality assurance 
and RSB/TC 46 RSB/TC 46 Metrology and physical phenomena  
In the preparation of this standard, reference was made to the following standard:  
ISO/IEC 17025:2017  General requirements for the competence of testing and calibration laboratories  
The assistance de rived from the above source is hereby acknowledged with thanks.  
Committee membership  
The following organizations were represented on the Technical Committee on Tourism and Hospitality 
(RSB/TC 014) in the preparation of this standard.  
Act Business S olutions  
Rwanda Development Board  (RDB)  
University of Rwanda -HQs 
Standards for Sustainability  
Life Long Education Group Ltd 
Rwanda Mines, Petroleum and Gas Board  (RMB)  
Meteo Rwanda  
Societe Petrolier (SP) Ltd  
Sulfo Rwanda Industries Ltd  
Cleaner Production and Climate Innovation Centre ( CPCIC ) DRS 438: 2020   
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 EseURWIBUTSO  
Rwanda  Standard s Board  (RSB) – Secretariat  
 DRS 438: 2020  
1                ©RSB 2020  - All rights reserved  
 General requirements for the competence of verification 
laboratories  
1 Scope  
1.1  This Committee Draft specifies the general requirements for the competence of laboratories to carry out 
the verification of measuring instruments and prepackages . It covers type evaluation, initial, subsequent and 
in-service verification of measuring instr uments and metrological supervision activities and prepackages  
control.  
1.2  This Committee Draft  applies to all verification laboratories that perform verification of measuring 
instruments and pre -packages regardless of the number of personnel or the exte nt of the scope of the 
verification activities.  
1.3  This Committee Draft  provides requirements for development, main tenance and implementation of 
management systems of verification laboratories.  
2  Normative references  
The following referenced documents ar e indispensable for the application of this document. For dated 
references, only the edition cited applies. For undated references, the latest edition of the referenced 
document (including any amendments) applies.  
RS ISO 9001  Quality management systems — Requirements  
ISO Guide 33  Reference materials — Good practice in using reference materials  
RS ISO 17020 Conformity assessment — Requirements for the operation of various types of bodies 
performing inspection  
3 Definitions  
For the purposes of this standard, t he following terms and definitions apply.  
3.1 
appeal  
request by the client or responsible party to the verification body for reconsideration of a decision it has made 
relating to the verification  
3.2 
complaint  
expression  of dissatisfaction, other than appeal, by any person or organization to a  verification laboratory 
relating to the activities of that verification laboratory, where a response is expected   
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 3.3 
permanent facility  
verification laboratory used or intended for  use as a permanent base, with an address that is used in the 
quality documentation of the relevant organization  
3,4  
prepackage   
single item for presentation as such to a consumer, consisting of a product and its packing material, made up 
before being offered for sale and in which the quantity of product has a predetermined value, whether the 
packing material encloses the product completely or only partially, but in any case in such a way that the 
actual quantity of product cannot be altered without the  packing material either being opened or undergoing a 
perceptible modification  
NOTE 1  For the purpose of this document,  prepackages include prepackages marked with a constant nominal quantity 
or random nominal quantities. The term “predetermined value ” refers t o the value determined prior to the prepackage 
being offered for sale.  
NOTE 2  The actual quantity of some products may change after packing due to desiccation or  chemical reactions  
3.5 
reference material  
any material that is stable and used in the pl ace of verification standards, and the quantity of which has been 
determined on a suitable instrument that has been calibrated or verified with standards traceable to national or 
international standards before such determination, for the purpose of verifyi ng instruments  
3.7 
rejection mark  
mark that is applied to a measuring instrument to indicate that it doesn’t comply with the requirements for such 
instrument in terms of the relevant national legisl ation and Standard  
3.7 
verification  
set of actions of insp ecting and testing measuring instruments or prepackages in order to ascertain  that such 
measuring instruments or prepackages comply with national standard and legislation  
NOTE  this includes stamping, sealing or marking instruments with a stamp, seal or ma rk and issuing a certificate of 
verification in writing.  DRS 438: 2020  
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 3.8 
verification laboratory  
Any competent verification laboratory that is approved by the national responsible body to verify prepackages  
or measuring instruments for use in trade, medical, law enforcement, safety and environmental protection in 
terms of the relevant national legislation from a permanent facility or on site  
3.9 
verification mark  
mark that is applied to a measuring instrumen t or prepackage to indicate that it complies with all the 
requirements for such instrument or product in terms of the relevant national standard and legislation  
3.10 
verification officer  
any person appointed by the national responsible body to verify measuring instruments or prepackages in 
terms of the relevant nati onal legislation and standard  
3.11 
verification standard  
equipment or document that is used by a verification officer to verify m easuring instruments or prepackages  
4 General requirements  
4.1 Impartiality  
4.1.1  Verification laboratory activities shall be undertaken impartially and structured and managed so as to 
safeguard impartiality.  
4.1.2  The verification laboratory top management sh all be committed to impartiality.  
4.1.3  The verification laboratory shall be responsible for the impartiality of its verification laboratory activities 
and shall not allow commercial, financial or other pressures to compromise impartiality.  
4.1.4  The ver ification laboratory shall identify risks to its impartiality on an on -going basis. This shall include 
those risks that arise from its activities, or from its relationships, or from the relationships of its personnel. 
However, such relationships do not nec essarily present a verification laboratory with a risk to impartiality.  
NOTE  A relationship that threatens the impartiality of the verification laboratory can be based on ownership, 
governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment 
of a sales commission or other inducement for the referral of new customers, etc.  
4.1.5  If a risk to impartiality is identified, the verification laboratory shall be able to demonstrate how it 
eliminates or mini mizes such risk.   
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 4.2 Confidentiality  
4.2.1  The verification laboratory shall be responsible, through legally enforceable commitments, for the 
management of all information obtained or created during the performance of verification laboratory activities.  
4.2.2  The verification laboratory shall inform the customer in advance, of the information it intends to place 
in the public domain.  
4.2.3  Except for information that the customer makes publicly available, or when agreed between the 
verification laboratory and  the customer (e.g. for the purpose of responding to complaints and appeals), all 
other information is considered proprietary information and shall be regarded as confidential.  
4.2.4  When the verification laboratory is required by law or authorized by contractual arrangements to 
release confidential information, the customer or individual concerned shall, unless prohibited by law, be 
notified of the information provided.  
4.3 Independence  
The verification laboratory shall be independent to the extent that is required with regard to the conditions 
under which it performs its services.  Depending on these conditions, it shall meet the minimum requirements 
stipulated in Annex A, as outlined be low: 
a) A verification laboratory providing third -party verifica tions shall meet the type A requirements of Clause 
A.1 (third -party verification laboratory).  
b) A verification laboratory providing first -party verifications, second -party verifications, or both, w hich forms 
a separate and identifiable part of an organization involved in the design, manufacture, supply, 
installation, use or maintenance of the items it verifies and which supplies verification services only to its 
parent organization (in -house verific ation laboratory) shall meet the type B requirements of Clause A.2.  
c) A verification laboratory providing first -party verifications, second -party verifications, or both, which forms 
an identifiable but not necessarily a separate part of an organization invol ved in the design, manufacture, 
supply, installation, use or maintenance of the items it verifies and which supplies verification services to 
its parent organization or to other parties, or to both, shall meet the type C requirements of Clause A.3.  
5 Structu ral requirements  
5.1  The verification laboratory shall be a legal entity, or a defined part of a legal entity, that is legally 
responsible for verification of measuring instrument and prepackages.  
NOTE  For the purposes of this standard, a governmental ver ification laboratory is deemed to be a legal entity on the 
basis of its governmental status.  
5.2  The verification laboratory shall identify management that has overall responsibility for the verification 
laboratory.  
5.3  The verification laboratory shall define and document the range of verification laboratory activities for 
which it conforms with this document.  DRS 438: 2020  
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 5.4 The verification laboratory shall only claim conformity with this document for this range of verification 
laboratory activities, which exclud es externally, provided verification laboratory activities on an ongoing basis.  
5.5  Verification laboratory activities shall be carried out in such a way as to meet the requirements of this 
standard, national legislation, and organizations providing recognition. This shall include verification laboratory 
activities performed in all its permanent facilities, at sites away from its permanent facilities, in associated 
temporary or mobile facilities or at a customer's facility.  
5.6  The verification labor atory shall:  
a) define the organization and management structure of the verification laboratory, its place in any parent 
organization, and the relationships between management, technical operations and support services;  
b) specify the responsibility, authority a nd interrelationship of all personnel who manage, perform or verify 
work affecting the results of verification  laboratory;  
c) document its procedures to the extent necessary to ensure the consistent application of its verification 
laboratory activities and t he valid ity of the verification results; and  
d) provide adequate supervision of verification officers; trainee verification officers shall be supervised by 
qualified verification officers;  
5.7  The verification laboratory shall have personnel who, irrespectiv e of other responsibilities, have the 
authority and resources needed to carry out their duties, including:  
e) follow up the development, implementation, maintenance and improvement of the management system;  
f) identification of deviations from the management sys tem or from the procedures for performing verification 
laboratory activities;  
g) initiation of actions to prevent or minimize such deviations;  
h) reporting to highest level of  verification laboratory management on the performance of the management 
system and any need for improvement;  
i) ensuring the effectiveness of verification laboratory activities.  
5.8 Verification laboratory management shall ensure that:  
a) communication takes place regarding the effectiveness of the management system and the importance of 
meeting customers satisfaction;  and 
b) the integrity of the management system is maintained when changes to the management system are 
planned and implemented.   
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 6 Resource requirements  
6.1 General  
The verification laboratory shall have personnel, facilities, standard equipment, systems and support services 
necessary to manage and perform its verification laboratory activities.  
6.2 Personnel  
6.2.1   All personnel of the verification laboratory that could influence the verification laboratory activities 
shall act impartially,  be competent and work in accordance with the verification laboratory's management 
system.  
6.2.2  The verification laboratory shall document the competence requirements for each function influencing 
the results of verification laboratory activities, includ ing requirements for education, qualification, training, 
technical knowledge, skills and experience.  
6.2.3  The verification laboratory shall ensure that the personnel have the competence to perform 
verification laboratory activities for which they are res ponsible and to evaluate the significance of deviations.  
6.2.4  The top management of the verification laboratory shall communicate to personnel their duties, 
responsibilities and authorities.  
6.2.5  The verification laboratory shall have procedure(s) and retain records for:  
a) determining the competence requirements;  
b)  selection of personnel;  
c) training of personnel;  
d) supervision of personnel;  
e) authorization of personnel;  and  
f) monitoring competence of personnel.  
6.3 Facilities and environmental conditions  
6.3.1  The facilities and environmental conditions shall be suitable for the verification laboratory and shall not 
adversely affect the validity of results.  
NOTE  Influences that can adversely affect the validity of results can include, but are not limited to, microbial 
contamination, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, sound and vibration.  
6.3.2  The requirements for facilities and environmental conditions necessary for the performance of the 
verification lab oratory activities shall be documented.  DRS 438: 2020  
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 6.3.3  The verification laboratory shall monitor, control and record environmental conditions in accordance 
with relevant specifications, methods or procedures or where they influence the validity of the results.   
6.3.4 Tests and verifications shall be stopped when the environmental conditions jeopardize the results of 
the tests or verifications.  
6.3.5   Measures to control facilities shall be implemented, monitored and periodically reviewed and shall 
include, but not  be limited to:  
a) access to and use of areas affecting verification laboratory activities;  
b) prevention of contamination, interference or adverse influences on verification laboratory activities;  
c) effective separation between areas with incompatible verificatio n laboratory activities.  
6.3.6  Measures shall be taken to ensure good housekeeping in the  verification laboratory. Special 
procedures  shall be prepared where necessary.  
6.3.7   When the verification laboratory p erforms verification activities at sites or f acilities outside its 
permanent control, it shall ensure that the requirements related to facilities and environmental conditions of 
this standard are met.  
6.4 Standard Equipment  
6.4.1  The verification laboratory shall be equipped with standard equipment (including, but not limited to, 
measuring instruments, software, reference materials, consumables or auxiliary apparatus) that is required for 
the correct performance of laboratory activities and that can influence the results.  ISO Guide 33 provides 
guidan ce on the selection and use of reference materials and ISO Guide 80 provides guidance to produce in -
house quality control materials.  
6.4.2  When the verification laboratory needs to use standard equipment outside its permanent control, it 
shall ensure that  the applicable requirements of this standard are met.  
6.4.3   Standard equipment used for verification and sampling, and its software shall be capable  of achieving 
the accuracy required and shall comply with the specifications relevant to the verification concerned.  
6.4.4   Standard equipment that requires specialized instructions to operate shall be operated only  by 
authorized personnel.  
6.6.5  Up-to-date instructions on the use and maintenance of standard equipment (including any relevant 
manuals provided  by the manufacturer of the standard equipment) shall be readily available for use by the 
appropriate authorized verification laboratory personnel.  
6.4.6   The verification laboratory shall have a procedure for safe handling, transport, storage, use and 
planned maintenance of standard equipment in order to ensure proper functioning, prevent contamination or 
deterioration and to protect calibration integrity.   
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 6.4.7   There shall be an issue register or comparable arrangement for issuing standard equipment, 
verification marks (stamps/stickers), sealing pliers, reports and certificate forms/books, etc. to individual 
verification officers.  
6.4.8   Where standard equipment, not issued to an individual verification officer, is removed from the 
verification laborator y, the relevant verification officer shall sign an issue register (or comparable arrangement) 
on removal, and a member of staff shall check for proper functioning and sign the said register on the return of 
the standard equipment.  
6.4.9   The verification laboratory shall verify that standard equipment conforms to specified requirements 
before being placed or returned into service.  
6.4.10   The standard equipment used for verification activities shall be capable of achieving the measurement  
accuracy and/or measurement uncertainty required to provide a valid result.  
6.4.11  Standard equipment shall be calibrated when:  
a) the measurement accuracy or measurement uncertainty affects the validity of the reported results, and/or  
b) calibration  of the standard equipment is required to establish the metrological traceability of the reported 
results.  
NOTE  Types of standard equipment having an effect on the validity of the reported results can include:  
1) those used for the direct measurement of the m easurand,  e.g. use of a balance to perform a mass 
measurement;  
2) those used to make corrections to the measured value, e.g. temperature measurements;  
3) those used to obtain a measurement result calculated from multiple quantities.  
6.4.12  The verification labor atory shall establish a calibration programme, which shall be reviewed and 
adjusted as necessary in order to maintain confidence in the status of calibration.   
6.4.13  All standard equipment requiring calibration or which has a defined period of validity s hall be labelled, 
coded or otherwise identified to allow the user of the standard equipment to readily identify the status of 
calibration or period of validity.  
6.4.14  Standard equipment that has been subjected to overloading or mishandling, gives question able 
results, or has been shown to be defective or outside specified requirements, shall be taken out of service. It 
shall be isolated to prevent its use or clearly labelled or marked as being out of service until it has been 
verified to perform correctly.  The verification laboratory shall examine the effect of the defect or deviation from 
specified requirements and shall initiate the management of nonconforming work procedure.  
6.4.15  When intermediate checks are necessary to maintain confidence in the per formance of the standard, 
these checks shall be carried out according to a procedure.  DRS 438: 2020  
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 6.4.16   When calibration of standard equipment  and reference material data require the use of  reference 
values or correction factors, the verification laboratory shall ensure the reference values and correction factors 
are updated and implemented, as appropriate, to meet specified requirements.  
6.4.17  The verification laboratory shall take practicable measures to prevent unintended adjustments of 
standard equipment from invalidating results.  
6.4.18  Records shall be retained for standard equipment which can influence verification activities. The 
records shall include the following, where applicable:  
a) the identity of standard equipment, including software and firmware versio n; 
b) the manufacturer's name, type identification, and serial number or other unique identification;  
c) evidence of verification that standard equipment conforms with specified requirements;  
d) the current location;  
e) calibration dates, results of calibrations, adju stments, acceptance criteria, and the due date of the next 
calibration or the calibration interval;  
f) documentation of reference materials, results, acceptance criteria, relevant da tes and the period of 
validity;  
g) the maintenance plan and maintenance carried out to date, where relevant to the performance of the 
standard;  
h) details of any damage, malfunction, modification to, or repair of, the standard equipment.  
6.4.19  The sealing pliers and stamps or stickers for applying as verification marks shall be formally  issued to 
verification officers and controlled to prevent fraudulent use.  
6.5 Metrological traceability  
6.5.1   The verification laboratory shall establish and maintain metrological traceability of its measurement 
results by means of a documented unbroken chai n of calibrations, each contributing to the measurement 
uncertainty, linking them to an appropriate reference.  
6.5.2   The verification laboratory shall ensure that measurement results are traceable to National 
measurement standards or the International Sys tem of Units (SI) through:  
a)  calibration provided by a competent laboratory; or  
NOTE  Laboratories fulfilling the requirements of current version of ISO 17025 are considered to be competent.  
b) certified values of certified reference materials provided by a competent producer with stated metrological 
traceability to the SI; or   
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 NOTE  Reference material producers fulfilling the requirements of current version of ISO 17034 are considered to be 
competent.  
6.5.3   When metrological traceability to the national measurement standards or the International System of 
Units (SI units) is not technically possible, the verification laboratory shall demonstrate metrological traceability 
to an appropriate reference, e.g.:  
a)  certified values of certified reference materi als provided by a competent producer;  
b)  results of reference measurement procedures, specified methods or consensus standards that are 
clearly described and accepted as providing measurement results fit for their intended use and ensured 
by suitable comp arison.  
6.6 Externally provided products and services or supplies  
6.6.1 The verification laboratory shall ensure that only suitable externally provided products and 
services or supplies that affect verification laboratory activities are used, when such product s and 
services:  
a)  are intended for incorporation into the verification laboratory’s verification activities;  
b)  are provided, in part or in full, directly to the customer by the verification laboratory, as received from the 
external provider;  
c) are used t o support the operation of the verification laboratory.  
NOTE  Products can include, for example, measurement standards, auxiliary standard equipment, consumable 
materials and reference materials. Services can include, for example, calibration services, samp ling services, testing 
services, facility and standard maintenance services, proficiency testing services and assessment and auditing services.  
6.6.2  The verification laboratory shall have a procedure and retain records for:  
a)  defining, reviewing and a pproving the verification laboratory’s requirements for externally provided 
products and services;  
b)  ensuring that externally provided products and services conform to the verification laboratory’s 
established requirements, or when applicable, to the rel evant requirements of this standard, before they 
are used or directly provided to the customer;  
c)  taking any actions arising from evaluations, monitoring of performance and re -evaluations of the external 
providers.  
7 Process requirements  
7.1 Review of requests, tenders and contracts  
7.1.1   The verification laboratory shall have a procedure for the r eview of verification requests. This  
procedure shall ensure that:  DRS 438: 2020  
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 a)  the verification requirements are adequately defined, documented and understood;  
b)  the verification laboratory has the capability and resources to meet the verification requirements;  
c)  Where external verification laboratory are to be used to perform verification work, the verification 
laboratory shall advise or inform the customer of the specific verification laboratory work to be performed 
by the external verification laboratory and any matters required for the success of verification work in 
writing;  
NOTE  It is recognized that externally verification laboratory activities can occur w hen: 
1) the verification laboratory has the resources and competence to perform the activities, however, for 
unforeseen reasons is unable to undertake these in part or full;  
2) the verification laboratory does not have the resources or competence to perform the activities.  
d) the appropriate verification methods or procedures are selected and are capable of meeting the relevant 
national standard and legislation.  
7.1.2  The verification laboratory shall cooperate with customers or their representatives in clarifying the 
customer's request and during verification work.  
NOTE 1  Such cooperation can include:  
a)  providing reasonable access to relevant areas of the verification laboratory to witness verification results  
b)  preparation, packaging, and dispatch of verifica tion items needed by the customer for verification 
purposes  
c) where necessary, the customer may provide needed transportation , equipment, materials and manpower for 
easy of verification work.  
NOTE 2  Clients value good communication, advice and guidance  in technical matters, and opinions and interpretations 
based on results. Communication with the client, especially in large assignments, should be maintained throughout the 
work. The laboratory should inform the client of any delays or major deviations in  the performance of the verification 
activities.  
7.1.3  The verification  laboratory shall inform the customer when the method requested by the customer is 
considered to be inappropriate or out of date.  
7.1.4  Any differences between the request or tender and the contract shall be resolved before verification 
laboratory activities commence. Each contract shall be acceptable both to the laboratory and the customer. 
Deviations requested by the customer shall not impact the integrity of the laboratory or the validity of the 
results.  
7.1.5   The customer shall be informed of any deviation from the contract.   
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 7.1.6  If a contract is amended after work has commenced, the contract review shall be repeated and any 
amendme nts shall be communicated to all affected personnel.  
7.1.7   Records of request reviews including any significant changes shall be retained. Records shall also be 
retained of pertinent discussions with a customer relating to the customer's requirements or the results of the 
verification laboratory activities.  
7.2 Subcontracting of verification work  
7.2.1  The verification laboratory shall only subcontract work that is within its scope of accreditation. When a  
laboratory subcontracts work, the laboratory to which the work is subcontracted shall be accredited  to verify 
the instrument concerned and shall issue the verification certificate.  
7.2.2  The verification laboratory shall advise the client and gain the client’s approval for the arrangement, in  
writing o r verbally.  
7.2.3  The verification laboratory is responsible to the client for the subcontractor's work, except in the case  
where the client specifies which subcontractor shall be used.  
7.2.4  The verification laboratory shall maintain a register of all s ubcontractors that it uses for verification and 
a record of the evidence of compliance with this standard for the work in question.  
7.3 Purchasing, services and supplies  
7.3.1  The verification laboratory shall have a policy and procedure(s) for the selection and procuring of  
services and suppliers of the calibrated verification standards it uses that affect the quality of the  verification 
activities.  
7.3.2  The verification laboratory shall ensure that the purchased supplies and verification standards that 
affect  the quality of verification are not used until they have been inspected or otherwise verified as  complying 
with standard specifications, approvals or requirements, and have been calibrated or  verified. Records of 
actions taken to check compliance sh all be maintained.  
7.4 Verification methods  
7.4.1  General   
7.4.1.1  The verification laboratory shall use the appropriate methods and procedures as prescribed in 
terms of the relevant national standard and legislation for all verification within its scope.  
NOTE  These include sampling, handling, transport, storage and preparation of verification items to be verified, and, 
where appropriate, the specified maximum permissible error, as well as statistical techniques for analysis of verification 
data. DRS 438: 2020  
13                ©RSB 2020  - All rights reserved  
 7.4.1.2  The verification laboratory shall have instructions on the use and operation of all relevant standard 
equipment, and on the handling and preparation of items for verification (or both), where the absence of such 
instructions could jeopardize the results of  verification.  
7.4.1.3  All instructions, standard equipment, manuals and reference data relevant to the work of the 
verification laboratory shall be maintained up to date and be made readily available to personnel.  
7.4.1.4  Deviation from verification met hods shall occur only if the deviation has been documented, 
technically justified and authorized, and accepted by the national responsible body.  
7.4.1.5  Where the relevant national legislation or international, national or regional standards or 
specifica tions which are recognized by the national responsible body contain sufficient and concise 
information on how to perform the verification, they do not need to be supplemented or re -written as internal 
procedures if they can be used as published by the veri fication officer in the verification laboratory.  
7.4.2  Selection of methods  
7.4.2.1  The verification laboratory shall select the appropriate methods and procedures as prescribed in 
terms of the relevant national standard and legislation for all verification with in its scope.  
7.4.2.2  The verification laboratory shall ensure that it uses the latest valid edition of a standard document 
unless it is not appropriate or possible to do so. When necessary, the standard document shall be 
supplemented with additional deta ils to ensure consistent application.  
7.4.2. 3  When the governing technical regulations as specified in the relevant national legislation do not 
specify the method to be used, the verification laboratory shall select appropriate methods that have been 
published either in international, regional or national standards, or by reputable technical organizations, or in 
relevant scientific texts or journals, or as specified by the manufacturer of the standard equipment after 
approval thereof by the national respon sible body.  
7.4.2.4  The verification laboratory shall confirm that it can properly operate standard methods before 
performing the verifications. If the standard method changes, the confirmation shall be repeated.  
7.5 Sampling  
7.5.1   The verification laboratory shall have a sampling plan and procedure when it carries out sampling for 
verification. The sampling procedure shall address the factors to be controlled to ensure the validity of 
verification results.  
7.5.2  The sampling plan and procedure shall be available at the site where sampling is undertaken. 
Sampling plans shall, whenever reasonable, be based on appropriate statistical methods.  
7.5.3  The sampling procedure shall describe:  
a)  the selection criteria of samples or sites;  
b)  the sampling plan;   
©RSB 2020 - All rights reserved                  14 
 c)  the preparation and treatment of sample(s) from a substance, material or product to yield the required 
item for verification.  
7.5.4  The verification laboratory shall retain records of sampling data that forms part of the verifi cation that 
is undertaken. These records shall include, where relevant:  
a)  reference to the sampling method used;  
b)  date and time of sampling;  
c)  data to identify and describe the sample (e.g. number, amount, name);  
d)  identification of the personnel performing sampling;  
e)  identification of the standard used;  
f)  environmental or transport conditions;  
g)  diagrams or other equivalent means to identify the sampling location, when appropriate; and  
h)  deviations, additions to or exclusions from the sam pling method and sampling plan.  
7.6 Handling of verification items  
7.6.1  The verification laboratory shall have a procedure for the transportation, receipt, handling, 
protection, storage, retention, and disposal or return of verification items, including all p rovisions necessary to 
protect the integrity of the verification item, and to protect the interests of the verification laboratory and the 
customer.  
7.6.2   Precautions shall be taken to avoid deterioration, contamination, loss or damage to the item during  
handling, transporting, storing/waiting, and preparation for verification. Handling instructions provided with the 
item shall be followed.  
7.6.3  The verification laboratory shall have a system for the unambiguous identification of verification 
items.  
7.6.4 The identification shall be retained while the item is under the responsibility of the verification 
laboratory.  
7.6.5  The system shall ensure that items will not be confused physically or when referred to in records or 
other documents. The system shal l, if appropriate, accommodate a sub -division of an item or groups of items 
and the transfer of items.  
7.6.6  Upon receipt of the verification item, deviations from specified conditions shall be recorded.  
7.6.7  When there is doubt about the suitability of an item for verification, or when an item does not conform 
to the description provided, the verification laboratory shall consult the customer for further instructions before 
proceeding and shall record the resu lts of this consultation.  DRS 438: 2020  
15                ©RSB 2020  - All rights reserved  
 7.6.8  When the customer requires the item to be verified acknowledging a deviation from specified 
conditions, the verification laboratory shall include a disclaimer in the report indicating which results may be 
affected by the de viation.  
7.6.9  When verification items need to be stored or conditioned under specified environmental conditions, 
these conditions shall be maintained, monitored and recorded.  
7.7 Technical records  
7.7.1  The verification laboratory shall ensure that technica l records are retained, such as records of original 
observations (raw data), derived data and  sufficient information to establish an audit trail, verification and 
calibration records, staff records and a copy of each verification certificate issued for a d efined period. 
Technical records, such as forms, contracts, raw data sheets, workbooks, verification certificates and shall be 
kept in prescribed format.  
NOTE 1  Records of observations may be in the form of a verification officer’s note, which contains su fficient 
information to establish an audit trail.  
NOTE 2  Technical records are accumulations of data and information which result from carrying out verification and 
which indicate whether specified quality or process parameters are achieved.  
7.7.2   Observations, data and calculations shall be recorded at the time they are made and be  identifiable 
to the specific task.  
7.7.3   When mistakes occur in records, each mistake shall be crossed out, not erased, made  illegible or 
deleted, and the correct value  shall be entered alongside. All such alterations to records shall be signed or 
initialled and dated by the person making the correction. In the case of records stored electronically, 
equivalent measures shall be taken to avoid loss or change of original d ata. 
7.7.4   The verification laboratory shall ensure that amendments to technical records can be tracked to 
previous versions or to original observations. Both the original and amended data and files shall be retained, 
including the date of alteration, an indication of the altered aspects and the personnel responsible for the 
alterations.  
7.8 Assuring the validity of verification results  
7.8.1   The verification laboratory shall have a procedure for monitoring the validity of verification results.  
7.8.2  The res ulting data shall be recorded in such a way that trends are detectable and, where practicable, 
statistical techniques shall be applied to review the results.  
7.8.3  This monitoring shall be planned and reviewed and shall include, where appropriate, but not  be limited 
to: 
a)  use of reference materials or quality control materials;  
b)  use of alternative instrumentation that has been calibrated to provide traceable results;   
©RSB 2020 - All rights reserved                  16 
 c)  functional check(s) of standard equipment;  
d)  use of check or working standards  with control charts, where applicable;  
e)  intermediate checks on measuring equipment;  
f) replicate verification using the same or different methods;  
g)  re-verification of retained verification items;  
h)  review of reported verification results;  
7.8.4   The verificat ion laboratory may monitor its performance by comparison with results of other 
laboratories, where available and appropriate.  
7.8.5   Data from monitoring activities shall be analyzed, used to control and, if applicable, improve the 
verification laboratory's activities. If the results of the analysis of data from monitoring activities are found to be 
outside predefined criteria, appropriate action shall be taken to prevent incorrect results from being reported.  
7.8.6  Records shall be kept of actio ns taken to monitor the validity of the verification undertaken.  
7.9 Reporting of verification results  
7.9.1  General  
7.9.1.1  The results of each verification activity carried out by the verification laboratory shall be reported 
accurately, clearly, unambiguously and  objectively, and in accordance with any specific instructions in the 
verification methods and procedure.  
7.9.1.2  The results shall be reported in a verification report or the verification or rejection certificate, and 
shall include all the information as  prescribed in the national standard and legislation and that is necessary for 
the interpretation of the verification results, and all the information required by the method used.  
7.9.1.3  A verification certificate shall not be combined with a rejection c ertificate.  
7.9.2  Verification certificate  
7.9.2.1  Each verification certificate shall include at least the following information, unless the verification 
laboratory has valid reasons for not doing so:  
a) the title "Verification Certificate";  
b) the name and address of the verification laboratory;  
c) the location of performance of the verification laboratory activities, performed at a customer facility or at 
sites away from the verification laboratory’s permanent facilities, or in associated temporary or mobile 
facilitie s; DRS 438: 2020  
17                ©RSB 2020  - All rights reserved  
 d) the unique identification  number of the verification certificate on all its pages to identify that each page is 
recognized as a part of the verification certificate;  
e) page numbers and a clear identifier of the number of pages in the verification certifi cate, e.g. page 1 of 1 
or a statement at the beginning of the certificate “This certificate consists of 1 page” or a statement at the 
end of the certificate “End of Certificate”;  
f) the name and address of the customer;  
g) the identification of  the verification  procedure used by the verification laboratory;  
h) a description, metrological parameters and unambiguous identification of the items verified including the 
serial number and the type approval number, if the instrument requires type approval in terms of the 
relevant national legislation.  
i) the date(s) of performance of the verification laboratory activity;  
j) identification of the person(s) authorizing the report or certificate;  
k) a statement that will serve as proof that the standard equipment directly related to t he reading or obtaining 
of the results of measurement is traceable to a national standard. The following data shall be included as 
a minimum:  
1) calibration certificate number;  
2) date of calibration of standard equipment;  
3) date of next calibration of standard eq uipment  
4) identification of standard equipment, e.g. serial numbers, description, set number, etc.; and  
NOTE   Standard Equipment for auxiliary measurements, such as hydrometers, thermometers and pressure gauges, 
need not be included in the statement of traceability provided that they are calibrated in accordance with clause 6.5 of this  
standard.  
l) the latest secur ity intervention value, which shall be indicated on the certificate if the instrument being 
verified is secured by means of a software or physical  seal. If the security intervention value indicated on 
the instrument differs from the security intervention value indicated on the certificate, this means that an 
unlawful intervention was made on the measuring instrument and, in terms of the relevant national 
legislation, the instrument shall not be used for the prescribed purpose;  
m) expiry date of the verificati on certificate, if a verification period has been prescribed for the measuring 
instrument concerned;  
n) the initials, surname and signature of the verification officer responsible for the verification, date of 
verification and a seal number used for identific ation of the responsible verification officer and the 
verification laboratory; and   
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 o) the following statement: "The verification item(s) (whatever named) was/were tested or verified and found 
to comply in all respects with the requirements of the national Leg islation or national Standards  and may 
be used for a prescribed purpose as governed by the national Legislation.  
7.9.2.2  The verification laboratory shall be responsible for all the information provided in the report, 
except when information is provided by the customer. Data provided by a customer shall be clearly identified.  
7.9.2.3  In addition, a disclaimer shall be put on the report when the information is supplied by the 
customer and can affect the validity of results.  
7.9.2.4  Where the verification  laboratory has not been responsible for the sampling stage (e.g. the 
sample has been provided by the customer), it shall state in the report that the results apply to the sample as 
received.  
7.7.2. 5  Any additional information that may be required by spec ific verification methods should be added.  
7.9.3  Rejection certificates  
7.9.3.1  A rejection certificate shall be issued for measuring instrument or prepackage that is false, 
inaccurate or defective and that is not immediately repaired and verified.  
7.9.3.2  Results of any tests conducted need not be attached to the rejection certificate but shall be 
recorded.  
7.9.3.3  The rejection certificate shall contain at least the following:  
a) the title "Rejection Certificate" and identification  number;  
b) the name and addr ess of the verification laboratory;  
c) the name and address of the customer;  
d) description and unambiguous identification of the item(s) rejected;  
e) statement that will serve as proof that the standard equipment directly related to the reading or obtaining 
of the  results of measurement is traceable to a national standard when the rejection is related to the 
inaccuracy of the instrument. The following data shall be included as a minimum:  
1) calibration certificate number;  
2) date of calibration of standard equipment;  
3) date of next calibration of standard equipment  
4) identification of standard equipment, e.g. serial numbers, description, set number etc.; and  
f) date of rejection;  DRS 438: 2020  
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 g) reason for rejection of the measuring instrument;  
h) initials, surname and signature of the verification officer responsible for the rejection and a seal number 
used for identification of the responsible verification officer; and  
i) the following statement: "The verification item(s) has/have been rejected and may not be used for a 
prescribed purpose  in terms of the national legislation until they have been verified as complying to all 
requirements of the national legislation and standard."  
7.9.4  Amendments to reports  
7.9.4..1  When an issued verification report or certificate needs to be changed, amended or  re-issued, any 
change of information shall be clearly identified and, where appropriate, the reason for the change included in 
the report.  
7.9.4..2  Amendments to a verification report or certificate after issue shall be made only in the form of a 
further  document, or data transfer, which includes the statement “Amendment to Report, serial number... [or 
as otherwise identified]”, or an equivalent form of wording. Such amendments shall meet all the requirements 
of this document.  
7.9.4..3   When it is necessa ry to issue a complete new report, this shall be uniquely identified and shall 
contain a reference to the original that it replaces.  
7.9.5  Electronic transmission of results  
In the case of transmission of verification results by facsimile or other electronic or electromagnetic means, 
data shall be safeguarded to protect confidentiality.  
7.9.6  Format of reports and certificates  
7.9.6.1  The format shall be designed to accommodate each type of verification carried out and to 
minimize the possibility of misunderstanding o r misuse and these formats shall be designed and used in 
accordance with national legislation.  
7.9.6.2  Attention shall be given to the layout of the verification or rejection certificate, especially with 
regard to the presentation of the verification dat a and ease of assimilation by the reader.  
7.9.6.3  The headings shall be standardized as far as possible.  
7.10 Complaints and appeals  
7.10.1  The verification laboratory shall have a documented process to receive, evaluate and make decisions 
on complaints and appeals from customers and other parties.  
7.10.2   A description of the handling process for complaints and appeals shall be available to any interested 
party on request. Upon receipt of a complaint, the verification laboratory shall confirm whether the complaint 
or appeal relates to verification laboratory activities that it is responsible for and, if so, shall deal with it. The  
©RSB 2020 - All rights reserved                  20 
 verificatio n laboratory shall be responsible for all decisions at all levels of the handling process for complaints 
and appeals.  
7.10.3  The process for handling complaints and appeals shall include at least the following elements and 
methods:  
a)  description of the process for receiving, validating, investigating the complaint or appeal, and deciding 
what actions are to be taken in response to it;  
b)  tracking and recording complaints and appeals, including actions undertaken to resolve them;  
c)  ensuring that any ap propriate action is taken.  
7.10 4  The verification laboratory receiving the complaint or appeal shall be responsible for gathering and 
verifying all necessary information to validate the complaint or appeal  
7.10.5  Whenever possible, the verification labo ratory shall acknowledge receipt of the complaint or appeal, 
and provide the complainant or appellant with progress reports and the outcome.  
7.10.6  The outcomes to be communicated to the complainant or appellant shall be made by, or reviewed and 
approved by, individual(s) not involved in the original verification laboratory activities in question.  
NOTE  This can be performed by external personnel.  
7.10.7  Whenever possible, the verification laboratory shall give formal notice of the end of the complaint or 
appeal handling to the complainant and appellant.  
7.10.8  Records shall be maintained of all complaints and appeals and of the investigations and corrective 
actions taken by the verification laboratory.  
7.11 Nonconforming work  
7.11. 1  The verification laborator y shall have a procedure that shall be implemented when any aspect of its 
verification laboratory activities or results of this work do not conform to its own procedures or the agreed 
requirements of the customer (e.g. standard or environmental conditions are out of specified limits, results of 
monitoring fail to meet specified criteria). The procedure shall ensure that:  
a)  the responsibilities and authorities for the management of nonconforming work are defined;  
b)  actions (including halting or repeating  of work and withholding of reports, as necessary) are based upon 
the risk levels established by the verification laboratory;  
c)  an evaluation is made of the significance of the nonconforming work, including an impact analysis on 
previous results;  
d)  a decision is taken on the acceptability of the nonconforming work;  
e)  where necessary, the customer is notified and work is recalled;  DRS 438: 2020  
21                ©RSB 2020  - All rights reserved  
 f)  the responsibility for authorizing the resumption of work is defined.  
7.11.2  The verification laboratory shall retain records of nonconforming work and actions as specified in 
7.11.1 , bullets b) to f).  
7.11.3  Where the evaluation indicates that the nonconforming work could recur, or that there is doubt about 
the conformity of the verification laboratory's operations with  its own management system, the verification 
laboratory shall implement corrective action.  
7.12 Control of data and information management  
7.12.1 The verification laboratory shall have access to the data and information needed to perform 
verification laborator y activities.  
7.12.2  The verification laboratory information management system(s) used for the collection, processing, 
recording, reporting, storage or retrieval of data shall be validated for functionality, including the proper 
functioning of interfaces within the verification laboratory information management system(s) by the 
verification laboratory before introduction. Whenever there are any changes, including verification laboratory 
software configuration or modifications to commercial off -the-shelf so ftware, they shall be authorized, 
documented and validated before implementation.  
NOTE 1  In this standard “verification laboratory information management system(s)” includes the management of data 
and information contained in both computerized and non -comp uterized systems. Some of the requirements can be more 
applicable to computerized systems than to non -computerized systems.  
NOTE 2  Commercial off -the-shelf software in general use within its designed application range can be considered to be 
sufficiently validated.  
7.12.3 The verification laboratory information management system(s) shall:  
a)  be protected from unauthorized access;  
b)  be safeguarded against tampering and loss;  
c)  be operated in an environment that complies with provider or verification la boratory specifications or, in 
the case of non -computerized systems, provides conditions which safeguard the accuracy of manual 
recording and transcription;  
d)  be maintained in a manner that ensures the integrity of the data and information;  
e)  include r ecording system failures and the appropriate immediate and corrective actions.  
7.12.4 When a verification laboratory information management system is managed and maintained off -site or 
through an external provider, the verification laboratory shall ensure that the provider or operator of the 
system complies with all applicable requirements of this standard.  
7.12.5 The verification laboratory shall ensure that instructions, manuals and reference data relevant to the 
verification laboratory information management system(s) are made readily available to personnel.   
©RSB 2020 - All rights reserved                  22 
 7.12.6 Calculations and data transfers shall be checked in an appropriate and systematic manner.  
8  Management system requirements.  
8.1 Options  
8.1.1  General  
The verification laboratory shall establish, doc ument, implement and maintain a management system that is 
capable of supporting and demonstrating the consistent achievement of the requirements of this standard and 
assuring the quality of the verification laboratory results. In addition to meeting the re quirements of Clauses 4 
to 7, the verification laboratory shall implement a management system in  accordance with option A or option 
B. 
8.1.2  Option A  
As minimum, t he management system of the verification laboratory shall address the following:  
a) management system documentation;  
b) control of ma nagement system documents;  
c) control of records;  
d) actions to address risks and opportunities;  
e) improvement;  
f) corrective actions;  
g) internal audits;  
h) management reviews.  
8.1.3  Option B  
A verification laboratory that has established and maintai ns a management system, in accordance with the 
requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfilment of the 
requirements of Clauses 4 to 7  of this draft standard , also fulfils at least the intent of the man agement system 
requirements specified in 8.2 to 8.9 of this standard.  
8.2 Management system documentation (Option A)  
8.2.1  Verification laboratory management shall establish, document, and maintain policies and objectives 
for the fulfilment  of the purposes of this standard and shall ensure that the policies and objectives are 
acknowledged and implemented at all levels of the verification laboratory organization.  DRS 438: 2020  
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 8.2.2  The policies and objectives shall address the competence, impartiality an d consistent operation of the 
verification laboratory.  
8.2.3  Verification laboratory management shall provide evidence of commitment to the development and 
implementation of the management system and to continually improving its effectiveness.  
8.2.4  All documentation, processes, systems, records, related to the fulfilment  of the requirements of this 
document shall be included in, referenced from, or linked to the management system.  
8.2.5  All personnel involved in verification laboratory activities sh all have access to the parts of the 
management system documentation and related information that are applicable to their responsibilities.  
8.3 Control of management system documents (Option A)  
8.3.1  The verification laboratory shall control the documents (int ernal and external) that relate to the 
fulfilment  of this standard.  
NOTE  In this context, “documents” can be policy statements, procedures, specifications, manufacturer’s instructions, 
calibration tables, charts, text books, posters, notices, memoranda, dr awings, plans, etc. These can be on various media, 
such as hard copy or digital.  
8.3.2  The verification laboratory shall ensure that:  
a)  documents are approved for adequacy prior to issue by authorized personnel;  
b)  documents are periodically reviewed, and updated as necessary;  
c)  changes and the current revision status of documents are identified;  
d)  relevant versions of applicable documents are available at points of use and, where necessary, their 
distribution is controlled;  
e)  documents are unique ly identified;  
f)  the unintended use of obsolete documents is prevented, and suitable identification is applied to them if 
they are retained for any purpose.  
8.4 Control of records (Option A)  
8.4.1   The verification laboratory shall establish and retain legib le records to demonstrate fulfilment of the 
requirements in this standard.  
8.4.2   The verification laboratory shall implement the controls needed for the identification, storage, 
protection, back -up, archive, retrieval, retention time, and disposal of its records. The verification laboratory 
shall retain records for a period consistent with its contractual obligations. Access to these records shall be 
consistent with the confidentiality commitments, and records shall be readily available.   
©RSB 2020 - All rights reserved                  24 
 NOTE  Additional r equirements regarding technical records are given in 7.7. 
8.5 Actions to address risks and opportunities (Option A)  
8.5.1  The verification laboratory shall consider the risks and opportunities associated with the verification 
laboratory activities in order to: 
a)  give assurance that the management system achieves its intended results;  
b)  enhance opportunities to achieve the purpose and objectives of the verification laboratory;  
c)  prevent, or reduce, undesired impacts and potential failures in the verific ation laboratory activities;  
d)  achieve improvement.  
8.5.2  The verification laboratory shall plan:  
a)  actions to address these risks and opportunities;  
b)  how to:  
1) integrate and implement these actions into its management system;  
2)  evaluate  the effectiveness of these actions.  
NOTE   Although this document specifies that the verification laboratory plans actions to address risks, there is no 
requirement for formal methods for risk management or a documented risk management process. Verificatio n 
Laboratories can decide whether or not to develop a more extensive risk management methodology than is required by 
this document, e.g. through the application of other guidance or standards.  
8.5.3  Actions taken to address risks and opportunities shall b e proportional to the potential impact on the 
validity of verification laboratory results.  
NOTE 1  Options to address risks can include identifying and avoiding threats, taking risk in order to pursue an 
opportunity, eliminating the risk source, changing t he likelihood or consequences, sharing the risk, or retaining risk by 
informed decision.  
NOTE 2  Opportunities can lead to expanding the scope of the verification laboratory activities, addressing new 
customers, using new technology and other possibilitie s to address customer needs.  
8.6 Improvement (Option A)  
8.6.1   The verification laboratory shall identify and select opportunities for improvement and implement any 
necessary actions.  
NOTE  Opportunities for improvement can be identified through the review of the operational procedures, the use of 
the policies, overall objectives, audit results, corrective actions, management review, suggestions from personnel, risk 
assessment, analysis of data, and proficiency testing results.  DRS 438: 2020  
25                ©RSB 2020  - All rights reserved  
 8.6.2  The verification laborator y shall seek feedback, both positive and negative, from its customers. The 
feedback shall be analysed and used to improve the management system, verification laboratory activities and 
customer service.  
NOTE  Examples of the types of feedback include custom er satisfaction surveys, communication records and review 
of reports with customers.  
8.7 Corrective actions (Option A)  
8.7.1  When nonconformity occurs, the verification laboratory shall:  
a)  react to the nonconformity and, as applicable:  
1) take action to contro l and correct it;  
2) address the consequences;  
b)  evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur 
or occur elsewhere, by:  
1) reviewing and analysing the nonconformity;  
2) determining the causes of the nonconformity;  
3) determining if similar nonconformities exist, or could potentially occur;  
c)  implement any action needed;  
d)  review the effectiveness of any corrective action taken;  
e)  update risks and opportunities determined during planning, if necessary;  
f)  make changes to the management system, if necessary.  
8.7.2  Corrective actions shall be appropriate to the effects of the nonconformities encountered.  
8.7.3  The verification laboratory shall retain records as evidence of:  
a)  the nature of the nonconformities, cause(s) and any subsequent actions taken;  
b)  the results of any corrective action.   
©RSB 2020 - All rights reserved                  26 
 8.8 Internal audits (Option A)  
8.8.1  The verification laboratory shall conduct internal audits at planned intervals to provide information on 
whether th e management system:  
a)  conforms to:  
1)  the verification laboratory’s own requirements,  for its management system, including the verification 
laboratory activities;  
2)  the national legislation;  
3)  the requirements of this standard;  
b)  is effectively implement ed and maintained.  
8.8.2 The verification laboratory shall:  
a) plan, establish, implement and maintain an audit programme including the frequency, methods, 
responsibilities, planning requirements and reporting, which shall take into consideration the impor tance 
of the verification laboratory activities concerned, changes affecting the verification laboratory, and the 
results of previous audits;  
b)  define the audit criteria and scope for each audit;  
c)  ensure that the results of the audits are reported to relevant management;  
d)  implement appropriate correction and corrective actions without undue delay;  
e)  retain records as evidence of the implementation of the audit programme and the audit results.  
NOTE  ISO 19011 provides guidance for internal audits.  
8.9 Management reviews (Option A)  
8.9.1 The verification laboratory management shall review its management system at planned intervals, in 
order to ensure its continuing suitability, adequacy and effectiveness, including the stated policies and 
objectives rela ted to the fulfilment  of this document.  
8.9.2  The inputs to management review shall be recorded and shall include information related to the 
following:  
a) changes in internal and external issues that are relevant to the verification laboratory;  
b) fulfilment  of objectives;  
c) suitability of policies and procedures;  DRS 438: 2020  
27                ©RSB 2020  - All rights reserved  
 d) status of actions from previous management reviews;  
e) outcome of recent internal audits;  
f) corrective actions;  
g) assessments by external bodies;  
h) changes in the volume and type of the work or in the range of  verification laboratory activities;  
i) customer and personnel feedback;  
j) complaints and appeals;  
k) effectiveness of any implemented improvements;  
l) adequacy of resources;  
m) results of risk identification;  
n) outcomes of the assurance of the validity of results; and  
o) other relevant factors, such as monitoring activities and training.  
8.9.3  The outputs from the management review shall record all decisions and actions related to at least:  
a) the effectiveness of the management system and its processes;  
b) improvement of the verification laboratory activities related to the fulfilment of the requirements of this 
document;  
c) provision of required resources;  
d) any need for change.  
  
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 Annex  A 
(Normative)  
Independence requirements for verification laboratories  
A.1 Requirements for verification laboratories  (Type A)  
The verification laboratory  referred to in 4.1.6 a) shall meet the requirements below : 
a) The verification laboratory shall be independent of the parties involved.  
b) The verification laboratory and its personnel shall not engage in any activities that may conflict with 
their independence of judgment and integrity in relation to their verification  activities. In particular, they 
shall not be engaged in the design, manufacture, supply, installation , purchase, ownership, use or 
maintenance of the items verified . 
NOTE 1  This does not preclude exchanging technical information between the client and the verification laboratory  
(e.g. explanation of findings or  clarifying requirements or training).  
NOTE 2  This does not preclude the purchase, ownership or use of verified  items that are necessary for the operations 
of the verification laboratory , or the purchase, ownership or use of the items for personal purposes by the personnel.  
c) A verification laboratory shall not be a part of a legal entity that is engaged in design, manufacture, 
supply, installation, purchase, ownership, use or maintenance of the items verified . 
NOTE 1  This does not preclude exchanging technical information between the client and any oth er part of the same 
legal entity of which the verification laboratory is a part (e.g. explanation of findings or  clarifying requirements or training).  
NOTE 2  This does not preclude the purchase, ownership, maintenance or use of verified  items that are nece ssary for 
the operations of another part of the same legal entity, or for personal purposes by the personnel.  
d) The verification laboratory shall not be linked to a separate legal entity engaged in the design, 
manufacture, supply, installation, purchase, own ership, use or maintenance of the items verified  by 
the following:  
1) common ownership, except where the owners have no ability to influence the outcome of a 
verification ; 
EXAMPLE 1  A cooperative type of structure where there are large numbers of stakeholders , but they 
(individually or as a group) have no ability to influence the outcome of a  verification . 
EXAMPLE 2  A holding company consisting of several separate legal entities (sister companies) under a 
common mother company, where neither the sister compani es nor the mother company can influence the 
outcome of a  verification . 
2) common ownership appointees on the boards or equivalent of the organizations, except where these 
have functions that have no influence on the outcome of a  verification ; DRS 438: 2020  
29                ©RSB 2020  - All rights reserved  
 EXAMPLE  A bank f inancing a company insists on an appointee to the board who will overview how the 
company is managed but will not be involved in any decision -making.  
3) directly reporting to the same higher level of management, except where this cannot influence the 
outcome of a verification ; 
NOTE  Reporting to the same higher level of management is permitted on matters other than design, manufacture, 
supply, installation, purchase, ownership, use or maintenance of the items verifi ed. 
4) contractual commitments, or other means th at may have an ability to influence the outcome of  a 
verification . 
A.2 Requirements for verification laboratories  (Type B)  
The verification laboratories  referred to in 4.1.6 b) shall meet the requirements below.  
a) Verification  services shall only be supplied to the organization of which the verification laboratory 
forms a part.  
b) b) A clear separation of the responsibilities of the verification  personnel from those of the personnel 
employed in the other functions shall be establi shed by organizational identification and the reporting 
methods of the verification laboratory within the parent organization.  
c) The verification laboratory and its personnel shall not engage in any activities that may conflict with 
their independence of jud gment and integrity in relation to their verifica tion activities. In particular, they 
shall not be engaged in the design, manufacture, supply, installation, use or maintenance of the items 
verifi ed. 
NOTE 1  This does not preclude exchanging technical inform ation between the verification laboratory and the other 
parts of the organization of which the verification laboratory forms a part, e.g. explanation of findings or clarifying 
requirements or training.  
NOTE 2  This does not preclude the purchase, ownership or use of verifi ed items that are necessary for the operations 
of the verification laboratory , or the purchase, ownership or use of the items for personal purposes by the personnel.  
A.3 Requirements for verification laboratories  (Type C)  
The verification labor atory referred to in 4.1.6 c) shall meet the requirements below.  
a) The verification laboratory shall provide safeguards within the organization to ensure adequate 
segregation of responsibilitie s and accountabilities between verification  and other activities.  
b) The design/manufacture/supply/installation/servicing/maintenance and the verification  of the same 
item carried out by a Type C verification laboratory shall not be undertaken by the same person. An 
exception to this is where a regulatory requirement expli citly allows an individual person from a Type 
C verification laboratory  to undertake both the 
design/manufacture/supply/installation/servicing/maintenance and the verification  of the same item, as 
long as this exception does not compromise the verification  resul ts. 
NOTE  Verifica tions carried out by Type C verification laboratory cannot be classified as third party verifica tions for 
the same verifica tion activities because they do not meet the requirements of independence of operations for Type A 
verificatio n laboratories .  
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  DRS 438: 2020  
31                ©RSB 2020  - All rights reserved  
  
Bibliography  
[1] SNS 10378:2012: General requirements for the competence of verification laboratories  
[2]   RS OIML R 79  Labeling requirements for prepackages  
[3] RS OIML R 87  Quantity of product in prepackages   
[4] JCGM 200, International vocabulary of metrology – Basic and general concepts and associated terms 
(VIM)  
 
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