AFRICAN CONFORMITY  
ASSESSMENT  
PROGRAMME  CACO  
ACAP 1 -4 
Second  Edition 20 22 
 
 
 
 
 
 
 
 
 
 
 
 
Conformity assessment  — Part 4: Requirements for 
recognition/ approval of testing and calibration laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reference No.  
ACAP 1  
- 
4:2022  
( 
E 
) 
 
ICS  
03.200/97.220.10  
 
© ARSO 2022  
 
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‘Conformity assessment’  
Commented [LC2R1]: Agreed  
 
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 ACAP 1 -4:2022 
Table of contents  
 
1 Scope ....................................................................................................................... ...................... 1  
2 Normative references .................................................................................... ................................. 1  
3 Terms and definitions ....................................................................................................... .............. 1  
4 ACAP laboratory license agreement .......................................... .................................................... 1  
5 Laboratory approval process ................................................................................................. ......... 1  
5.1 Preliminary entry requirements ............................... ............................................................... 1  
5.2 ACAP provisional entry requirements .................................................................................... 2  
5.2.1  Application ..................................................... .................................................................... 2  
5.2.2  Pre-assessment................................................................................................................. 2   
5.3 General Requirements for ACAP Laboratories approval . ..................................................... 2  
5.3.1  Accreditation ............................................................................................................... ....... 2  
5.3.2  Laboratories License agreement ................................ ....................................................... 3  
5.3.3  ACAP Management team .................................................................................................. 3  
5.4 Verification and approval for ACAP ....................................... ................................................ 5  
5.5 Termination of approval for an ACAP Laboratory.................................................................. 5  
5.5.1  Termination done by the Laboratory ..................................................... ............................ 5  
6 Management System requirements for ACAP implementation ...................................................... 6  
7 Additional requirements for ACAP implementation ............................................................... ......... 6  
8 Assessment process for Laboratory approval ................................................................................ 7   
8.1 Document review and on -site verification preparation .......................................................... 7  
8.2 Laboratory approval assessment .......................................................................................... 7  
8.2.1  Assessment at th e MS of the Laboratory ....................................................................... 7  
8.2.2  Closure of MS non -conformities ..................................................................................... 7  
8.2.3  Verification of technical activities d uring on -site inspection .............................................. 8  
8.3 Final evaluation and classification of findings ........................................................................ 8  
8.3.1  Major non -conformance ................................... ................................................................. 8  
8.3.2  Minor non -conformance .................................................................................................... 8  
8.3.3  Observation ................................................. ...................................................................... 9  
8.4 Rules for non -conformances closure ..................................................................................... 9  
8.5 First Laboratory approval verification ................... ............................................................... 10  
8.5.1  Factors affecting first approval ........................................................................................ 10  
8.6 Maintenance of the status of recognized Laboratory. .......... ............................................... 10  
8.6.1  Laboratory annual surveillance ....................................................................................... 10  
8.7 ARSO Sanctioning system ......................................................... ......................................... 10  
8.7.1  Contractual non -conformances ....................................................................................... 11  
8.7.2  General rules on non -conformances ....................................................... ........................ 11 
Annex A ( Normative)  Special additional requirements for non -accredited testing and calibration  
laboratories................................................................................................................. ...................... 12   
© ARSO 2022 —      
ii  © ARSO 20 22 — All rights reserved  
ACAP 1 -4:2022 
Foreword  
 
The African Organisation for Standardisation  (ARSO) is an African Intergovernmental organization 
made of Member States of the United Nations Economic Commission for Africa (UNECA) and the 
African Union (AU). One of the fundamental mandates of ARSO is the establishment of a conformity 
assessment syst em to promote the quality of African goods and services as a means of facilitating intra -
African trade as well as accessing global markets.   
 
The African  Conformity Assessment Programme (ACAP) is supported by a coherent set of documents 
which are develope d under the auspices of the ARSO Conformity Assessment Committee (ARSO 
CACO) which comprises experts from Member States. Member States participate in the committee on 
a voluntary basis and the documents developed follow the principles and procedures for th e 
development of African Standards outlined in the African Standards Harmonization Model (ASHAM) 
with the exception of the stages and voting thresholds. Being conformity assessment instruments, 
ACAP documents are subject to dynamic adaptations which must t imeously respond to changes in the 
conformity assessment fields.  
 
ACAP documents will be revised on a flexible basis to fit in with changes in global conformity assessment 
systems.  
 
 
 
 
 
 
 
 
 
© African Organisation for Standardisation 20 22 — All rights reserved1 
 
ARSO Central Secretariat  
International House 3rd Floor  
P. O. Box 57363 — 00200 City Square  
NAIROBI, KENYA  
 
Tel. +254 -20-2224561, +254 -20-3311641, +254 -20-3311608  
E-mail: arso@arso -oran.org http://www.arso -oran.org/arso@arso -oran.org  
Web: www.arso -oran.org http://www.arso -oran.org/  
  
 
 
 
1 © 2022 ARSO — All rights of exploitation reserved worldwide for African Member States’ NSBs.  
 All rights reserved  iii  
 ACAP 1 -4:2022 
 
Copyright notice  
 
This ARSO document is copyright -protected by ARSO. While the reproduction of this document 
by participants in the ARSO standards development process is permitted without prior permission 
from ARSO, neither this document nor any extract from it may be repro duced, stored or 
transmitted in any form for any other purpose without prior written permission from ARSO.  
 
Requests for permission to reproduce this document for the purpose of selling it should be 
addressed as shown below or to ARSO’s member body in the  country of the requester:  
 
 
© African Organisation for Standardisation 20 22 — All rights reserved  
 
ARSO Central Secretariat  
International House 3rd Floor  
P.O. Box 57363 — 00200 City Square  
NAIROBI, KENYA  
 
Tel: +254 -20-2224561, +254 -20-3311641, +254 -20-3311608  
 
E-mail: arso@arso -oran.org http://www.arso -oran.org/arso@arso -oran.org  
Web: www.arso -oran.org http://www.arso -oran.org/  
 
Reproduction for sales purposes may be subject to royalty payments or a licensing agreement. 
Violators may be prosecuted.  
 
 
 
   
© ARSO 2022 —    iv  © ARSO 2017 — All rights reserved  
ACAP 1 -4:2022 
Introduction  
 
This document specifies requirements, the observance of which is intended to ensure that testing and 
calibration laboratories conduct testing and calibration  activities  in a competent, consistent  and impartial 
manner, thereby facilitating the recognition of such bodies and the acceptance of the testing and 
calibration results  to enhance national and international trade   
 
This document describes the procedure for the approval of national and region al/continental  testing and 
calibration l aboratories hereafter referred to as laboratory willin g to be recognized as approved 
laboratories for ACAP.  
 
It summarizes the requirements which shall be met by a Laboratory, to be engaged in the 
calibration/ verifi cation and testing whose results will be relied on in the certification process for the ACAP 
and award of the ARSO  Mark s. 
 
ARSO will grant approval or disapproval for the Laboratory seeking to become recognized for ACAP, based 
on the result of the assessme nt.  
 
This document includes the rules to be complied with by National and International third-party  Laboratories 
seeking recognition  under ACAP.  
 
There are some basic principles that represent a “Must” in the development of the ACAP, in order to 
make a p roduct identified with the ARSO  Mark more “Robust” and acknowledgeable by the interested 
parties:  
 
(a) The level of control done by ARSO on the ACAP  Testing or  Calibration schemes  in order to  
guarantee the effectiveness and integrity of the system.  
 
(b) Independence and competence of the Laboratories involved in the process and the transparency of 
the schemes .  
 
(c) Clear rules in order to  guarantee and assess the competence of the Laboratories to carry out the 
required testing and/or calibration  activities .  
 
(d) Definition of sampling and testing methods and qualification of the dedicated personnel.  
 
(e) Technical support for capacity building for all the involved parties.  
 
(f) The Supply and  traceability of samples and test  or calibration results .  
 
Interested parties can expect or require the Laboratories to meet all the requirements included in the 
ACAP rules applicable  for testing  or calibration  scopes, as well as those of the specific ACAP  schemes.   
 
Parties that may have an interest in the ACAP schemes  include, but are not limited to:  
 
• the customers of the organizations whose products, processes or services are certified;   
 
• governmental auth orities;   
 
• non-governmental organizations; and   
 
• consumers and other members of the public.  
 
• Certification and inspection bodies  
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  All rights reserved  v  
© ARSO 2022 — All rights reserved   
 
AFRICAN CONFORMITY  ACAP 1 -4:2022 
 
Conformity assessment — Part 4: Requirements for 
recognition/ approval of  testing and calibration laboratories  
 
 
1 Scope  
 
This document specifies requirements, the observance of which is intended to ensure that testing 
and calibration laboratories conduct testing and calibration required by the A frican  Standards in a 
competent, consistent and impartial manner, thereby facilitating the recognition of such bodies and 
the acceptance of the testing and calibration results for the approval o f certified products, processes 
and services on a national and international basis and enhancing international trade.  
 
2 Normative references  
 
The following referenced documents are 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.  
 
ACAP 1 -1, Conformity assessment  — Part 1: General requirements for the certification systems  
 
ACAP 1 -2, Conformity a ssessment  — Part 2: Special requirements for the certification systems  
and standards design  
ACAP1 -3: Conformity assessment  - Part 3 Requirements for approval of certification bodies  
 
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles  
ISO/IEC 17011, Conformity assessment -Requirements for accreditation bodies accrediting 
conformity assessment bodies  
 
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories  
JCGM 200, International vocabulary of metr ology – Basic and general concepts and associated 
terms (VIM  
JCGM 100 Evaluation of measurement data – Guide to the expression of uncertainty in 
measurement (GUM  
IAF ID3, Management of extraordinary events or circumstances affecting ABs, Clients and 
certified organisations. (For guidance only)  
IAF MD4, Use of Information and Communication Technology (ICT) for Auditing/Assessment 
Purposes  (For guidance only)  
 
 
3 Terms and definitions  
 
For the purpose of this document the terms and definitions in ISO/IEC 17000 , ISO/IEC 17025 and 
ISO/IEC 17043 standards shall apply . 
 
ACAP  
Program  
Scheme  
 
 
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© ARSO 2022 — All rights reserved    
 
4 ACAP Laboratory License agreement  
 
The ARSO  Laboratory License  agreement is  the document  that establishes the rights and 
obligations of ACAP’s responsible owner and coordinator of  the Laboratories approved for testing 
and/or calibration activities within the ACAP  various schemes .  
 
The ARSO  Laborat ories license  agreement, including its updates, shall be accepted,  and signed by 
the Laboratories as part of the application procedure to become and to remain an ACAP approved 
Laboratory and to be listed as such on the ARSO  website.  
 
The License  Agreement  includes a complementary set of rules to be continuously complied  with by 
the recognized Laboratories.  
 
5 Laboratory approval process  
 
In order to become a recognized Laboratory for ACAP, a series of requirements shall be fulfilled for 
approval and confirmed in time for approval and continued maintenance  of the  license  agreement . 
 
5.1 Preliminary entry requirements  
 
To make an application to become a Laboratory recognized for ACAP, some basic requirements 
are necessary:   
 
(a) The Laboratory  or the organization of which it is part  shall be a Legal Entity registered with 
a scope of services aligned to the testing  or calibration  scope expected, and/or may be a 
government entity with the mandate to provide the Testing and or calibration services  
 
(b) The Laboratory shall be operating in the field of testing  falling under the schemes covered 
under the ACAP schemes .  
 
(c) For t he Laboratory that is already  accredited according to ISO/IEC 17025   with scope 
applicable for range of testing or calibration activ ity is included  in the ACAP qualification  
when the accreditation body is ILAC /AFRAC  recognized.  
 
 
(d) In case the Laboratory is not accredited (see 5.1(c)) , it shall be working according to 
ISO/IEC 17025 principles (specific ally requirements listed in Annex A of th is document ). 
 
A non -accredited Laboratory has up to  3 years  to complete accreditation for the scope 
approved by ACAP, according to ISO /IEC 17025 . 
 
 
5.2 ACAP provisional entry requirements  
 
5.2.1  Application  
 
The Laboratory shall complete the steps listed below before entering the phase of final approval 
that is explained in the following chapter.   
 
(a) The applicant Laboratory (both accredited and un -accredited)  shall register in the ACAP 
database as an applicant Laboratory, in order to receive all the information and 
documentation required for the application.  
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add any value  
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important to keep  
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© ARSO 2022 — All rights reserved   (b) The application shall be very clear about the field of activity (kind of testing, calibratio n) 
selected for the approval (ex: pesticide multi -residue testing on vegetables). The scope shall 
be clearly defined,  and documentation must indicate the limits of capability where applicable  
 
(c) Once the preliminary application is completed with all required information and 
documentation, it can be sent to ARSO Secretariat for evaluation and approval. A fee will 
be charged to the Laboratory for the evaluation of the application.  
 
(d) At any point dur ing the application process, if there is evidence of fraudulent behavior , or if 
the laboratory intentionally provides false information (or conceals important information), 
the application shall be rejected  
 
 
 
5.2.2  Pre-assessment  
 
 
 
If the Laboratory applying for ACAP recognition is already accredited as per 5.1( c) above, and 
provided they meet the necessary and additional requirements of the License agreement – the 
facility shall not go through the pre -assessment phase ( mutual recognition of schemes principl es), 
and proceed to section 5.3  
 
 
For those applicant laboratories without accreditation from mutually recognized Accreditation 
Bodies, d uring the pre -assessment of Laboratory’s provisional entry requirements, the scope of the 
assessment will cover the fo llowing areas, and the assessment will be carried out against the criteria 
indicated as follows:  
 
An examination of the Organization and Structure of the Laboratory. This requires the Laboratory to 
have:  
 
 documentation of the organization identifying its legal status , name, addresse(es) or  the 
locations (however named) at which they are currently  operating ; 
 
 An organization chart, with clearly defined lines of responsibility and reporting;  
 
 defined relationships between  management  system , technical operations,  and support  
services;  
 
 a clear description of the  laboratory activities under calibration and/or testing carried out by 
the laboratory to ensure the consistent application of its l aboratory activities and the validity of 
the results.  This includes information on activities conducted at all locations including virtual 
sites 
 
 
5.3 General Requirements for  Laboratories approval on the ACAP scheme  
 
In case of positive evaluation of the pre liminary application and after paying the fees for the first 
evaluation, the applicant Laboratory will receive a request to complete the following steps:  
 
5.3.1  Accreditation  
 
(a) If ISO/IEC 17025 for the field of testing or calibration included in the ACAP scope  is 
accredited ,  provide copy of a valid certificate (see 5.1(c)).  
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© ARSO 2022 — All rights reserved   (b) If NOT ISO/IEC 17025 accredited for the field of testing or calibration included in the ACAP 
scope, the laboratory shall document and implement procedures and instructions, specific 
for non-accredited  Laboratories, specified in Annex A.  
 
 
(c) All Laboratories will have to document and implement procedures and instructions specific 
for implementation and management of the test or calibration s required by the  ACAP 
Schemes  and selected for the scope of application.  
 
5.3.2  Laboratories License agreement  
 
The Laboratory shall have a legally enforceable agreement for the provision of testing and 
calibration activities to be carried out for ACAP approval  process. The License agreements shall 
take into account the responsibilities of the Laboratory, and its clients and will be enforced when all 
the evaluation activities are completed,  and final approval is granted to the Laboratory.  
 
5.3.3  Approved Laboratory  Management team  
 
The Laboratory shall demonstrate to have enough personnel, facilities, equipment, systems,  and 
support services necessary to manage and perform its laboratory activities. to comply with the ACAP 
requirements and to effectively manage the implementation  of the ACAP Testing  and /or Calibration  
Process. It is possible for the same person to cover more than one task if  the basic requirements 
for competence  are covered.  
 
Every Laboratory recognized for ACAP Testing  and /or Calibration  Process, shall nominate the 
following key staff, required for the implementation and maintenance of the testing process:  
 
(a) Administration Manager  
 
Every Laboratory recognized for the ACAP shall nominate one contact person, called the  
Testing  and /or Calibration  Administration Manager, who will be the representative of the 
Laboratory before the ARSO Secretariat for all issues regarding the testing and /or 
calibration activity related to the release of the final reports  for  use in the various AC AP 
schemes . This person:   
 
 Should  be fluent in AU official language s.   
 
 Should  be available full-time,  i.e. not hired occasionally by the Laboratory, and be part of 
the operational and/or management decision -making process of the Laboratory.  
 
 Should  attend the annual Admin Manager (Update) meeting carried out directly by ARSO  
 
 Shall be responsible for rec eiving and implement actions according to specific requests 
coming from ARSO and to update interested parties about changes or amendments 
related to the ACAP. This also includes registered /certified  Producers, when required.  
 
(b) Technical Manager -ACAP Activities  
 
All recognized Laboratories shall have a Technical Manager or a  person with overall 
responsibility for the technical operations and the provision of the resources needed to 
ensure the required technical competences and quality of  work from the laboratory  
operations  are  in  line with ACAP scheme requirements .  
 
The Technical Manager shall  
 
 be available full-time,  i.e. not hired occasionally by the Laboratory.   Commented [M27]: final 
Commented [EN28R27]: Comment accepted   
© ARSO 2022 — All rights reserved    
 take into consideration the specific requirements stated in the A RSO  license agreement 
as well as in the ACAP testing specification while implementing the Laboratories 
internal quality and testing procedures  
 
be required to  attend the specific Laborator y Technical Manager training, organized by 
ARSO, and pass the final exam.   
 
 After qualification, be expected to attend a “refresh” one day training every two years or 
more often if required by ARSO or in case of a significant review of the Certification  
Scheme.  
 
 
The Technical Manager shall be responsible for:  
 
 Provid ing accurate and updated technical interpretation of the requirement of ACAP  
 
 Support ing other Laboratory  functions  involved in testing for ACAP certification for any 
issue related to technical interpretation of the Standards (including ARSO Admin 
Manager)  
 
 Assur ing that all the personnel involved with the ACAP testing  program complies with the 
internal qualificatio n criteria approved by ARSO.  
 
 Organiz ing and deliver training to all the Laboratory personnel about ACAP requirements 
(based on ARSO documentation, guidelines,  and training material)   
 
 Cooperat ion with and support the Laboratory’s ARSO Sampling and T esting Responsible 
persons  
 
 Where required, evaluate,  and provide expert opinion for request of sanction to be applied 
by certified Producers (example: Suspension or withdrawal of use of ARSO  Mark, 
related to analytical issues)  
 
(c)  Sampling Program Manager  
 
Sampling capability: The Laboratory can agree and coordinate with the client / prod ucer/ 
certification body  about carrying out of the sampling services, to be delivered on -site during 
ACAP certification process.   
 
In this case, t he Laboratory shall have the necessary resources to carry out all activities 
associated with the sampling services. The sampling staff shall be technically qualified and 
have the ability to apply the necessary statistical techniques in sampling work.  
 
The ACAP recognized Laboratory shall have a person responsible for implementation of 
the sampling activity, as a part of the testing activity carried out by the Laboratory.  The 
Sampling program manager reports to the Techn ical Manager.  The Sampling Program  
Manager  responsible is in charge for  
 
Plan and coordinate the sampling of products in agreement with the ACAP approved 
certification body in charge for the specific Producer’s certification, and according to 
specific requirements from the different produ ct certification Schemes and Standards.  
 
 Supervise the correct implementation of the sampling procedures, including conservation 
and transportation of the products and traceability of the samples.   
© ARSO 2022 — All rights reserved    
Prepare sampling reports and deliver copy to the Prod ucer, the Laboratory,  and the 
Laboratory operational site.  
 
Receive specific training on ACAP scheme and on the specific ACAP Certification 
Scheme, as well as the specific sampling methods to be applied when sampling for an 
ACAP certification.  
 
(d)  Laboratory Technical and Administration team  
 
Verifying capability: The Laboratory shall have the necessary resources to carry out all 
activities associated with the testing and calibration services.  
 
 In order to carry out testing for ACAP, the Laboratory shall employ/contract only 
personnel that fulfil the requirements set for internal qualification set by the Laboratory 
and approved by ARSO according to specification from accreditation and/or Annex A . 
 
 Every Employee shall comply with the requirements set for the operations under their 
responsibility.  
 
 The Laboratory shall have documented procedures to assess the working team 
competence.  
 
 Where the testing work is sub -contracted to an outside L aboratory, the ACAP recognized  
Laboratory shall be responsible for selecting either another Laboratory ACAP approved 
for the specific tests sub -contracted or a Laboratory ISO / IEC 17025 accredited for the 
scope subcontracted. The verification of the compe tency of the sub -contractor shall be 
documented and evidences of this verification available to ARSO  on request.  
 
 Where a testing activity is subcontracted to a different laboratory, this has to be agreed 
with ARSO and communicated in writing to t he certification body  responsible for the 
product certification and to the Producer. The test subcontracted and the name of the 
sub-contracted Laboratory shall be specified.  
 
 If the subcontracted test implies additional costs, above what the ACAP f ee table 
established for specific testing, this shall not increase the cost for the Producer. Special 
situations can be discussed with ARSO Secretariat on case -by-case bases.   
 
 Laboratories shall commit to respect the rules for independence, impartialit y as part of a 
written contract. They shall also assure the same for all the internal and external 
personnel relevant for ACAP  scheme  and under the Laboratory’s responsibility.    
 
 A review of the Laboratory personnel, including a validation of their performances and 
technical knowledge, for tasks relevant for ACAP testing, is part of the approval 
process.  
 
 To be approved, the Laboratory shall provide detailed evidences for quali fication of at 
least 2 technical staff able to carry out the testing activity and to validate and verify 
testing results.  
 
 
 
 
 Commented [M29]: Replaced ‘must’ with ‘shall’  
Commented [EN30R29]: Comment accepted  
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Commented [EN32R31]: Comment accepted   
© ARSO 2022 — All rights reserved   5.4 Verification and approval for ACAP  
 
The final approval of a Laboratory for delivering testing and calibration testing within ACAP, depends 
on the successful finalization of the following steps:  
 
(a) Document review: the ACAP C ommittee  verifies and approve s the compliance of the 
documentat ion provided by the Laboratory. All Non - Conformities and o bservations raised 
during the document review must be satisfactory closed and approved by ARSO before 
proceeding with the approval process. For laboratories already accredited to ISO/IEC 
1702 5 by mutually recognized bodies, focus shall be only on the additional ACAP 
requirements.  
 
(b) On-site verification: the ACAP Assessor  verifies and approves the Laboratory by 
verification of the laboratory management and testing and /or calibration activity done by 
the laboratory on each one of the testing methods applied, as required by ACAP 
Standards. For laboratories that are accredite d to ISO/IEC  17025, depending on the 
outcome of document review the initial on -site verification m ay be skipped .  
 
All Non-Conformities  and Observations raised during the on -site verification must be satisfactory 
closed and approved by ARSO before proceeding with the approval process.  
 
(c) In case of successful completion of the previous steps or after closure of all Nonconformities 
and Obse rvations, ARSO ACAP Administrator  communicates to the Laboratory the formal 
approval as ACAP qualified Laboratory, for the required set of tests.  
 
(d) After approval, the Laboratory signs the A RSO  – Laboratory License  agreement.  
 
5.5 Termination of approval for an ACAP Laboratory  
 
5.5.1  Termination Requested  by the Laboratory   
 
In case an ACAP recognized Laboratory requests the termination of ARSO  License  agreement, the 
following actions shall be taken:  
 
(a) The Laboratory shall send a formal termination request to ARSO with specification of the 
timeframe for closing the contract. The minimum given timeframe is of 90 days from the 
formal communication to ARSO.   
 
(b) The Laboratory shall inform all clients and l aboratories of the termination of the ARSO 
License  and that it will not be any more approved for delivery of testing and calibration 
service for ACAP product certification. The minimum timeframe to be give n for 
communication to the clients and Laboratories is 90 days.   
 
(c) From a specific date onwards, the Laboratory shall be removed from the ARSO system and 
will not be allowed to accept new samples for ACAP testing.   
 
(d) The certificates of analysis /reports release d by the Laboratory during the period of validity 
of the ACAP Licen se, remain valid for evidence of compliance of the certified products.  
 
 
5.5.2  Termination done by ARSO  
 
(a) Refer to clause 8.7 of this document  
 
 
 Commented [M33]: Include in def initions and 
organization structure  
Commented [LC34R33]: Agree  
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Commented [EN36R35]: Comment accepted  
Commented [M37]: Include in definitions  
Commented [LC38R37]: agree  
Commented [M39]: Add section on termination by 
ACAP as 5.5.2  
Commented [LC40R39]: Agree. Section 5.5.2 added, 
but only reference section 8.7 which explains the 
sanctioning pro cess 
Commented [LC41R39]: Termination done by ARSO, 
not ACAP  
Commented [M42]: ARSO? or ACAP licence?  
Commented [LC43R42]: It is ARSO license   
© ARSO 2022 — All rights reserved    
 
6 Management System requirements for ACAP imp lementation  
 
The Laboratory shall establish and maintain a management system that is capable of achieving the 
consistent fulfilment of the requirements of the ACAP scheme , in accordance with requirements in 
Annex A of this document .   
 
It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way 
as to meet the requirements of the ARSO  Standards and to satisfy the needs of the customer, the 
regulatory authorities or organizations providing r ecognition.  
 
The management system shall cover work carried out in the laboratory’s permanent facilities, at 
sites away from its permanent facilities, or in associated temporary or mobile facilities.  
 
(a) The management system of the Laboratory shall inc lude the ACAP scope  and all the related 
testing and /or  calibration activities approved for the Laboratory. The following shall be 
addressed:   
 
(i) general management system documentation and records (e.g. manual, policies, 
definition of responsibilities)  
 
(ii) control of documents   
 
(iii) control of records   
 
(iv) contract review   
 
(v) Purchasing services and supplies. Incoming of materials  
 
(vi) sub-contracting of tests and calibration work  
 
(vii) complaints management  
 
(viii) Control of nonconforming testing and/or calibration work  
 
(ix) corrections and corrective actions   
 
(x) internal audit   
 
(xi) Management Review  
 
 
7 Additional requirements for ACAP implementation  
 
Where applicable, specifications regarding ACAP testing activity speci al provisions shall be included 
in the Laboratory documentation , such as:  
 
ACAP Related duties and responsibilities of the staff;  
 
As per list in annex A  
 
8 Assessment process for Laboratory approval  
 Commented [M44]: These requirements are also 
outlined in Annex A  
Commented [LC45R44]: Agreed, replaced with annex 
A  
© ARSO 2022 — All rights reserved   8.1 Document review and on -site verification preparation  
 
Prior to carrying out the assessment of Laboratory for first approval for ACAP accreditation, the 
ACAP Committee :  
 
(a) Will assign to an ACAP Team Leader and the Panel of Assessors the evaluation of  any 
observations resulting from the review of the Application Form and the supporting 
documentation submitted by the Laboratory.   
 
(b) The ARSO Secretariat will brief the ACAP Team Leader on any logistics of the operation.  
 
(c) The ACAP Team Leader, and other nominated members of the Panel of Assessors, will 
review the documentation prior to carrying out the assessment, and will update the 
assessment  documentation according to the information received.  
 
(d) The Team Leader will pro duce a Program for the on -site verification, and this will be 
submitted by the ARSO Secretariat to the applicant Laboratory, at least two weeks before 
the scheduled date of the commencement of the assessment.  
 
8.2 Laboratory approval assessment  
 
Following th e review of the Laboratory documented system (the System Assessment), the next 
important phase of the assessment is to observe the Laboratories activity on -site. This will be carried 
out in two basic areas.  
 
8.2.1  Assessment at the M anagement System(MS)  of the Laboratory  
 
During the MS assessment, the assessors will verify the implementation of the Laboratory MS, the 
effectiveness of the system, the competence of its administrative staff, and in particular, its ability 
to meet the Rules of the ACAP  scheme . Remo te auditing can be done for assessing management 
system requirements, however requirements from relevant guideline documents shall be adhered 
to. 
 
8.2.2  Closure of MS non -conformities  
 
(a) After the MS assessment and within a timeframe that cannot exceed 3 months, the 
Laboratory will provide an action plan with proposal of possible corrective actions to be 
implemented for the findings raised during the audit.  
 
(b) The ACAP  Team Leader will evaluate the action plan and, according to evaluation may 
approve the proposed corrective actions or require further improvements.  
 
(c) Within 3 months from the closure of the MS assessment, a follow up is carried out to verify 
the implementa tion of the corrective actions. According to the number and kind of findings 
and corrective actions to be evaluated, the ACAP Team Leader will decide if a follow up on -
site is required or it will be possible to verify documental evidences with a desk revie w.   
 
(d) In case a follow up on -site is required, only after all non -conformities have correctly 
addressed it is possible to proceed with the assessment of the technical implementation of 
the testing and calibration activity  
 
In case of Laboratory already ac credited for ISO / IEC 17025, the specific ACAP requirements shall 
be assessed with consideration of the integration of the ACAP rules and commitments within the 
MS of the Laboratory   
 
 Commented [M46]: Would be better if this activity was 
assigned to ACCAP body under ARSO Secretariat. 
Consider including in the ARSO structure or ARSO 
should collaborate with AFRAC  
Commented [LC47R46]: Replaced and proposed 
ACAP Committee   
© ARSO 2022 — All rights reserved   8.2.3  Verification of technical activities during on -site Assessment  
 
The ACAP a ssessor will verify the implementation of the testing activity in relation to the specific 
management and execution of the analytical verifications included in the scope of accredita tion.  If 
the Laboratory is already accredited for the specific test  method required by the ACAP Standard, 
the verification will be limited to specific aspects related to the implementation of specific ACAP 
standards requirements, such as sampling, tracea bility and documentation and presentation of the 
final results.  The preferred method shall be on -site assessment, and remote assessment shall be 
done only when faced with extraordinary events. Virtual assessment will not be conducted for initial 
assessment s. 
 
8.3 Final evaluation and classification of findings  
 
A final Report, including a list of all the findings with specific references to the requirements that 
have been infringed, is prepared by ACAP Team Leader to record areas for continual improvement 
and/or where non -conformities  against the  ACAP  requirements were identified .  
 
Non-conformances are classified into two types identified as major and minor.   
 
Other type of non -compliances or deviations can be highlighted for continual improvement but 
without having an immediate impact on the final evaluation of the Laboratory.  
 
8.3.1  Major non -conformance  
 
A Major non -conformance is allocated for a significant fail ure to comply with the ACAP Rules, or 
with the Laboratory’s own Management System  Manual.  
 
Examples would be:  
 Lack of independence and transparency of the third-party  testing program;  
 
 Non-availability of procedure and instructions for a specific AC AP test operated by the Laboratory  
 
 Failure to adequately qualify subcontractors performing testing on behalf of the Laboratory.  
 Failure to demonstrate competence of the key staff.  
 
This kind of deviation results  in the delay of the approval process at any step it is identified and 
requires for the Laboratory to prepare a correct ive action plan to be  approve d by ACAP  Committee.  
After the approval of the action plan, an on -site follow -up assessment  is carried out.   
 
During the approval process, it is not possible to progress to the next step with an open Major NC. 
(example: if one Major NC is raised during MS assessment, it is not possible to proceed to the 
technical activities verification without previously closing the Major N C)  
 
 
8.3.2  Minor non -conformance  
 
(a) A Minor non -conformance is raised for an isolated  failure to comply with the ACAP Rules, 
Standard requirements or with the  Laboratory own Management System  Manual, or if a 
series of minor but related discrepancies are observe d, which together are judged to be an 
unacceptable quality risk, without constituting an overall system failure in the area 
concerned.  
  
© ARSO 2022 — All rights reserved   (b) This kind of deviation results with the delay  of the final approval process and require for 
the Laboratory to prepare a corrective actions action plan to be to be approved  by the ACAP  
Committee.   
 
(c) After the approval of the action plan, it is possible to proceed to the next step for approval.   
Minor nonconformities  do not require the   follow up assessment  to close the n onconformity 
before approval.  
 
(d) During the approval process, it is possible to progress to the next step with an open Minor 
NC. The closure of all Minor NCs will be necessary before receiving final approval (example: 
if one Minor NC is raised during MS assessment, it is possible to proce ed to technical 
activities verification without previously close the Minor NC).  
 
 
8.3.3  Observation  
 
(a) One or more partial failures to fulfil requirements of the following types:  
 
 Formalities / documentary (in the interpretation of a requirement of ACAP and /  or in the 
formalisation of the quality records);  
 
 Operational (in the application of the requirements of ACAP and / or the documentation 
of the system); these should not, however, raise doubts about the real effectiveness of 
the system (the ability of the system to provide a report  in compliance with the major 
and minor Control Points and relate Compliance Criteria)  
 
(b) This kind of deviation neither delays the approval process nor  requires  the L aboratory  to 
prepare a corrective actions action plan to be sent for approval of the ACAP Team Leader  
 
The observation should be managed by the laboratory for improvement purpose and to prevent 
likely escalation into a nonconformity if not addressed.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
© ARSO 2022 — All rights reserved   8.4 Rules for non -conformances closure  
 
The rules for management and closure of findings, including the timeframe to be applied are 
reassumed in table 1.  
 
Table 1 — Rules for non -conformance closure  
 
Activity   Management of findings  
First  Laboratory  
Approval  Major NC  Minor NC  Observation  
Document Review  Follow up 90 days   Follow up  90 days  None  
MS verification  Follow up 90 days   Action plan  90 days  None  
Technical verification  Follow up 90 days   Follow up  90 days  None  
Subsequent 
Surveillances  Major NC  Minor NC  Observation  
MS verification  Follow up 30 days   Follow up  90 days  None  
Technical verification  Follow up 30 days   Follow up  90 days  None  
 
 
8.5 First Laboratory approval verification  
 
The final report, including the team's overall conclusions and recommendations, is prepared by the 
Team Leader, and is submitted to ACAP Committee .   
 
If requeste d, the Team Leader may  attend a meeting with the  ACAP  Committee , to answer any 
points of clarification concerning the report.  
 
8.5.1  Factors affecting first approval  
 
In deciding on his recommendation, the Team Leader will first consider the adequacy of the 
Laboratory’s management systems and how it is implemented, with regard to the ACAP  scheme 
requirements .  
 
The Team Leader  will report on the range of knowledge and e xperience on the part of the 
Laboratory staff, in the light of their scope of operations. The Team Leader will also take into 
account the number and seriousness of the individual non -compliances found during the 
assessment.  
 
Where competence is establishe d, and no non -conformances are found, or where they are few and 
have been closed out before the Final Closing Meeting, the Team Leader will normally recommend 
the approval of the Laboratory for the specific ACAP testing scope for the requested scheme.  
 
Where this is not the case, and some non -conformances are still outstanding at the Final Closing 
Meeting, a date for their close -out will be agreed. The period allowed is specified in Table 1.  
 
If the ACAP Committee  has some concern s over the report finding s, they can request an 
extraordinary extension of the assessment, which is then taken into account with the initial report, 
or can increase the normal frequency of periodic assessments/surveillances until the Assessment 
team is  satisfied that the Laborator ies’ performance is acceptable.  
  
© ARSO 2022 — All rights reserved   Where competence is not established, or where the number and seriousness of the non - 
compliances found is such that the whole of the laboratory  system and facilities are demonstrably 
inadequate, the ACAP Committee  shall not grant the approval status to the applicant laboratory.  
 
8.6 Maintenance of the status of recognized Laboratory.    
 
8.6.1  Laboratory annual surveillance  
 
The status of recognized Laboratory, needs to be re -confirmed annually by mean s of the following 
activit ies:  
 
(a) The recognized Laboratory re -confirms the validity of the ISO/IEC 17025 accreditation also 
for the subsequent year for the specified scopes  and provide proof to A CAP Committee  The 
appointed team will also assess how specific ACAP  requirements are being addressed and 
will only focus on those ACAP listed scopes granted to the laboratory  
 
(b) The Laboratory will have to comply with the requirements to maintain qualification of staff 
(e.g attending the annual refresher training for Technical Managers) or any other 
requirement specified in the general rul es of the ACAP  schemes that are in the scope of 
the ACAP  approval and are not clearly specified in the present document.  
 
(c) For the L aboratories that are not accredited for ISO/IEC 17025, ACAP  team of assessors  
will carry out an annual surveillance assessment  including Management System  and 
technical activity implementation.  
 
8.7 ARSO Sanctioning system  
 
The ARSO Secretariat, together wit h the ACAP  Committee has established the types and levels of 
sanctions described here.  The most severe ones include the withdrawal  of the ACAP  License  
agreement and the impediment for the Laboratory to carry out  testing  or calibration on the ACAP 
scope . .   
 
The sanctioned Laboratory can appeal against a sanction applied by ACAP  Committee within 10 
working days after the receipt of the sanction notifica tion. The ACAP  committee evaluates the 
appeal , and a separate team or members different from those that issued the initial sanction will be 
appointed to look at the appeal.  
The second appeal against a re -confirmed sanction by the A CAP Committee  follows the  arbitration 
procedure as described in the License Agreement and in Annex A of ACAP 1 -1:2022.  
 
The termination  of the ACAP - Laboratory License  agreement, is the consequence of the application 
of a sanction to an ACAP  approved Laboratory.  
 
Two types of n on-conformances can lead to sanctioning of Laboratories , and these are explained 
in detail under 8.7.1 and 8.7.2 below; .  
 
8.7.1  Contractual non -conformances  
 
Contractual non -conformances are at hand in the case that the Laboratory is not in compliance with 
contracts signed with ARSO. These may include, but are not limited to:  
 
(a) Misleading or false communication on ACAP testing and logo use.  
 
(b) Refusal to sign th e License Agreement   
 Commented [M48]: Need for clarification  
Commented [M49]: Sanctions an level are missing in 
this document and they are referenced in the 
reuirements here below  
Commented [LC50R49]: Comment not clear, but there 
is clarity on major, minor and observations in the 
document  
Commented [M51]: Consider to replace the term 
termination with withdrawal in clause 5.5 and related 
clauses  
Commented [EN52R51]: Comment accepted  
Commented [M53]: Which are the two types being 
mentioned here  
Commented [LC54R53]: Agreed, explained   
© ARSO 2022 — All rights reserved   (c) Neglecting to pay any of the ARSO fees (e.g. Laboratory license fee, training fee).  
 
(d) Confirmed fraud.  
 
(e) Loss of accreditation (based on AB decision) , which then requires ACAP Committee  to 
assess the laboratory against Annex A as a new process altogether .  
 
8.7.2   Non-conformances   arising from assessments  
 
During assessments, non -conformances may be raised against the laboratory. Depending on the 
category of the non -conformities , as wel l as failure to close the gaps within allocated  timeframes , 
may lead to termination or withdrawal of the license agreement. . Example:  
 
(a) Not participating in annual compulsory trainings.  
 
(b) Not comply with the staff qualification  
 
(c) Incomplete or late delive ry of test’s certificates.  
 
(d) Unreliable testing or calibration data.  
 
(e) Conflict of interest (e.g. consultancy for implementation and testing).  
 
(f) Inadequate internal training.  
 
(g) Do not carry out the external inspections.  
 
(h) Not obeying Laboratory operational requirements and deadlines.  
 
The ACAP Committee , shall be responsible for addressing these types of non -conformances.  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Commented [M55]: Clarification is required on this 
type/title  
Commented [LC56R55]: Agree, statement amended   
© ARSO 2022 — All rights reserved    
Annex A  
(Normative )  
 
Special additional requirements for non -accredited testing and calibration  
laboratories  
(Modified from ISO/IEC 17025:)  
 
For laboratories not accredited against ISO/IEC 17025 the Management System and Scope specific 
technical requirements, as summarized in chapters 6 and 7of this  document, must be documented 
and implemented . 
 
The following ISO/IEC 17025 chapters to be implem ented for ACAP qualification.   
ISO/IEC 17025 
Requirements  ACAP specific requirements  
Impartiality  - Staff and all relevant parties to sign  declaration 
confirming they commit to be free from both internal and 
external pressures  
- Laboratory must have risk re gister on identified 
risks/threats and relevant mitigation plans  
 
Confidentiality  All staff and other stakeholders with access to important 
producer /client information to sign non -disclosure agreement 
with laboratory  
Structural Requirements  - Legal documentation  
- Licence agreement with ARSO once approved  
- Clearly  documented information showing ACAP scope 
approved and /or indicating which items sub -contracted  
- Technical Managers for ACAP related activities, 
Administration Manager for ACAP related activit ies, 
Sampling Program Manager for ACAP related activities 
and formally authorized personnel to conduct tests/ 
calibration activities for ACAP scope  
- For sites or mobile facilities, document deputizing of the 
functions above  
- Job descriptions for staff as abo ve listing 
responsibilities , authorities,  and requirements to be 
appointed  
- Quality manager to drive quality culture and any other 
responsibilities delegated by Technical Manager  
Risk and opportunities procedure & updated risk register for the 
laboratory  
Resource Requirements -
General  The laboratory must have management system aligned to 
Annex A, facilities , staff , equipment,  and support services to 
ensure ACAP scheme requirements are met  
Resource Requirements - 
Personnel  Procedure and records for;  
- Personnel competence requirements and evaluation  
- Selection of personnel, training on ACAP scheme 
requirements, supervision,  and authorization to 
conduct ACAP scheme related activities  
- Job descriptions  specifying competence requirements, 
responsibilities, a nd authorities as well as confirmation 
all were made aware of the job descriptions  
- Job descriptions  to include commitment to be 
impartially and keep information confidential, 
maintenance competence to work according to ACAP  
© ARSO 2022 — All rights reserved   scheme requirements, the ability  to evaluate the 
significance of deviations  
- Monitoring of personnel and the records . annual 
monitoring plan for personnel, by competent staff.  
 
Resource requirements - 
Facilities and Environmental 
conditions  Ensure the facilities and environment conditions  are suitable to 
conduct the ACAP scheme related activities  
- Ensure there is documentation clearly showing the 
necessary facilities and environmental conditions for 
each ACAP scheme laboratory related activities  
- Monitoring of the laboratory conditions is re corded, 
controlled as necessary  
- If activities done also at sites or remote sites, ensure 
same controls applied  
Consistency important for all activities whether done inside  
laboratory or other sites  
Resource Requirements - 
Equipment  - list of all software, reference data or materials, 
measurement standards, consumables , instruments,  
and apparatus used for ACAP related activities  
- List of staff that can access and  perform tests on 
equipment  
- Procedures for mainte nance, transporting, in service 
checks, calibration  and routing maintenance  
- Calibration program for all critical equipment  
- Prevent use of defective equipment  
- Investigate through corrective action procedure if 
equipment found to have been defective  
- Maintain r ecords for equipment that could impact the 
validity of results . identity (name, serial number, 
manufacturer , where used,etc), maintenance program( 
to cover malfunction, damage, modification or repairs), 
calibration records (accredited service providers) 
including reference materials  
 
Resource requirements - 
metrological traceability  - Equipment identified to be critical, must be calibrated 
and be traceable to international standards  
- Each calibration is linked to appropriate refence  
- Measurement uncertainty is available  
- Use of laboratory accredited to conduct calibrations  
Certified reference materials from competent producer  
Resource requirements - 
Externally provided products 
and services  -If using another laboratory, ensure it is approved by ARSO and 
for the scope subcontracted  
- Clear communication of requirements to the service provider , 
and to include acceptance criteria and how it will be done or 
who shall perform the activity  
- Procedure for selection, evaluation, and monitoring and how 
the products or reports will be checked if they meet agreed 
requirements before the laboratory accepts them  
- 
Process requirements -Review 
of requests, tenders and 
contracts  The laboratory shall be able to confirm that there was 
communication and cooperation as shown b y; 
- Clarifying requests of what is needed  
- Making sure there is clarity what ACAP scheme requirement 
is tested for  
- Obtaining the permission of Certification body/producer if any 
subcontracting is to be done first   
© ARSO 2022 — All rights reserved   - Informing CB/producer if there is any  deviation of initial 
agreement  
- Reviewing contracts by Technical manager -ACAP related 
activities if there are any changes  
- Monitoring performance of performed work  
- allowing CB/producer reasonable access to witness specific 
activities related to their  contract  
Assist CB/producer with any items needed for verification  
Process requirements -
Selection, verification and 
validation of methods  - Apply relevant tests as required by ACAP scheme and 
ensure it’s the latest version  
- Plan development for any ACAP scheme related 
methods if need  
- Assign method activities to only formally authorized 
personnel  
- Use appropriate methods and procedures for 
validation, the evaluation of the measurement 
uncertainty, and statistical techniques for analysis of 
data 
- Verify that method works before introducing it  
- Validate methods developed or modified by the 
laboratory, non -standard methods and standard 
methods where scope is changed  
- Determine the influence of any changes to a valid 
method  
- Retain records of validations  
 
Process requirements -
Sampling  The Sampling program manager shall be responsible for all 
sampling activities  
Process requirements -
Handling of test or calibration 
items  -List  or register for all calibration or testing items ( ACAP related 
activities)  
-procedure for handling of test or calibration  items including 
their transportation and receipt at the laboratory.  
-their storage, protection during use, retention and/or return or 
disposal once activity completed  
- protect the integrity of test or calibration  items  
- follow handling instructions, when provided  
- record any deviations from specified conditions on receipt of 
the test or calibration item  
- uniquely identify all test or calibration items and retain the 
identification while being used or retained in the laboratory  
- identify, maintain, monitor, and record storage or conditioning 
requirements  when items must be stored or conditioned  
Process requirements -
Technical Records  Technical records irrespective of format include;  
- Formal authorizatio n records -including dates, for  
personnel responsible for each activity  
- Report of results, including the raw data, rough 
calculations  
- Suitable information to assist with determining  aspects 
that affect measurement uncertainty  and to allow for 
repetition of  activities under conditions replicating the 
original  
- Clear records and traceability of any amendments from 
original observations or versions, including the person 
responsible for the amendments, the date, and what 
changes were made  
  
© ARSO 2022 — All rights reserved   Process requirements -
Evaluation of measurement 
uncertainty  Procedure for evaluation of measurement uncertainty for ACAP 
scheme related testing or calibration activities  
Process requirements -
Ensuring the validity of results  Procedure for quality control activities, for the ACA P scheme 
related activities -internal checks, tests, correlations , and 
comparisons that are included  
- Monitoring schedule or peer review plan  
- Intra laboratory activities plan  
- Interlaboratory schemes for the ACAP related tests or 
calibrations  
Participation in proficiency testing schemes if available  
Process requirements -
Reporting of results  The laboratory must have a controlled format for reporting 
results  
- All results to be reviewed and authorized before release 
by ACAP scheme approved Manager s  
- Results are unambiguous, objective,  and accurate  
- Meet the content requirements  
- Indicate which data was supplied by producer/client  
- Place disclaimer on the report if customer supplied 
information could affect the result validity  
- Specify that results appl y to specific same  received -as 
received -, when the  laboratory was not responsible for 
sampling  
- Decision rule on any issued conformity statement  
- Clearly marked any expressed interpretations and /or 
opinions reported that are associated with the tested or 
calibrated item results  
- Identification  of any re -issued, changed, or amended 
reports and any changed information  
Refence original report if totally new report was issued after 
amendments  
Process requirements -
Complaints  Procedure for managing complaints and/ or appeals  
- Keep complaints register  
- Address complaints timely  
Allow independent staff to investigate complaints  
Process requirements -
Nonconforming  work  Procedure for treating non-conforming  work, when tests or 
calibration not done as per customer requirement or laboratory 
process  
Process requirements -Control 
of data and information 
management  -Applies to both computerized and non -computerized system 
data and information;  
- Validation of all LIMS including interfaces for functionali ty 
- authorize, document, and validate changes before 
implementation  
-operate LIMS according to the laboratory specifications to 
safeguard integrity of data and information  
- protect the system from unauthorized access  
- provide safeguards against tamperin g or loss  
- check data transfers and calculations in an appropriate and 
systematic manner  
- ensure any subcontracted LIMS complies with your system  
   
 
 
 
 
END…………………………………………