Executive-Committee
Andrea Melo | IAAC Chair
Warren Merkel | IAAC Vice-Chair
Rhonda Banks | IAAC Treasurer
Ferney Chaparro | IAAC Executive - Technical Secretary
Paola Mársico | MLA Committee and MLA Group Chair
Robert Knake | MLA Committe and MLA Group Vice-Chair
Eduardo Ceballos | Technical Committee Chair
Alba Cabrera | Technical Committee Vice-Chair
Carlos Echeverría | Management Committee Chair
Alejandra Avelar | Management Committee Vice-Chair
Israel Teixeira | Stakeholders Committee Chair
Jose Luis Ogando | Stakeholders Committee Vice-Chair
Yrene Caballero | Laboratories Subcommittee Chair
Mauricio Rodríguez| Laboratories Subcommittee Vice-Chair
Rita Cinca | Certification Bodies Subcommittee Chair
Patricia Aguilar | Certification Bodies Subcommittee Vice-Chair
Diego Rodriguez | Inspection Bodies Subcommittee Chair
Renato Ortiz | Inspection Bodies Subcommittee Vice-Chair
Miriam Romo | Documentation Subcommittee Chair
Gabrielle Andrade-Bell | Documentation Subcommittee Vice-Chair
Wendy Regalado | Training Subcommittee Chair
Mirtha Cuevas | Training Subcommittee Vice-Chair
Mirta Leiva | Promotions Subcommittee Chair
Veronica Ruano | Promotions Subcommittee Vice-Chair
Liliane Somma | Former IAAC Chair
IAAC STRUCTURE
Frequently Asked Questions
What is IAAC?
What is IAAC?
The InterAmerican Accreditation Cooperation (IAAC) is a regional association of accreditation bodies and other organizations interested in conformity assessment in the Americas.
IAAC promotes cooperation among accreditation bodies and interested parties of the Americas, aiming at the development of conformity assessment structures to achieve the improvement of products, processes and services and to reduce risk for business and its customers by assuring them that accredited certificates may be relied upon. Accreditation assures users of the competence and impartiality of the accredited body.
What is IAAC for?
What is IAAC for?
IAAC’s main objectives are:
- To develop Multi-lateral Recognition Arrangements (MLA) in the Americas.
- To provide confidence in the results of the work of conformity assessment bodies that are accredited by its members.
- To provide, transfer and share technical information and expertise in the region.
- To strengthen cooperation of the accreditation bodies through Multi-lateral Recognition Arrangements (MLA).
What does IAAC do?
What does IAAC do?
- Ensures that clients accredited by its members are competent to do work in the areas for which they are accredited.
- IAAC maintains and manages the Multi-lateral Recognition Arrangements among its accreditation body members which reduces risk to business and its customers by ensuring that an accredited certificate may be relied upon anywhere in the world.
- IAAC promotes the harmonization of accreditation programs of its members with the aim to eliminate the need for separate accreditations in each country.
- IAAC promotes the concept of accredited once - accepted everywhere.
- IAAC promotes collaboration and cooperation among accreditation bodies and between its members and other relevant bodies and groups not only in the region but worldwide.
- IAAC provides a wide array of training activities.
- IAAC ensures the representation of the Americas in international accreditation fora.
- IAAC encourages and supports the development of accreditation bodies in the region of the Americas.
What Officers does IAAC have?
What Officers does IAAC have?
IAAC has a Chair and a Vice Chair, a Treasurer and an Executive Secretary.
Each committee and subcommittee has a Chair and a Vice Chair.
Click below to read the list of IAAC Officers.
How is IAAC structured?
How is IAAC structured?
The IAAC General Assembly is made up of all IAAC members.
Daily functioning of the organization is the responsibility of the IAAC Secretariat.
The IAAC Executive Committee is charged with advancing the objectives, goals and tasks of the Cooperation and to implement its policy and administration.
The Committees and Subcommittees address the various areas where IAAC is working.
Who are IAAC members?
Who are IAAC members?
The main participants in IAAC are accreditation bodies that operate programs under which they accredit bodies for certification of quality and environmental management systems, persons, products, for inspection and for laboratories.
Other bodies and groups related to or interested in conformity assessment are also involved in IAAC activities.
IAAC has 3 categories of membership: Full, Associate and Stakeholder Members.
IAAC Full Members are accreditation bodies that operate according to international requirements.
IAAC MLA Signatories are accreditation bodies which are peer evaluated by IAAC at a set interval to ensure their operation continues to comply with the set international criteria.
IAAC Associate Members are accreditation bodies that do not yet operate according to international requirements. Nations that do not yet have an established accreditation body and other organizations may also be Associate Members.
IAAC Stakeholder Members are certification bodies, inspection bodies, and/or testing and calibration laboratories that are accredited or in the process of being accredited by IAAC’s full members; business entities; or other users of conformity assessment services in the region.
How does an organization become a member?
How does an organization become a member?
The steps involved in applying for IAAC membership are:
- The applicant submits a completed IAAC Membership Application Form and supporting documentation to the IAAC Secretariat. The application form is available from the IAAC web site or it may be requested from the IAAC Secretariat.
- When the application is complete, the Secretariat submits it to the IAAC Executive Committee for review.
- When the Executive Committee has accepted the application, the Secretariat submits the application to the IAAC General Assembly.
- The IAAC General Assembly votes and approves the membership application.
- The applicant is then notified by the IAAC Secretariat of the General Assembly decision. The applicant becomes a member when it signs the IAAC Memorandum of Understanding and submits payment of its annual membership fee.
What is an accreditation body?
What is an accreditation body?
A procedure by which an authoritative body gives formal recognition to a competent body or person to carry out specific tasks.
The ISO / IEC 17000 (and ISO / IEC 17011) defines accreditation as "third party testimony (5.2) related to a conformity assessment body (2.5) that leads to the formal verification of its competence to carry carry out the specific tasks of conformity assessment."
The numbers in parentheses in the ISO / IEC 17000 definition cited above refer to other clauses in that standard.
What is conformity assessment?
What is conformity assessment?
Conformity assessment is a demonstration that specified requirements relating to a product, process, system, person or body are fulfilled. The subject field of conformity assessment includes activities such as testing, inspection and certification, as well as the accreditation of conformity assessment bodies. Each of these activities is also formally defined in ISO/IEC 17000.
Conformity assessment provides benefits for every level involved, from manufacturers to consumers as well as for trade in general.
What is certification?
What is certification?
What is Inspection?
What is Inspection?
Examination of a product design, product, process or installation and determination of its conformity with specific requirements, or on the basis of professional judgment, with general requirements.
Note: Inspection process can include inspection of persons, facilities, technology and methodology.
What is an accredited Inspection Body?
What is an accredited Inspection Body?
It is an organization whose technical competence has been recognized to carry out conformity assessment activities as an inspection body. The recognition is obtained through accreditation by an accreditation body.
The standard used to assess inspection bodies is ISO/IEC 17020.
The application information for ISO/IEC 17020:2012 is included in ILAC P15 Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies
Do inspection bodies participate in Proficiency Tests?
Do inspection bodies participate in Proficiency Tests?
What are Inter-laboratory comparisons?
What are Inter-laboratory comparisons?
Inter-laboratory comparisons are processes that help determine the performance of individual laboratories for specific tests or measurements and monitoring laboratories' continuing performance.
The standard ISO/IEC 17043 defines interlaboratory comparisons as “organization, performance and evaluation of tests on the same or similar items by two or more laboratories in accordance with predetermined conditions."
What is Proficiency Testing?
What is Proficiency Testing?
Proficiency Testing is defined in the ISO/IEC 17043 standard as the “evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons”.
Proficiency Testing helps determine laboratory testing and measurement performance. Participation in proficiency testing may be required for a laboratory to be accredited. Participation and the performance in proficiency testing is considered during the assessment and decision making process for accreditation. Proficiency testing may be carried out in several ways, including laboratory comparisons. Examples of different ways laboratory proficiency testing may be carried out are provided in the ISO/IEC 17043 standard.
How can I find a particular Proficiency testing program?
How can I find a particular Proficiency testing program?
There is not a particular website to check, however there are some websites that can help to find what you are looking for.
If you are looking for accredited Proficiency Testing providers, the first place to look is on the ILAC website’s Online Directory www.ilac.org. Many of ILAC’s members have an on-line database of their accredited testing and calibration facilities and these can be found in the second column of the ILAC directory (the column headed Accredited Laboratory Directory). Simply click on the link in this column and you will be taken to the member’s own directory. However, please note that the contents and accuracy of the listings in these directories are the responsibility of the member concerned and ILAC takes no part in their updating or checking.
Try also the EPTIS database www.eptis.bam.de. It has a list of Proficiency Testing schemes (PT schemes) operated in Europe, the Americas and in Australia, accredited and non-accredited. EPTIS does not provide any dates of next rounds. The information contained in the EPTIS database is based on self-declarations from the Proficiency Testing providers.
Some accrediting bodies list Proficiency Testing programs on their own web sites and may require the use of a specific program for accreditation by that body.
The Witnessing of a Certification Body’s Audit by an Accreditation Body
What is a Witnessed Audit?
What is a Witnessed Audit?
It is the observation by an Accreditation Body’s assessor of one or more audits carried out by the Auditor Teams assigned by a Certification Body.
The witnessing of a Certification Body’s audit of one of its clients by the Accreditation Body is valuable for:
- Verifying, on site, the effectiveness of the Certification Body’s programmes and procedures,
- Assessing the technical competence of the Certification Body’s audit team, as they perform an accredited certification audit, and
- Assessing the ability of a Certification Body to assign competent teams to perform audits.
How is it done?
How is it done?
The Accreditation Body selects an audit to be witnessed according to its own procedures and the signed agreements with the Certification Body.
Furthermore, the Certification Body has an enforceable arrangement with its clients that establishes that the Accreditation Body may evaluate the files that the CB has of its audit and certification activities, and that Accreditation Body may witness an audit the CB is conducting for any client with an accredited certification.
The arrangements between the Accreditation Body and the Certification Body maintain confidentiality. Any information collected during the witnessing of an audit is confidential and is treated by the Accreditation Body assessors and staff accordingly.
It shall be made clear that the Accreditation Body assessors, when witnessing the Certification Bodies’ audits, are not auditing the Certification Bodies clients’ management system or product, as this is the sole duty and responsibility of the Certification Body.
During their witnessing of Certification Body audits, Accreditation Body assessors shall limit their participation in the audits to that of an observer; they shall not interfere in a Certification Body’s audit of a client and not influence the outcome of a Certification Body audit.
Source: ISO-IAF AAPG Document: The Witnessing of CRB Audits by an Accreditation Body.
The IAF MLA Structure and IAF MLA Mark
How is the new structure of the IAF MLA and how can the MLA Mark be used?
How is the new structure of the IAF MLA and how can the MLA Mark be used?
Since 2013 there have been some significant changes in the IAF MLA. In response to a question relating to “what is covered by the IAF MLA” the IAF has moved away from three MLAs covering QMS, EMS and Product to one MLA with scope and changed the way the IAF MLA Mark is used in connection with Product certification.
The amendment and publication of IAF PR 4:2010 Structure of IAF MLA and Endorsed Normative Documents introduced the new IAF MLA structure, moving away from three MLAs; QMS, EMS and Product to one MLA with scope. The IAF MLA is structured in five levels:
Level 1 - ISO/IEC 17011, specifies the criteria for the Accreditation Body (AB).
Level 2 - Accreditation Activities, in which the AB has demonstrated competence to perform accreditation as specified by the IAF endorsed generic accreditation normative documents listed in Level 3.
IAF MLA accreditation activities are:
• Management Systems Certification
• Product Certification
• Certification of Persons
Level 3 - IAF endorsed generic accreditation normative document used by the AB to assess the Conformity Assessment Body (CAB) competence for each accreditation activity. For example: ISO/IEC 17021, ISO/IEC 17065, ISO/IEC 17024
Level 4 – IAF endorsed sector specific normative documents which specify internationally recognized applications of the generic normative document listed in Level 3. The documents are used by the AB, in combination with the generic normative document listed in Level 3 to assess the CAB competence in the relevant sector. For example: ISO/TS 22003, ISO/IEC 27006.
Level 5 – IAF endorsed conformity assessment normative document used by CABs
For example: ISO 9001, ISO 14001;
Note: The combination of a Level 2 activity and the Level 3 relevant normative document is called a main scope of the MLA. The attestations made by CABs where the MLA is at the main scope level are considered to be equally reliable. Level 4 and Level 5 do not exist for all main scopes. Level 4 and Level 5 are called sub-scopes of the MLA. The attestations made by CABs where the MLA is at the sub-scope level are considered to be equivalent. There may not be a level 4 document (e.g. ISO 9001) however there must always be a Level 5 document for equivalence to be claimed.
Since the introduction of the Product MLA in 2004, the product MLA has been known as a “framework” MLA based on ISO/IEC 17065, as there were no common product certification schemes or product standards recognized by the IAF. Even though the Product MLA was a framework MLA, the IAF MLA Mark was allowed to be used on certificates of conformity, implying equivalence. However it has been recognized that this is misleading in the context of product certification. IAF ML 2 General Principles on Use of the IAF MLA Mark precludes the use of the IAF MLA Mark on product certificates unless issued under the terms of an IAF endorsed scheme. Having an IAF endorsed scheme, provides normative documents at Levels 4 and 5. The process for the endorsement of schemes is detailed in IAF PL 3 Policy and Procedure for Expansion of the Scope of the MLA.
Recognizing the significance of the changes in the use of the IAF MLA Mark in the activity of product certification, the IAF has introduced a relatively long transition period associated with the changes in the use of the IAF MLA Mark. The following transition arrangements apply:
A) As there are no IAF endorsed product certification schemes, ABs should require the CABs with whom they have a sub-license covering product certification to immediately cease including the combined IAF MLA Mark/AB symbol on product certificates.
B) A one year transition period will apply to allow ABs to establish new sublicenses with CABs providing product certification,
C) A four-year transition period will apply to allow CABs to withdraw product certificates that include the combined IAF MLA Mark /AB symbol.
IAAC operates in accordance with which standards and/or rules?
IAAC operates in accordance with which standards and/or rules?
IAAC itself operates in accordance with its Bylaws and other governing documents. Accreditation bodies that are full members of IAAC use for their operation the relevant ISO/IEC standards and guides that apply to their field of activity, as well as the appropriate ILAC and IAF documents for the application of ISO/IEC guides and standards.
What is ISO? What is IEC? What are the ISO/IEC standards and guides?
What is ISO? What is IEC? What are the ISO/IEC standards and guides?
ISO, the International Organization for Standardization, and IEC, the International Electrotechnical Organization, are two international standardization organizations that develop standards in a wide array of topics and subjects.
ISO/IEC conformity assessment standards and guides are consensus documents that define criteria, procedures and principles for conformity assessment and accreditation, prepared by working groups of the Conformity Assessment Committee (CASCO) of the International Organization for Standardization (ISO). IEC participates in the work of CASCO and the documents are jointly approved and published.
Which ISO/IEC standards and guides are relevant to the IAAC?
Which ISO/IEC standards and guides are relevant to the IAAC?
ISO/IEC 17000 Conformity assessment- Vocabulary and general principles.
ISO/IEC 17011 Conformity assessment- General requirements for accreditation bodies accrediting conformity assessment bodies.
ISO/IEC 17020 General criteria for the operation of various types of bodies performing inspection.
ISO/IEC 17021-1 Conformity assessment – Requirements for bodies providing audit and certification of management systems.
ISO/IEC 17024 Conformity assessment – General requirements for bodies operating certification of persons.
ISO/IEC 17065 - Conformity assessment — Requirements for bodies certifying products, processes and services
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.
ISO 15189 Medical laboratories - Particular requirements for quality and competence.
ISO/IEC 17043 Conformity Assessment - General requirements for Proficiency Testing.
ISO 17034 - General requirements for the competence of reference material producers
What is ILAC?
What is ILAC?
What is IAF?
What is IAF?
Frontpage Who We Are
Especificación de la acreditación en el Reglamento – Hoja Informativa
Primera reunión de acercamiento e intercambio entre PAQI y QICA 2023
Día Mundial de la Acreditación 2023
Expertos Técnicos
PREGUNTAS FRECUENTES Y RESPUESTAS SOBRE LA ISO/IEC 17020
Infraestructura de la Calidad para la Economía Circular - Publicación de QICA
Actividades de QICA
Taller Formación de Nuevos Evaluadores Pares IAAC
IAAC mantiene su reconocimiento internacional como Región
Transición a ISO 15189:2022
La norma ISO 15189:2022 Laboratorios clínicos: requisitos de calidad y competencia se publicó el 6 de diciembre de 2022. La Cooperación Internacional de Acreditación de Laboratorios (ILAC) acordó que habrá un período de transición de tres años.
59ª Reunión del Comité Ejecutivo de IAAC
Webinar "Normas, Sellos & Certificaciones para la Economía Circular de los plásticos"
Informe anual de la presidenta de IAAC
Liliane Somma presidenta de IAAC presentó su informe anual durante la XXX reunión de la Asamblea General realizada el 19 de agosto de 2022.
Proyecto de Infraestructura de la Calidad para la Economía Circular – QI4CE
IAAC tiene nueva Presidenta
PREGUNTAS FRECUENTES Y RESPUESTAS SOBRE LA ISO/IEC 17011
Inicio - EN
The IAAC General Assembly Grants Voting Rights to Stakeholder Members
Specifying accreditation in Regulation – Fact Sheet
First Approach and Exchange Meeting between PAQI and QICA 2023
World Accreditation Day 2023
Technical Experts
FREQUENTLY ASKED QUESTIONS AND ANSWERS ABOUT ISO / IEC 17020
- An ILAC FAQ Working Group has published a list of Frequently Asked Questions and answers on the implementation of specific clauses of ISO / IEC 17020. The Spanish translation was carried out by the IAAC Executive Secretariat.
Quality Infrastructure for Circular Economy - QICA Publication
QICA's latest activities
Training workshop for new IAAC Peer Evaluators
IAF/ILAC maintain the International Recognition of IAAC
Transition to ISO 15189:2022
The ISO 15189:2022 standard, Medical Laboratories – Requirements for quality and competence was published on 6th December 2022. The International Laboratory Accreditation Cooperation (ILAC) has agreed that there shall be a three-year transition period.
Webinar on Standards, Labels & Certifications for the Circular Economy of Plastics
Annual Report of the IAAC Chair
Liliane Somma, IAAC Chair, presented her annual report during the XXX IAAC General Assembly meeting held in Antigua, Guatemala, on August 19, 2022.
Quality Infrastructure for the Circular Economy Project – QI4CE
IAAC has new leadership
FREQUENTLY ASKED QUESTIONS AND ANSWERS ABOUT ISO / IEC 17011 (UPDATE)
- The IAF / ILAC A-Series Working Group has published a list of Frequently Asked Questions and answers on the implementation of specific clauses of ISO / IEC 17011. The Spanish translation was carried out by the IAAC Secretariat.
Meetings
XXXII IAAC General Assembly meetings
August 18 to 23, 2024.
Medellin, Colombia
GA MEETINGS SCHEDULE
GA MEETINGS SCHEDULE
Committee and Subcommittee acronyms
IAAC Library
Links to technical publications and documents of interest to IAAC members and the wider community are listed here.
If you wish to have a technical document considered for addition to the library please contact the IAAC Secretary at: This email address is being protected from spambots. You need JavaScript enabled to view it.
APLAC
Asia Pacific Laboratory Accreditation Cooperation www.aplac.org/publications.html
Laboratory Accreditation Bodies & Laboratories |
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Release | Document | Purpose | |
Issue No.2 Dated: 03/04
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APLAC TC 005, APLAC Interpretation and Guidance on the estimation of uncertainty of measurement in testing
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This document provides interpretation and guidance on measurement uncertainty in testing for various technical disciplines. It is intended for use by laboratory accreditation bodies as well as laboratories.
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Inspection bodies & Laboratories in General |
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Release | Document | Purpose | |
Issue No.2 Dated: 02/04 |
APLAC TC 2 Guidelines for Internal Audits
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This document gives guidance to laboratories and inspection bodies on how to establish and implement a program of internal audits. | |
Issue No.2 Dated: 02/04 |
APLAC TC 3 Guidelines Management reviews
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This document gives laboratories and inspection bodies guidance on how to establish and implement a program for management reviews. |
BMC/CMC
Best Measurement Capability (BMC) and Calibration Measurement Capability (CMC) http://www.ilac.org
Laboratory Accreditation Bodies & Laboratories in General |
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Release | Document | Purpose | |
Dated: August 2009 |
Change in Terminology Relating to BMC/CMC
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This ILAC circular explains the action required by ILAC members regarding the change in Terminology Relating to Best Measurement Capability (BMC) and Calibration Measurement Capability (CMC).
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EA
European Cooperation for Accreditation www.european-accreditation.org
Sensory Testing Laboratories & Sensory Testing Accreditation Bodies |
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Release | Document | Purpose | |
Rev.1 Dated: July 2003 |
EA-4/09 Accreditation for sensory testing laboratories
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This document supplements EN ISO/IEC 17025, and provides specific guidance on the accreditation of sensory testing laboratories for both assessors and laboratories preparing for accreditation. It gives detailed guidance for the interpretation of EN ISO/IEC 17025 for those undertaking sensory testing.
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Testing Laboratories |
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Release | Document | Purpose | |
Rev.00 Dated: Dec 2003 |
EA 4/16 EA guidelines on the expression of uncertainty in quantitativetesting
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The purpose of this document is to harmonise the evaluation of uncertainties associated with measurement and test results within EA. To achieve this, recommendations and advice are given for the evaluation of those uncertainties. |
EURACHEM
EURACHEM/CITAC www.eurachem.org
Testing Laboratories |
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Release | Document | Purpose | |
2003
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EURACHEM/CITAC Guide 2003 Traceability in Chemical Measurement - A guide to achieving comparable measurement results in chemical measurement
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This Guide gives detailed guidance for the establishment of measurement traceability in quantitative chemical analysis, based on the definition in the international vocabulary of basic and general terms in metrology (VIM). Though it is aimed principally at testing and measurement laboratories carrying out chemical measurement, the principles are expected to apply from routine analysis to basic research. The document is also intended to assist laboratories in meeting the requirements on traceability of results given in ISO 17025.The version of the guide that is available on the website follows a detailed discussion over the last year of the previous version of the document.
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2002 |
EURACHEM/CITAC Guide 2002 Guide to Quality in analytical Chemistry - An aid to accreditation |
The aim of this guide is to provide laboratories with guidance on best practice for the analytical operations they carry out. The guidance covers both qualitative and quantitative analysis carried out on a routine or non-routine basis. A separate guide covers research and development work (Quality Assurance for Research and Development and Non-routine Analysis,1998). | |
2012 |
EURACHEM/CITAC Guide CG 4 2012 Quantifying Uncertainty in Analytical Measurement - 3rd Edition |
This Guide gives detailed guidance for the evaluation and expression of uncertainty in quantitative chemical analysis, based on the approach taken in the ISO “Guide to the Expression of Uncertainty inMeasurement” [H.2]. It is applicable at all levels of accuracy and in all fields - from routine analysis to basic research and to empirical and rational methods (see section 5.3.). Some common areas in whichchemical measurements are needed, and in which the principles of this Guide may be applied, are:• Quality control and quality assurance in manufacturing industries.• Testing for regulatory compliance.• Testing utilising an agreed method.• Calibration of standards and equipment.• Measurements associated with the development and certification of reference materials.• Research and development. | |
1998 |
EURACHEM/CITAC Guide 1998 Quality Assurance for Research & Development and Non-routine Analysis |
This guide, produced by a joint Eurachem/CITAC working party representing industrial, academic, and governmental interests, promotes and describes the concepts of quality assurance in the non-routine environment. The guide promotes a nested approach to quality assurance, dealing with it at a general organisational level, a technical level and a project specific level. It is intended to promote the use of QA as an effective tool for establishing and maintaining quality in R&D and non-routine operations. It does not seek to set criteria for accreditation of R&D although there is a section describing various methods for third party assessment of quality systems. The guidance may form the basis on which accreditation criteria can be set in the future. The guidance is intended to complement the existing CITAC guide (CG1) which describes QA in the routine environment. It is primarily directed towards analytical chemistry establishments but is, in principle, applicable to other sectors. An extensive bibliography is included. | |
1998 |
EURACHEM Guide 1998 The Fitness for Purpose of Analytical Methods - Alaboratory guide to method validation and related topics
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This guide, produced by a correspondence group, comprising mainly Eurachem members is based on an earlier LGC-produced draft. A number of papers have been published promoting validation at a policy level. Others give guidance on validation for particular applications and the use of interlaboratory trials. The Eurachem guide aims to fill the gap in between by providing guidance on the various elements of validation (when methods should be validated, who carries out the validation, how methods should be validated, use of blanks, standards and replication) and is directed primarily towards laboratories working in isolation. Related issues are also dealt with: use of validated methods; designing quality control from validation data; implications of validation data for reporting; and documentation of methods. | |
Microbiological Testing Laboratories and testing accreditation bodies |
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2002 |
EURACHEM/EA Guide 2002 Accreditation for Microbiological Laboratories |
This document has been produced by a joint EURACHEM/EA Working Group. It supplements ISO/IEC 17025 and provides specific guidance on the accreditation of laboratories performing microbiological testing, for both assessors and laboratories preparing for accreditation. |
JAB
Japan Accreditation Board for Conformity Assessment www.jab.or.jp
Electrical Testing Laboratories & Calibration |
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Release | Document | Purpose | |
Ed. 1 March 25th. 2003
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JAB has published an explanatory document, JAB NOTE 4, about the uncertainty of measurement concerning High Power Testing, after two year dedication to the development. This document supervised by the Technical Sub-committee will be of help to those who are involved in calibration as well as high power testing.The document has been distributed to ILAC TAIC members for their comments. JAB also offered this to the APLAC Training Committee members as study aid for assessors and laboratory staff.It is our sincere hope that JAB NOTE 4 deepens readers understanding of measurement uncertainty.
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Medical Laboratories Reference Documents and Information
Laboratories Accreditation Bodies |
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Medical Laboratories Information Page |
The IAAC Laboratories Subcommittee has collected number of useful documents and links for medical laboratory accreditation. Including the following topics: ISO/IEC 15189 accreditation, Biosafety, Equipment, Validation, Preanalytical and Postanalytical procedures, Quality Assurance, Quality Control, EQAs, Uncertainty, Traceability, and useful links. |
NIST
National Institute for Standards and Technology www.nist.gov/nvlap
Laboratories Accreditation Bodies |
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Release | Document | Purpose | |
Technology Services Laboratory Metrology Metrology resources for government and commercial laboratories |
Round Robin Tools (Interlaboratory comparison, Proficiency Testing) NIST has developed a number of training tools and templates for use in conducting Interlaboratory Comparisons and Proficiency Tests. There is a great deal of useful information here as well as templates for worksheets, data analysis, etc. |
UKAS
United Kingdom Accreditation Service www.ukas.com
Laboratories Accreditation Bodies |
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Release | Document | Purpose | |
Edition 2, January 2007
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The Expression of Uncertainty and Confidence in Measurement |
The purpose of these guidelines is to provide policy on the evaluation and reporting of measurement uncertainty for testing and calibration laboratories. A number of worked examples are included in order to illustrate how practical implementation of the principles involved can be achieved. |
UNIDO
United Nations Industrial Development Organization www.unido.org
Laboratories Accreditation Bodies |
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Release | Document | Purpose | |
2003
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Laboratory Accreditation in Developing Economies: Tested Once - Accepted Everywhere Working paper No.2 - UNIDO/ILAC |
The purpose of this publication is to address the issue of accreditation for testing and calibration laboratories with special emphasis on the developing economies. The details of the intricacies of such accreditation are covered in the relevant ISO/IEC Guides and Standards and references are given to the appropriate documentation that is available from national and international standard organizations. What this document provides is a detailed step by step guide to the process of accreditation and its requirements in terms of governmental, technical and human resources support. The need for accreditation, what it means for the economy of any country and the role that it plays on the facilitation of both domestic and export trade is also addressed. It is stressed that accreditation is not the only recognized route for the conformity assessment but it is the one that offers the least duplication of effort, is the most transparent, most widely accepted and is the least discriminatory option.
It should however be stressed that while is a guide to accreditation for developing economies, there is no easy panacea for international recognition |
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2021 |
Use of uncertainty information in compliance assessment. (2nd ed. 2021) |
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2021 |
Selection, Use and Interpretation of Proficiency Testing (PT) Schemes by Laboratories |
International Recognition
IAAC is a Regional Cooperation Body recognized by IAF and ILAC
ILAC Recognition
The Inter American Accreditation Cooperation (IAAC) was accepted as a Regional Cooperation Body signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) for the scopes of Testing and Calibration Laboratories (under ISO/IEC 17025) and Medical Laboratories (under ISO 15189), as of November 2006.
IAAC was accepted as a Regional Cooperation Body signatory to the ILAC MRA for the scope of Inspection Bodies (under ISO/IEC 17020) as of October 2012.
IAAC was accepted as a signatory Regional Cooperation Body to the ILAC MRA for the scope of Proficiency Testing Providers (under ISO/IEC 17043) as of June 2020.
IAAC was accepted as a signatory Regional Cooperation Body to the ILAC MRA for the scope of Reference Materials Producers (RMP) (under ISO 17034) as of June 2021.
ILAC MRA recognition:
Main scopes:
Testing Laboratories - ISO/IEC 17025 - 12 November 2006
Medical Laboratories - ISO 15189
Calibration Laboratories - ISO/IEC 17025 - 12 November 2006
Inspection Bodies - ISO/IEC 17020 - 24 October 2012
Proficiency Testing Providers - ISO/IEC 17043 - 21 June 2020
Reference Materials Producers - ISO 17034 - 21 June 2021
IAF Recognition
IAAC was accepted as a signatory Regional Cooperation Body to the International Accreditation Forum (IAF), Multi-Lateral Recognition Arrangement (MLA) for the main scope of Management Systems Certification Bodies (under ISO/IEC 17021-1) with subscopes for Quality Management Systems (QMS), Environmental Management Systems (EMS), Food Safety Management Systems (FSMS), Information Security Management Systems (ISMS), Medical Devices Management Systems (MDMS), Energy Management Systems (EnMS) and Occupational Health & Safety Management Systems (OH&SMS). The first subscope for QMS was accepted in November 2006 and the additional subscopes have been accepted at different dates as listed below.
IAAC was accepted as a signatory Regional Cooperation Body to the IAF MLA for the scope of Product Certification Bodies under ISO/IEC 17065 (with subscope Global G.A.P) as of May 2011.
In 2020, IAAC submitted an application to IAF to extend its MLA recognition to the scopes of Persons Certification Bodies and Green House Gases (GHG) Validation/Verification Bodies. The IAF evaluations for these scopes is in process.
IAF MLA recognition:
Main scopes
Product Certification - ISO/IEC 17065 - 05 May 2011
Management Systems Certification - ISO/IEC 17021-1
Sub scopes
Level 4Product: GlobalG.A.P. IFA General Regulations - 22 May 2014Level 5
MS: ISO/TS 22003 - 05 Apr 2018
MS: ISO/IEC 17021-3 - 12 Nov 2006
MS: ISO/IEC 17021-2 - 05 May 2011
MS: ISO/IEC 27006 - 05 Apr 2018
MS: ISO 50003 - 18 Feb 2019
MS: ISO/IEC TS 17021-10 - 27 Oct 2020Product: GlobalG.A.P. IFA CPCCs - 22 May 2014
MS: ISO 22000 (FSMS) - 05 Apr 2018
MS: ISO 9001 (QMS) - 12 Nov 2006
MS: ISO 14001 (EMS) - 05 May 2011
MS: ISO/IEC 27001 (ISMS) - 05 Apr 2018
MS: ISO 13485 (MDMS) - 05 Apr 2018
MS: ISO 50001 (EnMS) - 18 Feb 2019
MS: ISO 45001 (OH&SMS) - 27 Oct 2020
International Recognition of IAAC
IAAC is a signatory to seven MLA/MRA main scopes with multiple subscopes, achieved after years of hard work undertaken by Accreditation Body members in the Americas who contributed their share to achieve this historic milestone. As a Regional Cooperation, IAAC is equivalent to the European Co-operation for Accreditation (EA), the Asia-Pacific Accreditation Cooperation (APAC), the Arab Accreditation Cooperation (ARAC), and the African Accreditation Cooperation (AFRAC), who have also been granted Regional Body recognition by IAF and ILAC.
What does this mean to us as members of IAAC? We are recognized members of the international accreditation communities. We are expected to promote and abide by ILAC and IAF Arrangements and to participate in ILAC and IAF activities. There are numerous committees in both organizations that are working on activities of interest to our region. A visit to the IAF website at www.iaf.nu or the ILAC site at www.ilac.org will give you a background on each organization and lists of committees and contact information.
Congratulations to all IAAC members and thank you to all who have contributed to these accomplishments!
IAAC Promotions Subcommittee
ILAC MRAs with IAAC |
IAF MLAs with IAAC |
Quality Management Systems Certification MLA | |
MD - Mandatory Documents
IAAC Mandatory Documents are documents that provide MLA requirements and mandatory applications of MLA requirements published under the authority of the IAAC General Assembly.
This category also includes the International Documents Mandatory for the MLA which are ILAC and IAF mandatory documents adopted by IAAC, as described in IAAC PR 001. Translations of ILAC/IAF documents prepared by IAAC also apply to this category.
Mandatory Documents issued by IAAC
Mandatory document for all scopes of the IAAC MLA.
Mandatory document for all scopes of the IAAC MLA.
Mandatory document for all scopes of the IAAC MLA.
Mandatory document for all scopes of the IAAC MLA.
Mandatory Documents issued by IAF-ILAC
Mandatory document for all scopes of the IAAC MLA.
Mandatory document for all scopes of the IAAC MLA. The application date of this document is immediate for all peer evaluations carried out on the basis of ISO/IEC 17011:2017
The IAF and ILAC General Assemblies have supported the publication of this statement, Replacement of Assessments During the COVID-19 Pandemic, developed by a Joint IAF/ILAC Executive Committee Task Force. The implementation date for this statement is the date of publication, i.e. March 2021.
This addendum to IAF/ILAC A1 and A2, which will remain in effect for the duration of the pandemic, provides policies for the role and conduct of remote peer evaluations and allows for a more flexible approach to remote witnessing activities.
A Word version of this document is available for use by ABs when writing their own self-evaluation.
Mandatory Documents issued by ILAC
Mandatory document for the IAAC MLA for Testing Laboratories including Medical/Clinical Laboratories, Calibration Laboratories, Inspection Bodies, Proficiency Testing Providers and Reference Materials Producers, for those ABs that are ILAC members.
Mandatory document for the IAAC MLA for Testing including Medical/Clinical, Calibration and Inspection.
Mandatory document for the IAAC MLA for Testing including Medical/Clinical and Calibration Laboratories, and Inspection Bodies.
Mandatory document for the IAAC MLA for Testing including Medical/Clinical and Calibration Laboratories.
This latest version of ILAC P10 has an implementation period of 12 months from the date of publication, ie July 2021.
Mandatory document for the IAAC MLA for Calibration.
This document sets out the requirements and guidelines for the estimation and statement of uncertainty in calibration. This latest revision reflects the 2017 versions of ISO/IEC 17011 and ISO/IEC 17025. The policy continues to be based on the Guide to Uncertainty in Measurement (GUM) and retains the common understanding of the term CMC from the joint declaration issued by the BIPM and ILAC https://ilac.org/about-ilac/partnerships/international-partners/bipm/ The implementation date for this most recent version of ILAC P14 is March 2021.
Mandatory document for the IAAC MLA for Inspection. This revision includes updates as a result of the outcome of the ILAC Inspection Committee workshops, ISO CASCO clarification requests, the experience gained in the application of ISO/IEC 17020:2012, and the previous version of ILAC P15. The implementation date for ILAC P15:05/2020 is 18 months from the date of publication on the ILAC website (November 2021).
Mandatory Documents issued by IAF
Mandatory document for the IAAC MLA for certification of management systems.
Mandatory document for the IAAC MLA for certification of management systems.
The scope of this document is for the auditing/assessment of management systems, persons and product and is applicable to conformity assessment bodies and accreditation bodies. The use of ICT is not mandatory and may be used for other types of conformity assessment activities, but if used as part of the audit/assessment methodology, it is mandatory to conform to this document.
This document is mandatory for the consistent application of the relevant clauses of ISO/IEC 17021-1 for audits of quality, environmental, and occupational health and safety management systems. All clauses of ISO/IEC 17021-1 continue to apply and this document does not supersede any of the requirements in that standard. Application deadline: May 7, 2020.
Mandatory document for the IAAC MLA for Green House Gases -validation/verification.
Mandatory document for the IAAC MLA for certification. This Mandatory document clarifies situations where sanctions are to be applied to applicant or accredited conformity assessment bodies.and the subsequent necessary communication which shall be taken by accreditation bodies.
Deadline for implementation: February 21, 2024.
Mandatory document for the IAAC MLA for medical devices quality management systems certification.
Mandatory document for the IAAC MLA for medical devices quality management systems certification.
Provides requirements for the application of ISO/IEC 17021 for the planning and delivery of audits of IMS and, if appropriate, the certification of an organization’s management system(s) against two or more sets of audit criteria/standards.
Mandatory document for the IAAC MLA for certification.
Mandatory document for the IAAC MLA for certification of information security management systems. The implementation deadline is 3 December 2020. This document provides specific knowledge requirements for Accreditation Body personnel to harmonize their application of Clause 6.1.2.1 of ISO/IEC 17011:2017 for the accreditation of bodies providing audit and certification of information security management systems (ISMS) to ISO/IEC 27001.
Mandatory document for the IAAC MLA for verification/validation of Green House Gases.
Mandatory document for the IAAC MLA for certification of management systems.
Mandatory document for the IAAC MLA for certification of Food Safety Management Systems.
This document is mandatory for the consistent application of the relevant clauses of ISO/IEC 17011:2017 Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies. Application deadline: May 7, 2020.
This document is mandatory for the consistent application of ISO/IEC 17021-1:2015 for the accreditation of Certification Bodies providing certification of Occupational Health and Safety Management Systems (OH&SMS).
This document relates to entities, performing and/or managing management system certification activities, on behalf of Certification Bodies (CBs) holding accreditation, which are not wholly or partly owned or employed by the CB.
This new Mandatory Document contains minimum requirements for conformity assessment schemes (CAS) to be applied by IAF member accreditation bodies when evaluating national, regional or international CAS to ensure they meet requirements specified in ISO/IEC 17011, Clause 4.6.3.
Implementation deadline is January 7, 2024.
This document provides transition requirements for ISO/IEC 27001:2022.
The deadline for implementation is February 15, 2023.
Mandatory document for the IAAC MLA for certification of management systems, product and persons, and for green house gases validation/verification, for those ABs that are IAF members.