Feedback

Complaints provide a valuable mechanism for receiving feedback relating to the effectiveness of the MLA. This often confirms that the MLA is working effectively and that the process in place is suitably robust. It can also provide information that can be used to improve areas of the MLA. The following numbers of complaints were raised during this period:

IAF:

• Direct complaints against IAF – one received and closed during 2021
• Complaints referred to IAF – one received and closed during 2021; two received in previous years of which one was closed, and one remains open.
• Complaints referred to ABs – eight received and remain open

EA:

• 3 new complaints received; 5 complaints (including cases opened before 2021) were processed and 4 complaints (including cases opened before 2021) were closed; 1 complaint remained open on 31 December 2021
• 0 new appeals were received in 2021; 0 appeals were processed; 0 appeals remained open on 31 December 2021

APAC: 4 complaints received

IAAC: 0 complaints received regarding MLA related issues; 3 appeals of AB members’ findings raised by the peer evaluation team during its evaluation

ARAC: 0

AFRAC: 0

SADCA: 0

COVID-19 Response

Following the declaration of COVID-19 as a pandemic and the imposition of social distancing and travel restrictions, IAF immediately began developing resources in response, working closely with stakeholders to address their needs. In collaboration with ILAC and the RAGs, a framework of measures was developed to allow assessments and peer evaluations to be performed remotely, guaranteeing the maintenance of a high level of competence and harmonization.

In 2021, IAF and ILAC published several new documents relating to the pandemic:

• IAF/ILAC Approach to Remote Peer-Evaluations of Regions and Single Accreditation Bodies During the COVID-19 Pandemic, an addendum to IAF/ILAC A1 – IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Requirements and Procedures for Evaluation of a Regional Group and IAF/ILAC A2 – IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Requirements and Procedures for Evaluation of a Single Accreditation Body. This addendum provides policies for the role and conduct of remote peer evaluations and allows for a more flexible approach to remote witnessing activities.
• The joint statement Replacement of Assessments During the COVID-19 Pandemic, which addresses situations where pandemic-related circumstances such as travel restrictions, social distancing, and health and safety considerations disrupt mandatory scheduled on-site or remote assessments by IAF MLA or ILAC MRA signatories. This statement allows for an off-site review of documentation to replace an assessment in extraordinary circumstances caused by the pandemic and only under specific conditions as defined in the statement.

These documents supplement resources published in 2020, which include:

• An IAF Statement on COVID-19, which highlights relevant IAF documents on extraordinary events and the use of information and communications technology in audits and assessments.
• A series of COVID-19 FAQs endorsed at the 2020 IAF General Assembly, which helps certification-based stakeholders (certified clients, certification bodies, accreditation bodies, scheme owners and regulators) maintain a harmonized approach.
• An IAF-ILAC Statement re Delayed Evaluations – March 2020, which provides guidelines that ensured the consistent transition of all IAF MLA and ILAC MRA signatories to the latest version of ISO/IEC 17011.

The COVID-19 hub on the IAF website contains links to all current resources.

The IAF MLA Management Committee and ILAC Arrangement Management Committee continued meeting remotely following the imposition of travel restrictions. Additionally, IAF collaborated with other international organizations to share experiences of working remotely and highlight the role of conformity assessment in supporting health and safety during the pandemic.

IAF, ILAC and ISO undertook a joint survey in 2021 to obtain the views of a diverse range of stakeholders on the use of remote techniques in audits, assessments and evaluations, which has increased during the pandemic. In total, 4350 responses were received. Results showed that a large majority of respondents prefer remote or blended audits, assessments, and evaluations, feel that remote activities provide as much confidence as on-site, and would like to see continued or increased use of remote activities in the future. More information on the results is available here.

Improvement Activities

IAF consults widely with stakeholders to deliver a high standard of conformity assessment, and to provide stakeholders with a value-added outcome. The following activities were carried out to improve the MLA in 2021:

IAF: Collaboration with ILAC has continually improved to a point where only IAF/ILAC Joint Management Committee (JMC) meetings are held and there are no separate meetings of the IAF MLA MC and the ILAC AMC. This provides for a better understanding of the few different requirements and the many commonalities in the MLA area between the two organisations. Changes to the IAF membership on the JMC was implemented on 01 January 2021 to achieve a more balanced representation from both organisations.

EA:

• The EA peer evaluation process is under continuous review. Regulation (EC) No 765/2008 reinforces the role of EA and its peer evaluation role in both voluntary and regulated sectors. EA aims to support and harmonize the implementation of stringent rules to achieve consistency throughout Europe, as well as greater transparency and acceptability to all, including national authorities. The peer evaluation process is also further strengthened to accommodate the specific needs of regulatory fields to raise the assurance of regulators and stakeholders that ABs’ technical competence is thoroughly assessed.
• The Multilateral Agreement Council (MAC) project aiming at re-engineering the peer evaluation system, one of the key actions of the EA Strategy 2025, progressed in 2021 and is nearing its goal.
• The MAC has been finalising the revision of EA-2/02: EA Procedure for the Evaluation of a National Accreditation Body, as well as the revision of the MAC Terms of Reference in order to include the role and responsibilities of the Secretariat and to annex the competence criteria for decision-makers.
• The MAC has also been developing five supplements to EA-2/02 in order to set out:
  1. EA-2/02 S1: Description of Competence Criteria of the EA Secretariat Personnel Involved in the Management of the Peer-Evaluation Process
  2. EA-2/02 S2: Circumstances and Process of Involving EA Technical Committees in Peer-Evaluation Issues
  3. EA-2/02 S3: Risk-Based Approach for the Planning of a Peer Evaluation of a National Accreditation Body
  4. EA-2/02 S4: Procedure for Remote Peer Evaluations during the COVID-19 Pandemic
  5. EA-2/02 S5: Procedure for Remote Decision-Making
• EA-2/02 S1, S2 and S4 were published in February 2022; the S3 and S5 supplements, whose title may still be changed, should be available in the first half of 2022.

APAC: Review of the APAC MRA evaluation procedures (APAC MRA-001) is underway to take into account experiences over the past three years and remote evaluation. APAC also revised and republished APAC TEC1-008 Guidance for Accreditation of Reference Material Producers and APAC TEC1-001 APAC Guidance on Scopes of Accreditation for Biobanks.

IAAC: In 2021, IAAC created a new Technical Secretariat position to help improve the MLA processes and to develop new MLA scopes.

ARAC:

• In its second edition and on the occasion of World Accreditation Day (WAD) 2021, ARAC organized the Arab Accreditation Week (AAW) during the period 06-11 June 2021 under the theme “Together towards enhancing the role of accreditation in supporting the achievement of the Sustainable Development Goals (SDGs) in the Arab region”.
• Several online activities held during the AAW demonstrated ways to further develop the accreditation infrastructure in the Arab region and highlight the pivotal role it plays in achieving the Sustainable Development Goals (SDGs), in addition to capacity building activities implemented to strengthen the ARAC member competencies:
  1. Webinar on the benefits of ARAC MLA recognition to the ARAC AB members and the benefits of accreditation to governments: The event, organised as part of the ARAC communication strategy, further contributed to strengthening the visibility of ARAC inside and outside the accreditation community, supporting recognition and acceptance of the IAF MLA and ARAC MLA and services/products provided under accreditation issued by the ARAC AB members. By the end of the awareness sessions, the participants had a good understanding of how accreditation, the ARAC MLA and its members benefit regulators, industries, economies and CABs.
  2. Webinar on accreditation in the digital era: This webinar aimed to review the experiences from ARAC ABs on how they had operated under the specific situation of COVID-19 by using information and communication technologies while, most importantly, maintaining the integrity of a robust accreditation system. The event gave ARAC AB members a common understanding and a guidance on how to go digital in a harmonized way with adequate digitalization tools to operate efficiently and effectively.

AFRAC:

• AFRAC continues to promote the IAF MLA and ILAC MRA in the current Continental Free Trade Area (FTA) discussions. The MRA has already been incorporated in the FTA between SADCA, the East African Community and the Common Market for Eastern and Southern Africa, which consists of 26 economies in Africa.
• The AFRAC MRA brochure is aligned to ILAC MRA and IAF MLA requirements.
• AFRAC publishes a newsletter twice yearly with articles promoting the AFRAC MRA and IAF MLA as well as WAD celebrations where IAF and ILAC are given prominence by ABs and National Accreditation Focal Points (NAFPs) across the continent.
• AFRAC documents are aligned to the IAF requirements, with continued adoption and promotion of IAF mandatory and guidance documents by AFRAC.
• AB transitions to new standards are continuously monitored by AFRAC.
• The incorporation of AFRAC as a legal entity is in its final stages.

SADCA:

• AB transitions to new standards are continuously monitored by SADCA.
• SADCA documents are aligned to the IAF requirements, with continued adoption of IAF mandatory and guidance documents by SADCA.
• SADCA publishes an annual newsletter promoting SADCA AB and NAFP members, WAD and the IAF MLA.
• SADCA posts articles on the website under latest news and in the SADCA summit brochure.

Training

A number of training sessions, seminars and workshops took place during 2021 to extend the knowledge base, share best practices, and to maintain the competence of peer evaluators and assessment personnel:

EA:

• In order to support the ongoing improvement of EA’s pool of evaluators, three refresher training sessions were organised remotely in 2021 due to the health and travel conditions related to the COVID-19 pandemic:
  1. The first refresher training session held on 8-9 June 2021 was dedicated to Management Systems Certification and Certification of Persons. 31 participants from 20 NABs took part in the program covering:
     1. The procedural aspects related to the peer-evaluation process.
     2. The more technical aspects directly related to the specific fields and applicable standards, namely ISO/IEC 17021-1 and 17024.
  2. The second refresher training session held on 15-16 June 2021 gathered 26 team leaders and deputy team leaders from 16 NABs to discuss:
     1. The specificities of on-site evaluations and remote evaluations.
     2. The application review and preparation of the evaluation.
  3. The third refresher training session held on 8-9 December 2021 was dedicated to testing, medical examination and reference material producers. 33 peer evaluators from 22 NABs participated in the program covering:
     1. The procedural aspects related to the peer evaluation process.
     2. The more technical aspects directly related to the specific fields and applicable standards, namely ISO/IEC 17025, ISO 15189 and ISO 17034.
• Other training sessions:
  1. Jointly with the European Network of Forensic Science Institutes (ENFSI), EA organised an online seminar on accreditation in the sector of crime scene investigation (CSI) on 22 March 2021. Initiated by the EA Inspection Committee (IC), this seminar enabled six speakers from ENFSI to share their experience in accreditation of forensic laboratories in Europe with almost 300 participants. As part of the AFORE (Accreditation of Forensic Laboratories in Europe) project, aiming to support forensic science laboratories across the European Union Member States to move towards accreditation, the objective of this seminar was to promote awareness of CSI processes towards EA and provide a better understanding of the whole forensic process, including:
     1. CSI and laboratory activities (e.g., logistics, search for traces, different types of traces).
     2. The different roles of personnel conducting CSI (e.g., crime scene manager, scene of crime examiner, forensic scientist).
     3. The principles and importance of CSI (such as documentation of the scene, identification of the crime, etc.).
     4. A concrete rape and murder case.
     5. The benefits of accreditation of CSI.
  2. Another seminar was organised together with the European Union Agency for Cybersecurity (ENISA) on 24 September 2021 to support EA NABs in the implementation of the European candidate cybersecurity certification (EUCC) scheme and to start with the accreditation of CBs and IT Security evaluation facilities (ITSEFs) as soon as the scheme is published in the Official Journal of the European Union in 2022. More than 100 participants including representatives from EA NABs and Recognised Stakeholders, as well as National Cybersecurity Certification Authorities (NCCA), attended this EA/ENISA webinar focused on the following issues under the Cybersecurity Act (CSA):
     1. Common Criteria based EUCC.
     2. EUCC: Guidelines on the accreditation of laboratories (ITSEFs: IT Security evaluation facilities).
     3. Pilot run to the EUCC scheme.
  3. EA launched its eLearning platform in summer 2021. So far one e-Learning module dedicated to Regulation (EU) 2015/757 on the Monitoring, Reporting and Verification (MRV) of Carbon Dioxide Emissions from Maritime Transport has been made accessible.

APAC: No evaluator training took place in 2021.

IAAC:

• IAAC held a virtual workshop on ISO/IEC 17029:2019 Conformity assessment — General principles and requirements for validation and verification bodies on 22 and 24 February 2021.
• IAAC held a virtual workshop for IAAC peer evaluators regarding ISO/IEC 17024, IAAC and IAF requirements.

ARAC:

• Peer evaluators workshop on ARAC MLAG Policy and Procedure for Guiding Remote Peer Evaluations: Further to the publication of the IAF/ILAC document IAF/ILAC Approach to Remote Peer Evaluations of Regions and Single Accreditation Bodies during the COVID-19 Pandemic, a workshop for ARAC peer evaluators was conducted on 23 and 24 March 2021 on the developed ARAC MLA Group guidance document ARAC MLAG Policy and Procedure for Guiding Remote Peer Evaluations, which provides requirements and guidance for ARAC peer evaluators on how to plan, manage, and facilitate remote evaluations using information and communications technology as a complement or substitute to traditional evaluation techniques.
• Online Regional workshop on ISO/IEC 17024:2012: Within the framework of the implementation of the ARAC capacity building program, and with the participation of more than 60 ARAC ABs’ personnel involved in the accreditation process (ARAC ABs’ staff, lead assessors, technical assessors, technical experts and decision makers), the ARAC online Regional workshop on ISO/IEC 17024:2012 Conformity assessment – General requirements for bodies operating certification of persons requirements and the applicable IAF documents was successfully conducted during the period of 14–17 June 2021. The regional training workshop was facilitated by Dr. Cynthia D Woodley and was aimed at helping the ARAC ABs extend their activities in order to operate effectively in the area of accreditation of bodies certifying persons.

AFRAC: The following trainings/workshops took place in 2021:

• Evaluator and AB training on ILAC P15:2020 on 25-26 February 2021.
• Peer evaluator workshop on Remote Evaluation Processes presented via Zoom teleconference on 8 April 2021.
• Open training on ISO/IEC 17034 on 8 June 2021.
• Open training on ISO 15190 – Medical Laboratories – Requirements for Safety on 10 June 2021.
• Open training on calibration and metrological traceability in medical laboratories on 11 June 2021.
• Open workshop on Sharing of Experiences – Remote Technique in Assessments on 27 September 2021.

SADCA: On 8 April 2021, SADCA evaluators and AB members attended the training on remote evaluation processes and techniques, hosted by AFRAC. This training was aimed at evaluators and AB members.