Inter American Accreditation Cooperation

IAAC Evaluation: <insert AB acronym – <insert report status> REPORT Issued on: <XX/XX/XXX

Inter American Accreditation Cooperation

<insert report status (draft #, final)REPORTON THE<type of>EVALUATIONOF THE

<insert AB full name (and acronym)

BY THE

INTERAMERICAN ACCREDITATION COOPERATION

(IAAC)

<insert dates of on-site evaluation>

EVALUATION TEAM MEMBERS:

<insert name, accreditation body, economy & role for each team member e.g.

Ms AAA (AB1, Country) – Team Leader

Mr. BBB (AB2, Country) – Team member

Mr CCC(AB3, Country) – Team Member

Observers

Ms. OOO (Organization) - Observer

<TL andAB: INSTRUCTIONS FOR USE OF THIS TEMPLATE:

(Note: These instructions are to be removed from the final report.

This document is largely based on document IAF/ILAC A3. It contains instructions to the evaluation team and the accreditation body. Instructions to the accreditation body are identified by “AB” and are written in blue. Instructions to the evaluation team are identified by “TL” and are written in red. Those instructions are to be removed from the final report.)

This Report is

CONFIDENTIAL

to the

Evaluation Team Members

Members of the IAAC MLA Group

IAAC PEER EVALUATION REPORT TEMPLATE

Prepared by: MLA CommitteeApproved by: Executive CommitteePage 1 of 41

Issue Num. 3 Rev.1Issue Date:September8, 2016 IAAC FM 033/16 Application date: Immediate

IAAC Evaluation: <insert AB acronym – <insert report status> REPORT Issued on: <XX/XX/XXX

CONTENTS

Section / Title / Page
Contents. / 2
1 / Summary / 4
2 / Introduction
2.1 / Reason for the Evaluation
2.2 / Participants in the Evaluation
2.3 / Evaluation Criteria
2.4 / Evaluation Activities
2.5 / Follow-up on Previous Evaluation Findings
2.6 / Recommendation to the IAAC MLA Group
3 / Background and History of <insert acronym of AB> .
4 / Performance of the <insert acronym of AB> System – ISO/IEC 17011 Clauses Report .
4.1 / Accreditation Body
4.2 / Management
4.3 / Human Resources
4.4 / Accreditation Process
4.5 / Responsibilities of the Accreditation Body and the CAB
5 / Mutual Recognition Arrangement (MLA) Obligations
Annex 1 / FM 005 - Findings, AB’s Responses and Evaluation Team’s Reactions
Annex 2 / FM 004 - Evaluation Program
Annex 3 / FM 012 - Reports on the assessments witnessed

Section 1: SUMMARY

TL:This section shall be completed by the evaluation team, and presented to the AB, normally on the last day of the on-site evaluation. It would normally be produced as a separate documentand inserted in to the evaluation report in this section. Once accepted by the AB at the conclusion of the on-site evaluation it cannot be changed. The following is a possible template for presentation of the Summary but the evaluation team shall ensure the wording is relevant to the scope of the evaluation. This template does not attempt to cover all eventualities.>

(Note: This summary was presented to <insert acronym of AB>on <insert date> following conclusion of the evaluation.)

This is a report on the <type of evaluation e.g. initial, periodic re-, etc. evaluation of the <insert full name and (acronym) of AB>on behalf of the Interamerican Accreditation Cooperation(IAAC) for the purpose of obtaining evidence to determine:

(a)<for a re-evaluation>Whether theIAAC Mutual Recognition Arrangement (MLA) signatory status of <insert acronym of AB>for the accreditation of <insert MLA scope of the AB e.g. testing laboratories (ISO/IEC 17025, ISO 15189), calibration laboratories, inspection bodies, reference material producers, proficiency testing providers, managements system certification bodies for QMS, EMS, FSMS, ISMS, MDMS, product certification bodies, certification bodies of persons, validation and verification bodies should be maintained; <and/or>

(b)<for an initial evaluation or MLA scope extension evaluation>Whether<insert acronym of AB>should be recommended as a full signatory to the IAACMLA for the accreditation of <insert evaluated scope for which AB has applied e.g. testing laboratories (ISO/IEC 17025, ISO 15189), calibration laboratories, inspection bodies, reference material producers, proficiency testing providers, managements system certification bodies for QMS, EMS, FSMS, ISMS, MDMS, product certification bodies, certification bodies of persons, validation and verification bodies for GHG.

The evaluation visit took place from <insert day and date> to <insert day and date> inclusive, The evaluation was conducted in accordance with, and against the requirements specified in IAACMD 002.

TL:The next section should give overview statements on the general level of compliance with MLA criteria, and should be itemized to reflect the evaluation criteria listed in Section 2.3 of this report. The statements shall be factual and representative of the situation as observed by the evaluation team. Strengths of the AB’s accreditation system should include reference to relevant sections / topics of ISO/IEC 17011 and other MLA requirements. The following is an example of an accreditation body that has performed well – actual statements used in your report may not be so positive.>

The evaluation team has the pleasure to confirm that the overall operation of <insert acronym of AB>is in accordance with the requirements of IAACMD 002. In particular:

(a)<insert acronym of AB>operates its <insert MLA scope e.g. testing laboratory, calibration laboratory, inspection body, reference material producer, proficiency testing providersaccreditation program(s)substantially in accordance with the requirements of ISO/IEC 17011 and IAF/ILAC-A5; and <where relevant>for its proficiency testing provider accreditation program, substantially in accordance with the requirements of ILAC-P13, for MDMS accreditation, <substantially> in accordance with the requirements of IAF MD 008.

(b)<insert acronym of AB> has implemented a sound (oreffective) <refer to any part of the management system that is worth mentioning and refer to the relevant section of ISO/IEC 17011> e.g. management system (ISO/IEC 17011, section 5), system for ensuring the competence of assessors (section 6) etc.;

(c)<where relevant>Laboratories accredited by <insert acronym of AB>have been assessed against and found to comply with the requirements of ISO/IEC 17025;

(d)<where relevant> Medical testing laboratories accredited by <insert acronym of AB> have been assessed against and found to comply with the requirements of ISO 15189;

(e)<where relevant>Inspection bodies accredited by <insert acronym of AB>have been assessed against and found to comply with the requirements of ISO/IEC 17020 andILAC P-15;

(f)<where relevant>Reference material producers accredited by <insert acronym of AB>have been assessed against and found to comply with the requirements of ISO Guide 34;

(g)<where relevant>Proficiency testing providers accredited by <insert acronym of AB> have been assessed against and found to comply with the requirements of ISO/IEC 17043;

(h)<where relevant> Management System Certification Bodies accredited by<insert acronym of AB> have been assessed against and found to comply with the requirements of ISO/IEC 17021, and the relevant standards for each scope of certification: <as relevant>ISO 9001 (QMS), ISO 14001 (EMS), ISO 22003 and ISO 22000 (FSMS), ISO 27006 and ISO 27001 (ISMS), ISO 13485 (MDMS) and relevant IAF Mandatory Applications (IAF MD);

(i)<where relevant> Product Certification Bodies accredited by<insert acronym of AB> have been assessed against and found to comply with the requirements of ISO/IEC 17065;

(j)<where relevant> Certification Bodies of Persons accredited by<insert acronym of AB> have been assessed against and found to comply with the requirements of ISO/IEC 17024;

(k)<where relevant> Validation and Verification Bodies for GHG accredited by<insert acronym of AB> have been assessed against and found to comply with the requirements of ISO 14065, and the relevant application to the scope of validation or verification: <as relevant> ISO 14064-1, ISO 14064-2, ISO 14064-3, ISO 14066 and IAF MD 006

(l)<insert acronym of AB> adopts and substantially implements the International Laboratory Accreditation Cooperation (ILAC) policy on traceability of measurement results (ILAC-P10), and the <insert country national measurement system can provide satisfactory measurement support to <insert acronym of AB>accredited <as relevant>laboratories, inspection bodies, reference material producers, and proficiency testing providers in the basic physical units;

(m)<insert acronym of AB> adopts and <substantially> implements the International Laboratory Accreditation Cooperation (ILAC) supplementary requirements and guidelines for the use of accreditation symbols and for claims of accreditation status (ILAC-P8)

(n)<insert brief overview description of skills, experience and levels of qualification of AB staff and access to assessors and their skills, experience and qualifications e.g.<insert acronym of AB>permanent staff are skilled and satisfactorily technically qualified for the functions they perform, and the organization has an excellent foundation of accreditation experience. <insert acronym of AB>has access to a sufficient number of well qualified, experienced and competent external Technical Assessors and Experts (ISO/IEC 17011, section 6);

(o)<insert a brief overview description of the accreditation process, its maturity and its application in practice e.g.> <insert acronym of AB>has a well established accreditation processwhich is applied consistently to the accreditation of its <where relevant>laboratories, inspection bodies, reference material producers, proficiency testing providers, managements system certification bodies for QMS, EMS, FSMS, ISMS, MDMS, product certification bodies, certification bodies of persons, validation and verification bodies (ISO/IEC 17011, section 7);

(p)<insert acronym of AB>has the necessary commitment, financial and other resources to continue to operate an independent (suite of) accreditation program(s)(ISO/IEC 17011, section 4.5);

(q)<insert acronym of AB>and its accredited laboratories meet, as far as practicable, the ILAC P9 requirements for proficiency testing activity and has participated in a number of IAAC PT programs. The performance of their accredited laboratories since <insert date of last IAAC evaluation> has been generally satisfactory and outliers have been investigated. <insert acronym of AB> has organized a range of PT programs for its accredited organizations;

(r)<insert acronym of AB> has documented and implemented an appropriate cross-frontier accreditation policy taking into account ILAC G21 and incompliance with IAF MD 12;

(s)<insert acronym of AB>fulfils its MLAobligations under the IAAC MD 001 andILAC P5, IAF ML 4.

(t)<as relevant>and<insert acronym of AB> has implemented the General principles on use of the IAF MLA Mark (IAF ML2) and the Rules for the Use of the ILAC MRA Mark (ILAC R7);

(u)The assessment and surveillance activities of <insert acronym of AB>provide a degree of assurance such that the results and data obtained by <insert acronym of AB>accredited organizations are equivalent to those issued by organizations accredited by other (potential <for MLA scope extensions>) IAACMLA partners.

<as relevant>In addition, the evaluation team has verified the implementation of the actions taken by <insert acronym of AB> to address the findings of the previous evaluation and found that they were <generally> addressed satisfactorily.

During this evaluation the <insert acronym of AB>offices in <insert city and economy> were visited. The following accreditation assessments were witnessed by the evaluation team:

<list type and duration of assessments observed>

Testing: / <e.g. 1 initial assessment (2 days; food chemical testing); 1 surveillance assessment (1 day; electrical/EMC testing)>
Medical Testing: / <e.g. 1 reassessment (3 days)>
Calibration: / <e.g. 1 reassessment (3 days; dimensional, electrical, temperature)>
Inspection: / <e.g. 1 reassessment (2 days; engineering safety)>
Reference Material Producer: / <e.g. 1 initial assessment (3 days; chemical solutions)>
Proficiency Testing Provider: / <e.g. 1 reassessment (2 days; food chemistry and microbiology>
QMS Certification Body / <e.g. 1 surveillance visit where all requirements of ISO/IEC 17021 were assessed, 2 days>
EMS Certification Body / <e.g. 1 surveillance visit with an extension of scope where all requirements of ISO/IEC 17021 were assessed, 2 days>
FSMS Certification Body / <e.g. 1 extension of scope, 1,5 days>
ISMS Certification Body / <e.g. 1 extension of scope, 1 day>
MDMS Certification Body / <e.g. 1 initial assessment , 3 days)>
Product Certification Body / <e.g. 1 surveillance visit 2 days, 1 surveilance visit 1 day>
Certification Body of Persons / <e.g. 1 initial assessment, 2,5 days >
Validation and verification Body for GHG / <e.g. 1 initial assessment, 4 days >

<insert statement(s) as to the witnessed conduct of the assessments e.g. All the assessments witnessed were, without exception, of a high standard in terms of their scope and depth.

<as relevant> The evaluation team also visit the facilities of <name of the NMI> to discuss its calibration and measurement capabilities.

The evaluation team was impressed with <list those elements that are especially noteworthy e.g. the expertise of staff and/or assessment teams; the quality and/or thoroughness of assessments; knowledge of and adherence to procedures; etc.>

TL: insert brief summary of the findings in relation to nonconformities, concerns and comments, as appropriate e.g.>

The evaluation team raised <number>nonconformities, <number> concerns, and <number> comments. The <number>nonconformities relate to <brief statement on the area of ISO/IEC 17011 they relate to e.g. assessor monitoring, related body analysis,etc.>, and the <number>concerns relate to <brief statement on the area of ISO/IEC 17011 they relate to e.g. assessor monitoring, related body analysis, etc.>.Full details of all nonconformities, concerns and comments are given in Annex 1 to this report.

<as relevant> <insert acronym of AB> is required to respond to those findings within the deadline established in IAAC MD 002. In that response <insert acronym of AB> shall:

For initial evaluations and extensions of scopes>

- Within 3 months from the evaluation <insert acronym of AB>shall present an action plan and time schedule for implementation of actions for nonconformities and concerns as well as responses to the comments.
- within 8 months from the evaluation< or as agreed with the TL>,<insert acronym of AB>should provide evidence of effective implementation of corrective actions for nonconformities and evidence to confirm that implementation of actions plans for concerns have started.
<as relevant> <In case there is a need for a follow up visit to confirm implementation of actions,<insert acronym of AB>shall present evidence of implementation of actions at least two months before the follow up visit, or as agreed with the TL.

For re-evaluations

- Within 1 month from the reevaluation ,<insert acronym of AB>shall present an action plan and time schedule for implementation of corrective actions for nonconformities and concerns, as well as responses to the comments;
Within 3 months from the evaluation,<insert acronym of AB>shallprovide evidence of effective implementation of corrective actions for nonconformities and evidence to confirm that implementation of actions plans for concerns has started.
-<as relevant>In case there is a need for a follow up visit to confirm implementation of actions<insert acronym of AB>shall present evidence of implementation of actions at least two months before the follow up visit, or as agreed with the TL.

The evaluation team will forward its recommendation to the IAAC MLA Group when it has received satisfactory responses to non-conformities, concerns and comments.

TL: If a follow up visit is recommended by the evaluation team to be done before a final decision by the MLA Group is made , the evaluation team shall inform in the summary section the reasons for the visit including the MLA scopes that are affected, preferably with reference to the findings to be checked, and propose a composition of the evaluation team.>

<TL: In the case where during an on-site the evaluation team finds non conformities that clearly show that the AB is not able to ensure confidence in the accreditations granted and the competence of the accredited CAB is questioned, the evaluation team shall make a recommendation for suspension of the AB. The recommendation shall indicate the reason for the suspension including the MLA scopes that are affected, with reference to the relevant findings. >

The evaluation team would like to thank <insert acronym of AB> and its staff for their co-operation in the arrangements for, and conduct of the evaluation and for the hospitality shown to the team during the evaluation. The evaluation team would also like to thank the <insert acronym of AB> external assessors<and experts>, and the accredited and applicant organizations involved in the witnessing of assessments for their co-operation and hospitality.

Evaluator’s name (Team Member; AB2, Country)

Evaluator’s name (Team Member; NMI, Country)>

Evaluator’s name (Team Leader; AB1, Country)>

<as relevant> < if a follow up visit is done before a final decision by the IAAC MLA Group> Section 1.1:Summary of the follow up

TL: If the follow up visit aims at checking implementation of corrective actions before IAAC MLA Group makes a decision on granting or maintaining recognition, the information on the activities done in the follow up visit shall be included in the summary section of the Final Report of that evaluation as follows:

a)The report shall include a section with a summary of the follow up visit, including the reasons for the follow up visit; reference to the decision authorizing the visit, either by the MLA Group or the Chairperson of the MLA Group; the evaluators participating in the visit and dates of the visit; a summary of the activities performed by the evaluation team: confirmation whether or not all findings have been closed; and the next steps of the process.

b)An annex with the follow up visit program.

c)An annex with the report on any assessments witnessed using form FM 012.

d)In form FM 005 (Annex 1), information about the evidence obtained by the evaluation team for each of the findings that was checked, if relevant confirmation that the finding is closed or information on the actions that are still pending.

The summary section about the follow up visit and the updated form FM 005 shall be provided to the AB at the end of the follow up visit.

Section 2: INTRODUCTION

2.1Objectives of the Evaluation

This was a <insert type of evaluation e.g. initial, periodic re-, etc. > evaluation conducted on behalf of the InteramericanAccreditation Cooperation (IAAC) to:

(i)<for re-evaluations> Reconfirm conformity with specified criteria for the continuation of <insert acronym of AB> Signatory Status in the IAAC Mutual Recognition Arrangement (MLA) for the accreditation of <insert existing IAACMLA scope of the AB>(and thus also continuation of <insert acronym of AB> Signatory Status in the ILAC MLA for <insert existing ILAC MLA scope>and IAF MLA <insert existing IAF MLA scope>by virtue of IAAC’s status as a Regional Co-operation recognized by ILAC and IAF);

(ii)<and/or for initial evaluations and MLA scope extension evaluations> Establish conformity with specified criteria for <insert acronym of AB> possible entry into the IAACMLA for the accreditation of <insert evaluated MLA scope extension>.