standard no. rev. no. regulation for the...

REGULATION FOR THE ACCREDITATION OF LABORATORIES, REFERENCE MATERIAL PRODUCERS

AND PROFICIENCY TESTING PROVIDERS

STANDARD No. NIT-DICLA-031

REV. No. 13

APPROVED IN APR/2013

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Disclaimer: In case of doubts in translation, the Portuguese version prevails. The version given below may not reflect the translation of the most recent version of the document. Please visit http://www.inmetro.gov.br/credenciamento/organismos/doc_organismos.asp?tOrganismo=CalibEnsaios to make sure you have the most up-to-date version of the applicable document. CONTENTS

1 Objective 2 Application Field 3 Responsibility 4 Revision Background and Implementation Deadline 5 Supplementary Documents 6 Acronyms 7 General considerations 8 Deadlines established by Cgcre 9 Conditions to be met by the CAB 10 Warning and Sanctions Applicable to CABs 11 Changes in Accreditation Requirements and Regulations 12 Complaints and Appeals Annex 1 Warning and Sanctions applicable to a CAB in accreditation or extension stage Annex 2 Warning and Sanctions Applicable to Accredited CABs

1 OBJECTIVE

This standard establishes the regulation to be met by accredited laboratories, reference material producers and proficiency testing providers or applicants to accreditation by Cgcre.

2 APPLICATION FIELD

This Standard applies to Dicla, accredited CABs and CABs applying to accreditation and assessors and experts who act on the accreditation of CABs. For the purposes of this Standard, CAB means testing, calibration and medical testing laboratories, reference material producers and proficiency testing providers.

3 RESPONSIBILITY

Dicla/Cgcre is responsible for the revision of this standard.

4 REVISION BACKGROUND AND IMPLEMENTATION DEADLINE

4.1 Items 7.7 and 7.8 – The accreditation formalization format has been changed. 4.2 Item 8.1.1(j) – The deadline for the second measurement audit has been clarified. 4.3 Item 9.2.1(d): It was included the information that Cgcre shall have access permission to records, so as to confirm the compliance with accreditation requirements, even when the CAB has not issued reports, certificates, opinions or statements with the accreditation symbol. 4.4 Items 9.2.1 (j) and 9.4.10: It has been clarified that the requirement also applies to PTP and RMP.

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4.5 Item 9.4.11: Revision of the requirements regarding subcontracting by laboratories, so as to restrict it to accredited laboratories. 4.6 Clause 10: The requirements relative to warning and sanctions have been revised in order to: a) clarify which sanctions are appropriate and that the warning is not a sanction; b) specify the period to consider that a nonconformity is recurrent; c) clarify when the notification issue occurs and the inception of the administrative process; d) clarify the need of corrective action, of invalidating the services and collecting material in

case of undue use of accreditation; e) establish a deadline for the CAB to submit a new accreditation application, in case of

withdrawal; f) inform that Cgcre can divulgate the applied sanctions. 4.7 Annexes 1 and 2 have been revised to fit the changes made in clause 10 and to make the application of sanctions clearer and more consistent. 4.8 The changes implemented in this revision reflect the practice consolidated in Cgcre, therefore they enter into force in the issue date of this standard. 5 SUPPLEMENTARY DOCUMENTS

ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories

ISO 15189 Medical laboratories - Particular requirements for quality and competence

ISO Guide 34 General requirements for the competence of reference material producers

ISO/IEC 17043 Conformity assessment -- General requirements for proficiency testing

DOQ-Cgcre-020 Definitions of terms used in the documents related to laboratory, reference material producers and proficiency testing providers accreditation

MOD-Cgcre-017 Amendment to the commitment statement of accreditation - ACSA

MOD-Cgcre-001 Commitment Statement of Accreditation - CSA NIE-Cgcre-009 Use of the Mark, Symbol and References to Accreditation NIT-Dicla-011 Prices charged for the activities of accreditation of

laboratories, reference material producers and proficiency testing providers

NIT-Dicla-026 Requirements about the Participation of Testing and Calibration Laboratories in Proficiency Testing Activities

6 ACRONYMS

Cgcre General Coordination for Accreditation Dicla Laboratory Accreditation Division ACSA Amendment to the Commitment Statement of Accreditation (MOD-CGCRE-017) AM Accreditation Manager CAB Conformity Assessment Body PTP Proficiency Testing Provider RMP Reference Material Producer Secre Accreditation Support Section CSA Commitment Statement of Accreditation (MOD-CGCRE-001)

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7 GENERAL CONSIDERATIONS

7.1 Cgcre, through the Laboratory Accreditation Division (Dicla), offers 04 (four) accreditation modalities of CABs: a) Accreditation according to ISO/IEC 17025 standard requirements, applicable to calibration and

testing laboratories.

b) Accreditation as per the requirements established in ISO 15189, applicable to laboratories carrying out examinations on samples coming from human beings for preventive, diagnosis, prognosis and monitoring purposes of human health, according to specific standards.

c) Accreditation of reference material producers according to the requirements of ISO Guide 34.

d) Accreditation of proficiency testing providers according to the requirements of ISO/IEC 17043 standard.

7.2 Cgcre grants accreditation for CABs performing: - calibration and/or testing in permanent facilities, mobile facilities and/or client facilities. - examinations in permanent facilities; - production of reference materials in permanent facilities; - proficiency testing schemes in permanent facilities.

7.3 The CAB accreditation is granted by address and by nature of the services, namely: calibration, testing, examination, categories of reference materials or proficiency testing schemes. Notes: For laboratory accreditation, it is meant that:

a) If one organization has more than one permanent facility, in different addresses, each one of such facilities is individually accredited;

b) The accreditation granting for mobile facilities for calibration and testing laboratories is independent of the number of facilities;

c) Services to be conducted in the permanent facility, in mobile and/or client facilities may be included for the same accreditation application for calibration and testing laboratories.

7.4 The granting, maintenance and extension of accreditation are subject to the CAB that: a) undertake to comply with all clauses of the Commitment Statement of Accreditation;

b) meet the accreditation requirements established by Cgcre to the modalities to which they apply to;

c) comply with this regulation and all other normative documents established by Cgcre, applicable to the modality.

7.5 Cgcre establishes the normative (NIG, NIE, NIT) and guidance (DOQ) documents that are available on the Accreditation website at http://www.inmetro.gov.br/credenciamento. 7.5.1 The normative documents are also requirements for accreditation, as they define the policies, criteria and regulations for the granting and maintenance of accreditation. The CAB compliance with these documents is assessed along all accreditation steps.

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7.5.2 The purpose of the guidance documents is to provide information about the CAB accreditation activity. They include mostly applications of accreditation requirements aiming at assisting the CAB in their implementation. Although its implementation is not considered mandatory, the CAB following these applications meet the respective requirements; otherwise the CAB shall demonstrate how its compliance is assured.

7.6 On the accreditation application, the CAB shall submit the document Commitment Statement of Accreditation – CSA (MOD-Cgcre-001), signed by the person in charge for the CAB, together with copies of identity card and Individual’s Identifying Number of the CSA signatory.

7.7 The accreditation formalization occurs by sending the Accreditation Certificate, letter and authorization for the use of the accreditation symbol to the CAB, as well as making the CAB accreditation scope available at the following addresses: – Calibration laboratories - http://www.inmetro.gov.br/laboratorios/rbc/; – Testing laboratories - http://www.inmetro.gov.br/laboratorios/rble/; – Medical testing laboratories - http://www.inmetro.gov.br/laboratorios/rble/; – Reference material producers - http://www.inmetro.gov.br/credenciamento/acre_prod_mr.asp; – Proficiency testing providers - http://www.inmetro.gov.br/credenciamento/acre_prod_ep.asp.

7.7.1 The accreditation certificate is valid for 4 (four) years from its issue date. At the end of the validity period, if the accreditation of the CAB is in force, the certificate is automatically renewed by the same period of 4 (four) years.

7.8 The formalization of the extension, maintenance, suspension, withdrawal, changes and reduction of the scope of accreditation is made through a Letter issued by Cgcre and, when relevant, by making the new accreditation scope available at Internet.

7.10 Cgcre carries out periodical reassessments in order to see if the requirements established for accreditation are still being met by the laboratory. The first reassessment is carried out within 12 (twelve) months from the initial accreditation date and subsequent reassessments shall be performed at 2-year intervals from the date of the last reassessment. Cgcre reserves the right to perform reassessments at intervals different to what is established, as well as extraordinary assessments whenever necessary.

Between reassessments, Cgcre can also perform the laboratory monitoring through documentation review.

7.10.1 Cgcre carries out periodical reassessments to see if the requirements established for accreditation are still being met by the reference material producer (RMP) and the proficiency testing provider (PTP). The first reassessment is carried out within 12 (twelve) months from the initial accreditation date and subsequent reassessments shall be performed at 12-months intervals from the date of the last reassessment. Cgcre reserves the right to perform reassessments at intervals different to what is established, as well as extraordinary assessments whenever necessary.

Between reassessments, Cgcre can also perform the RMP or PTP monitoring through documentation review.

7.11 The CAB shall pay for all expenses related to accreditation, extension, maintenance, as well as those relating to extraordinary assessments resulting from changes in the CAB, from complaints received (if valid), or further verify the implementation of corrective actions, as defined in NIT-Dicla-011.

7.12 All information relative to the accreditation of a CAB is treated as confidential by all personnel involved in the process, and is restricted to those involved, be they from Cgcre or from the assessment team, except in such cases as determined by law, when the information are disclosed only once the CAB involved has been informed.

http://www.inmetro.gov.br/laboratorios/rbc/

http://www.inmetro.gov.br/laboratorios/rble/

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8 DEADLINES ESTABLISHED BY CGCRE

8.1 The CAB shall meet the deadlines established below: a) Application documents: if the accreditation or extension application is submitted through

Orquestra system, the required documentation shall be sent to Dicla within 20 days after the date the application is included in the Orquestra. Failure to submit the documentation before the deadline will lead to the cancellation of the application at Orquestra.

b) Register at Orquestra system: If Dicla receives the documentation of an accreditation application or accreditation extension of laboratories, without the application being submitted through Orquestra system, the laboratory will be notified and a deadline of 20 days will be allowed for it to register the application in the Orquestra system. If the application is not registered in Orquestra within this deadline, the documentation will be returned to the CAB.

c) Complementary documents: If the documentation submitted along with the accreditation application or accreditation extension is not complete, the CAB will be notified and a deadline of 20 days will be allowed for it to complement the documentation of an accreditation application or extension. If the complementary documentation is not submitted, the documentation will be returned to the CAB and the application will be cancelled in Orquestra.

d) Feasibility of the measurement audit in the assessment for the granting or extension of the accreditation: If the laboratory doesn´t take the artifact intended for the measurement audit or doesn´t deliver the results of its calibration within the deadlines established by Cgcre in the instructions for the measurement audit, the laboratory will be notified and a deadline of 20 days will be allowed for it to take the artifact or submit the results. Furthermore, Cgcre may postpone the measurement audit according to the availability of the artifact.

e) Unsatisfactory results in the first measurement audit of the assessment for the granting of accreditation or extension: the information that the laboratory is ready to perform the second measurement audit and the evidences of implemented corrective actions shall be submitted within 90 days after issuance of the measurement audit report.

f) Corrective action proposal: if the corrective action proposal is not defined during the assessment or reassessment, it shall be submitted within 7 days after the issuance of the assessment report.

g) Initial assessment: the evidences of the implemented corrective actions shall be submitted within 90 days after the date of the closing meeting of the respective assessment.

h) Assessment for accreditation extension: the evidences of the implemented corrective actions shall be submitted within 90 days after the date of the closing meeting of the respective assessment.

i) Reassessment: the evidences of the implemented corrective actions shall be submitted within 45 days after the date of the closing meeting of the respective assessment.

j) Extraordinary assessment for the assessment of changes in accreditation: the evidences of the implemented corrective actions shall be submitted within 45 days after the date of the closing meeting of the respective assessment.

k) Unsatisfactory results in mandatory proficiency testing activities for accredited laboratories: the evidences of the implemented corrective actions for the mandatory proficiency testing activities, established in NIT-Dicla-026, shall be submitted within 90 days from the date of receipt of the result of proficiency testing activity. If the measurement audit is to be carried out, the laboratory shall also inform, within the same deadline, that it is ready to perform the second measurement audit.

l) Extraordinary assessment for interruption of suspension (or resuming of accreditation): the evidences of the implemented corrective actions shall be submitted within 45 days after the date of the closing meeting of the respective assessment.

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m) Assessment for follow-up of corrective actions: if Cgcre decides it is necessary to perform an assessment to follow-up corrective actions, the CAB shall take measures to enable the conduction of the assessment immediately after the established deadline in order to evidence the implementation of corrective actions as established in clauses 8.1 (e), (f), (g), (h), (i), (j), (k) and (l).

n) Extraordinary assessment for handling whistleblowing or complaints: the deadline to implement the corrective actions is related to the type of sanction that is imposed to the CAB and will not be above 45 days.

8.1.1 The CAB will be notified and an additional unprorogued deadline of 20 (twenty) days will be allowed for it to submit complementary evidences of the implemented corrective actions for the cases mentioned below: a) If Cgcre deems unsatisfactory the implemented corrective actions for the clauses 8.1 (e), (f),

(g), (h), (i), (j), (k), (l) and (n); b) When a follow-up assessment finds that the implemented corrective actions are unsatisfactory; c) When, during a follow-up assessment, according to clause 8.1(m), new nonconformities are

recorded. d) When the laboratory gets unsatisfactory results in the second measurement audit, carried out

due to unsatisfactory results in the first measurement audit. In this case, only corrective actions that do not require the conduction of a third measurement audit will be considered to prove its effectiveness.

8.1.1.1 After the additional deadline allowed by Cgcre is due, and if applicable, after the review of the complementary evidences submitted by the CAB within this deadline, if nonconformities persist, the sanctions provided in this regulation shall apply. 9 CONDITIONS TO BE MET BY THE CAB

9.1 Legal Obligations

9.1.1 The CAB shall be liable for the labour, social security, fiscal and insurance obligations of its staff, exempting Cgcre of any liability.

9.1.2 The CAB shall be liable for the taxes and fees that can result from the performance of accredited services, exempting Cgcre of any liability. 9.2 Cooperation with Cgcre

9.2.1 The CAB shall assure Cgcre and their representatives the conditions necessary to monitor the conformity with this regulation and the accreditation requirements. Such cooperation includes:

a) permission to Cgcre and its representatives to access all facilities subject to laboratory accreditation, including permanent, mobile, associated and client facilities to follow-up calibration and testing services.

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b) permission to Cgcre and its representatives to access all facilities subject to accreditation of reference material producers. Cgcre may, at its discretion, require the RMP to witness its assessments in its subcontractors. Assessments shall be made possible by the producer itself. Thus, the RMP shall allow Cgcre and its representatives the access to the facilities of its subcontractors, as appropriate.

c) permission to Cgcre and its representatives to access all facilities subject to accreditation of proficiency testing provider. Cgcre may, at its discretion, require the PTP to witness its assessments in its subcontractors. Assessments shall be made possible by the provider itself. Thus, the PTP shall allow Cgcre and its representatives the access to the facilities of its subcontractors, as appropriate.

d) permission to Cgcre and its representatives to access and review all documents and records needed to demonstrate CAB’s compliance with the accreditation requirements and compliance with this regulation and all other normative documents established by Cgcre, including Quality Manual, technical, administrative and operational procedures, certificates, reports, opinions, calculations, softwares, and other technical and management system documents. This permission includes access to any information and records required to confirm that the CAB has ability to perform the services of its accreditation scope and issue reports, certificates, opinions and statements in compliance with such requirements, even though the CAB has not issued reports, certificates, opinions or statements using the accreditation symbol.

e) presence of representatives of the top management, technical management, quality manager and deputies and authorized signatories during assessments and reassessments, as well as representatives from other sectors of the organization that is involved in the CAB activities.

f) permission to Cgcre and its representatives to access and review the records of the legal status and organizational structure of the CAB, its associated facilities, and the organization to which it belongs, records of other organizations related to the CAB or to the organization to which it belongs, that have any owner, control, subordinate, structural, organizational, contractual, collaboration relationship or another relation, paid or not, in order to prove CAB´s independence and impartiality, as well as CAB´s compliance with any accreditation requirement, and investigate complaints against the CAB.

g) participation in proficiency testing activities to allow verification of its technical competence to perform calibrations and tests, as established in NIT-Dicla-026.

h) preparation, packaging and shipping of equipment and samples necessary for the purposes of mandatory proficiency testing activities, as established in NIT-Dicla-026.

i) organization and conduction of tests, examinations, calibrations and sampling, as well as technical activities required for proficiency tests and production of reference materials, for the services included in the accreditation scope, in all facilities object of accreditation, upon request, to be accompanied by Cgcre and its representatives in order to demonstrate the competence of the CAB for these activities.

j) submission to Cgcre and its representatives of information concerning the accreditation scope, services performed, management system, proficiency testing activities and compliance with accreditation requirements, this regulation and all other normative documents, when requested by Cgcre.

k) assistance to Cgcre and its representatives in the investigation and settlement of whistleblowings and complaints by third parties relating to the accreditation scope, compliance with the accreditation requirements, this regulation and all other normative documents established by Cgcre.

l) ethically and morally act to prevent any embarrassment to the representatives of Cgcre.

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9.3 Notification of Changes in Accreditation and Interruption of Rendering Accredited Services 9.3.1 The CAB shall inform right away to Cgcre, by letter or email addressed to the accreditation manager (AM), when the changes below occur: 9.3.1.1. Change of ownership of the organization to which the CAB is bound; 9.3.1.2 Change of corporate name of the organization to which the CAB is bound; 9.3.1.3 Change of corporate Taxpayer Identifying Number of the organization to which the CAB is bound; 9.3.1.4 Unification of accreditation of accredited CABs of the same organization, under the same management system; The CAB shall inform Cgcre which accreditation number shall be maintained and request the withdrawal of other accreditation(s).

9.3.1.5 Change of organizational structure, key policies and/or responsibilities of the CAB; 9.3.1.6 Change of the CAB´s name; 9.3.1.7 Change of the street name where the CAB is located or any other address change without alteration in the CAB´s facilities; 9.3.1.8 Improvement of facilities where conformity assessment services are performed; 9.3.1.9 Change of the place of facilities, with or without a change of address, including permanent, mobile and associated facilities. Besides submitting the documents mentioned in 9.3.2, the CAB shall notify Cgcre early enough so that an extraordinary assessment is made possible, if necessary. The CAB shall interrupt the rendering of accredited services since it receives express authorization from Cgcre to resume them. 9.3.1.10 Change in the technical management, quality manager, authorized signatories, financial and/or commercial contacts. Besides submitting the documents mentioned in 9.3.2, in case of change of all authorized signatories, the CAB shall notify Cgcre early enough so that an extraordinary assessment is made possible. The CAB shall interrupt the rendering of accredited services since it receives express authorization from Cgcre to resume them. 9.3.1.11 Application for updating the accreditation scope Besides submitting the documents mentioned in 9.3.2, in case of need to maintain outdated versions of technical standards in the scope, the CAB shall inform Cgcre about this with appropriate justification. The use of these versions can only occur with Cgcre´s permission.

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9.3.2 The table below defines for each type of change the documents required for approval of the change by Cgcre.

Document Required TYPE OF CHANGE

9.3.1.1 9.3.1.2 9.3.1.3 9.3.1.4 9.3.1.5 9.3.1.6 9.3.1.7 9.3.1.8 9.3.1.9 9.3.1.10 9.3.1.11

Detailed description of the change

X X X X X X X X X X X

ACSA (02 signed original copies)

X (1) X (1) X (1) X X X X (2)

Copy of identity card of the ACSA signatory

X X X X X X X (2)

Copy of Individual’s Identifying Number of the ACSA signatory

X X X X X X X (2)

Copy of the changed articles of organization

X X X X X (2)

Quality Manual X X

CAB Layout and environment control data

X

Copy of Vehicle Registration and Licensing Certificates

X (3)

FOR-Cgcre-012, FOR-Cgcre-014, FOR-Cgcre-015, FOR-Cgcre-021 or FOR-Cgcre-131

X

Standards and technical procedures

X (4)

Calculation memories X (4)

Notes: (1) The CAB shall submit a CSA instead of an ACSA, if a copy of the new articles of organization is sent rather

than its amendment in force. (2) The CAB shall submit the respective document just in case of change. (3) The CAB shall submit the respective document just in case of change in mobile facilities, with the inclusion of

new units. (4) The CAB shall only submit the respective document if applicable. (5) All documents shall be provided in hard copy. The Quality Manual, standards, technical procedures and

calculation memories shall be submitted in electronic means. (6) The request for a change in accreditation may involve more than one type of change at the same time. In this

case, the CAB shall submit the documents applicable to all changes.

9.4 Use of accreditation 9.4.1 The CAB shall meet the conditions defined in NIE-Cgcre-009 for the use of the accreditation symbol and to refer to its accreditation. 9.4.2 The accreditation cannot be used in a misleading way or likely to bring harm to Cgcre and to the system administered by it. 9.4.3 The accreditation shall not be relied upon to exclude contractual liability between the CAB and the customer. Although accreditation is an indicator of the quality of services rendered by the CAB, it cannot be used as a guarantee given by Cgcre that the CAB always keeps the same level of performance. 9.4.4 The accreditation is exclusively granted to the CAB, for the services and places included in its accreditation certificate and scope. The CAB cannot grant, allow or authorize that any other organization bound or not with the accredited CAB by means of partnership structure, administrative control, contractual relationship, cooperation agreements etc, paid or not, make use of the accredited status.

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9.4.5 During the suspension period and upon withdrawal of accreditation, the CAB shall immediately discontinue the use and disclosure of all material that makes reference to accreditation that has been suspended or withdrawn. 9.4.6 The laboratory shall strive to ensure that no calibration certificate or test report, or examination report or part thereof, is used, or has its use authorized by a customer for advertising or promotional purposes, if such use is considered deceptive. 9.4.7 The laboratory authorized to perform internal calibration has no right to use the accreditation symbol nor can make any reference to this authorization in their advertising documents and calibration certificates issued to third parties or customers within the same organization. 9.4.8 The RMP shall strive to ensure that no reference material certificate or any other documentation relating to the produced reference materials, or part thereof, is used, nor has its use authorized by a customer, for advertising or promotional purposes, if such use is considered misleading. 9.4.9 The PTP shall strive to ensure that no report of proficiency testing schemes, or part thereof, is used, or has its use authorized by a customer, for advertising or promotional purposes, if such use is considered deceptive. 9.4.10 The laboratory, RMP or PTP cannot issue any statement to their subcontractors or suppliers making reference to their compliance with any standard used by Cgcre for CAB accreditation purposes. 9.4.11 Subcontracting by laboratories

9.4.11.1 The laboratory can only subcontract another laboratory provided that the subcontractor is accredited for the services object of the subcontract, be it by Cgcre or by accreditation bodies with which Cgcre keeps mutual recognition arrangements for laboratory accreditation.

Note 1: The definition of subcontracting and application examples are mentioned in DOQ-Cgcre-

020.

Note 2: The requirements applicable to the presentation of results issued by a subcontracted

laboratory are mentioned in the standards ISO/IEC 17025, ISO 15189 and NIE-Cgcre-009.

Note 3: The requirements for the subcontracting by reference material producers and proficiency

testing providers are established in the standards ISO Guide 34 and ISO/IEC 17043, respectively.

9.4.11.2 The laboratory cannot subcontract services for which its accreditation is suspended or withdrawn.

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10 WARNING AND SANCTIONS APPLICABLE TO CABs 10.1 The sanctions that can be applied to a CAB are:

a) Reduction in the interval between assessments or reassessments; b) Reduction of scope; c) Partial or total suspension of the accreditation until meeting the conditions established by

Cgcre; d) Partial or total suspension of the accreditation for a fixed period; e) Writ of prevention of suspension; f) Interruption of the accreditation or extension process; g) Filing of the accreditation or extension application (equivalent to not granting accreditation

or extension); h) Withdrawing of accreditation.

Note: The definitions regarding sanctions are mentioned in DOQ-Cgcre-020. 10.2 As a means of educating the CAB, Cgcre can notify it with the purpose of warning it about the noncompliance with an accreditation normative requirement that, if recurrent, can lead to a sanction. The sanction arising from the recurrence of noncompliance with the requirement will be applied even if Cgcre has not issued a warning for the first recurrence. 10.3 If the situation that gave rise to the application of the sanction occurs again during the period of 5 (five) years from the date of the previous occurrence, this will be considered a recurrence. 10.4 During the assessment process for granting or extending accreditation, Cgcre may warn the CAB or apply sanctions to it, as detailed in Annex 1. 10.5 After the granting of accreditation, Cgcre may warn the CAB or apply sanctions to it, as detailed in Annex 2. 10.6 The sanction depends on the nature and recurrence of the situation that has occurred and the risk to society. Based on this, Cgcre reserves the right to apply stricter or less strict sanctions than what was originally established in Annexes 1 and 2 or apply them before the deadline granted for the CAB to submit its defense. 10.7 More than one sanction can be applied simultaneously due to the noncompliance with more than one accreditation requirement. 10.8 During the process of applying the sanction, new situations can be found implicating other irregularities that may worse the sanction. 10.9 As a part of the process of applying the sanction, Cgcre notifies the CAB, granting a deadline for its right of legal defense and contradictory, except in the case of Writ of Prevention of Suspension, and initiates an administrative process as specified below:

a) For the cases mentioned in 8.1 (a), (b) and (c), the notification is established in these clauses. No administrative process is initiated, as the accreditation or extension application does not meet the requirements for its acceptance by Cgcre.

b) For the cases mentioned in clauses 8.1 (d), (e), (f), (g), (h), (i), (j), (k), (l), (m) and (n), the notification and the deadline are established in clause 8.1.1. In these situations, the administrative process will be initiated if the CAB does not meet the deadline established in the notification and before applying the sanction.

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c) In the case of applying the sanction “Writ of prevention of suspension”, there is no need to previously notify the CAB. In this situation, the administrative process will be initiated after applying the sanction.

d) For the sanction “Reduction in the interval between assessments or reassessments”, the notification will be in the decision letter about the granting of accreditation or extension or about the accreditation maintenance of the CAB. In this case, the administrative process will be initiated only if the CAB questions this sanction within 20 days after receiving the notification.

e) For other cases, the deadline for defense is unprorogued 20 (twenty) days. In this situation, the administrative process will be initiated if the CAB does not meet the deadline established in the notification and before applying the sanction.

Note 1: For warning cases, an administrative process will not be initiated and there will be no previous notification to the CAB, since it is a merely educative act, with no punitive character. Note 2: The notification can be issued by electronic means, letter or fax.

10.10 Upon application of the sanction, the CAB shall in all cases:

a) take actions to prevent recurrences of the nonconformities that originated the sanction and evidence them to Cgcre.

b) take immediate measures to void the rendered services and eliminate all advertising material, Internet website, document or record where there is undue use of accreditation and evidence them to Cgcre.

10.11 The interruption of the suspension (or resume of accreditation) may imply the need of a document review and/or extraordinary assessment in the CAB prior to its authorization by Cgcre. 10.12 The maximum length for suspension is 12 months. After that, if established conditions are not met, the accreditation will be withdrawn. 10.13 Upon withdrawal of the accreditation, due to frauds or technical matters, a new application from the CAB´s legal entity, or its partners, will only be accepted after 2 (two) years from the withdrawal date. 10.14 During the period of suspension of the accreditation, by decision of Cgcre or request of the CAB, the CAB shall continue meeting the financial obligations established in the normative documents of Cgcre. 10.15 In case of withdrawal of accreditation, by Cgcre´s decision or CAB request, the CAB shall meet the financial obligations, established in the standard NIT-Dicla-011, until the date of withdrawing. 10.16 In the case of filing of accreditation or extension application, the CAB shall comply with the financial obligations set forth in the standard NIT-Dicla-011, until the date of filing. 10.17 In addition to the sanctions established in the Annexes of this document, Cgcre will withdraw the accreditation of the CAB in the following cases:

a) In the event of bankruptcy, if it is a company;

b) In the event of insolvency, if it is a civil society. 10.18 Cgcre can divulgate information about suspension or withdrawal of the accreditation of the CAB. Cgcre will notify stakeholders of the application of sanctions that imply suspension or

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withdrawal of accreditation, as well as in the case of interruption of suspension, when such notification is established in this regulation or in accreditation specific standards.

10.19 The application of a sanction does not prevent from an action by Inmetro, third parties, regulatory agencies, public authorities or any other stakeholder. 11 CHANGES IN ACCREDITATION REQUIREMENTS AND REGULATIONS 11.1 Any changes in this regulation, in accreditation requirements and in the other normative documents established by Cgcre are notified to the CAB. When changes affect CAB operation, Cgcre notifies the CAB and allows a period for the implementation of the necessary actions due to the changes. 12 COMPLAINTS AND APPEALS 12.1 The CAB may submit to Cgcre complaints with respect to any action taken by Cgcre itself or its representatives concerning any accreditation activity. 12.2 The CAB may appeal against any decision taken by Cgcre, related to granting, extension, suspension, reduction, withdrawal or change of accreditation, or the application of sanctions established in this regulation. Note: Appeal is not compatible with warning, as it is a merely educative act, with no punitive character. 12.3 Cgcre establishes the actions necessary to clarify and address the complaints and the handling of appeals in an impartial way. 12.4 Cgcre reserves the right to perform extraordinary assessments, without previous notice to the CAB, at the facilities of the CAB and of any organization using the accreditation granted to the CAB, so as to investigate the noncompliance of this regulation, in particular if there is unduly or misleading use of accreditation.

/ANNEX 1

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ANNEX 1 - WARNING AND SANCTIONS APPLICABLE TO A CAB IN ACCREDITATION OR EXTENSION STAGE

SITUATIONS THAT ORIGINATE SANCTION IN THE FIRST OCCURRENCE IN CASE OF RECURRENCE

FINANCIAL OR OPERATIONAL LOGISTIC ASPECTS

1.1. Noncompliance of financial obligations charged by Cgcre, after they are due for 60 days.

Filing. The application for a new accreditation or extension will only be possible after discharge of debts.

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1.2. Non-payment to assessors or experts, in the conditions established by Cgcre, up to 20 (twenty) working days after the assessment.

Interruption of the accreditation process until the CAB proves to Cgcre the effective payment of the amount or by the maximum deadline of 60 days, after which the process will be filed. The application for a new accreditation or extension will only be possible after discharge of debts.

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1.3. Not making the conditions possible for the assessments to occur in the deadline established by Cgcre.

Filing.

UNDULY USE OF ACCREDITATION

1.4. Use of accreditation symbol or reference to its accreditation as accredited, prior to formalization of accreditation granting.

Interruption of the accreditation process until confirmation of the evidences of the actions required in clause 10.10 of this regulation.

Filing. Prevention for at least 2 (two) years of application of a new accreditation by the organization and its owners.

ASPECTS RELATED TO CAB OPERATION

1.5. Existence of nonconformities that due to its relevance or quantity evidence that the CAB is not competent for the services included in the scope applied for accreditation

Reduction of the scope to be accredited excluding the affected services. Filing, if all services are excluded from the scope.

1.6. Existence of nonconformities that due to their relevance or quantity evidence that CAB´s management system is not implemented.

Filing.

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SITUATIONS THAT ORIGINATE SANCTION IN THE FIRST OCCURRENCE IN CASE OF RECURRENCE

1.7. Noncompliance of the deadlines established in clause 8.1 for the implementation of corrective actions and conduction of the measurement audit.

Filing.

1.8. Unsatisfactory results in two subsequent mandatory proficiency testing activities, organized or chosen by Cgcre, for the same service or for services for which the same method is used.


1.9. Not implementing necessary corrective actions or not showing effective corrective actions regarding mandatory proficiency testing activity or proficiency testing activity in which it has participated by its own initiative.


1.10. Existence of nonconformities that, even after being solved by the CAB, indicate that many actions require verification of effectiveness in the next assessment or that its management system is still not stable.

Reduction in the interval between reassessments.

1.11. Issuance of reports, certificates or opinions without performing the respective services; falsification of records or other information.

Filing. Prevention for at least 2 (two) years of application of a new accreditation by the organization and its owners.

/Annex 2

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ANNEX 2 - WARNING AND SANCTIONS APPLICABLE TO ACCREDITED CABS

SITUATIONS THAT ORIGINATE SANCTION

IN THE FIRST OCCURRENCE

IN THE SECOND OCCURRENCE

IN THE THIRD OCCURRENCE

IN THE FORTH OCCURRENCE

FINANCIAL OR OPERATIONAL LOGISTIC ASPECTS

2.1. Noncompliance of financial obligations charged by Cgcre, by an accredited CAB, after they are due for 60 days.

Suspension until complying financial obligations Note: This sanction also applies to occurrences after the forth occurrence.

2.2. Non-payment to assessors or experts, in the conditions established by Cgcre, up to 20 (twenty) working days after the assessment.

Suspension until complying financial obligations Note: This sanction also applies to occurrences after the forth occurrence.

2.3. Not making the conditions possible for the assessments to occur in the deadline established by Cgcre.

Suspension until the effective conduction of the assessment.

Suspension until the effective conduction of the assessment. Reduction in the interval between reassessments.



UNDULY USE OF ACCREDITATION

2.4. Issuance of reports, certificates, opinions and statements as an accredited CAB for a service or place outside the scope of its accreditation or approved by a signatory not authorized by the CAB.

Warning. Note: As part of the handling of the nonconformity, the CAB shall evidence the actions required in the clause 10.10 of this regulation.

Suspension until confirmation of the evidences of the actions required in the clause 10.10 of this regulation, more 90 days.

Withdrawing. A new application from the CAB´s legal entity, or its partners, will only be accepted after 2 (two) years from the withdrawal date.

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2.5. (For laboratories) Issuance of reports, certificates and opinions that include results of subcontracted laboratories not accredited for the subcontracted service.

Warning. Note: As part of the handling of the nonconformity, the CAB shall evidence the actions required in the clause 10.10 of this regulation.



2.6. Unduly use of the accreditation symbol or of reference to accreditation in advertisement material, budgets,

Warning. Note: As part of the handling of the

Suspension until confirmation of the evidences of the actions required in the clause

Suspension until confirmation of the evidences of the actions

Withdrawing. A new application from the CAB´s legal entity, or its

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forms, records, business cards, vehicles and others.

nonconformity, the CAB shall evidence the actions required in the clause 10.10 of this regulation.

10.10 of this regulation. Reduction in the interval between reassessments.

required in the clause 10.10 of this regulation, more 60 days. Reduction in the interval between reassessments.

partners, will only be accepted after 2 (two) years from the withdrawal date.

2.7. Use of the accreditation symbol or of reference to accreditation, during the suspension of accreditation, for suspended services, in reports, certificates, opinions, statements, advertisement material, budgets, forms, records, business cards, vehicles and others.


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2.8. Misleading use of accreditation; issuance of reports, certificates, opinions or statements with the accreditation symbol without performing the conformity assessment services; falsification of records or other information.


2.9. Grant, allow or authorize that any other organization bound with the accredited CAB by means of partnership structure, administrative control, contractual relationship, cooperation agreements etc, paid or not, make use of the accredited status.

Suspension until confirmation of the evidences of the actions required in the clause 10.10 of this regulation. Reduction in the interval between reassessments.


ASPECTS RELATED TO CAB OPERATIONS AS ACCREDITED

2.10. Not complying with the deadlines established in clause 8.1 of this Regulation for the implementation of corrective actions.

Suspension until confirmation of the evidences of the actions required in the clause 10.10 of this regulation.



Withdrawing. A new application from the CAB´s legal entity, or its partners, will only be accepted after 2 (two) years from the withdrawal

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Reduction in the interval between reassessments.

date.

2.11. No interruption of the accredited service when the recorded nonconformity affects its performance.





2.12. Existence of nonconformities that due to its relevance or quantity evidence that the CAB is not competent for the services included in the accreditation scope.

Partial suspension of the affected services until confirmation of the evidences of the actions required in the clause 10.10 of this regulation. Reduction in the interval between reassessments.

Reduction of the accreditation for the affected services. Withdrawal if all services are excluded from the scope.

2.13. Existence of nonconformities that due to their relevance or quantity evidence that CAB´s management system is not implemented.



2.14. Recurrence of nonconformities that due to their relevance or quantity show that the CAB does not assure the continuous implementation and stability of its management system.



2.15. Not participating in a mandatory proficiency testing activity organized or chosen by Cgcre, defined in NIT-DICLA-026.

Partial suspension of the affected services until confirmation of the evidences of the actions required in the clause 10.10

Partial suspension of the affected services until confirmation of the evidences of the actions required in the clause 10.10 of this

Reduction of the accreditation for the affected services. Withdrawal if all services are excluded from the

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of this regulation, as well as the satisfactory participation in a mandatory or equivalent proficiency testing activity. Note: Depending on the frequency of participation in proficiency testing activity, Cgcre may decide to interrupt the suspension when it has evidence of registration or submittal of the results of the laboratory to the proficiency testing provider or still satisfactory participation in another proficiency testing activity provided in Nit-Dicla-026.

regulation, as well as the satisfactory participation in a mandatory or equivalent proficiency testing activity. Reduction in the interval between reassessments.

scope.

2.16. Not participating in the minimum amount of proficiency testing activities defined in NIT-Dicla-026.

Warning. Note: As part of the handling of the nonconformity, the CAB shall, besides implementing corrective action, evidence successful participation in a proficiency testing activity.

Partial suspension of the affected services until confirmation of the evidences of the actions required in the clause 10.10 of this regulation, as well as the satisfactory participation in a mandatory or equivalent proficiency testing activity. Reduction in the interval between reassessments.


2.17. Not participating of any proficiency testing activity in four years.

Suspension of the accreditation until confirmation of the evidences of the actions required in the clause 10.10 of this regulation, as well as


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the satisfactory participation in a mandatory or equivalent proficiency testing activity. Reduction in the interval between reassessments.

2.18. Unsatisfactory results in two subsequent mandatory proficiency testing activities, organized or chosen by Cgcre, for the same service or for services for which the same method is used.

Partial suspension of the affected services until confirmation of the evidences of the actions required in the clause 10.10 of this regulation.


2.19. Continue to render the service as an accredited CAB without taking needed corrective actions or not showing effective corrective actions regarding mandatory proficiency testing activity or proficiency testing activity in which it has participated by its own initiative.

Warning. Note: As part of the handling of the nonconformity, besides implementing corrective action, the CAB shall, interrupt performing the services.

Partial suspension of the affected services until confirmation of the evidences of the actions required in the clause 10.10 of this regulation. Reduction in the interval between reassessments.


OTHER ASPECTS ESTABLISHED IN THIS REGULATION

2.20. No formal and previous notification to Cgcre about the changes established in clause 9.3 of this Regulation.

Warning, with possible reduction in the interval between reassessments. Note: The CAB shall implement corrective action for the nonconformity.


Suspension until confirmation of the evidences of the actions required in the clause 10.10 of this regulation, plus 30 days.

Withdrawing.

2.21. Suspension of the accreditation by CAB´s request for more than 12

Withdrawing --- --- ---

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months.

2.22. Rendering of services as accredited after all authorized signatories have left and without the new signatories being assessed by Cgcre.

Suspension until the new signatories are assessed and deemed competent.

Suspension until the new signatories are assessed and deemed competent, plus 30 days. Reduction in the interval between reassessments.

Suspension until the new signatories are assessed and deemed competent, plus 60 days. Reduction in the interval between reassessments.


2.23. Not taking actions defined by Cgcre due to the handling of complaints/ whistleblowing received by Cgcre.


Suspension until confirmation of the evidences of the actions required in the clause 10.10 of this regulation, plus 30 days. Reduction in the interval between reassessments.

Suspension until confirmation of the evidences of the actions required in the clause 10.10 of this regulation, plus 60 days. Reduction in the interval between reassessments.


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