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ACC-LAB(E) — Procedure for the Accreditation of Testing Laboratories by Industry Canada

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Issue 4
April 2003

Spectrum Management and Telecommunications Policy
Procedures for Conformity Assessment Bodies

©Her Majesty the Queen in right of Canada, as represented by the Minister of Industry
(Published in 2002)

Foreword

This document specifies the procedure used by Industry Canada for the accreditation of testing laboratories. Accreditation is required for the designation and recognition of Canadian testing laboratories.

This document will be reviewed and amended from time to time to reflect necessary changes in procedural requirements. The Department encourages comments and suggestions that will enhance the effectiveness of the document. They may be forwarded to:

Director
Telecommunication Engineering and Certification
Spectrum Engineering Branch
Industry Canada
300 Slater Street
Ottawa, Ontario
Canada
K1A 0C8

Issued under the authority
of the Minister of Industry

R.W. McCaughern
Director General Spectrum Engineering

Table of Contents

1. Purpose

1.1 This document specifies the procedure used by the Department for the accreditation of testing laboratories to test telecommunications terminal equipment, information technology equipment, radio apparatus and Electromagnetic Compatibility (EMC) when such accreditation is required.

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2. Definitions

2.1 Department means Industry Canada.

2.2 Bureau means the Department's Certification and Engineering Bureau.

2.3 Accreditation is a procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.

2.4 Conformity Assessment is a systematic examination to determine the extent to which a product, process, or service fulfils specified requirements.

2.5 Conformity Assessment Body is a body engaged in the performance of procedures for determining whether the relevant requirements in technical regulations or standards are fulfilled.

2.6 Designation is the nomination by a Designating Authority of a Conformity Assessment Body as competent to perform conformity assessment activities under the terms of an agreement or arrangement.

2.7 Designating Authority is a body with authority to designate, monitor, suspend designation, or withdraw designation of Conformity Assessment Bodies under its jurisdiction.

2.8 Recognition is the acceptance of a designated Conformity Assessment Body by a Regulatory Authority.

2.9 Recognized Accreditation Organizations are accreditation organizations that have been recognized by the Standards Council of Canada (SCC) or a Mutual Recognition Agreements/ Arrangements partner as competent to perform accreditation.

2.10 Regulatory Authority is a government agency or other entity with the power to regulate the use or sale of products within its jurisdiction.

2.11 Testing Laboratory is a testing laboratory that performs tests (ISO/IEC Guide 2:1996).

3. General Information

3.1 Information on these procedures can be obtained from:

Certification and Engineering Bureau
Industry Canada
P.O. Box 11490, Station H
3701 Carling Avenue
Building 94
Ottawa, Ontario
Canada
K2H 8S2

Telephone no.: 613-991-9311
Facsimile no.: 613-990-4752
E-mail Address: certification.bureau@ic.gc.ca

3.2 The Department's documents and other information are also available on the Spectrum Management and Telecommunications Web site at http://www.ic.gc.ca/spectrum.

4. General Conditions

4.1 Testing laboratories shall comply with the Procedure for Designation and Recognition of Canadian Testing laboratories by Industry Canada (DES-LAB) in addition to obtaining accreditation by the Department, the SCC or a Recognized Accreditation Organization. Accreditation shall be followed by designation or recognition by the Department.

4.2 Testing laboratories shall be accredited to ISO/IEC 17025:1999 General Requirements for the Competence of Testing and Calibration Testing laboratories.

4.3 The Department will accredit Canadian testing laboratories for telecommunications terminal equipment, information technology equipment, radio apparatus and electromagnetic compatibility (EMC) when such accreditation is required.

4.4 The Department does not require testing laboratories to be accredited to perform radio and EMC testing to Canadian requirements. However, when Open Area Test Site (OATS) facilities are used, there is a requirement to submit the OATS information to the Certification Bureau in accordance with RSS-212, Test Facilities and Test Methods for Radio Equipment. Detailed information on OATS filings can also be found at: http://www.ic.gc.ca/eic/site/ceb-bhst.nsf/eng/h_tt00016.html.

4.5 This procedure applies in the following situations:

  1. a testing laboratory in Canada requests accreditation to test to Canadian telecommunications terminal equipment requirements or for the purpose of section 5.1.1(c) of CB-02 Recognition Criteria, and Administrative and Operational Requirements Applicable to Certification Bodies for the Certification of Radio Apparatus to Industry Canada's Standards and Specifications;
  2. a testing laboratory in Canada requests accreditation to test to the requirements of a foreign country with whom Canada has a Mutual Recognition Arrangement or Agreement (MRA); or
  3. a testing laboratory in a foreign country where an agreement or arrangement with that country allows the Canadian accreditation of that foreign testing laboratory to Canadian telecommunications terminal equipment requirements or for the purpose of section 5.1.1(c) of CB-02 Recognition Criteria, and Administrative and Operational Requirements Applicable to Certification Bodies for the Certification of Radio Apparatus to Industry Canada's Standards and Specifications.

4.6 Testing laboratories shall have a permanent facility to be considered for accreditation. Testing at a client's location will, however, be considered and authorized on a case-by-case basis, subject to the conditions and requirements of this procedure. A detailed test plan must be submitted, and the Bureau will determine the formalities of the on-site testing.

4.7 The Bureau will provide the applicant with an estimate of the total cost of services and related expenses. Expenses incurred by the Department in the process of accreditation and subsequent reassessments include the assessment of information supplied in support of an application, on-site assessment, report writing, and related administrative activities. The cost of travel, accommodations, meals, and incidental expenses will also be recovered from the applicant. Expenses will be calculated in accordance with the rates in effect when services are rendered.

4.8 The Department requires full payment of the estimated expenses prior to undertaking an assessment. In the event the actual cost of the accreditation exceeds the estimated cost, payment of the difference must be received prior to the granting of the accreditation. Payment shall be made by cheque or credit card in Canadian funds payable to the Receiver General for Canada.

4.9 In order to obtain accreditation, the applicant shall cooperate with the assessors to verify compliance with the requirements of this procedure. This includes provision of the required documents, and access to all relevant personnel, records, and testing areas for the purposes of assessment, surveillance, reassessment, and resolution of complaints.

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5. Procedure

5.1 Testing laboratories shall submit to the Bureau as indicated in Section 3.1, the following documents:

  1. a signed application (see Appendix I);
  2. a covering letter;
  3. the information required under Section 6; and
  4. payment in full of the costs described in Section 4.

5.2 The applicant shall specify the applicable standards, specifications, or parts thereof, for which accreditation is sought.

5.3 The assessors will be assigned by the Bureau.

5.4 Accreditation will be carried out on a first-come-first-served basis, based on the date when the application is received. The applicant will be sent a proposed agenda for an on-site assessment of the testing laboratory and the names of the assigned assessors a minimum of 10 business days prior to the proposed assessment date. The applicant will therefore have an opportunity to appeal against the appointment of any of the assessors and agree to the date of the on-site assessment. The on-site assessment will not occur until after any deficiencies noted in the documentation received with the application have been resolved.

5.5 If the conditions of Section 4 of this procedure have been satisfied, and the information required has been provided in accordance with Section 6, the Bureau will evaluate the application package and determine whether the testing laboratory is ready for an on-site assessment. The duration of the on-site assessment will ordinarily be two days and will be, at a time, mutually agreeable to the Bureau and the applicant.

5.6 The testing laboratory personnel who are involved in testing will be required to demonstrate their technical competence in the performance of testing in accordance with the standards, specifications, or parts thereof for which accreditation is sought. This will include:

  1. technical knowledge of the relevant equipment, processes or services;
  2. understanding of the technical regulations and the general protection requirements for which accreditation is sought;
  3. the practical capability to perform the relevant tests;
  4. an adequate management of the tests concerned; and
  5. any other evidence necessary to give assurance that the test will be adequately performed on a consistent basis.

5.7 The testing laboratory management will be required to show how its internal organization and procedures meet the quality system aspects of ISO/IEC 17025:1999.

5.8 At the conclusion of the on-site assessment, a meeting will take place between testing laboratory management and the assessors, at which time a written or oral report will provide the status of the testing laboratory's compliance with the accreditation requirements. It will also make the applicant aware of any technical or procedural problems that require remedial action.

5.9 The assessment is based on the Assessment Rating Guide in Appendix III. Upon their return from the on-site assessment, the assessors will write a report which summarizes their observations, describes any technical or procedural shortcomings, and concludes with a recommendation for accreditation or rejection of the application, with a description of any remedial action that must be taken by the testing laboratory in order to meet the requirements for accreditation. In the event that remedial actions are required, the Bureau will specify in writing the means by which the results of the remedial action will be verified. A copy of the report will be sent to the applicant. The testing laboratory will be invited to provide comments on this report and describe any specific actions taken or planned to remedy any non-compliance.

5.10 Remedial actions may be verified by means of a supplementary submission of technical or procedural documentation or by further on-site assessments. Supplementary written reports from the assessors may also be required. The assessor will sign off on the corrective actions taken by the applicant.

5.11 The reports will be reviewed by the Bureau. If, based on the information gathered during the accreditation process, the testing laboratory meets all of the conditions and requirements for accreditation under this procedure, the Bureau will issue a letter stating that the testing laboratory is accredited for testing under the standards, specifications or parts thereof for which the testing laboratory has proven technical competence and compliance to ISO/IEC 17025:1999. The letter will specify the name and address of the testing laboratory, the scope of accreditation, and the period and effective date of the accreditation. A certificate of accreditation to this procedure will be issued, and a unique identifying code number for the testing laboratory will be assigned.

5.12 Subject to Section 4.7, the Bureau will calculate the total expenses for accreditation and a financial statement will be prepared. The statement will be sent to the accredited testing laboratory with the accreditation documents.

5.13 Following the granting of accreditation, the testing laboratory will be added to the list of accredited testing laboratories that is compiled by the Bureau.

5.14 All documents submitted to the Department in support of a testing laboratory accreditation application, an application for change of scope of accreditation, or a reassessment will be retained by the Bureau in accordance with Section 7 of this procedure.

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6. Information Required

6.1 The testing laboratory shall provide a completed Document Review Form and supporting information (as specified in Appendix II) in addition to the following information:

  1. testing laboratory's legal, commercial or organizational status;
  2. testing laboratory's organization and management, key personnel (including qualifications), and authorized signatories;
  3. a copy of the testing laboratory's quality manual and associated documents;
  4. all other applicable documentation referred to in ISO/IEC 17025:1999, including technical specifications for equipment used and associated quality, testing and calibration procedures;
  5. a matrix diagram that shows the applicable tests to be performed, versus the names of the testing laboratory's staff that are qualified to perform the tests;
  6. complete schematic diagrams, component values and tolerances, and descriptions of the features and operation for all custom-built test equipment and circuits; and
  7. a sample copy of the test report to be used by the testing laboratory.

7. Disclosure of Information

7.1 The applicant shall indicate which information and documents provided support of an application for accreditation is confidential. The provisions of the Access to Information Act will apply.

7.2 The Department will not disclose the status of applications for accreditation, reassessments, or applications for change of scope to any third party until the process is completed.

8. Disclaimer

8.1 The Department does not accept any responsibility for the effects or consequences of services provided by an accredited testing laboratory on users of such services.

8.2 The accreditation of a testing laboratory by the Department does not imply or otherwise suggest approval of a product or that the testing laboratory is an agent or representative of the Department.

9. Surveillance and Reassessment

9.1 Surveillance and reassessment will be carried out in accordance with ISO/IEC Guide 58: 1993.

9.2 The Bureau will conduct a control visit and audit of testing laboratory quality systems after the first year of accreditation in accordance with Section 6.7 of ISO/IEC Guide 58:1993.

9.3 Following the control visit, reassessments of accredited testing laboratories, including an on-site component, will take place every two years or whenever any of the conditions of accreditation described in Section 4 of this procedure have changed. The procedure for reassessments is the same as that for original accreditations.

9.4 In the case of two-year reassessments, the date of the assessment will be based on the date when the original accreditation was granted.

9.5 If no deficiencies are discovered during the on-site assessment, the accreditation will be renewed for a further two years.

9.6 If any deficiencies are discovered during the on-site assessment, the deficiencies may be corrected during the assessment. If this is not possible, the testing laboratory must provide evidence of the corrective action to be taken within 30 days of the assessment. All deficiencies must be resolved before the accreditation is renewed.

10. Change of Scope of Accreditation

10.1 An accredited testing laboratory can request a change in the scope of their accreditation at any time.

10.2 Requests for changes in scope must be made to the Bureau using the application in Appendix I. They shall include a detailed description of the proposed changes.

10.3 In the case of an increase in the scope of testing, the description must identify the applicable standard or specification and include detailed descriptions of the test equipment to be used, the test equipment configurations, and the test methods for the additional tests. Any changes to the information in Section 6.1 resulting from a change in scope should also be submitted.

10.4 The Bureau will review the submitted documents and decide whether the testing laboratory has satisfied the procedural and technical requirements for the desired increase in scope. An on-site assessment may be required. If any deficiencies are discovered, they must be resolved to the satisfaction of the Bureau.

10.5 In the case of a decrease in the scope of testing, a notification to the Bureau of the tests to be deleted is required.

10.6 When the Bureau is satisfied with the change in the scope of testing, the letter and certificate of accreditation described in Section 5.11 and the list of accredited testing facilities described in Section 5.13 of this procedure will be amended. Any expenses incurred by the Department regarding a change in scope will be recovered from the applicant in accordance with Section 4.6 of this procedure.

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11. Retaining Accreditation

11.1 In order to maintain their accreditation status, testing laboratories shall:

  1. comply, at all times, with the requirements of this procedure;
  2. advertise or provide notice of accreditation only within the scope of the accreditation;
  3. comply with the surveillance and reassessment requirements of Section 9;
  4. ensure that test reports, or parts thereof, are made available to the Bureau and to the testing laboratory's clients only, and are not used in a misleading manner;
  5. inform the Bureau within 10 business days, in writing, in accordance with Section 7.3.1 of ISO/IEC Guide 58: 1993, Calibration and Testing laboratory Accreditation Systems General Requirements for Operation and Recognition, of any changes with respect to the testing laboratory's status or operation that may affect the testing laboratory's capability, competency, scope of accreditation, or compliance with the Bureau's accreditation policies and procedures, including but not limited to its:
    1. legal, commercial or organizational status;
    2. organization and management (e.g., key managerial staff);
    3. appropriate policies or procedures;
    4. premises;
    5. key personnel, test equipment, facilities, working environment; or other
    6. resources, where significant; or
    7. authorized signatories; and
  6. make any changes to procedures, test equipment or test methods that are deemed necessary by the Bureau in order to affect continuing compliance with this procedure and with ISO/IEC 17025:1999, and notify the Bureau when such changes have been carried out.

11.2 A testing laboratory shall not advertise its accreditation status for testing activities that are outside of the scope of its accreditation.

12. Suspension or Withdrawal of Accreditation

12.1 When a testing laboratory is the subject of an investigation for non-compliance with this procedure, and in situations where a formal review process exists, such as in Mutual Recognition Agreements through a joint committee, a suspension may be issued to the testing laboratory until the formal review process is completed. The testing laboratory is required to take immediate corrective action to the Department's satisfaction. Where it is found that a testing laboratory does not comply with the requirements of this procedure, the accreditation may be withdrawn or the scope of accreditation may be reduced until corrective action is taken. Such action will, however, take place only after full consultation between the Bureau and the affected testing laboratory.

12.2 Testing laboratories whose accreditation has been suspended or withdrawn will be removed from the list of recognized testing laboratories.

12.3 A testing laboratory whose accreditation has been suspended or withdrawn shall stop advertising its accreditation and shall immediately return accreditation letters and certificates to the Department.

13. Complaints and Appeals

13.1 If, during the assessment process, deficiencies cannot be resolved during the on-site visit or by subsequent written communications between the testing laboratory and the assessors, the testing laboratory can appeal the corrective action decisions of the assessors.

13.2 The complaint or appeal must be made in writing to the Laboratory Director of the Bureau at the address given in Section 3.1 of this document. The technical or procedural reasons for the complaint or appeal must be described in detail.

13.3 After due consideration of the complaint or appeal, the Laboratory Director of the Bureau will render a written decision on the corrective action to be taken.

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