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Canada Organic Office - Operating Manual

Part A - Assessment and Designation of Conformity Verification Bodies (CVB)

Table of Contents

Preamble

These requirements apply to the CVB's accreditation services provided for the purposes of the Regulations. Participation in the COR accreditation program is not intended to prevent CVBs from carrying out other business activities, especially those involving the accreditation of CBs not covered by the Regulations.

Operations resulting from these other activities however should neither constitute an infringement nor result in conflicts of interest with the accreditation activities performed by the CFIA.

Further consideration shall be given to address COR requirements that will be additional to those required by ISO/IEC 17011:2004.

A.1 Objective

To outline the process under which the CFIA shall enter into an agreement with a CVB.

A.2 Requirements for entering into an agreement between CFIA and a CVB

Only entities that meet the requirements set out in ISO/IEC 17011:2004 may enter into agreement with the CFIA to assess, recommend for accreditation and monitor certification bodies.

A.3 Initial Assessment and Designation of the CVB (Also For Reassessments)

A.3.1 Application and documents screening

A.3.1.1 Any applicant seeking information from the CFIA regarding the conditions under which CFIA shall enter into an agreement with a CVB may consult the CFIA Web site and access information from COO Homepage.

A.3.1.2 Upon request, the CFIA sends to the applicant an information package which contains list of documents to be provided to initiate an assessment.

A.3.1.3 The applicants may be either private or government entities.

A.3.1.4 The applicant shall submit to the CFIA the documents listed in Appendix A.

A.3.1.5 The CFIA (COO) reviews for adequacy the information supplied by the applicant and sends acknowledgement of receipt within 5 working days after reception of the application and proceeds with the assessment.

A.3.1.6 The application and accompanying documents are reviewed by the COO Lead Auditor to completeness of the application within 15 working days.

A.3.1.7 When information is missing, the COO Lead Auditor informs the applicant of the necessary additional documentation and indicates that no further processing of the application will take place until all required information is submitted.

A.3.1.8 The applicant is required to respond to the clarification questions and document requests within 30 working days or the file will be closed.

A.3.1.9 When the COO Lead Auditor determines that the information is complete, the process of document and record review starts.

A.3.2 Document and Record Review

A.3.2.1 The COO Lead Auditor shall review all relevant documents and records supplied by the applicant to evaluate its system, as documented, for conformity with the ISO 17011 requirements as referenced in the Regulations.

A.3.2.2 Upon completion of the document review, the COO Lead Auditor prepares Document Review report which indicates any non-conformities and deficiencies with the requirements and requests for further information, if necessary.

A.3.2.3 In some cases, when the number of non-conformities and deficiencies are very high the COO Lead Auditor may decide to cease the document review and will notify the applicant accordingly.

A.3.2.4 The Document Review report is sent to the applicant, with a request to take necessary actions to conform to the applicable requirements.

A.3.2.5 The CVB has 60 working days to submit evidence of corrective actions for all deficiencies and non-conformities.

A.3.2.6 On receipt of the corrective actions COO Lead Auditor reviews the submission and assesses the extent to which the required non-conformities and deficiencies have been addressed.

A.3.2.7 Once the COO Lead Auditor assesses that all the amended documents confirm with ISO 17011 and, an on-site assessment will be arranged.

A.3.3 On-site assessment and witness audit

A.3.3.1 The on-site assessment including a witness audit is conducted by the COO Lead Auditor and /or other designated CFIA staff.

A.3.3.2 The COO Lead Auditor prepares and sends to the applicant all the information and documentation needed for the on-site assessment and the witness audit.

A.3.3.3 During the on-site assessment, the COO Lead Auditor shall require access to the following information: organizational setup, personnel, management system documents, internal audit reports, management review reports, accreditation procedures, accreditation records, certification bodies' files, personnel files for the purpose of verifying training records and performance monitoring. The applicant shall ensure this information is available and easily retrievable whether in hard copy or electronic form.

A.3.3.4 The witness audit is conducted as a means of verifying that the applicant is satisfactorily implementing its procedures.

A.3.3.5 During the witness audit, the COO Lead auditor shall examine the applicant's auditor's preparation for the audit and the implementation of the CVB's auditing procedures.

A.3.3.6 Any nonconformity noted during the witness audit shall be added to the Evaluation Report.

A.3.3.7 The Evaluation Report follows a standard format and includes the findings from the on- site assessment and the witness audit.

A.3.3.8 The Evaluation report is sent to the applicant within 30 days after the witness audit is completed. It includes non-conformities, if any, comments and recommendations.

A.3.3.9 The applicant reviews the report content, verifies the accuracy of the facts and submits any corrections to CFIA.

A.3.3.10 The final Evaluation Report is sent to the applicant and to the COO National Manager.

A.3.3.11 When non-conformities and deficiencies are identified, the applicant is allowed time period (from 60 days to 180 days) to make the necessary corrective actions.

A.3.3.12 COO Lead Auditor verifies the effective implementation of the corrective actions (document review or additional on-site assessment) before submitting the documentation to the COO National Manager for decision on entering into an Agreement with the applicant.

A.3.3.13 In case that the COO National Manager decides not to enter into an agreement with the applicant, he will notify the applicant of its right to request a decision review by the Director of the Agrifood Division.

A.3.4 Decision Review Process

A.3.4.1 Any CVB can request a review of a decision. The request shall be made within 30 days of notification of the decision in writing to Director of the Agrifood Division and accompanied by all the relevant supporting documentation.

A.3.4.2 The Director shall review the request and notify the applicant of his decision.

A.3.4.3 The decision of the Director in this regard shall be final.

A.3.5 Agreement signature

A.3.5.1 Based on the results from the Final Evaluation report, the CFIA enters into an agreement with the applicant.

A.3.5.2 The agreement between the CFIA and the CVB expires on the 5th year and shall require renewal every five years following the initial assessment.

A.4 Monitoring and Surveillance of CVBs

A.4.1 The CFIA monitors the ongoing compliance of the CVB with the Regulations and the Agreement.

A.4.2 The CVB shall submit an annual update report including the number of CBs who have applied for assessment, complaints, appeals, internal audit report, to the COO during the first quarter following the end of the accreditation program's fiscal year.

A.4.3 Under the COO agreement cycle as outlined in Appendix B, the CFIA shall conduct CVB on-site surveillance assessment in the 1st, 3rd and 5th year. In the 2nd and 4th year there shall be a document review.

A.4.4 The surveillance assessments are conducted following a review of the updated report. During the surveillance assessment the COO shall review the compliance with the agreement.

A.4.5 During the five year agreement cycle, the COO Lead Auditor will conduct witness audits every year. The number of the witness audits will depend on the number of the CBs under each CVB.

A.4.6 Following the surveillance assessment the CFIA shall prepare and send a report to the CVB within 30 days.

A.4.7 If any non-conformities are found during the surveillance the CVB shall be given up to 90 days to respond.

A.4.8 At any time and upon its own discretion, the CFIA may carry out additional assessments for any major non-conformities with the Regulations and CFIA requirements. The CFIA shall advise the CVB of this possibility.

A.4.9 The CFIA may conduct unscheduled assessments as a result of complaints.

A.5 Renewal of the Agreement

A.5.1 All the CVBs shall undergo full reassessment on the fifth year of the Agreement signature. The procedure for the agreement renewal is the same as the one for initial CVB assessment and includes resubmission of all required documentation, on- site assessment and witness audit.

A.6 Breach of the Agreement, Suspension and Early Termination

A.6.1 The CVB understands that its failure to meet any of the terms of the Agreement is considered by the CFIA a breach of the Agreement and as a result, the CFIA could take actions including suspension measures and termination of the Agreement.

A.6.2 If during monitoring of the compliance with the agreement, the CFIA notices non-compliances, it shall issue a report to the CVB outlining the non-compliances and the period in which a corrective action plan should be submitted to the CFIA for approval. Upon receipt of the report, the CVB signs it.

A.6.3 Following the report, the CFIA shall provide a notice to the CVB which specifies the period within which the CVB shall have to provide to the CFIA a corrective action plan with defined timeline for approval.

A.6.4 If the CVB fails to provide a corrective action plan within the specified period in the notice, the CFIA shall suspend the CVB.

A.6.5 If the CVB provides to the CFIA a corrective action plan within the specified period in the notice, the CFIA shall verify the adequacy of the proposed corrective action and approve it if it is satisfactory to the CFIA.

A.6.6 If the CFIA is not satisfied with the adequacy of the proposed corrective action, the CFIA shall send a notice for revision to the CVB to revise their corrective action plan with a specified period.

A.6.7 The CVB shall submit to the CFIA a revised corrective action plan for approval within the period specified in the notice for revision.

A.6.8 The CFIA shall review and approve the revised correction action plan if it is satisfactory. (The process is on-going until corrective action plan is approved by the CFIA).

A.6.9 The CVB shall implement the corrective action plan as approved by the CFIA. The CVB could be subject to suspension if failing to do so.

A.6.10 The CFIA shall verify the implementation of the corrective action plan and submit a report to the CVB.

A.6.11 If the CVB fails to implement the corrective action plan within the prescribed time period to the CFIA's satisfaction, the CFIA shall submit a report to the CVB outlining the non-compliances.

A.6.12 The CFIA shall send a notice of suspension to the CVB, outlining the grounds for suspension, the required corrective measures and the period within which those measures must be implemented to avoid termination of the Agreement.

A.6.13 During the suspension period, the CVB is not authorized to accept new applications for accreditation and conduct initial assessment and reassessment for accreditation however the CVB shall continue conducting its surveillance activities as planned.

A.6.14 Furthermore, the CVB shall provide to the CFIA an updated list of the CBs under their supervision and a list of pending applications for accreditation within five working days after receipt of the notice of suspension.

A.6.15 The CFIA may revoke the suspension after it has conducted an assessment to verify that the CVB has implemented the corrective measures within the period specified in the notice of suspension.

A.6.16 The CFIA may, at its sole discretion, terminate the Agreement in the event the CVB does not implement the corrective measures within the period specified in the notice of suspension.

A.6.17 Each Party may decide to terminate the Agreement for any other reasons. That Party will give to the other Party a minimum of 60 days notice prior to the termination of the Agreement.

A.6.18 In the event that the Agreement is terminated, CFIA will notify the affected CBs and give them some time to find another assessed CVB to continue their accreditation.

A.7 Complaints against CVBs

A.7.1 Every complaint concerning a CVB's accreditation activities shall be submitted to COO National Manager in writing and accompanied by justifying evidence or documents.

A.7.2 The COO National Manager shall acknowledge the complaint within 5 days in writing.

A.7.3 The COO National Manager shall appoint a person from CFIA to investigate the complaint or decide to investigate the complaint itself.

A.7.4 The investigator shall gather all required information and prepare a report which is submitted to the COO National Manager at the conclusion of the investigation.

A.7.5 The complainant shall be informed that the CFIA took appropriate action to correct the situation. However the nature of the action will remain confident. If no further issues arise, the CFIA will close the file.

A.7.6 The CFIA maintains the record of each complaint, the corrective and preventive actions taken and the effectiveness of such action.

A.8 CVB Documents Required for Initial Assessment

This section lists those documents or information that the applicant CVB is to submit to the CFIA as part of its initial assessment as a CVB.

A.8.1 CVB Documents to be Submit Along with the Application for Designation.

A.8.1.1 The Corporate Charter

A.8.1.2 Any Government Act, Regulation or Decree that gives the CVB the legal authority to accredit prior to becoming a CVB under the COR.

A.8.1.3 The Corporate structure showing graphically and quantitatively relations of control by shareholders, companies or other groups of the organization.

A.8.1.4 The general bylaws.

A.8.1.5 A list of directors, comprising:

  1. Members of the board of directors (including specific function, duration of mandate, and affiliation).
  2. Board members of a sponsoring organization (if applicable).

A.8.1.6 The addresses of all locations where the CVB does business and summary of activities from each location.

A.8.1.7 A copy of the compliance mark (body's name such as it appears on accreditation certificates and any property rights related to it prior to becoming a CVB under the COR.

A.8.1.8 A copy of the liability insurance for directors and employees.

A.8.2 Description of CVB Decision Making Structures

A.8.2.1 A description of individuals or Internal bodies making decisions covering:

  1. Assessment of applicants
  2. Accreditation of applicants
  3. Appeals
  4. Complaints

A.8.2.2 A description of sharing of responsibilities between Head Office and Affiliates (if applicable).

A.8.2.3 An Organization Chart related to the general administration of the program including names of persons occupying managerial positions in both Head Office and Affiliates (when it applies).

A.8.3 Information on CVBs Operations

A.8.3.1 Audited Annual Financial Accounts

A.8.3.2 A complete list of all CBs including the name and address of every one to which the CVB has granted accreditation for production of organic products prior to becoming a CVB under the COR.

A.8.3.3 A copy of the board of Director's latest annual report to members or stockholders.

A.8.4 CVB Standards, Policies and Technical procedures (Quality Manual)

A.8.4.1 The Quality Manual related to the accreditation program.

A.8.4.2 The templates for assessment questionnaires used by auditors.

A.8.4.3 The templates for audit reports.

A.8.4.4 Lists of documents included in the file on each CB having requested accreditation.

A.9 Canada Organic Regime Assessment Cycle

The following table outlines the types of audits that the CFIA will conduct of its designated CVBs in the first 5 years after the COR became effective. This same sequence of events will be logically extended to cover those years subsequent to those shown below.

Assessment Cycle of CVBs by CFIA
2009 2010 2011 2012 2013 2014
Initial Assessment** On-site surveillance** Document review** On-site surveillance** Document review** Re-assessment
Witness audit needed* Witness audit needed* Witness audit needed* Witness audit needed* Witness audit needed* Witness audit needed*

* The number of the witness audits will depend on the number of Certification Bodies recommended by a CVB.

** The COO may conduct unscheduled assessments or visits as a result of valid complaints or changes to the regulations.

A.10 Annual Information From The Designated CVBs

This section lists those documents or information that the designated CVBs shall submit annually to the CFIA as a part of the on-going monitoring of the designated CVBs.

The information shall be submitted before the end of the first quarter of the calendar year and shall cover the previous 12 months.

A.10.1 A list of all CBs under their supervision including those transferred from other CVBs with information concerning their corporate entity, name, business addresses; and a description of the certification services that the CBs undertake.

A.10.2 The number of CBs who have applied for assessment.

A.10.3 Total number of surveillance audits.

A.10.4 Total number of witness audits.

A.10.5 Total number of verification audits.

A.10.6 Total number of reassessment audits.

A.10.7 Total number of complaints under COR.

A.10.8 Total number of appeals under COR.

A.10.9 Copy of the internal audit report.

Next Page: Part B - Accreditation of Certification Bodies | Previous Page: Table of Contents

Date Modified: 2010-10-25

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