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Canada Organic Office - Operating Manual

Part B - Accreditation of Certification Bodies (CB)

Table of Contents

Preamble

Participation in the COR accreditation program is not intended to prevent Certification Bodies (CBs) from carrying out other business activities, especially those involving the certification of agricultural products 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 certification program accredited by the CFIA.

B.1 Objective

This section outlines the accreditation procedure for CBs responsible for the organic certification of agricultural products under the Canada Organic Regime (COR) and the requirements for the certification bodies.

The CVB shall ensure that CBs seeking CFIA accreditation to certify products under COR demonstrate conformance to ISO/IEC Guide 65 in addition to the requirements of this manual.

Accreditation is obtained as a result of a rigorous process. The applicant will undergo an assessment conducted by CVBs in accordance with ISO/IEC 17011 to verify its compliance with ISO/IEC Guide 65. The accreditation steps described in this section assure that Conformity Verification Bodies (CVBs) which entered into an Agreement with the CFIA manage the accreditation process in a consistent and reliable way.

On the recommendation of the CVB, the CFIA accredits the applicant CB. The CFIA shall provide the accredited CB with an accreditation number. The accreditation number granted by the CFIA to a CB means the latter, being a responsible and qualified party, has the financial and organizational capacity to manage a certification program that shall result in consistent and credible decisions. An accreditation is valid for five year, and in order to have its accreditation renewed once this period has ended, the CB must be re-evaluated, recommended by a CVB and accredited by the CFIA.

In the event that the agreement between the CVB and the CFIA is terminated the CB under the supervision of the affected CVB shall be notified by the CFIA and shall be given enough time to find another assessed CVB to continue their accreditation.

B.2 Initial CB Accreditation

B.2.1 Application by CB and Screening of Documents by CVB

B.2.1.1 An applicant applying for accreditation under the Canada Organic Regime shall submit an application form to a designated CVB.

B.2.1.2 In addition to the application form, the applicant shall provide all supporting documents as listed in Appendix A, and any additional documents deemed essential to the assessment as requested by the CVB.

B.2.1.3 The CVB shall send acknowledgement of receipt to the applicant CB within five working days after reception of the application, notifies the CFIA about the application and proceeds with the assessment.

B.2.1.4 The applicant shall pay the application fees determined by the CVB.

B.2.1.5 The CVB shall conduct resource review (as of ISO/IEC 17011 Section 7.3) to assess the CVB's ability to carry out the assessment.

B.2.1.6 The CVB shall prepare for the assessment (as of Section 7.5 from ISO/IEC 17011).

B.2.1.7 The CVB shall conduct the document review against the ISO/IEC Guide 65 and shall communicate the findings of the document review to the CB. It shall include the identification of any non-conformities and / or information requests.

B.2.1.8 The CVB shall require that responses by the applicant CB are provided for all non-conformities and information requests. The CVB shall determine which non-conformities shall be resolved before processing with the on-site assessment.

B.2.1.9 The CVB may communicate with the applicant or an independent source, in order to obtain any other information needed to examine the application, with costs being paid by the applicant.

B.2.2 Assessment of CB performance

B.2.2.1 The CVB shall conduct the assessment following the requirements outlined in Section 7.7 from ISO/IEC 17011.

B.2.2.2 The CVB shall select an assessment team that will proceed with an on-site evaluation covering the applicant's certification procedure. In order to carry out this evaluation, the CVB may assign one or more members of its personnel and may also retain the services of external auditors or technical experts or both.

B.2.2.3 The appointed CVB auditor(s) should not have been employed by a CB in a position within a 2 years period of time that might affect their impartiality.

B.2.2.4 The criteria relative to a CVB auditor's expertise shall include, among others:

  1. knowledge and understanding of the COR's accreditation criteria and procedures;
  2. knowledge of Canada's national organic standard and generally accepted experience (practical experience in production, processing, inspection or certification management would be a major asset) relative to conformity assessments;
  3. knowledge of evaluation methods including, among others, interviewing techniques and an ability to draft reports.

B.2.2.5 The names of the assigned auditors shall be communicated to the CB, which may, when based on serious motives, object to the assignment of any auditor mentioned. In light of the reasons stated by the CB, the CVB may appoint another auditor or shall retain the one initially selected.

B.2.2.6 In circumstances where the applicant CB has more than three offices, including its main office, the CVB shall use a sampling process in order to determine which offices will be visited, based on the following criteria:

  1. an obligatory visit to the main office, then
  2. the two offices handling most of the applicant's clients, or
  3. the two offices carrying out the key activities concerning the certification process.

B.2.2.7 The CVB shall send to the applicant the information, documentation and instructions needed to conduct witness audit visits, as well as an estimate of expenses pertaining to this visit.

B.2.2.8 The CVB auditor shall begin every visit with an opening meeting with the applicant's administrative officers, in order to explain the audit's objectives relative to accreditation criteria, to announce the audit plan, and at the same time to confirm the extent of evaluation to be conducted.

B.2.2.9 The CVB auditor shall interview managers, employees and contractors as required.

B.2.2.10 The CVB auditor shall carry out rigorous examination of the applicant CB certification files. The examination of files shall ensure that:

  1. the documentation found in a case file (i.e. signed contracts, updated production/preparation plans, inspection reports, decision sheets and other correspondence, copies of certificates, etc.) are complete and up to date;
  2. the inspection reports include a sufficient quantity of information elements needed to make a certification decision;
  3. the decision made by the applicant is congruous with the evaluation of the production/preparation plan as submitted by the applicant and the report resulting from inspection visits to operation sites
  4. the applicant has monitored the implementation of all necessary corrective measures that it requested from each operator having products certified.
  5. the applicant is operating in accordance with ISO/IEC Guide 65.

B.2.2.11 The CVB auditor will base the quantity and selection of files examined on the following sampling rules.

  1. The CVB auditor shall carry out an in-depth review of files of all active operators according to the table below.

    Number of files to be reviewed for CB initial accreditation
    Number of active operators registered with the CB under COR Number of files to be reviewed
    240 or less Between 10 and 12 files, 10 of which must be full reviews
    400 or less Between 12 and 15 files, 10 of which must be full reviews
    1000 or less Between15 and 20 files, 10 of which must be full reviews
    More than 1000 Between 20 and 25 files, 10 of which must be full reviews

  2. B.2.2.11.2 The CVB auditor shall randomly select the files to be included in the sample, with consideration given to the various categories of operations being carried out by the operations registered with the CB. The auditor shall also review files for operations based outside of Canada, when the operator's products are certified in accordance with the OPR.

B.2.2.12 The CVB auditor shall verify the competence of the personnel involved in the certification activities of the CBs, within the framework of the positions they occupy. The CVB auditor shall review these employees' competence, training and education and shall conduct interviews with some of them.

B.2.2.13 The CVB auditor shall conduct at least one witness audit as a means of verifying that the applicant is satisfactory implementing its procedures.

B.2.2.14 The CVB auditor shall, during the witness audits, examine the VO preparation for the inspection, and the implementation of the CBs inspection procedures.

B.2.2.15 The CVB auditor shall record the findings from the on-site visit and the witness audit. The format of the report is determined by the CVB.

B.2.2.16 For CBs that do not yet have clients in the organic sector, the CFIA and the CVBs shall jointly determine the appropriate evaluation system.

B.2.2.17 The CVB reporting procedures shall comply with the requirements outlined in section 7.8.3 from the ISO/IEC 17011.

B.2.2.18 The CVB shall allow the applicant a time period for taking the necessary corrective actions.

B.2.2.19 Failure to meet the deadlines for the required corrective actions may results in the CVB not recommending the CB accreditation to the CFIA.

B.2.2.20 COO Lead Auditor may accompany the CVB assessment team to observe the accreditation process.

B.2.3 CVB Recommends Accreditation to the CFIA

B.2.3.1 The CVB assessment team shall analyse all relevant information and evidence gathered during the document and record review and the on-site review to determine the competence and extend of conformity of the applicant with the COR requirements. The assessment team shall evaluate whether the responses and action taken by the applicant to resolve any nonconformity appears sufficient and effective.

B.2.3.2 If the CVB determines that the provided information is not sufficient or adequate, further information may be requested and /or additional assessment activities may be conducted.

B.2.3.3 The CVB shall decide to either recommend or not the accreditation of the applicant to CFIA.

B.2.3.4 The CVB shall only recommend the applicant for accreditation if all identified non-conformities have been adequately addressed by the applicant and when the CVB is confident that the applicant has fulfilled the requirements for accreditation.

B.2.3.5 The CVB shall advise the CFIA of the recommendation decision in writing and will provide a copy of the CVB evaluation report on the applicant for the accreditation decision.

B.2.3.6 If the CVB refuses to recommend the accreditation of the applicant, the CVB will send a notice to the applicant by registered mail, stating the reason for the decision and advising the applicant of their right to request that the CFIA review the decision within 30 days after the receipt of the notice.

B.2.3.7 The CFIA shall review the CVB recommendation. If the CFIA decides to confirm the CVB recommendation, it shall send a copy of its decision with the reason, in writing, to the applicant and a copy to the CVB.

B.2.3.8 If the CFIA does not confirm the CVB recommendation, the CFIA shall follow-up with the CVB to discuss their recommendation.

B.2.3.9 The CFIA shall review the applicant's documentation and conduct its own assessment, if necessary.

B.2.3.10 The CFIA shall inform the applicant on its decision to accredit or not.

B.2.4 CFIA Grants the Accreditation

B.2.4.1 The CFIA reviews the CVB's recommendation and makes the decision on whether to grant accreditation based on the submitted information.

B.2.4.2 The applicant and the CVB shall be informed in writing of the accreditation decision made by the CFIA.

B.2.4 3 The CFIA shall grant accreditation, the length of which may vary from one CVB to another (it would be valid for four or five years), beginning on the date the accreditation number is granted by the CFIA.

B.2.5 Requirements for Granting Accreditation Number to the CBs

B.2.5.1 A CB is assigned an accreditation number by CFIA allowing it to provide certification services under the COR, and would be entitled to keep its accreditation number as long as the CB demonstrates that it is in compliance with the Regulations. Only the CFIA can revoke the accreditation number.

B.2.5.2 The COO National Manager shall assign the accreditation number no later than 14 days after the decision on accreditation is taken.

B.2.5.3 The CB shall keep the same accreditation number that they have received originally as long as its accreditation remains valid.

B.3 Monitoring and Surveillance of a CB

B.3.1 The CVB shall be responsible for monitoring the compliance of accredited CBs with the Regulations on an ongoing base.

B.3.2 The surveillance visits shall target the verification of specific program elements.

B.3.3 The CVB shall document procedures and plans for carrying out periodic surveillance on- site assessments, other surveillance activities and reassessments at significantly close intervals to monitor the accredited CBs continued fulfilment of requirements for accreditation following the requirements of Section 7.11 from ISO/IEC 17011:2004.

B.3.4 After initial accreditation, the CVB shall conduct an on-site surveillance of the CB within twelve months of the initial accreditation date.

B.3.5 The CVB shall request from the CB, on a date specified by the CVB, an annual update report. This information shall be reviewed by the CVB, when provided, and any significant issues provided to the COO. The report from the CB shall include:

  1. Changes in the CB information.
  2. Major changes to the CB policies, procedures and protocols.
  3. Number of complaints and appeals.
  4. The most recent internal audit report.
  5. The most recent management review report.
  6. All reported misuses of the Canada Organic Logo received by the CB.
  7. All changes in the CB personnel that are critical to the operation of its certification activities.
  8. Complete list of certified operations in the COR including name, address and phone number of the certified entity, the type of the operation certified (crops, livestock, processing, wild crop). If provided via a directory on the Internet, it is acceptable provide the URL to the directory instead.
  9. Complete list of operations certified to the terms of the US/Canada import/export equivalence arrangement including name, address and phone number of the certified entity, the type of the operation certified (crops, livestock, processing, wild crop). If provided via a directory on the Internet, it is acceptable provide the URL to the directory instead.

B.3.6 The CVB may determine not to request from a CB the information required by 2.6.5 for a given year if the audit of a CB by the CVB for this year addresses all of these requirements. Any of these items not addressed by the audit shall still be requested from the CB.

B.3.7 Over the length of the accreditation cycle, for each surveillance visit, the CVB auditor shall examine a number of files, proportional to the number of the active operators registered with the CB, and based on the numbers shown in the table below.

Number of files to be reviewed during each CB surveillance visit.
Number of active operators registered with the CB under COR Number of files to be reviewed
240 or less Between 7 and 10, 6 of which must be full reviews
400 or less Between 10 and 12, 6 of which must be full reviews
1000 or less Between 12 and 15 files, 6 of which must be full reviews
More than 1000 Between 15 and 20 files, 6 of which must be full reviews

B.3.8 The CVB shall, over the length of the accreditation cycle, conduct witness audits according to the table below as a means of verifying that the accredited CB satisfactorily implements its procedures.

Number witness audits to be performed over the CB accreditation cycle
Number of active operators registered with the CB under COR Total number of witness audits over the CB accreditation cycle
240 or less 2 witness audits
400 or less 3 witness audits
1000 or less 4 witness audits
More than 1000 5 witness audits

Note: If the accreditation cycle is reduced to less than five years, by this manual, or at the discretion of the CVB, the total number of witness audits in a given year shall not exceed one.

B.3.9 The CVB shall, over the length of the CB accreditation cycle, conduct verification audits according to the table below to verify the information appearing in the files.

Number of verification audits to be performed over the CB accreditation cycle
Number of active operators registered with the CB under COR Total verification audits over the CB accreditation cycle
1000 or less 2 verification audits
More than 1000 3 verification audits

Note: If the accreditation cycle is reduced to less than five years, by this manual, or at the discretion of the CVB, the total number of verification audits in a given year shall not exceed one.

B.3.10 The CVB shall choose the operators where the verification and witness audits shall be conducted. In selecting the operator for witness audits, CVB should take into consideration the CBs schedule of on-site inspections.

B.3.11 During the verification audit the CVB auditor shall verify, among other matters, that:

  1. The operator has on hand a copy of the CBs requirements, as well as any requests for corrective measures submitted to the operator by the CB from the previous CB audit.
  2. The certified production is within the scope of the OPR.
  3. The inspection report adequately describes the production system.
  4. The inspection process was able to adequately reveal points of non-compliance with the standard.

B.3.12 The CVB auditor shall record the findings from the on-site visit, the witness audit and the results from the verification audits. The format of the report is determined by the CVB. The CVB shall inform the CB of the results from the surveillance activities by issuing a letter indicating that the CB continues to maintain its compliance with the COR.

B.3.13 The CVB may conduct additional assessments as a result of complaints or significant changes that have affected CBs operations at the expense of the CB, at any time during the accreditation period, or upon its own initiative.

B.3.14 The CVB shall impose sanctions such as recommend to the CFIA suspension of the CB if the CB has failed to effectively implement the corrective actions or where the visit reveals that the CB has failed to effectively implement the corrective actions related to conditions that have previously been considered fulfilled.

B.3.15 The CFIA may conduct an unscheduled assessment of a CB as a result of complaints or concerns at any time during the accreditation period, or upon its own initiative.

B.4 Reassessments of a CB

B.4.1 The CVB shall require that during reassessment and continued accreditation oversight activities, the CB shall continue to be responsible for providing access to records, files and other related documentation and personnel. The CB shall be required to make available to the CVB the records of all the complaints, appeals and disputes.

B.4.2 In the event of reassessment the CVB auditor shall follow the requirements for initial assessment outlined in section 2 except the requirement for surveillance visit within 12 months.

B.5 Appeals of CFIA Accreditation Decision by a CB

B.5.1 Any applicant has the right to request that the Agency review the accreditation decision. The appeal against the decision must be made within 30 days of notification of that decision pursuant of the Regulations.

B.5.2 The appeal shall be filed in writing along with all the necessary supporting documents.

B.5.3 The Director of the Agrifood Division shall give the decision on the appeal. The decision of the Director of the Agrifood Division in this regard shall be final.

B.6 Appeals of CVB Recommendation Decision of a CB

B.6.1 The CVB shall document their own appeal policy to deal with appeals against final recommendations made by the CVB to the CFIA and also against specific CVB decisions.

B.6.2 The CVB policies shall address appeals of the following decisions as minimum:

  1. Decision whether to proceed to a visit.
  2. Decision regarding any additional visit.
  3. Decision to terminate an evaluation process.

B.7 Suspension and Cancellation of a CB

B.7.1 The CVB shall recommend to the CFIA suspension of the accreditation of a CB if the CB has not complied with any provision of the Act, the Regulations or ISO/IEC Guide 65.

B.7.2 The CVB shall document procedures for identification and management of non-conformities and recommendations for CB suspension to the CFIA as per section 9 from the Regulations.

B.7.3 The CVB shall apply one or more of the following sanctions in event of non-compliance with the accreditation contact, failure to fulfill conditions or breach of the accreditation requirements:

  1. issue of warning letter;
  2. impose additional conditions and insist on corrective action according to a timetable;
  3. recommend to the CFIA accreditation suspension;
  4. recommend to the CFIA accreditation cancellation.

B.8 Complaints against CBs

B.8.1 The CVB shall document its policies and procedures that will regulate how complaints related to accredited CBs and their operators are handled by the CVB.

B.8.2 In case that the complaints cannot be resolved between the CB and the CVB, the COO National Manager is the final step to hear the issue.

B.9 Records maintained by the CVB

B.9.1 The CVB shall maintain records on the CB they recommended for accreditation to demonstrate that the requirements for accreditation, including competence, have been effectively fulfilled. The records to be maintained include:

  1. general features of the CB, including corporate entity, name, addresses, legal status and human and technical resources;
  2. general information concerning the CB such as its activities, its relationship in a larger corporate entity if any, and addresses of all its physical location(s) to be covered by the scope of accreditation;
  3. clearly defined scope of accreditation;
  4. a contract to fulfil the requirements for accreditation and the other obligations of the CB, including submitting all necessary documentation requested in Section B.11;
  5. a description of the conformity assessment services that the CB undertakes, and a list of standards, methods, or procedures for which the CB seeks accreditation, including limits of capability where applicable;
  6. a copy (on paper or in electronic form) of the quality manual of the CB, and relevant associated documents and records (see Appendix B: Documents to submit along with application).

B.9.2 The CVB shall provide annually (by December 31st) to CFIA the following:

  1. an updated list of all accredited CBs including information concerning their corporate entity, name and business addresses
  2. the CB's countries of operation list

B.10 CVB Agreement With The CB

B.10.1 The CVB shall prepare and implement an agreement between the CB and CVB that outlines the rights and duties of the CB and the CVB which shall be signed by the CB and the CVB.

B.10.2 The CVB shall provide a sample of this agreement as part of the application package provided to the CB.

B.11 CB Documents Required for Initial Application for Accreditation

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

B.11.1 Documents Pertaining to the CB

B.11.1.1 The Corporate Charter.

B.11.1.2 The corporate structure showing graphically and quantitatively relations of control by shareholders, companies or other groups for the organization.

B.11.1.3 The general by laws.

B.11.1.4 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).

B.11.1.5 The addresses of all locations where the firm does business and summary of activities from each location.

B.11.1.6 A copy of the compliance mark (body's name such as it appears on on the label or certified product) and any property rights related to it.

B.11.1.7 Copy of the liability insurance for directors and employees.

B.11.1.8 In the case of CBs already accredited by an official organization (e.g. another accreditation body), a copy of the accreditation certificate for the CB from the other organization.

B.11.2 Description of Decision Making Structures

B.11.2.1 A description of individuals or internal bodies making decisions covering:

  1. Product certification;
  2. Appeals;
  3. Brand name control (certifying bodies name and logo);
  4. Along with their mandate, their procedures, and the manner in which they are designated.

B.11.2.2 A description of sharing of responsibilities between Head Office and Affiliates (if applicable).

B.11.2.3 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).

B.11.3 Information on CBs Operations

B.11.3.1 Copy of latest annual financial statements, including balance sheet, revenues and expenses.

B.11.3.2 List of countries, provinces or states in which the body is carrying out certification activities.

B.11.3.3 Complete list of all firms including the name and address of every one to which the body has granted a compliance certificate, in the one or more fields for which it has applied for accreditation:

  1. A compliance certificate for the certified products with their mention on the list;
  2. A certificate of recognition for any inputs or services with their mention on the list.

B.11.3.4 Copy of the Board of Director's latest annual report to members or stockholders.

B.11.4 Standards, Policies and Technical procedures (Quality Manual)

B.11.4.1 The Quality Manual related to the certification program.

B.11.4.2 Templates of inspection questionnaires used by VO.

B.11.4.3 Templates for inspection reports.

B.11.4.4 Lists of documents included in the file for each operator having requested certification.

B.11.5 CB Human Resources Management.

B.11.5.1 A complete list of certification employees including the status and position held by each one.

B.11.5.2 A copy of the standard contract with certification employees.

B.11.5.3 The selection criteria for persons making certification decisions and persons in charge of overseeing people who make certification decisions.

B.11.5.4 The name of person or list of the members of the internal body (committee, etc.) assigned either to make certification decisions or to oversee those who make them (with their experience or specific training).

B.11.5.5 The selection criteria for the VOs.

B.11.5.6 Copy of standard contract between the CB and VO.

B.11.5.7 Complete list of VOs (including their training and years of experience, their commercial or financial affiliation).

B.11.5.8 A copy of the standard contract used with any other type of subcontractors (if applicable).

B.11.6 Information Material and Forms Forwarded to Certification Applicants.

B.11.6.1 A detailed fee schedule for the certification services offered.

B.11.6.2 Copies of information documents about the certification program.

B.11.6.3 A copy of the application forms to fill by applicants.

B.11.6.4 Copies of production or preparation compliance plan forms to be filled yearly by applicants.

B.11.7 Documents Concerning Rights and Obligations of Certified Operators.

B.11.7.1 Contract(s) to be signed by certification applicants, regulating the use of marks of compliance (licenses).

B.11.7.2 Copy of the certificate issued by the CB in accordance with COR.

B.11.7.3 Electronic copy of a label using the name of the CB and Canada Organic Logo.

Next Page: Part C - Certification of Organic Product and CB Requirements | Previous Page: Part A - Assessment and Designation of Conformity Verification Bodies

Date Modified: 2010-10-25

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