AQIS Administrative Arrangements for approved certifying organisations operating inspection and certification activities for Australian organic and biodynamic produce

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Issue 1, 26 November 2003

  1. Introduction
  2. Purpose
  3. Interpretation/Definitions
  4. Part 1 - Certification
  5. Mutual Recognition
  6. Documentation
  7. Publications
  8. Personnel
  9. Approved Certifying Organisation Conduct
  10. Changes to Accreditation
  11. Appeals, Complaints, Sanctions and Disputes
  12. Application for Certification
  13. Surveillance
  14. Inspection Process
  15. Certification/Certificates
  16. Critical Non-Confrmity
  17. Use of Licences, Certificates, Marks and Logos
  18. Complaints to Certified Operators
  19. Part 2 - AQIS Arrangements

1. Introduction

1.1 Australian Quarantine and Inspection Service (AQIS) is the competent authority for the Australian organic and biodynamic export sector. AQIS operates a co-regulatory arrangement with approved certifying organisations.

1.2 Legislation, the National Standard for Organic and Bio-dynamic Produce as well as these Administrative Arrangements underpins the AQIS export program for organic and bio-dynamic produce.

1.3 Organic and bio-dynamic produce is deemed to be prescribed goods under the Export Control (Organic Produce Certification) Orders 1997. These Orders require AQIS to conduct audits of approved certification organisations to ensure on-going compliance against legislation, the National Standard and importing country requirements.

1.4 Where a certifying organisation satisfies these requirements, it is given the authority to issue export documentation on behalf of the Australian government.

1.5 This document has been divided into two parts. The first part contains information applicable for approved certifying organisations and/or organisations applying for approval. The second part relates to how AQIS undertakes its activities. Note Part 2 will be removed following amendments to export legislation.

2. Purpose

2.1 Organisations seeking accreditation from AQIS as an approved certifying organisation shall establish and maintain a documented system in accordance with these and other legal requirements. This documented system is termed the QM system.

2.2 This document has been developed to enable AQIS approved certifying organisations to:

a) harmonise interpretation and application of the National Standard for Organic and Bio-dynamic Produce requirements, and

b) form the basis for mutual recognition between AQIS approved certifying organisations, and

c) consistently apply the requirements of EN 45011 and ISO/IEC Guide 65.

3. Interpretation/Definitions

In this document, unless otherwise stated:

3.1 Act means the Export Control Act 1982.

3.2 Approved certifying organisation means an organisation approved by the competent authority as satisfying the National Standard, these Administrative Arrangements and specific legislation.

3.3 AQIS means the Australian Quarantine and Inspection Service.

3.4 Audit means a systematic and functionally independent examination to determine whether activities and related results comply with legislative or documented requirements.

3.5 Authorised officer means a government officer authorised under the Export Control Act, 1982.

3.6 Certification/certified means procedures by which an approved certifying organisation provides written assurance that an operator has been determined to be in compliance with the Standard. Certification is based on the inspection of practices used, verification against records maintained by the operator and sampling of product.

3.7 Competent authority means an official government agency having legal jurisdiction. In relation to this document, this currently means AQIS.

3.8 Conflict of Interest means a situation in which a person has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties.

3.9 Consultancy means advice or information provided by a person on a commercial basis (e.g. exchanged for money, or goods, or services).

3.10 Critical non-conformity means a non-conformity that has the potential to seriously compromise the:

a) accreditation of the approved certifying organisation; or

b) certification of the operator

and warrants immediate remedial action.

3.11 Expert means a person who has expertise in production and/or preparation of organic produce.

3.12 Inspection means the process of verifying a certified or non-certified operation against the National Standard and/or importing country requirements.

3.13 Inspector means a person deemed by an approved certifying organisation or other recognised authority to have the expertise and knowledge to competently evaluate systems for organic/bio-dynamic certification.

3.14 National Standard means the National Standard for Organic and Bio-dynamic Produce (as amended).

3.15 Non-conformity means the absence of, or the failure to implement and maintain one or more requirements or a situation, which would based of objective evidence raise significant doubt as to the capability of a system to achieve the objectives of legislation and/or National Standard.

3.16 Operator means a person or business entity that has responsibility for the management of operations including, but not limited to, preparation, production, transportation, marketing export/import, and storage.

3.17 Orders mean the PrescribedGoods (General) Orders (as amended) or Export Control (Organic Produce CertificationOrders, 1997. )

3.18 Organic produce certificate is an export certificate as prescribed under the Export Control (Organic Produce Certification) Orders 1997 that can be issued by an AQIS approved certifying organisation or AQIS.

3.19 Personnel means any person undertaking administrative or operational duties on behalf of an approved certifying organisation who is employed on a full time or part-time, casual or contract basis.

3.20 Produce transfer certificate means a document issued by a certified operator for the transfer of certified produce.

3.21 Sanction means a penalty, either financial or administrative in scope, applied by an approved certifying organisation as a result of nonconformity in relation to the National Standard or importing country requirements.

4. Part 1 - Certification

4.0 Requirements

4.0.1 An approved certifying organisation will ensure that inspection and certification are carried out effectively and uniformly.

4.0.2 The policies and procedures of an approved certifying organisation shall be non-discriminatory and shall be administered in a non –discriminatory manner.

4.0.3 An approved certifying organisation’s procedures shall not be used to impede or inhibit operator access to its services.

4.0.4 An approved certifying organisation shall make its services accessible to all applicants whose activities fall within its declared field of operation.

4.0.5 An approved certifying organisation shall not impose undue financial or other conditions on any operator.

4.0.6 Access by operators to an approved certifying organisation shall not be conditional upon the size of the supplier or membership of any association or group, nor shall certification be conditional upon the number of certificates already issued to the operator by other approved certifying organisations.

4.0.7 An approved certifying organisation shall confine its requirements, inspection and decision on certification to those matters specifically related to the scope of the certification being considered.

4.0.8 All operations from production through to exportation must be verified to the point of final packaging.

4.0.9 Where certified produce is not in its final packaging (i.e. bulk produce) enters an operation that is not certified the produce will automatically be deemed as “non compliant” with the National Standard.

4.1 Structure

4.1.1 The approved certifying organisation shall have:

a) an organisation chart showing clearly the responsibility and reporting structure of the organisation, in particular, the relationship between testing, inspection and certification functions; and

b) a description of the means by which the approved certifying organisation obtains financial support; and

c) documentation of its certification systems including its rules and procedures for granting, maintaining, withdrawing and suspending certification.

4.2 Administrative structure

4.2.1 For the purposes of business the approved certifying organisation will be a legal entity, which complies with Australian business law.

4.2.2 The approved certifying organisation shall have a structure which requires the choosing of its governing board from among those interests involved in the process of certification without any single interest predominating.

4.2.3 The approved certifying organisation shall identify management positions which have responsibility for the:

a) performance of testing, inspection and certification, and

b) decisions on certification, and

c) technical basis for granting certification, and

d) formulation of policy matters relating to the operation of the approved certifying organisation, and

e) supervision of the implementation of its policies, and

f) supervision of the finances of the body, and

g) delegation of authority to committees or individuals as required to undertake defined activities on its behalf.

4.2.4 The approved certifying organisation shall ensure that certification decisions are taken by person(s) who are different from those who carried out the inspection.

4.2.5 If the certification activities are carried out by a legal entity, which is part of a larger organisation, the links with other parts of the larger organisation shall be clearly defined and identified in the QM manual.

4.2.6 Approved certifying organisations shall ensure that the activities of related bodies do not affect the confidentiality, objectivity and impartiality of its certification and inspection systems.

4.2.7 The approved certifying organisation shall have the financial stability and resources necessary for undertaking certification and inspection activities.

4.3 QM System

4.3.1 Each approved certifying organisation will ensure their certified operators:

a) comply with the relevant sections of the certification system; and

b) make the essential arrangements for an inspection, including an examination of all documentation and all areas of the certified operation, and resolution of complaints; and

c) only make claims regarding certification with respect to the scope for which certification has been granted; and

d) do not use product certification in such a manner as to bring any approved certification organisation into disrepute; and

e) do not make any statement regarding product certification which the approved certification organisation may consider misleading or unauthorized; and

f) upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and returns any certification documents as required by the certification organisations; and

g) use certification to indicate that their products are certified as compliant with the National Standard; and

h) use no certificate or report nor any part thereof in a misleading manner; and

i) can only reference product certification in communication media such as documents, brochures or advertising, which complies with the requirements of the approved certification organisation.

4.3.2 When the desired scope of certification is related to a specific system or type of system operated by the approved certifying organisation, any explanation needed shall be provided to the applicant.

4.3.3 The documented certification policies and procedures shall include all procedural steps in processing the application, until final certification.

4.3.4 The approved certifying organisation shall conduct its activities in accordance to the scope of the AQIS approval.

4.3.5 An approved certifying organisation must immediately notify AQIS when it ceases to meet the requirements of the National Standard, and/or export legislation, and/or importing country requirements and/or the AQIS Administrative Arrangements.

4.4 QM Manual

4.4.1 The QM manual of an approved certifying organisation shall include, at least the following;

a) quality policy statement signed by a management representative; and

b) an organisational chart displaying the lines of authority stemming from Senior Executive positions (or equivalent); and

c) a brief description of the legal status of the certification organisation; and

d) the details of any governing board, constitution, terms of reference and rules of procedure; and

e) the names, qualifications, experience of all personnel, both internal and external, who are involved in day-to-day operational, administrative, managerial and executive duties; and

f) the details of initial and on-going training for all personnel, and

g) the details for assessing initial and on-going inspections; and

h) the details of a product/soil sampling program and laboratory testing facilities; and

i) the details for the surveillance of certified operators including a provision for unannounced inspections; and

j) a list of all subcontractors and their details; and

k) the details for assessing subcontractor competence and compliance against the QM system; and

l) the details for appeal and sanctions; and

m) the procedures for the administrative control and operational procedures in ensuring organic produce certificates are used in accordance with the Act and relevant Orders; and

n) the procedures for the regular distribution of information to all other approved certifying organisations pertaining to operators who are currently under sanction(s).

4.5 Internal audits/reviews

4.5.1 The approved certifying organisation shall conduct internal audits covering all documented procedures, to verify that the QM system is effective.

4.5.2 The approved certifying organisation shall ensure that all elements of its QM system are audited (internally) at least once in a twelve-month period; and that

a) personnel in the area audited are informed of the audit findings.

b) corrective action is taken in a timely and appropriate manner.

c) the records of internal audits be retained.

4.5.3 The approved certifying organisation shall review the QM system at sufficiently defined intervals to ensure continuing suitability and effectiveness in satisfying the quality policy and objectives of the organisation.

4.6 Records

4.6.1 The approved certifying organisation shall maintain records, which satisfies its management system and complies with the Orders.

4.6.2 Records must be retained for at least five years.

4.6.3 Records of the approved certifying organisation shall give a clear indication that administrative and operational procedures have been effectively fulfilled, particularly with respect to:

a) completion of application forms; and

b) completion of inspection reports; and

c) any surveillance activities; and

d) approving, maintaining or extending certification status of the certified operator; and

e) suspending or revoking the certification of a certified operator.

4.6.4 The approved certifying organisation shall identify, manage and dispose of all records in such a way as to ensure integrity and confidentiality of the information.

4.6.5 The approved certifying organisation shall maintain records pertaining to the qualifications, training and experience of personnel, either full or part time, casual or subcontracted, involved in administrative or operational procedures of the organisation.

These records shall include:

a) name(s) and addresses; and

b) the person’s affiliation with all certifying organisations and

c) current and pervious employment positions held; and

d) educational qualification(s) and

e) the details of membership of any professional body; and

f) the experience and training undertaken by each individual whilst in the employment of the approved certifying organisation; and

g) a performance appraisal assessing the competencies of each personnel against the objectives and policies of the approved certifying organisation.

5. Mutual Recognition

5.1 Where requirements are based only on the National Standard, an AQIS approved certifying organisation shall recognise the QM system of another AQIS approved certifying organisation.

5.2 In instances where an AQIS approved certifying organisation has not achieved specific accreditation, the requirements of the Memorandum of Understanding on Mutual Recognition for Australian approved certifying organisations shall apply.

6. Documentation

6.1 The approved certifying organisation shall maintain a documented system for the control of all documentation relating to the QM system to ensure that:

a) appropriate documentation is available at relevant locations; and

b) all changes to QM system documents are covered by the correct authorisation by a management representative; and

c) all changes are processed in a manner that ensures direct and timely action; and

d) superseded documents are removed from use throughout the approved certifying organisation, its agencies and all certified operators; and

e) there is a register of all appropriate documents with the respective issue identified; and

f) documentation clearly indicates its date of implementation; and

g) there is a determination of which documents are available to the public and which are not.

7. Publications

7.1 Approved certifying organisations shall make publicly available at either regular intervals, or upon request, the following information:

a) the authority under which the approved certifying organisation operates; and

b) a statement about its product certification system, including its rules and procedures for granting, maintaining, extending, suspending and withdrawing certification; and

c) information about the inspection procedures and certification process related to each product certification system; and

d) a description of the means by which the certifying organisation obtains financial support; and

e) general information on the fees charged to operators; and

f) a description on the rights and duties of operators, and

g) a description of the requirements, restrictions or limitations on the use of the approved certifying organisation’s logo and the ways of referring to the certification granted; and

h) procedures for handling complaints, appeals and disputes; and

i) a directory of certified products and their operators.

8. Personnel

8.1 All personnel of the approved certifying organisation shall be competent for the functions they perform.

8.2 Clearly documented instructions shall be available to each person involved in certification and inspection that clearly describes their duties and responsibilities.

8.3 Minimum competence criteria of approved certifying organisation personnel shall be defined in the QM system.

8.4 The approved certifying organisation shall require all people involved in the inspection and certification process to sign a Conflict-of-Interest document by which they legally commit themselves to:

a) comply with the rules defined by the approved certifying organisation, including those relating to confidentiality and independence from commercial and other interests; and

b) declare any prior and/or present association on their part, or on the part of their employer, with a supplier or designer of products to the inspection or certification of which they are to be assigned.

8.5 Conflict-of-Interest forms shall be completed by personnel and scrutinised by the approved certifying organisation each time there is a change to any of the details.

8.6 Conflict-of-Interest details shall include both direct and indirect interests of each person.

9. Approved Certifying Organisation Conduct

9.1 Confidentiality

9.1.1 The approved certifying organisation shall ensure confidentiality of all information obtained in the course of inspection and certification activities at all levels of the organisation, including any committees, external bodies or sub contractors acting on its behalf.

9.1.2 Information acquired during the course of inspection or certification activity will not be disclosed to a third-party without the written consent of the operator in question. Where legislation or government accreditation requires information to be disclosed to a third party such as a foreign government agency, the operator shall be informed by the approved certification organisation.

9.2 Impartiality

9.2.1 The approved certifying organisation shall have a documented structure which safe guards impartiality including provisions to ensure the impartiality of the operations of the approved certifying organisation.

9.2.2 Inspection and certification shall be based on an objective assessment of relevant factors, following documented procedures.

9.2.3 The approved certifying organisation shall not:

a) supply or design products to the type that it certifies; or

b) provide any other service which could compromise confidentiality, objectivity or impartiality of its certification process and decisions; or

c) provide consultancy services to an operator as to the methods of dealing with matters which are barriers to the certification requested; or

d) receive any remuneration for any advice.

9.2.4 The approved certifying organisation shall be free from any commercial and financial involvement or any other pressures that might influence its decisions with respect to inspection and certification activities.

9.2.5 Payment of fees and expenses shall be made through the approved certifying organisation and not directly to an inspector.

9.2.6 The approved certifying organisation shall decide on what constitutes a conflict-of-interest, and shall take into consideration perceived conflicts-of-interest.

9.2.7 All persons who have a conflict-of-interest shall be excluded from all stages of the inspection and certification process, for at least two-years.

9.2.8 The exclusion of any person(s) with conflict(s)-of-interest must be recorded and those records retained.

9.3 Consultancy

9.3.1 The approved certifying organisation shall not provide consultancy services to operators.

9.3.2 Consultancy and certification shall never be marketed together.

9.3.3 Marketing material, written or oral information pertaining to inspection or certification activities must not give the impression that consultancy services are linked.

9.3.4 Nothing will be said or indicated by an approved certifying organisation that would suggest certification would be simpler, easier, or less expensive if any specified consultancy services were used.

9.3.5 An inspector will not provide consultancy as part of the inspection program. Advice is limited to an explanation of the National Standard or certification requirements.

9.3.6 The approved certifying organisation will ensure that none of its certified operators are given any impression that the use of both services, certification and consultancy, would bring any business advantages to the client so that the certification remains and is seen to remain impartial.

9.4 Subcontracting

9.3.7 Any decision concerning certification shall not be sub contracted to an external business or third party.

9.3.8 When duties relating to inspection or certification (or any other duties) are subcontracted to an external body or person, a properly documented agreement covering the arrangements including confidentiality and conflict-of-interest shall be drawn up by the approved certifying organisation and signed by both parties.

9.3.9 When work is subcontracted to an external business, the approved certifying organisation shall ensure through documented instructions and review that the personnel of the external business satisfy the QM system requirements.

9.3.10 Competence, integrity and transparency of any subcontracted components of the inspection and certification system shall remain the responsibility of the approved certifying organisation.

10. Changes to Accreditation

10.1 The approved certification organisation shall give notice to the competent authority of any changes it intends to make to its QM system which has the potential to alter its core business activities; for example changes to:

a) the name and/or business address of the organisation; or

b) key personnel or their details; or

c) the inspection or certification procedures; or

d) the organizational structure.

10.2 Following a decision on, and publication of any QM manual amendments, the approved certification organisation shall verify that each operator has made the necessary adjustments within the specified time period, usually 12 months.

11 Appeals, Complaints, Sanctions and Disputes

11.1 Approved certifying organisations shall:

a) record all appeals, complaints sanctions and disputes; and

b) document all follow-up actions relating to the issue(s) in question; and

c) document the effectiveness of the follow-up action.

11.2 The approved certifying organisation shall establish an appeals, complaints, dispute review procedure which enables all matters to be considered by people who are not directly involved in the decision being appealed.

12 Application for Certification

including previously certified operators

12.1 Following a request for information, the approved certifying organisation shall provide an operator with a current description of the inspection and certification procedures of the organisation, as well as:

a) the documents detailing the requirements for certification, and

b) the applicant’s rights and responsibilities; and

c) a list of all fees and charges.

12.2 Each operator shall provide the following information to an approved certifying organisation on official form, which includes:

a) the business entity name, contact details and address, including postal details; and

b) the legal status of the business entity; and

c) a list of products including the area or process to be certified; and

d) a statement identifying any previous certification; and

e) a signed Declaration (preferably a Statutory Declaration) confirming that the application and supporting documentation is true and correct.

12.3 Where requested, additional information shall be provided to the operator.

12.4 The approved certifying organisation will not retrospectively grant certification to any operator prior to the inspection date.

13 Sureveillance

13.1 The approved certifying organisation shall have documented procedures to enable inspections to be carried out in accordance with the relevant certification system, the documented procedures shall include the following:

a) frequency, this requires that inspections of all operators occur at least annually; and

b) have provision for additional inspections both under normal and emergency situations; and

c) scheduling of inspections shall not be at regular intervals as to become predictable; and

d) scheduling of unannounced inspections should be based on five percent (5%) of the total number of certified operators under the administrative control of the organisation.

14 Inspection Process

14.1 New Applicants

14.1.1 The approved certifying organisation shall first conduct an initial inspection of the operator’s records to ensure that:

a) the requirements for certification are clearly defined, documented and understood; and

b) if appropriate, that any differences between the approved certifying organisation and the operator are resolved; and

c) the approved certifying organisation has the capability to perform the service with respect to the scope of the certification sought and, if applicable, the location of the operations.

14.1.2 The approved certifying organisation shall schedule inspection activities to allow for the necessary arrangements to be effectively managed.

14.1.3 The approved certifying organisation shall assign personnel appropriately qualified and experienced to perform the inspection.

14.1.4 All persons that have been involved in the design, or supply, or installation or maintenance of systems or products, shall not be appointed by the approved certifying organisation to inspect the same system/product within a two-year time period.

14.1.5 Approved certifying organisations will inform their certified operators that they have neither the right to choose nor to recommend inspectors.

14.1.6 To ensure that a comprehensive inspection is carried out, all person’s involved shall be provided with the appropriate working documents prior to the inspection. These can include:

a) application form; and

b) previous inspection reports; and

c) a comprehensive description of the certified activities/processes; and

d) plans/maps of the certified operation; and

e) product specifications; and

f) a list of all inputs used; and

g) any previous conditions, non-conformities; and

h) a list of any previous sanctions (if appropriate).

14.1.7 Prior to an inspection, the approved certifying organisation shall contact the operator and:

a) advise of the inspector’s details, and

b) scope of the inspection; and

c) make the operator aware that they can raise objections relating to any potential conflict-of-interest; and

d) confirm any outstanding issues.

14.2 Inspections

14.2.1 Inspections shall facilitate nondiscriminatory and objective procedures.

14.2.2 The approved certification organisation shall ensure that all products and all systems of an operator are inspected at least once every 12-months.

14.2.3 As a minimum, the approved certifying organisation shall inspect products and systems of the operator against the relevant sections of the National Standard.

14.2.4 The approved certifying organisation shall ensure the majority of questions are documented prior to commencing the inspection and that they address the relevant sections of the National Standard.

14.2.5 The approved certification organisation will inform the operators under its administrative control that unless there is “conflict-of-interest” matter are under consideration, the operator will allow the inspector access to all:

a) production and storage areas; and/or

b) preparation and packaging areas; and/or

c) records pertaining to either of the above; and

d) equipment associated with product certification.

14.2.6 During an inspection, the inspector may request additional information from the operator or any related person or business entity, to support the inspection objectives.

14.2.7 Where appropriate and as a minimum, the inspector will undertake the following activities in relation to a primary production operation:

a) review all of the operator’s details prior to the inspection; and

b) physically examine the soil condition relative to the size of the production areas to determine the biological soil condition improvement; and

c) closely examine all livestock and plants for the presence of pests and/or disease; and

d) closely examine all buildings for the presence of pests; and

e) appraise all production or preparation procedures; and

f) review other aspects of the operation such as identifying/investigating areas of risk from neighboring properties; and

g) review all operator records and supporting documentation that enables the inspector to trace:

i. the origin, nature and quantities of all input materials and the use of such materials; and

ii. the origin, nature and quantities of agricultural products as specified in the National Standard which have been delivered to the premises; and

iii. the nature and quantity of both certified and non-certified products which have left the operators system; and

iv. the details of all declarations and/or invoices; and

h) if required, take samples of soil and/or tissue for laboratory analysis; and

i) inspect any storage and handling facility which is separate from buildings; and

j) review the effectiveness documented organic management plan; and

k) prepare a detailed objective report noting any discrepancies or departures from the relevant sections of the National Standard.

14.2.8 As a minimum, the inspector will undertake the following activities in relation to a preparation operation:

a) review all of the operator’s details prior to the inspection; and

b) closely examine all buildings for the presence of pests; and

c) appraise all preparation procedures; and

d) review other aspects of the operation such as identifying/investigating areas of risk from neighboring activities; and

e) review all records and supporting documentation that enables the inspector to trace:

i. the origin, nature and quantities of all input materials and the use of such materials; and

ii. the origin, nature and quantities of agricultural products as specified in the National Standard which have been delivered to the premises; and

iii. the nature and quantity of both certified and non-certified products which have left the operators system; and

iv. the details of all declarations and/or invoices; and

f) if required, take samples of product for laboratory analysis; and

g) inspect any storage and handling facility which is separate from buildings; and

h) review the effectiveness documented organic management plan; and

i) prepare a detailed objective report noting any discrepancies or departures from the relevant sections of the National Standard.

14.2.9 An inspection may include non-certified operations, where there is reason and acceptance for doing so. Where this activity is undertaken, an inspection report must be completed.

14.2.10 Where the presence of substances not compatible with the National Standard is likely to contaminate a product, the inspector must take samples for laboratory analyses.

14.2.11 Approved certifying organisations will ensure that only a National Association of Testing Authorities (NATA) accredited laboratory performs the analyses on any samples taken for testing.

14.2.12 For an operator who imports organic/biodynamic produce into Australia or sources and uses imported produce, the inspector will verify records to determine whether the produce has been subject to any treatment under the QUARANTINE ACT 1908 not in compliance with the National Standard.

14.3 Inspection report

14.3.1 Inspection reports shall be non-discriminatory, objective in format and should not include comments that have not been fully verified during the course of the inspection.

14.3.2 Inspection reports shall be clearly written (preferable using a computer/printer or typewriter) and professionally presented to the approved certifying organisation for consideration.

14.3.3 The operator shall be entitled to a copy of the Inspection report.

14.3.4 Where an inspection includes more than one operator, the report will include all details.

14.3.5 The approved certifying organisation shall ensure that personnel appointed to carry out inspections shall provide the approved certifying organisation with a detailed report no later than four weeks following the inspection date(s).

14.3.6 An Inspection report will detail the inspector’s observations together with the operator’s responses to the questions raised by the inspector.

14.3.7 Inspection reports will report all non-conformities.

14.3.8 Inspection reports shall provide comprehensive information for certification review members’ to make a competent and objective decision concerning certification.

14.3.9 Inspectors will record the following on the Inspection Report:

a) the date and duration of the inspection; and

b) all relevant observations; and

c) names of the person(s) interviewed and their responses to the questions raised; and

d) all documents that have been examined by the inspector during the course of the inspection.

14.3.10 At the end of each inspection, the operator shall countersign the Inspection report.

14.3.11 Timelines for rectifying minor non-conformities may be negotiated between the certified operator and the approved certifying organisation.

15 Certification/Certificates

15.1 Certification decisions

15.1.1 The approved certification organisation shall specify conditions under which it grants, and the procedures for granting certification.

15.1.2 The decision as to whether or not to certify a system shall be undertaken by the approved certifying organisation on the basis of the information gathered during the inspection process and the supply of other relevant information.

15.1.3 Certification decisions, including those concerning the maintenance of certification, shall be objective and transparent.

15.1.4 Certification decisions shall be recorded in such a way as to enable the decision to be traced back to the point of origin.

15.1.5 The certification organisation shall not delegate authority for granting, maintaining, extending, and suspending or withdrawing certification to an outside person(s) or body. Nor should the person(s) who conducted the inspection have any input into the certification decision process other than to make recommendations.

15.1.6 When certification is denied, the reasons shall be clearly stated by the approved certifying organisation in a written response to the operator.

15.2 Certified operator certificate

15.2.1 The approved certifying organisation will provide each certified operator with a document such as a letter and/or contract and/or certificate signed by a management representative. As a minimum, the information shall include the:

a) name and address of the certified operator; and

b) name and address of the approved certifying organisation; and

c) program under which the operator is certified; and

d) scope of the certification including reference to the National Standard, and

e) products or product categories, and

f) certification state (e.g. in conversion, bio-dynamic or organic) of each product; and

g) date of letter/certificate issuance; and h) period of certification.

15.2.2 Certification procedures shall be clearly documented in the QM manual describing the circumstances and conditions in which certificates or licenses will be withdrawn if non-conformities are identified.

15.3 Produce transfer certificate

15.3.1 The approved certifying organisation shall ensure that certified operators use produce transfer certificate or similar documented processes for the transfer of certified produce between certified operators.

15.3.2 Produce transfer certificates or similar system shall contain sufficient information to prevent fraudulent transfer of certified produce and include:

a) the seller/certified operator name and address/certification number; and

b) the customer/certified operator name and address/certification number; and

c) the transaction date and signature of the seller/certified operator; and

d) an accurate and complete description of the certified produce; and

e) the quantity of certified produce; and

f) current certification status of the produce; and

g) produce lot numbers or other identification marks; or

h) reference to any other relevant documentation such as an invoice, packing list or bill of lading,.

15.3.3 The approved certifying organisation shall require copies of signed produce transfer certificates to be retained by the certified operator for at least five years.

16 Critical Non-Conformity

Note Critical non-conformities that fall into this category may include: a severe beakdown in operator procedures, false or misleading trade description, substitution or contamination of produce, the use of non-allowed inputs, inspector inducement.

16.1 The Inspector shall immediately notify the approved certifying organisation of the critical non-conformity and await further instructions.

16.2 Upon notification, the approved certifying organisation may delegate power to an inspector to immediately suspend certification where the critical non-conformity has been clearly identified during a scheduled or unannounced inspection.

16.3 The approved certifying organisation shall have a documented range of sanctions to deal with critical non-conformity, including but not limited to, certified product recall, quarantining of existing certified product, suspension or revocation of certification status, overseas client notification.

16.4 The approved certifying organisation shall, without delay, immediately notify the competent authority of any critical non-conformity.

17 Use of Licences, Certificates, Marks and Logos

17.1 The approved certifying organisation shall have documented procedures for the control and use of its logo by certified operators.

17.2 The approved certifying organisation will document procedures for the intended or unintentional misuse of its logo by certified operators, including any false claims as to certification status of a product.

17.3 The approved certifying organisation should avoid using the same mark to indicate different certification systems.

17.4 The approved certifying organisation shall avoid confusion between marks, if there is more than one. This does not exclude the use of the same corporate logo in different marks for different systems of conformity.

17.5 Inaccurate references to the certification system or misleading use of licenses, certificates, or marks/logos shall be attended to by the approved certifying organisation via operator sanctions.

17.6 Use and distribution of the government regulatory mark by approved certifying organisations shall be in accordance with the “Rules for Design and Procedure Governing Australian Regulatory Marks for Certified Organic, Bio-dynamic or In conversion Produce” document (as amended).

18 Complaints to Certified Operators

18.1 The approved certifying organisation shall require the certified operator to:

a) keep a record of all complaints made known to him/her which relate to a certified product or system compliance with the National Standard; and

b) take appropriate action with respect to such complaints and any deficiencies found in products or services that effect compliance with the requirements for certification; and

c) document any corrective or follow up action taken.

19 Part 2 – AQIS Arrangements

19.1 Auditing

19.1.1 An authorised officer will ensure through audit activities that each approved certifying organisation or applicant organisation complies with the requirements of the National Standard for Organic and Bio-dynamic Produce (2002), these Administrative Arrangements and relevant legislation.

19.1.2 If deemed necessary, AQIS will arrange for an “expert” to:

a) audit the Approved certifying organisation; and

b) detail audit findings in a report; and

c) be cognisant of the confidentiality issues when dealing with other affiliated industries.

19.1.3 The authorised officer (or expert) will report any infringements to AQIS, who will then follow up with the relevant approved certifying organisation.

19.1.4 The authorised officer (or expert) must abide by the Public Service official Code of Conduct whilst performing any duties.

19.2 Application for Accreditation

19.2.1 Application for accreditation as an approved certifying organisation must be made in writing to AQIS Canberra using the preferred format.

19.2.2 Following receipt of an application, AQIS will:

a) advise the applicant their application has been received; and

b) desk audit the QM manual; and

c) make arrangements for an audit of the office(s) of the applicant organisation to verify that the procedures are carried out are as described in the Quality Management manual (on-site audit); and auditing of the premises of a representative sample of the operators in the scheme (field/on-site audit).

19.2.3 On completion of the applicant assessment, AQIS will prepare a report within 2 weeks.

19.2.4 In case of discrepancies in an applicant's Quality Management manual, the applicant will be advised and allowed to rectify issues before a final assessment is undertaken.

19.2.5 On receipt of the auditor's report, AQIS may seek further explanation before making a final decision on the application.

19.2.6 If AQIS is satisfied that the applicant's scheme meets the stated requirements, it will register the organisation as an Approved Certifying Organisation and issue a QM Certificate (Certificate of Accreditation).

19.2.7 If approval is not granted, the reason(s) will be given to the organisation in writing. The organisation may appeal against the non-granting of a Certificate of Accreditation under Part 20 of the Prescribed Goods (General) Orders as amended.

19.3 AQIS Accreditation

19.3.1 AQIS accreditation of approved certifying organisations remains valid subject to continuing satisfactory performance against the stated requirements.

19.3.2 Approved certifying organisations QM system shall be audited each year by AQIS.

19.3.3 The right to use the QM Certificate (Certificate of Accreditation) is not transferable.

19.4 Withdrawal of accreditation

19.4.1 An AQIS authorised officer may decide to revoke a QM Certificate (Certificate of Accreditation) if the certificate holder is not complying with its QM manual.

19.4.2 AQIS accreditation may be withdrawn in cases of failure to:

a) comply with the requirements of the approval system, including failure to correct deficiencies; or

b) pay AQIS charges in the specified time; or

c) comply with importing country requirements.

19.4.3 Notwithstanding the above, AQIS may withdraw the accreditation where it has reasonable grounds to believe that an action by an approved certifying organisation may have an adverse effect on the integrity of this system.

19.4.4 Upon withdrawal of a QM Certificate, the approved certifying organisation (including certified operators) will discontinue any claims of AQIS accreditation and will not be permitted to issue and authorise organic produce certificate(s) for export consignments.


Attachment 1 – AQIS Sanctions

The sanctions identified below are a guide only and may change without notice. AQIS reserves the right to alter any sanction/penalty depending on the specific situation and relevant information. AQIS will endeavor to communicate with OPEC members leading to and during the application of sanction(s).

Any approved certifying organisation or operator that does not satisfy:

- the Export Control (Organic Produce Certification) Orders 1997; and

- relevant importing country requirements; and

- the National Standard for Organic and Bio-dynamic Produce 2nd edition may be deemed to have not met the requirements and may be subjected to AQIS sanctions.

According to the AQIS Organic Produce Export Certification Program AQIS will decide the severity of the sanction to be applied to the approved certifying organisation. A number of factors will determine the type of action to be taken for example:

  • Failure to comply with the importing country requirements may result in revocation of the QM certificate.
  • Failure to comply with the Export Control (Organic Produce Certificate) Orders 1997 may result in revocation of the QM certificate.
  • Failure to correctly complete organic produce certificate(s) may result in revocation of the QM certificate.
  • Failure to comply with the National Standard for Organic and Bio-dynamic Produce 2002 may result in revocation of the QM certificate.
  • Failure to comply with any other requirement pertaining to the export process (e.g. Administrative Arrangements) may result in suspension or revocation of the QM certificate.

Any Approved certifying organisation which is deemed not to comply, may be subject to increase in the number of AQIS audits and this increased frequency will attract additional AQIS charges.

Any approved certifying organisation can appeal a decision made by AQIS by utilising the provisions of the Administrative Appeal Tribunal process.


Annex A

Bibliography

  • Export Control Act 1982
  • Prescribed Goods (General) Orders (as amended)
  • Export Control (Organic Produce Certification) Orders 1997.
  • National Standard for Organic and Bio-Dynamic Produce 2002, 3rd edition.
  • ISO/IEC Guide 65: 1996 (E) – General requirements for bodies operating product certification systems.
  • EAC/G2 EN 45011: 1995 – European standard for bodies operating product certification.
  • Importing country legislation including:
  • European Regulation (EEC) No 21092/91; and
  • United States Department of Agriculture Code of Federal Regulations 7, Part 205; and
  • Japan Law No. 175 of 1950 (amended 1999) and JAS Notification No. 59.
  • CODEX Alimentarius Guidelines for the production, processing, labelling and marketing of Organically Produced Foods
  • IFOAM Accreditation Criteria for Bodies Certifying Organic Production and Processing (Aug 2002)
  • National Competition Policy review of the Export Control Act 1982.