Aquatic Animal Health Code |
Quality of Aquatic Animal Health Services
The quality of Aquatic Animal Health Services depends on a set of factors, which include fundamental principles of an ethical, organisational, legislative, regulatory and technical nature. The Aquatic Animal Health Services shall conform to these fundamental principles, regardless of the political, economic or social situation of their country.
Compliance with these fundamental principles by a Member Country’s Aquatic Animal Health Service is important in the establishment and maintenance of confidence in its aquatic animal health status and international aquatic animal health certificates provided by the Aquatic Animal Health Service of other Member Countries.
These fundamental principles are presented in Article 3.1.2. Other factors to consider when evaluating Aquatic Animal Health Services are described in the Aquatic Code (notification, principles of certification, etc.).
The ability of Aquatic Animal Health Services to deliver appropriate services, monitor and control aquatic animaldiseases based on Member Countries’ aquatic animal health legislation and regulations, can be measured through an evaluation or audit whose general principles are described in Articles 3.1.3. and 3.1.4.
A procedure for evaluating Aquatic Animal Health Services by OIE experts, on a voluntary basis, is described in Article 3.1.5.
Fundamental principles of quality
Aquatic Animal Health Services should comply with the following principles to ensure the quality of their activities:
Professional judgement
Aquatic Animal Health Services should ensure that personnel have the relevant qualifications, scientific expertise and experience to give them the competence to make sound professional judgements.
Independence
Care should be taken to ensure that the Aquatic Animal Health Service personnel are free from any commercial, financial, hierarchical, political or other pressures which may inappropriately influence their judgement or decisions.
Impartiality
Aquatic Animal Health Services should be impartial. In particular, all the parties affected by their activities have a right to expect their services to be delivered under reasonable and non-discriminatory conditions.
Integrity
Aquatic Animal Health Services are responsible for ensuring that the work of each of their personnel is of a consistently high level of integrity. Any fraud, corruption or falsification should be identified, documented and corrected.
Objectivity
Aquatic Animal Health Services should conduct themselves, in an objective, transparent and non-discriminatory manner.
Aquatic animal health legislation and regulations
Aquatic animal health legislation and regulations are a fundamental element that supports good governance and provides the legal framework for all key activities of the Aquatic Animal Health Service.
Legislation and regulations should be suitably flexible to allow for judgements of equivalence and efficient responses to changing situations. In particular, they should define and document the responsibilities and structure of the organisations in charge of traceability and control of aquatic animal movements, aquatic animal disease control and reporting systems, epidemiological surveillance and communication of epidemiological information.
General organisation
Aquatic Animal Health Services should be able to demonstrate that they are able to anticipate the requirements for, and have control of, the establishment and application of aquatic animal health measures, and of international aquatic animal health certification activities. This should be demonstrated by means of appropriate legislation and regulations, sufficient financial resources and effective organisation.
Aquatic Animal Health Services should have at their disposal effective systems for aquatic animal disease surveillance, diagnosis and notification of disease problems that may occur in the national territory, in accordance with the provisions of the Aquatic Code. They should at all times endeavour to improve their performance in terms of aquatic animal health information systems and aquatic animal disease control.
Aquatic Animal Health Services should define and document the responsibilities and structure of the organisation (in particular the chain of command) in charge of issuing international aquatic animal health certificates.
Each position within the Aquatic Animal Health Services that has an impact on their quality should be described.
These job descriptions should include the requirements for education, training, technical knowledge and experience.
Quality policy
Aquatic Animal Health Services should define and document their policy and objectives for, and commitment to, quality, and should ensure that this policy is understood, implemented and maintained at all levels in the organisation. Where conditions allow, they may implement a quality system corresponding to their areas of activity and appropriate for the type, range and volume of work that they have to perform. The recommendations provided in this chapter describe a suitable reference system, which should be used if a Member Country chooses to adopt a quality system.
Procedures and standards
Aquatic Animal Health Services should develop and document appropriate procedures and standards for all providers of relevant activities and associated facilities. These procedures and standards may for example relate to:
programming and management of activities, including international aquatic animal health certification activities;
prevention, control and notification of disease outbreaks;
risk analysis, epidemiological surveillance and zoning;
emergency preparedness for disasters which could have an impact on aquatic animal health and welfare of farmed fish;
inspection and sampling techniques;
diagnostic tests for aquatic animal diseases;
preparation, production, registration and control of biological products for use in the diagnostic or prevention of diseases;
border controls and import regulations;
treatments intended to inactivate pathogens in aquatic animal products.
Where there are standards in the Aquatic Code or in the Aquatic Manual, Aquatic Animal Health Services should comply with these standards when applying aquatic animal health measures and when issuing international aquatic animal health certificates.
Information, complaints and appeals
Aquatic Animal Health Services should undertake to reply to requests from Aquatic Animal Health Services of other Member Countries or any other authority, in particular ensuring that any requests for information, complaints or appeals that are presented are dealt with in a timely manner.
A record should be maintained of all complaints and appeals and of the relevant action taken by Aquatic Animal Health Services.
Documentation
Aquatic Animal Health Services should have at their disposal a reliable and up-to-date documentation system suited to their activities.
Self-evaluation
Aquatic Animal Health Services should undertake periodical self-evaluation especially by documenting achievements against goals, and demonstrating the effectiveness of their organisational components and resource adequacy.
A procedure for evaluating Aquatic Animal Health Services by OIE experts, on a voluntary basis, is described in Article 3.1.5.
Communication
Aquatic Animal Health Services should have effective internal and external systems of communication covering administrative and technical staff and parties affected by their activities.
Human and financial resources
Responsible authorities should ensure that adequate resources are made available to implement effectively the above activities.
For the purposes of the Aquatic Code, every Member Country should recognise the right of another Member Country to undertake, or request it to undertake, an evaluation of its Aquatic Animal Health Services where the initiating Member Country is an actual or a prospective importer of aquatic animalcommodities and/or where the evaluation is to be a component of a risk analysis process that is to be used to determine or review sanitary measures which apply to such trade.
A Member Country has the right to expect that the evaluation of its Aquatic Animal Health Services will be conducted in an objective and transparent manner. A Member Country undertaking an evaluation should be able to justify any measure taken as a consequence of its evaluation.
A Member Country which intends to conduct an evaluation of another Member Country's Aquatic Animal Health Services should provide notice in writing, and allow sufficient time for the other Member Country to comply with the request. This notice should define the purpose of the evaluation and details of the information required.
On receipt of a formal request for information to enable an evaluation of its Aquatic Animal Health Services by another Member Country, and following bilateral agreement of the evaluation process and criteria, a Member Country should expeditiously provide the Member Country requesting the evaluation with meaningful and accurate information of the type requested.
The evaluation process should take into account the fundamental principles and other factors of quality laid down in Article 3.1.1. and in Article 3.1.2. It should also take into consideration the specific circumstances regarding quality, as described in Article 3.1.1., prevailing in the countries concerned.
The outcome of an evaluation conducted by a Member Country should be provided in writing as soon as possible, and in any case within four months of receipt of the relevant information, to the Member Country which has undergone the evaluation. The evaluation report should detail any findings that affect trade prospects. The Member Country which conducts the evaluation should clarify in detail any points of the evaluation on request.
In the event of a dispute between two Member Countries over the conduct or the conclusions of the evaluation of Aquatic Animal Health Services, the matter should be dealt with having regard to the procedures set out in Article 3.1.3.
Evaluation facilitated by OIE experts under the auspices of the OIE
The OIE has established procedures for the evaluation of Aquatic Animal Health Services of Member Countries. Member Countries can make a request to the OIE for an evaluation of their Aquatic Animal Health Services.
The World Assembly of OIE Delegates may endorse a list of approved experts to facilitate the evaluation process.
Under these procedures, the Director General of the OIE recommends an expert(s) from that list.
The expert(s) facilitate(s) the evaluation of the Aquatic Animal Health Services of the Member Country using the OIE Performance of Veterinary Services and/or Aquatic Animal Health Services (OIE PVS Tool: Aquatic).
The expert(s) produce(s) a report in consultation with the Veterinary Services of the Member Country.
The report is submitted to the Director General of the OIE and, with the consent of the Member Country, published by the OIE.
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