Decree No. 204 / 2012 Coll.
Ordinance on technical requirements for the designation of a reference laboratory
Valid
Effective from 01.07.2012
Text versions:
01.07.2012
18.06.2012
204
DECLARATION
of 6 June 2012
on the technical requirements for the delegation of the reference laboratory
According to Article 88 (6) of Act No. 326 / 2004 Coll., on Phytosanitary Care and on the Amendment of Certain Related Acts, as amended by Act No. 245 / 2011 Coll. and Act No. 199 / 2012 Coll., (hereinafter "the Act '), the Ministry of Agriculture provides for the implementation of Article 6a (2) (c) of the Act:
Subject matter
This decree implements the relevant European Union Regulation (1) and amends the technical requirements for the designation of the reference laboratory.
Technical requirements for delegation of the reference laboratory
(1) The legal person complies with the technical requirements for the designation of the reference laboratory if:
(a) it has a quality management system in place, documented and maintained which corresponds to the scope of the professional activities for which it is to be entrusted;
(b) it has a defined organisational structure of the laboratory, including the powers of staff;
(c) have documents drawn up containing technical procedures and instructions related to the conduct of professional activities;
(d) it has equipment and procedures for the processing, security, storage and sharing of records and data relating to professional activities, including electronic communications;
(e) professional activities shall be carried out only by persons responsible for such activities and with appropriate qualifications;
(f) its spatial, instrumental and material equipment and environmental conditions enable the quality of the performance and evaluation of professional activities;
(g) provision is made for measures to manage access to and use of premises which may affect the quality of the professional activities carried out;
(h) be equipped with instructions and procedures for the use, storage, maintenance and other handling of equipment and material for professional activities;
(i) have in place a programme and procedure for the recording, calibration and inspection of equipment and reference materials for the performance of professional activities;
(j) there are procedures for the transport, reception, storage and disposal of samples, including measures to prevent contamination and degradation, and a system of unambiguous identification of samples,
(k) be able to ensure the quality and validity of the results of the tests and analyses carried out by repeating them, using reference materials or other appropriate standards, participating in inter-laboratory comparison programmes and systematic monitoring of the data obtained;
(l) the results of the tests and analyses shall be clearly and unequivocally stated in a protocol containing the identification of the laboratory, customer and sample and any information necessary for the interpretation of the results, including the method used for the relevant test or analysis;
(m) keep records of the resolution of customer complaints and the corrective measures taken;
(n) carry out professional activities according to the methods laid down by other legislationsm2) and, if such methods are not laid down by law, according to the methods established by the national reference laboratory; and
(o) for the work of the quarantine material, the plant health authority's authorisation under Section 8 of the Act is in compliance with the quarantine regime provided for by this authorisation.
(2) The requirements for the delegation of the reference laboratory referred to in § 2 (a) to (m) are met if they comply with the Czech technical standard (3).
Efficacy
This decree shall take effect on the first day of the calendar month following its publication.
Minister:
Ing. Bendl v. r.
1) Council Directive 2009 / 143 / EC of 26 November 2009 amending Directive 2000 / 29 / EC as regards authorisation to carry out laboratory testing tasks.
2) For example, Decree No. 332 / 2004 Coll., on measures to ensure protection against the introduction and spread of potato cancer, Potato PWN and Yellow PWN, as amended by Decree No. 75 / 2010 Coll.
3) ČSN EN ISO / IEC 17025 Conformity assessment - General requirements for the competence of test and calibration laboratories.
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Regulation Information
| Citation | Decree No 204 / 2012 Coll., on technical requirements for the designation of the Reference Laboratory |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.06.2012 |
|---|---|
| Effective from | 01.07.2012 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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