Information provided pursuant to Act No. 106/1999 Coll.

In accordance with the requirement of Section 5, paragraph 3 of Act No. 106/1999 Coll., on free access to information, as amended (hereinafter referred to as “Act No. 106/1999 Coll.”), the Czech Accreditation Institute, ops (“CAI”) publishes below the information and documents that, in accordance with the requirements of Act No. 106/1999 Coll., it provided to applicants for the provision of information based on their requests.

29. 4. 2026

Based on a request received on February 16, 2026 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information:

"1) Accreditation of forensic testing, including forensic toxicology, is possible in the field of testing laboratories, according to the accreditation standard ČSN EN ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories. In the field of medical laboratories, accreditation is carried out using the standard ČSN EN ISO 15189 ed. 3:2023 Medical laboratories - Requirements for quality and competence, but in this area the scope of accreditation may only include the examination of materials obtained from the human body for the purpose of providing information for the diagnosis, monitoring, management, prevention and treatment of diseases or the assessment of health, including toxicological examinations. The list of accredited laboratories, including the scope of accreditation granted, can be found in the database of accreditation bodies for conformity assessment, available on the website of the accreditation body www.cai.cz.

2) Accreditation is not a guarantee of the "correct" performance of the accredited laboratory's practice, but rather a document of the laboratory's ability to meet the accreditation requirements set by the relevant harmonized technical standard, which was demonstrated in the proceedings before the accreditation body.

3) CAI carries out accreditation of conformity assessment bodies within the meaning of Section 14 et seq. of Act No. 22/1997 Coll., on technical requirements for products and on amendments to certain acts, as amended (hereinafter referred to as “Act No. 22/1997 Coll.”), as the (sole) national accreditation body of the Czech Republic in accordance with the designated Act and the requirements of Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the placing of products on the market and repealing Regulation (EEC) No. 339/93 (hereinafter referred to as “Regulation (EC) No. 765/2008”). Accreditation is carried out in the areas specified by the mandate of the Ministry of Industry and Trade in individual decisions, which are published on the CAI website. www.cai.cz. Accreditation is always carried out at the request of the applicant for accreditation, who specifies in the application the scope of specific conformity assessment activities for which accreditation is requested (Section 16(2) of Act No. 22/1997 Coll.). In the accreditation procedure, the accreditation body subsequently assesses whether the applicant, within the scope of the conformity assessment activities defined by it, meets the accreditation requirements set out in the relevant harmonised technical standard. As regards the "types" of accreditation carried out in the area covered by the request for information, reference can be made to point 1) of the information, i.e. the accreditation of testing laboratories and the accreditation of medical laboratories. The scope of accreditations granted by CAIs is published in the database of accreditation bodies for conformity assessment on the CAI website. www.cai.cz, which allows both detailed search and viewing of individual attachments to the accreditation certificate.

4) Regulation (EC) No 765/2008 lays down requirements for national accreditation bodies, including in Article 4 the requirement for the existence of (at most) one national accreditation body in each Member State and in Article 6 the principle of non-competition of national accreditation bodies both with conformity assessment bodies and with other national accreditation bodies. At the same time, Regulation (EC) No 765/2008 establishes the territorial jurisdiction of the accreditation body in which the applicant for accreditation is established and, for specific cases that may arise in practice, grants national accreditation bodies the right to carry out cross-border activities in the territory of another Member State under the conditions specified in Article 7 of the said Regulation. If the conditions set out in Article 7 of Regulation (EC) No 765/2008 are met, conformity assessment bodies established in the Czech Republic could apply for accreditation from an accreditation body of another Member State – for example, if the national accreditation body does not carry out accreditation in relation to the conformity assessment activities for which accreditation is sought. However, as the CAI currently provides accreditation in all available areas, the accreditation of an applicant established in the Czech Republic by a foreign national accreditation body under Regulation (EC) No 765/2008 is at least unlikely.

5) The accreditation body carries out accreditation in the form of an objective, impartial and independent assessment of the fulfilment of accreditation requirements by conformity assessment bodies. For this reason, Article 4.4.11 of the harmonised technical standard ČSN EN ISO/IEC 17011:2018 Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies expressly prohibits it from offering or providing services that would affect its impartiality, including the provision of proficiency testing, which is specifically mentioned in the marked Article.

24. 4. 2026

Based on three requests for information pursuant to Act No. 106/1999 Coll., delivered on 9 April 2026, CAI provided the applicant with the requested information via separate documents. 1), 2), 3) to 4).

9. 4. 2026

Based on a request received on 10 May 2024 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the requested copies the art.

25. 3. 2026

Based on a request received on February 20, 2026 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information:

"1) According to the valid accreditation legislation contained in Act No. 22/1997 Coll., on technical requirements for products and on amendments and supplements to certain acts, as amended, the accreditation body shall grant accreditation to a conformity assessment body that demonstrates that it meets the requirements for carrying out a specific conformity assessment activity set out in harmonised standards or other documents valid for the area of ​​conformity assessment (hereinafter referred to as "accreditation requirements"). In the area of ​​medical laboratories, accreditation is carried out using the standard ČSN EN ISO 15189 ed. 3:2023 Medical laboratories - Requirements for quality and competence, however, in this area the scope of accreditation may only include the examination of materials obtained from the human body for the purpose of providing information for the diagnosis, monitoring, management, prevention and treatment of diseases or health assessment, including toxicological examinations. Accreditation of forensic testing, including forensic toxicology, is possible in the field of testing laboratories, according to the accreditation standard ČSN EN ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories.

2) CAI is not aware whether accreditation is required to perform hair toxicology analysis. If so, accreditation in the areas and according to the standards listed in point 1) would be considered.

3) Accreditation is carried out at the request of the applicant for accreditation, to the extent of the conformity assessment activities carried out by the applicant, to the extent of which the applicant demonstrates compliance with the accreditation requirements. The standard used for the accreditation of conformity assessment activities that can be considered as "forensic analysis of biological materials" is the standard ČSN EN ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories, as explained in point 1).

4) Accreditation does not constitute approval, validation or confirmation of specific procedures and methods used by individual conformity assessment bodies or their laboratories, but rather an assessment and, where applicable, confirmation of the conformity assessment body's activities with the accreditation requirements laid down in the relevant harmonised technical standard (ČSN EN ISO 15189 ed. 3:2023 or ČSN EN ISO/IEC 17025:2018, as mentioned above). If this standard sets out a requirement for validation or verification of procedures or tests that are to be (or are) included in the scope of accreditation, the accreditation body assesses whether these requirements of the specific harmonised technical standard are also met by the conformity assessment body.

5) The University Hospital Hradec Králové is an accredited conformity assessment body, which currently holds accreditation for four laboratories, which are: No. 8091, Laboratories of the Fingerland Institute of Pathology (Laboratories of the FÚP); No. 8234 Molecular Genetics Laboratory of the ÚKBD and OLG, No. 8248 Cytogenetics Laboratory of the Department of Medical Genetics and No. 8267 Transfusion Department, Laboratory of the HLA System and PCR Diagnostics. Detailed information on the accreditation granted, including the scope of accreditation granted for individual laboratories, can be found in the database of accreditation bodies, publicly available on the CAI website. www.cai.cz.

6) The Czech Accreditation Institute, a public benefit corporation, maintains a publicly accessible database of conformity assessment accreditation bodies on its website. www.cai.cz, specifically at the link https://www.cai.cz/?page_id=4499. The database contains detailed information on the accreditations granted, including full information on their scope. The database also allows for detailed searches, including full-text searches in the text of the annex to the accreditation certificate, in which the scope of the accreditation is defined.

"2. In accordance with the submitted application, CAI provides the following information on the professional qualifications of the CAI employees designated by the applicant, in the order of the submitted application.

2.1. The employee obtained the highest education achieved at the educational institution Vysoká škola báňská – Technical University of Ostrava, with its registered office at 17. listopadu 2172/15, 708 00 Ostrava-Poruba, in the field of Electrical Power Engineering, studying in the master's degree program Electrical Engineering and Informatics at the Faculty of Electrical Engineering and Informatics. His professional experience is 22 years in the field of quality management and control, implementation, development and auditing of quality management systems in the Czech Republic and abroad, in professional and managerial positions. As for completing other courses and long-term work experience, he completed educational events in the field of conducting internal and external audits, statistical process management and implementation of standards in the field of accreditation, and he also works as a lecturer.

2.2. The employee obtained the highest education achieved at the educational institution University of Chemical Technology in Prague, Faculty of Food and Biochemical Technology, Technická 5, Dejvice, 160 00 Prague 6, in the field of Fermentation Chemistry and Bioengineering. His professional experience is 14 years in the field of food and chemical production in the positions of head of the testing and development laboratory and 13 years in CAI in the positions of head assessor, guarantor, deputy director of the accreditation activities department and director of the accreditation activities department. The employee also works as a lecturer.

2.3. The employee received his highest education at the educational institution of the Czech Technical University in Prague, Faculty of Mechanical Engineering, Technická 4, 160 00 Prague 6, in the field of 2301T Mechanical Engineering, field of Environmental Technology. Professional experience amounts to 21 years in managerial and expert positions, including as Head of the Environmental Assessment Department, Senior Innovation Consultant, Chief Assessor, Guarantor of Accreditation Development and Director of the Accreditation Activities Department. As for completing other courses and long-term work experience, the employee is the author of a number of articles in professional publications and participates in further education both as a student and as a lecturer.

2.4. The employee received his highest education at the educational institution Czech Technical University, Faculty of Mechanical Engineering, Technická 4, 160 00 Prague 6, in the field of M2301 Mechanical Engineering, Production Engineering. His professional experience is 21 years in the field of quality management. As for completing other courses and long-term work experience, the employee received further education at the institutions Dominican University, Brennan School of Business and Brno University of Technology, Faculty of Business, in the field of Master of Business Administration, and he himself acts as a lecturer at educational events.

2.5. The employee obtained the highest education achieved at the educational institution Secondary Vocational School: Podnikatelská akademie, sro, K Milíčovu 674, Prague 4, in the field of Business and Management. His professional experience is 19 years in positions with an economic focus. As for completing other courses and long-term work experience, the employee completed a course at the educational institution Educational and Language Bohemia Institute, Nad Vodovodem 20, Prague 10, in the field of Business Management.

3. In accordance with the submitted application, CAI encloses a copy of the requested documents for the years 2024 a 2025. The hourly wage was 2.000 CZK + VAT. The total number of hours in the year was 2024 42 hours, in the year 2025 10:20 a.m., so the service was provided for a total of 52:20 hours. List of actions including the number of hours is attached (in the overview for 2025 the plaintiff's surname was illegible). The calculation of the price for individual acts is attached. Pages of the request for "a copy of the relevant part of the CAI budget chapter, from which the payment of tax documents (invoices) issued by the lawyer for legal services provided in the period from 1. 9. 2024 do 21. 7. 2025“ CAI reports that the costs of legal services fall under Chapter A Costs, item AI Purchases and purchased services, item 6. Other services, as listed on page 25 CAI annual reports for 2024, published on the CAI website, a copy of which is attached to this information. The legal services expenses for 2025 will be included in the same chapter in the 2025 annual report, which CAI will publish in 2026.

4. In accordance with point 4.1 requests provides the CAI with the requested document. 5. In accordance with point 5. requests provides CAI with the requested document.'

25. 7. 2025

Based on a request received on March 14, 2025 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information:

"Accreditation of conformity assessment bodies within the meaning of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, as amended by the correction of 3 July 2015, constitutes the confirmation by the national accreditation body that the conformity assessment body meets the requirements set out in harmonised standards and, where relevant, any other requirements, including those set out in the relevant sectoral schemes, for the performance of a specific conformity assessment activity. Act No 22/1997 Coll., on technical requirements for products and on amending and supplementing certain acts, as amended, specifically provides in Section 16(3) that the accreditation body shall grant accreditation to a conformity assessment body which demonstrates that it meets the requirements for the performance of a specific conformity assessment activity, which set out harmonised standards or other documents applicable to the area of ​​conformity assessment (hereinafter referred to as the "accreditation requirements"), and that if the conformity assessment body does not meet the accreditation requirements, the accreditation body shall reject the application for accreditation by decision. As regards accreditation already granted, the accreditation body is obliged to suspend it with the potential for subsequent cancellation if remediation is not carried out within the specified period pursuant to Section 16(6) of the same Act, if it finds that the conformity assessment body does not meet the accreditation requirements on the basis of which it was granted accreditation.

In the field of accreditation of inspection bodies, accreditation requirements are prescribed by the harmonised technical standard ČSN EN ISO/IEC 17020:2012 Conformity assessment - Requirements for the activities of different types of bodies carrying out inspection (hereinafter referred to as the "standard"). In order to obtain (and maintain) accreditation, a conformity assessment body must demonstrate that it meets all applicable requirements of the standard, including the requirements for procedures and methods used by inspection bodies in carrying out activities that are (or are) included in the scope of the accreditation granted, contained in Article 7.1 of the standard.

Article 7.1.3 of the standard, which the applicant identified and to which the applicant's application relates, sets out requirements for the inspection body in the event that the inspection body must use inspection methods or procedures that are “non-standard”. In a note to the same article, the standard states which methods are considered standard and which are non-standard.

When assessing the fulfilment of the accreditation requirements in the context of the inspection procedures IP01 and IP02, which the applicant indicated in the submitted application, the CAI considered whether the requirements set out in Article 7.1.3 of the standard were applicable in the given case or not. To this end, it considered whether, using the criteria of the text in the note to Article 7.1.3 of the standard, the inspection methods and procedures used by the inspection body could be considered standard or non-standard.

According to the findings made by the accreditation body, both the inspection procedure IP01 and the inspection procedure IP02 were developed on the basis of legal regulations (regulations of the European Parliament and of the Council, directives of the Council and of the Commission, laws, decrees), international technical standards adopted into the system of Czech technical standards (ČSN EN ISO), and on the basis of foreign technical directives. An overview of all documents in accordance with which the inspection procedures IP01 and IP02 were developed was available to the accreditation body during the assessment of the fulfillment of the accreditation requirements. The documents for the development of the inspection procedures are managed by the inspection body in a folder, the designation of which is known to the accreditation body and which it was allowed to view during the assessment. Therefore, when assessing the fulfillment of the accreditation requirements, both the content of the inspection procedures and the list and content of specific documents on the basis of which the inspection procedures were developed were made available to the accreditation body. Based on the information submitted, the accreditation body concluded that inspection procedures IP01 and IP02 use standard inspection methods within the meaning of Article 7.1.3 of the standard, including the note.

The accreditation body could therefore conclude that the additional requirements contained in Article 7.1.3 of the standard, prescribed in the event that the inspection body must use non-standard methods or procedures, are not applicable when proceeding according to inspection procedures IP01 and IP02, or that the requirement of Article 7.1.3 of the standard was “met by using standard methods or procedures” in the sense of the formulation used by the Ministry of Industry and Trade.”

5.3.2025

Based on a request received on February 18, 2025 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information:  

"1) CAI does not have inspection procedures of accredited conformity assessment bodies at its disposal. CAI carries out accreditation of conformity assessment bodies in accordance with Section 14 et seq. of Act No. 22/1997 Coll., consisting in assessing the compliance of the conformity assessment body with the accreditation requirements when performing conformity assessment activities specified in the annex to the accreditation certificate. In relation to inspection procedure IP01, CAI assessed whether the conformity assessment body meets the accreditation requirements, set out in particular by the harmonised technical standard ČSN EN ISO/IEC 17020:2012, when carrying out the activity "Determination of the occurrence and determination of asbestos and other hazardous fibres in the indoor and outdoor environment and risk analysis" in the type and scope of "Indoor and outdoor environment: - determination of the occurrence of materials containing asbestos and other hazardous fibres - determination of the extent of the occurrence of materials containing asbestos and other hazardous fibres - determination of the extent of the occurrence of materials containing asbestos and other hazardous fibres together with the determination of their degree of hazard" according to its own inspection procedures prepared by the inspection body IP01 - version 10. 5. 2017, IP01-3.1, IP01-3.2, IP01-3.3. The content of the inspection procedures is not subject to accreditation, which in no way validates, confirms or otherwise evaluates the inspection procedures of conformity assessment bodies.

2) As explained in the previous point, the content of inspection procedures is not subject to accreditation, which in no way validates, confirms or otherwise evaluates the inspection procedures of conformity assessment bodies. The accreditation body is not responsible for assessing the compliance of inspection procedures with technical standards or legal regulations, but only for assessing the performance of the conformity assessment body in terms of fulfilling the accreditation requirements, set in particular by the harmonised technical standard ČSN EN ISO/IEC 17020:2012. The IP01 inspection procedure is owned by the accredited inspection body and the CAI has not accredited it, nor has it validated its content in any way by accreditation, and does not have its text available.

3) CAI as an accreditation body does not assess the "professional correctness" of inspection procedures. When carrying out accreditation, CAI assesses whether the conformity assessment body, when performing inspection activities according to the procedures specified in the application for accreditation, or subsequently in the annex to the accreditation certificate, meets the accreditation requirements set out for such activities, in particular in the form of the requirements of the harmonised technical standard ČSN EN ISO/IEC 17020:2012. The assessment of compliance with accreditation requirements is carried out using assessment techniques listed in Article 3.24 of the harmonised technical standard ČSN EN ISO/IEC 17011:2018, which include, for example, on-site assessment, remote assessment, witness assessment, document review, file review or interviews.

4) As explained above, inspection procedures are the property of the relevant inspection bodies, and CAI does not accredit inspection procedures, nor does it validate their content by accreditation. This also applies to inspection procedure IP02.

5) As explained above, the content of inspection procedures is not subject to accreditation, which in no way validates, confirms or otherwise evaluates the inspection procedures of conformity assessment bodies. It is not the role of the accreditation body to assess the compliance of inspection procedures with technical standards or legal regulations, but only to assess the performance of the conformity assessment body in terms of fulfilling the accreditation requirements, set in particular by the harmonised technical standard ČSN EN ISO/IEC 17020:2012. The IP02 inspection procedure is owned by the accredited inspection body and CAI has not accredited it, nor has it validated its content in any way by accreditation, and does not have its text available.

6) As explained above, CAI as an accreditation body does not assess the “professional correctness” of inspection procedures. When carrying out accreditation, CAI assesses whether the conformity assessment body, when performing inspection activities according to the procedures specified in the application for accreditation, or subsequently in the annex to the accreditation certificate, meets the accreditation requirements set out for such activities, in particular in the form of the requirements of the harmonised technical standard ČSN EN ISO/IEC 17020:2012. This also applies to the inspection procedure IP02. The assessment of compliance with the accreditation requirements is carried out using the assessment techniques listed in Article 3.24 of the harmonised technical standard ČSN EN ISO/IEC 17011:2018, which include, for example, on-site assessment, remote assessment, witness assessment, document review, file review or interviews.

7) The above inspection procedures are not considered non-standard inspection methods.

8) These are not non-standard inspection methods.

9) No. As set out in Article 2(10) of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (as corrected on 3 July 2015), accreditation means the attestation by a national accreditation body that a conformity assessment body meets the requirements set out in harmonised standards and, where relevant, any other requirements, including those set out in relevant sectoral schemes, for the performance of a specific conformity assessment activity. 

10) The granting of accreditation for any type of inspection body, including type A, is not related to the type of inspection method used by the inspection body. The accreditation of an inspection body is not conditional on the type of inspection procedure, but on the inspection body demonstrating compliance with the accreditation requirements, as explained above.

11) Yes, the accreditation granted by CAI is internationally recognised in accordance with Article 11(2) of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, and the content of multilateral international agreements on the mutual recognition of accreditation results concluded within the framework of the European Organisation for Cooperation in the Field of Accreditation (more information can be found on the website https://european-accreditation.org/mutual-recognition/the-ea-mla/) and the International Association for Laboratory Accreditation (for more information, see the website https://ilac.org/ilac-mra-and-signatories/). This fact also applies to the aforementioned inspection body, to the full extent of the accreditation granted to it.

12) For accredited conformity assessment bodies, the CAI subsequently verifies the fulfillment of accreditation requirements in accordance with Section 16(6) of Act No. 22/1997 Coll., both on a regular basis and ad hoc if there is any doubt about the fulfillment of accreditation requirements by the accredited conformity assessment body; also during the subsequent verification of the fulfillment of accreditation requirements by the accredited conformity assessment body, the assessment techniques listed in Article 3.24 of the harmonized technical standard ČSN EN ISO/IEC 17011:2018, which are listed above, are used. More detailed information on the subsequent verification of the fulfillment of accreditation requirements of the activity is contained in the methodological guideline for accreditation MPA 00-01-24 Basic rules of the accreditation process, ver. 2, available on the CAI website in the Documents for download section (https://www.cai.cz/?page_id=2961). "

26. 7. 2024

Based on a request received on May 10, 2024 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following documents.

Lease agreement Olšanská PP

Lease agreement Olšanská NP

27. 5. 2024

Based on a request received on May 10, 2024 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"2. The designated employees of the accreditation body have achieved university education in a master's degree program in a technical field, have obtained the degree of Ing. and have taken up the specified positions with at least 12 years of professional experience. The designated qualification is in accordance with the requirements for the professional competence of the employees of the accreditation body.

3. The required contracts, including their amendments, are published in the Register of Contracts. Copies of the contracts and their amendments are available at https://smlouvy.gov.cz/smlouva/4598172.

4. The method of appointing members of the Board of Directors is regulated by the CAI's founding charter (registered in the Collection of Documents of the Register of Public Benefit Societies kept by the Municipal Court in Prague, No. O 47, the full text of which is also published on the CAI website in the Statutory Documents section at https://www.cai.cz/?page_id=1920) in the Eighth Part: Board of Directors, paragraph 3, when it stipulates that the members of the board of directors are always appointed by the founder, namely one member directly, one member at the joint proposal of business associations and the Czech Chamber of Commerce, and one member at the joint proposal of the association of accredited entities and the company director.

The designated member of the Board of Directors is a candidate according to Article Eight, Paragraph 3, Letter b) of the CAI's founding charter, i.e. a person appointed to the position of member of the Board of Directors "upon a joint proposal of business associations and the Chamber of Commerce". This means that the CAI does not propose the designated person, but merely forwards the joint proposal of the designated institutions - business associations and the Czech Chamber of Commerce - to the Ministry of Industry and Trade, which, as the founder of the CAI, decides on the appointment to the position of member of the Board of Directors. In the interest of the independence of the proposed candidates and the proper functioning of the CAI bodies on the basis of tripartite representation of interested parties, the CAI is not competent to influence the institutions that propose the candidate, nor to evaluate or contradict their choice. 

5. The method of appointing members of the Supervisory Board is regulated by the CAI's founding charter in the Tenth Part: Supervisory Board, paragraph 4, when it stipulates that members of the Supervisory Board are always appointed by the founder, namely one member directly, one member at the joint proposal of business associations and the Czech Chamber of Commerce, and one member at the joint proposal of the association of accredited entities and the company director.

The designated member of the Supervisory Board is a candidate according to Article Ten, paragraph 4, letter c) of the CAI Articles of Association, i.e. a person appointed to the position of member of the Board of Directors “upon a joint proposal of the association of accredited entities and the company director”. In connection with the vacancy of the position by the previous member of the Supervisory Board, the CAI director approached a representative of the association of accredited bodies with a request for a proposal of a candidate for appointment to the vacant position of member of the Supervisory Board, and received a proposal for the appointment of the designated person, which was agreed upon by the other associations of accredited entities. Since the proposed candidate received unanimous support from the association of accredited entities and demonstrated that he meets the requirements of Section 10, paragraphs 2 and 4 in conjunction with Section 15, paragraph 4 of Act No. 248/1995 Coll., on Public Benefit Corporations and on Amendments and Supplements to Certain Acts, as amended (hereinafter referred to as the "Act on Public Benefit Corporations"), the Director of CAI joined the proposal of the association of accredited entities and submitted this joint proposal to the founder for a decision on appointment in accordance with Article Ten, paragraph 4, letter c) of the CAI founding charter.

5.1 The Director of CAI joined the proposal for the appointment of the designated member of the Supervisory Board on the grounds that this is a candidate whose appointment was proposed and unanimously supported by the association of accredited entities in accordance with Article Ten, paragraph 4, letter c) of the CAI Articles of Association, and it was verified that the candidate meets the requirements imposed on members of the Supervisory Board by applicable law, as described above.

5.2 With regard to the universal support of the candidate proposed by the associations of accredited entities and verification that he meets the requirements imposed on members of the supervisory board by applicable law, the Director of CAI joined the joint proposal of the associations of accredited entities and did not propose his own candidate.

6. CAI has a clearly defined organizational structure, powers and responsibilities of employees, so as to minimize the risks of threats to impartiality and independence. As the national accreditation body of the Czech Republic, CAI meets the requirements set out in Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93 (hereinafter referred to as "Regulation 765/2008"), including the requirements for the independence of its activities and the absence of conflicts of interest, an organisation ensuring the objectivity and impartiality of its activities, the separation of its activities from the duties and tasks of other bodies, non-profitability in carrying out accreditation, a ban on competition with other accreditation bodies or conformity assessment bodies and balanced involvement of stakeholders (in particular Articles 4 and 8 of Regulation 765/2008), while the fulfilment of these requirements is regularly reviewed within the framework of the peer evaluation pursuant to Article 10 of the said Regulation, carried out by the European Organisation for Cooperation in the Field of Accreditation (EA) as a body recognised by the European Commission. As repeatedly verified by peer review, the CAI management system is implemented and maintained in accordance with the requirements of the standard ČSN EN ISO/IEC 17011:2018 Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies (hereinafter referred to as "ČSN EN ISO/IEC 17011:2018") so that the impartiality and objectivity of its activities are reliably ensured and protected, including from influences that can be described as a "conflict of interest" (e.g., according to Article 4.4.4 of the standard ČSN EN ISO/IEC 17011:2018, all employees and committees of the accreditation body who could influence the accreditation process must be free from all undesirable commercial, financial and other pressures that could threaten impartiality; according to Article 7.7.2 of the same standard, accreditation decisions are made by persons who did not carry out the actual assessment of compliance with accreditation requirements, etc.).

CAI employees are obliged to notify CAI of all past, current and possibly anticipated ties to entities whose accreditation they participate in in accordance with their job classification or whose accreditation they could influence in any way from their position, as well as to entities operating in the same or related field, if these ties could affect their impartiality in the performance of the assigned tasks. The provisions on the exclusion of officials from the consideration and decision-making of a case pursuant to Section 14 of Act No. 500/2004 Coll., Administrative Procedure Code, as amended, shall apply in full – both with regard to the right of a party to the proceedings to object to the bias of an official and with regard to the immediate notification of the official's superior of facts that may indicate his/her exclusion by the official directly concerned.

7. The designated member of the Supervisory Board was appointed to the position by the Ministry of Industry and Trade as the founder of CAI on the joint proposal of the association of accredited entities and the director of CAI in accordance with Article Ten, paragraph 4, letter c) of the CAI founding charter. Before supporting the proposal of the association of accredited entities and submitting the proposal to the Ministry of Industry and Trade, the director of CAI verified that the requirements of Section 10, paragraphs 2 and 4 in conjunction with Section 15, paragraph 4 of the Act on Public Benefit Societies were met, i.e. that the proposed candidate or persons close to him are not in an employment or other similar relationship with CAI and the candidate is not a member of the CAI board of directors. The considerations that guided the founder of CAI when appointing the proposed candidate to the position are not known to CAI.

13. 5. 2024

Based on a request received on May 29, 2024 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"8th No."

9. The requirements for the impartiality and objectivity of the accreditation body are set out in Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (as amended on 3 July 2015) and in the standard ČSN EN ISO/IEC 17011:2018 Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies. Their fulfilment is regularly verified by the European Organisation for Cooperation in the Field of Accreditation (EA) as a body recognised by the European Commission pursuant to Article 10 of the said Regulation.

9.1. No.

9.2. CAI has in place appropriate mechanisms to manage impartiality risks in accordance with the requirements for accreditation bodies.

10. CAI is obliged to act in accordance with the requirements for accreditation bodies and fulfill the obligations established by applicable legislation and normative documents binding on accreditation bodies, which it does, while the established mechanisms are reviewed over the long term (see information on point 9) and found to be compliant with the prescribed requirements.

11. No.”

2. 4. 2024

Based on a request received on March 18, 2024 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following document.

15 3

Based on a request received on May 29, 2024 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"1. The fulfillment of the accreditation requirements was verified by subsequent verification of whether the accreditation body meets the accreditation requirements on the basis of which it was granted accreditation, within the meaning of Section 16, paragraph 6 of Act No. 22/1997 Coll., on technical requirements for products and on amendments and supplements to certain acts, as amended (hereinafter referred to as "Act No. 22/1997 Coll.") through the so-called extraordinary supervisory action ("MD").

2. The proceedings in the MD case were initiated by delivering a notice of initiation of proceedings to the party to the proceedings (accredited conformity assessment body) in accordance with Section 46 of Act No. 500/2004 Coll., Administrative Procedure Code, as amended (hereinafter referred to as the “Administrative Procedure Code”).

3. Yes.

3. 1. Within the framework of the MD, the fulfillment of the requirements of Articles 4.3, 4.4, 4.8, 4.9, 4.10, 4.11, 4.13, 4.14, 5.1, 5.8 and 5.10 of the standard ČSN EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence was assessed, in relation to the subject of the complaint, i.e. to the result sheet No. 83136 dated 31. 8. 2023. The assessment included the entire process of examining the sample from its receipt to the issuance of the result sheet, with an emphasis on examination within the scope of accreditation (total protein), resolution of the complaint and reference to accreditation.

3.2. Within the framework of the MD, compliance with the requirements of the laboratory information system at the workplace of the accredited entity in relation to the subject of the complaint was assessed.

3.3. Within the framework of the MD, the compliance of the primary examination data within the scope of accreditation was verified and, in addition, the laboratory also submitted ELFO records with an explanation of their modification. A more detailed investigation of the ELFO records was not carried out, as this is an examination outside the scope of accreditation.

3.4. Verification of compliance with the accreditation requirements set out in Articles 5.1.5 to 5.1.8 of the standard ČSN EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence was carried out by reviewing the records of all persons participating in the examination of the sample, the output of which was the result sheet No. 83146 dated 31. 8. 2023.

4. Yes.

5. Yes.

6. The examination of total protein is within the scope of the accreditation granted and was stated on the results sheet that was the subject of the complaint. For this reason, it was included in the assessment of compliance with the requirements of the ČSN EN ISO 15189:2013 standard by the accredited conformity assessment body.

7. No.”

11. 12. 2023

Based on a request received on May 24, 2023 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"The Czech Society for Quality, zs, IČO 00417955, with its registered office in Prague 1, Staré Město, Novotného lávka 200/5, was an accredited conformity assessment body in 2018, and for its accredited certification body No. 3014, Certification Body for Certification of Persons – Czech Society for Quality, two accreditation certificates were in force in 2018, namely No. 373/2017, valid from 26. 6. 2017, and No. 350/2018, valid from 29. 6. 2018. Copies of the above-mentioned accreditation certificates, including the annexes, which are an integral part of them and define the scope of the granted accreditation, are attached as an annex to this note."

OA No. 373/2017

OA No. 350/2018

_________________________________________________________________________________________________________

5. 12. 2023

Based on a request received on May 20, 2023 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"Your submission, dated 24. 10. 2023 and delivered to the CAI on the same day, was assessed as a complaint against the activities of an accredited conformity assessment body in accordance with Section 16, paragraph 9 of Act No. 22/1997 Coll., in accordance with its content and designation, and as such is currently being examined in accordance with the designated legal provision. A report on the outcome of the investigation will be submitted to you within 60 days of the date of delivery of your complaint, as provided for in Section 16, paragraph 9 of Act No. 22/1997 Coll.."

20. 11. 2023

Based on a request received on May 20, 2023 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"When processing the petition of a natural person, marked "Petition to withdraw accreditation from the Health Institute based in Ústí nad Labem", dated 20 April 2023 and marked Z/890/2012, the CAI obtained the following documents:

CAI note to the author of the initiative no. j. 002732/23/CAI_001 dated 12. 5. 2023,

CAI note to the author of the initiative ref. no. 002732/23/CAI_002 dated 20. 9. 2023

CAI note to the author of the initiative ref. no. 002732/23/CAI_003 of 4/10/2023.

Copies of the marked documents are, in accordance with your request, attached to this letter. In accordance with Section 15, paragraph 3 of Act No. 106/1999 Coll., personal data have been excluded from the copies. With regard to the subject of the complaint and the time gap since the implementation of the contract affected by it, no other supporting documents were provided by the accreditation body in the context of handling the complaint. As stated in the attached notes to the author of the complaint, CAI relied on the documents provided by the submitter when handling the complaint. During the subsequent verification of the compliance with the accreditation requirements by the conformity assessment body (in the form of a regular surveillance visit in accordance with the Plan of Regular Surveillance Visits, i.e. not a procedure initiated on the basis of a submitted complaint leading to its investigation), the accreditation body found that the records related to the measurement, the results of which were disputed by the complaint in question dated 20 April 2023 and recorded in the 2017 protocol attached to the complaint, are no longer kept in the laboratory, because the period for storing records, defined in the quality management system of the relevant laboratory, has expired. For this reason, the accreditation body could not provide further documents for the investigation of the complaint.

12. 10. 2023

Based on a request received on May 27, 2023 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"A) CAI does not approve methods. The scope of the accreditation body's activities is the assessment of compliance with accreditation requirements, set primarily by harmonized standards or other documents valid for the field of conformity assessment, by applicants for accreditation or accredited conformity assessment bodies within the framework of the so-called subsequent verification of compliance with accreditation requirements.

B) The procedures for conformity assessment activities, contained in the draft scope of accreditation of the applicant for the granting, extension or extension of the scope of accreditation of the conformity assessment body or in the scope of accreditation granted during the subsequent verification of compliance with accreditation requirements, are available to the group of assessors of the accreditation body in the relevant procedure within which compliance with accreditation requirements in relation to the given activity is assessed.

C) See point B)

D) The accreditation certificate is a document confirming the granting of accreditation and the existence of the authorisation of its holder to act as an accredited conformity assessment body within the scope of the granted accreditation, which is specified in the annex to the accreditation certificate. Identification of the test procedure/method in the annex to the accreditation certificate can be carried out by referring to the standard/decree/pharmacopoeia/technical specification/other legal regulation, their part or relevant articles, according to which the testing procedure in the laboratory is carried out (as follows from the instructions for processing Annex No. 3 of the application/proposal for the conclusion of a public contract for Testing Laboratories, which specifies the scope of the requested accreditation and is available on the website of the accreditation body www.cai.cz in the Downloadable Documents section). References to legal regulations may also be part of the laboratory's internal testing procedure.

E) The accreditation certificate does not constitute an authorisation to perform conformity assessment activities, nor does it constitute an authorisation to carry out legal evaluations, to issue opinions or other activities. Accreditation is the confirmation by a national accreditation body that a conformity assessment body meets the requirements set out in harmonised standards and, where relevant, any other requirements, including those set out in relevant sectoral schemes, for the performance of specific conformity assessment activities covered by its scope. However, it does not constitute an authorisation to perform them.

24. 5. 2023

Based on a request received on May 24, 2023 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"Workplace 2. "Department of Forensic Techniques and Expertise, Department of Biology and Genetics" is included in the scope of accreditation of the conformity assessment body of the Police of the Czech Republic, Regional Police Directorate of the South Moravian Region granted for its accredited laboratory No. 1584, Department of Forensic Techniques and Expertise, from 10 March 2022. Before this date, only one workplace was included in the scope of accreditation of the designated laboratory, namely at Kounicova 687/24, 611 32 Brno."

11. 5. 2023

Based on a request received on May 11, 2023 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"1) A laboratory examination procedure performed strictly according to the instructions of the manufacturer of the CE marked IVD is considered validated.

2) Act No. 268/2014 Coll. on in vitro diagnostic medical devices, as amended, regulates only administrative fees, and Government Regulation No. 56/2015 Coll. on technical requirements for in vitro diagnostic medical devices was repealed as of 22 December 2022. In order for a laboratory to be accredited according to ČSN EN ISO 15189:2013, it must meet the requirements of this standard, including ensuring that the performance requirements of a specific procedure are met. As for the wording of specific requirements, this is enshrined in the Czech technical standard ČSN EN ISO 15189:2013. It should be noted here that Czech technical standards are made available in the manner and under the conditions regulated by Act No. 22/1997 Coll., on technical requirements for products and on amendments and supplements to certain acts, as amended (hereinafter referred to as "Act No. 22/1997 Coll."), and the content of Czech technical standards is not permitted to be reproduced outside the established procedure. Furthermore, I would like to point out that the information obligation of the CAI under Act No. 106/1999 Coll. is limited to information on the decision-making activities of the accreditation body and does not include the preparation of interpretations or expert opinions according to the requests of the information applicant.

3) The laboratory must establish and maintain procedures for document and record management. The laboratory must create and maintain legible records demonstrating compliance with the requirements of the standard. As for the wording of specific requirements, this is enshrined in the standard ČSN EN ISO 15189:2013, the content of which is made available under the conditions described in point 2) of this text.

4) A "correctly" performed record of verification of an analytical procedure By accreditation standard ČSN EN ISO 15189:2013 must meet the requirements set out in this standard. As for the wording of specific requirements, this is enshrined in the standard ČSN EN ISO 15189:2013, the content of which is made available under the conditions described in point 2) of this text.

5) The accreditation process includes an assessment of whether the applicant for accreditation meets the requirements for carrying out a specific conformity assessment activity, which are set out in harmonised standards or other documents valid for the area of ​​conformity assessment (so-called accreditation requirements). If the applicant proves that he meets the accreditation requirements, the CAI will grant him accreditation. If the CAI finds that the applicant does not meet the accreditation requirements, it will reject the application. As regards the wording of the specific requirements for the accreditation of medical laboratories, this is enshrined in the standard ČSN EN ISO 15189:2013, the content of which is made available under the conditions described in point 2).

6) Accreditation may be granted exclusively to a conformity assessment body that demonstrates that it meets the accreditation requirements prescribed for the conformity assessment activities for which the applicant is applying for accreditation. Accreditation for a medical laboratory according to the accreditation standard ČSN EN ISO 15189:2013 may be granted only if the applicant demonstrates compliance with the accreditation requirements contained in this standard.

7) CAI is the national accreditation body of the Czech Republic within the meaning of Regulation (EC) No. 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93 (hereinafter referred to as "Regulation No. 765/2008"), which accredits conformity assessment bodies in the manner and under the conditions prescribed by Regulation No. 765/2008 and related European and national legislation. Only accreditation granted by the national accreditation body of a Member State of the European Union, i.e. for entities established in the Czech Republic, accreditation granted by CAI, is accreditation within the meaning of this Regulation and establishes a presumption of conformity pursuant to Article 11 thereof. The information obligation of CAI laid down in Act No. 106/1999 Coll. does not apply to the provision of information about other entities and the nature of the services offered by them.

8) All national accreditation bodies within the meaning of Regulation No 765/2008, as described above, must be part of the so-called European Accreditation Infrastructure, i.e. in accordance with the requirements of Regulation No 765/2008, they must be members of the European Organisation for Cooperation in the Field of Accreditation and must be subject to peer evaluation carried out pursuant to Article 10 of Regulation No 765/2008.

25. 4. 2023

Based on a request received on May 25, 2023 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"1. The conformity assessment body of the Police of the Czech Republic, the Regional Police Directorate of the South Moravian Region, was granted accreditation for its Department of Forensic Technology and Expertise (accreditation object No. 1584) according to the accreditation standard "ISO 17025" for the first time in 2010, according to the harmonized technical standard ČSN EN ISO/IEC 17025:2005.

2. The accreditation of facility 1584 has not been suspended, revoked or restricted by the accreditation body during the current accreditation cycle, nor during previous accreditation cycles.

3. According to the requirement of Article 7.8.2.1 letter f) of the ČSN EN ISO/IEC 17025:2018 standard, each results report must contain identification of the method used, unless the laboratory has substantial reasons not to provide this information.

4. According to the requirement of Article 7.8.2.1 letter m) of the ČSN EN ISO/IEC 17025:2018 standard, each results report must contain the results and, if necessary, the units of measurement, unless the laboratory has substantial reasons not to provide this information.

5. Accreditation of conformity assessment bodies constitutes confirmation of the professional competence of its holder to carry out the given conformity assessment activities in accordance with the accreditation requirements, i.e. in particular with the requirements of harmonised technical standards. The accreditation body does not guarantee that the accredited laboratory “always produces correct results” and the granting of accreditation does not mean that the CAI “guarantees the correctness of all the results of the accredited laboratory”.

6. Accreditation of conformity assessment bodies constitutes confirmation of the professional competence of its holder to carry out the given conformity assessment activities in accordance with the accreditation requirements, i.e. in particular with the requirements of harmonised technical standards. Within these, the laboratory must, inter alia, use appropriate methods and procedures for laboratory activities and must ensure that the latest valid version of the method is used, unless this is not appropriate or possible. However, the accreditation body does not guarantee that the accredited laboratory “uses in all cases procedures that are correct according to current scientific knowledge”.

7. Accreditation of conformity assessment bodies constitutes confirmation of the professional competence of its holder to carry out the given conformity assessment activities in accordance with the accreditation requirements, i.e. in particular with the requirements of harmonised technical standards. The accreditation body does not guarantee that the accredited laboratory “always interprets test results in a way that is correct according to current scientific knowledge”.

19. 1. 2022

Based on a request received on May 19, 2022 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"The scope of accreditation granted to the Ministry of the Interior of the Czech Republic for its laboratory No. 1494 "Criminal Institute of the Police of the Czech Republic" is published on the CAI website www.cai.cz in the database of accreditation bodies conformity assessment. From this database, it can be verified that the valid accreditation granted to the Ministry of the Interior of the Czech Republic for its accredited laboratory No. 1494 is documented by the accreditation certificate No. 465/2020 dated 21. 7. 2020, i.e. completely identically as it was at the time of your previous request for the provision of the same information. The conformity assessment activity "Determination of the order of manual recording and electrographic printing according to the distribution of toner particles" indicated by you is not included in the scope of this accreditation. As in the previous information that CAI has provided to your repeated requests of the same content since 2017, I would like to inform you again that the Ministry of the Interior of the Czech Republic and its accredited laboratory No. 1494 "Forensic Institute of the Police of the Czech Republic" have not been granted accreditation including the activity "Determination of the order of manual recording and electrographic printing according to the distribution of toner particles" in the past either. The same applies to the second test procedure/method you indicated – “Visual-optical and comparative methods performed according to SOP GRA05 (this SOP is not included in the scope of accreditation)”, in the exact name of which you yourself stated that they are not included in the scope of accreditation. As for the information on test procedures/methods “or under any other similar name”, this requirement is not specific enough to provide unambiguous information.”

10. 11. 2020

Based on a request received on May 10, 2020 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"The scope of accreditation granted to the Ministry of the Interior of the Czech Republic for its laboratory No. 1494 "Criminal Institute Prague of the Police of the Czech Republic (KÚP PČR)" is published on the CAI website www.cai.cz in the database of accredited conformity assessment bodies. From this database, it can be verified that the valid accreditation granted to the Ministry of the Interior of the Czech Republic for its accredited laboratory No. 1494 is documented by the accreditation certificate No. 465/2020 dated 21 July 2020. The conformity assessment activity you indicated, “Determination of the order of manual recording and electrographic printing according to the distribution of toner particles”, is not included in the scope of this accreditation. As in the previous information provided to you in 2017 and 2019, as well as in April of this year, I would like to inform you that the Ministry of the Interior of the Czech Republic and its accredited laboratory No. 1494, “Criminal Institute Prague of the Police of the Czech Republic (KÚP PČR)”, have not been granted accreditation including the activity “Determination of the order of manual recording and electrographic printing according to the distribution of toner particles” in the past either. The same applies to the second test procedure/method you indicated – “Visual-optical and comparative methods performed according to SOP GRA05 (this SOP is not included in the scope of accreditation)”, in the exact name of which you yourself stated that they are not included in the scope of accreditation. As for the information on test procedures/methods “or under any other similar name”, this requirement is not specific enough to provide unambiguous information.”

6. 4. 2020

Based on a request received on May 3, 2020 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"The scope of accreditation granted to the Ministry of the Interior of the Czech Republic for its laboratory No. 1494 "Criminal Institute Prague of the Police of the Czech Republic (KÚP PČR)" is published on the CAI website www.cai.cz in the database of accreditation bodies conformity assessment. From this database it can be verified that the valid accreditation granted to the Ministry of the Interior of the Czech Republic for its accredited laboratory No. 1494 is documented by the accreditation certificate No. 425/2017 dated 18. 7. 2017. The conformity assessment activity “Determination of the order of manual recording and electrographic printing according to the distribution of toner particles” indicated by you is not included in the scope of this accreditation. As in the previous information provided to you in 2017 and 2019, I would like to inform you that the Ministry of the Interior of the Czech Republic and its accredited laboratory No. 1494 “Criminal Institute Prague of the Police of the Czech Republic (KÚP PČR)” have not been granted accreditation including the activity “Determination of the order of manual recording and electrographic printing according to the distribution of toner particles” in the past either. The same applies to the second test procedure/method you indicated – “Visual-optical and comparative methods performed according to SOP GRA05 (this DOP is not included in the scope of accreditation)”, in the exact name of which you yourself stated that they are not included in the scope of accreditation. As for the information on test procedures/methods “or under any other similar name”, this requirement is not specific enough to provide unambiguous information.”

9. 12. 2019

Based on a request received on May 28, 2019 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

" I. The formulation "monitoring of air pollution (outdoor air)", which you used to designate the subject conformity assessment activity, is very general. The activity designated in this way is explicitly included in the subject of the single accreditation granted to the Czech Hydrometeorological Institute, IČO 00020699, and its laboratory No. 1460, Air Pollution Monitoring. Details, including the scope of the granted accreditation, can be found at the following link https://www.cai.cz/?subjekt=1460-cesky-hydrometeorologicky-ustav.

Regarding the substance of your question, as of the date of application, a total of 20 accreditations have been issued, the scope of which includes conformity assessment activities related to emissions. You can find a list of them on the CAI website, www.cai.cz, specifically here https://www.cai.cz/?page_id=4499&title_search=&cislo=&cislo_osvedceni=&akreditace=&fulltext=&accred_text=imis (full-text search within the scope of accreditation filtered to the term "imis").

II. Of the above 20 accreditations, 3 are granted to a conformity assessment body with a registered office in the South Moravian Region. In this regard, however, I would like to point out that the registered office of the accredited conformity assessment body (the registered office of the legal entity holding the accreditation) may not be identical to the location in which the accredited conformity assessment object or its workplace is actually located. For example, the above-mentioned accredited laboratory No. 1460 has a total of 7 workplaces, one of which is in Brno. The list of conformity assessment bodies that have activities related to air pollution included in the scope of accreditation and at the same time have a registered office in the South Moravian Region is as follows:

III. The list of conformity assessment bodies whose scope of accreditation includes activities related to air pollution and whose registered office is in the South Moravian Region is as follows:

• LABTECH sro, company ID 44014643 (accredited laboratory No. 1147);
• Veterinary Research Institute, vvi, ID number 00027162 (accredited laboratory no. 1354);
• Transport Research Center, vvi, ID number 44994575 (accredited laboratory no. 1506).

In conclusion, it is appropriate to refer again to the database of accreditation bodies for conformity assessment, available on the CAI website. Since this database allows for a relatively detailed search, as well as complete information on the scope of all valid accreditations (in the annexes to the accreditation certificate), I believe that you will find all the necessary information there. If you need a consultation, you can also contact our staff by phone, using the contact details provided on the same website.

1. 11. 2019

Based on a request received on May 20, 2019 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"CAI has not yet initiated the accreditation of certification bodies within the meaning of Section 15 of Act No. 110/2019 Coll., on the processing of personal data, or Article 43 of Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). The accreditation of certification bodies within the meaning described above is being prepared in close cooperation with the Office for Personal Data Protection. This service has not yet been implemented, as the competent European authorities have not yet approved the certification scheme, without which the provision of this service cannot be initiated. As of 1 October 2019, CAI had not received any application for accreditation to this extent. As of 1 October 2019, CAI had not granted any accreditation to this extent."

29. 5. 2019

Based on a request received on May 20, 2019 for the provision of information pursuant to Act No. 106/1999 Coll., CAI provided the applicant with the following information.

"CAI is a national accreditation body within the meaning of Section 15 of Act No. 22/1997 Coll., on technical requirements for products and on amending and supplementing certain acts, as amended, and Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the placing of products on the market and repealing Regulation (EEC) No. 339/93. As a national accreditation body, CAI accredits conformity assessment bodies within the meaning of these legal regulations. As part of accreditation, CAI checks whether the applicant for accreditation / accredited conformity assessment body meets the requirements for carrying out specific conformity assessment activities set out in harmonised standards or other documents applicable to the field of conformity assessment (so-called "accreditation requirements"). CAI does not accredit fields, methods, procedures, expert opinions or other documents and does not grant authorisation to perform any activity.

Regarding your individual questions, CAI states the following:

1. Have you accredited the L 1508 testing laboratory for the method for identifying handwriting – SOP-PERP-01-OKTE-PL?

No. CAI has not accredited any test method, including the method "SOP-PERP-01-OKTE-PL". CAI has granted accreditation to the conformity assessment body Ministry of the Interior of the Czech Republic, Regional Directorate of the Pilsen Region for its testing laboratory No. 1508, Department of Forensic Technology and Expertise. Valid accreditation is granted within the scope of forensic testing defined in the annex to the accreditation certificate No. 747/2015 of 3 November 2015 and is evidence that the laboratory in question has met all accreditation requirements prescribed by the Czech technical standard ČSN EN ISO/IEC 17025:2005 Conformity assessment - General requirements for the competence of testing and calibration laboratories. Within the scope of this accreditation, which is published on the CAI website www.cai.cz, includes, among others, the examination "Examination of handwriting for the purpose of identifying the writer" according to the method "SOP-PERP-01-OKTE-PL" with the subject of the examination "Forensic material". The test procedures/methods listed in the annex to the accreditation certificate are the property of the accredited conformity assessment body, CAI has not accredited them, nor has it been validated in any way by accreditation.

2. Have you accredited the following relevant measuring instruments to this accreditation method: PERP-PM-4, PERP-PM-5, PERP-ZZ-3 and PERP-ZZ-4?

No. The method "SOP-PERP-01-OKTE-PL" is a test method of the accredited Testing Laboratory No. 1508. It is not an accreditation method. CAI does not perform accreditation of measuring instruments, neither separately nor in conjunction with a specific test procedure or method.

3. Have you accredited the field of forensic science – the branch of handwriting examination?

No. CAI does not accredit fields.

4. Who was the main expert assessor who approved this accredited method - in the field of forensics - handwriting examination branch of the testing laboratory L 1508? Please name a specific person, for the purpose of summoning him to the court hearing as your expert assessor of this accredited method, namely: SOP-PERP-01-OKTE-PL.

The test method “SOP-PERP-01-OKTE-PL” has not been accredited or approved by CAI. It is not an “accredited method”. It is a test method of a conformity assessment body. No CAI expert assessor (or lead assessor) has approved the method “SOP-PERP-01-OKTE-PL”.

5. Is the testing laboratory authorized, after obtaining your accreditation, to issue judicial - expert opinions in the field of forensics - the branch of handwriting examination under your accreditation in this field?

Accreditation is evidence of the professional competence of a conformity assessment body to carry out conformity assessment activities that are included in the scope of accreditation. The granting of accreditation does not constitute an authorisation, permission or any other recognition of the right of the conformity assessment body to perform the activity.

6. Who is authorized, according to your accreditation, to sign the outputs of forensic expert opinions for accredited laboratory No. L1508 pursuant to Act No. 36/1967 Coll., on experts and interpreters, as amended?

Accreditation does not establish an authorization to perform activities, nor does it establish the conditions for performing conformity assessment activities; it is evidence of compliance with the accreditation requirements set out in the standard ČSN EN ISO/IEC 17025:2005 Conformity assessment – ​​General requirements for the competence of testing and calibration laboratories. The person authorized to sign the output documents of an accredited testing laboratory is the person who has such authorization according to the laboratory's internal regulations. As for the requirements for reporting results by testing laboratories and the content requirements of the documents issued, these are enshrined in Article 7.8 of the standard ČSN EN ISO/IEC 17025:2005 Conformity assessment – ​​General requirements for the competence of testing and calibration laboratories.

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