Required documents per standard with your accreditation application

Below you will find an overview by standard of all the documents you need to submit with your accreditation application.
If you have any questions, please contact us at nieuweaanvragen@rva.nl.

Documents to be provided for ISO 15189 – Medical laboratories

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual and general management system procedure;
  4. A cross-reference table establishing the relationship between the requirements of ISO 15189 and your quality system;
  5. Report(s) of recent internal audit(s) (not older than 6 months) including action plans;
  6. Internal audit planning (annual review);
  7. Report of most recent management review (not older than 6 months);
  8. The technical implementation requirements for all requested testing, including POCT and R&D studies if applicable;
  9. Verification/Validation reports for all requested tests;
  10. Overview of interlaboratory comparisons (ring tests, proficiency testing, etc.) in which participated (see RvA-T030);
  11. General procedures which have been developed or modified and not included in the quality manual;
  12. Sample anonymized report for the requesting physician;
  13. Farmatec license/approval (if applicable);
  14. A transaction list which is traceable to the flexible scope elements under accreditation (as per SAP M000);

Documents to be provided for ISO/IEC 17020 – Inspection

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual and general management system procedures;
  4. A cross-reference between the requirements from ISO/IEC 17020:2012 and your quality system;
  5. Internal audit report (not older than 6 months);
  6. Management review report (not older than 6 months);
  7. Applicable normative documents and methods, with associated work instructions;
  8. General procedures which have been developed or adapted (and not included in manual);
  9. Competence requirements and qualification procedure;
  10. The impartiality risk analysis referred to in ISO/IEC 17020:2012, section 4.1.3;
  11. A sample inspection report and inspection certificate (not applicable for sampling);
  12. Statements of competence, if applicable for sampling (e.g. AS 1000/2000)
  13. If there is external scheme manager: own assessment of the scheme, as explained in RvA-T033, in combination with an application for scheme assessment (F207) according to policy rule RvA-BR012;
  14. If the specific version of the scheme for which accreditation is sought is included in the list of schemes for which the RvA can grant accreditation (see policy rule RvA-BR010 list), a new application for scheme evaluation is not necessary.

Documents to be provided for ISO/IEC 17021-1 – Management system certification

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual and general management system procedures;
  4. A cross-reference between the requirements from ISO/IEC 17021-1 and your quality system;
  5. Internal audit report (not older than 6 months);
  6. Management review report (not older than 6 months);
  7. Internal operating procedures and regulations used in certification;
  8. General procedures which have been developed or modified (and not included in handbook);
  9. Competency requirements and qualification procedure;
  10. A sample certificate;
  11. Your own review of the certification scheme, as explained in RvA-T033 if applicable for the new activity(ies). If not considered applicable, please explain why;
  12. An application for scheme evaluation (F207) according to policy rule RvA-BR012 if an external scheme manager is involved
  13. If the specific version of the scheme for which accreditation is sought is included in the list of schemes for which the RvA can grant accreditation (see policy rule RvA-BR010 list), a new application for scheme evaluation is not necessary.
  14. If applicable, relevant (local) legislation and regulations.

Documents to be provided for ISO/IEC 17024 – Person Certification

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual and general management system procedures;
  4. A cross-reference between the requirements from ISO/IEC 17024 and your quality system;
  5. Internal audit report (not older than 6 months);
  6. Management review report (not older than 6 months);
  7. Operating procedures and requirements for all requested certification schemes;
  8. Competency requirements and qualification procedure;
  9. A sample certificate;
  10. The outcome of the job/task analysis;
  11. Your own assessment of the certification scheme, as explained in RvA-T033; if applicable for the new activity(ies). If not considered applicable, please explain why;
  12. An application for scheme evaluation (F207) according to policy rule RvA-BR012 if an external scheme manager is involved;
  13. If the specific version of the scheme for which accreditation is sought is included in the list of schemes for which the RvA can grant accreditation (see policy rule RvA-BR010 list list), a new application for scheme evaluation is not necessary;
  14. Current examination regulations, if applicable with ‘master version’ of the CB, in case of outsourcing of the examination if the examination organization has its own examination regulations;
  15. Manual/instruction for chairman/exam leader and other examination staff;
  16. Blank copy/sample of the written exam to be taken, on site if required;
  17. Correction model/checking key, if necessary or applicable, on site;
  18. Competency requirements, composition of tasks/assignments, theory and/or practice, including test matrix;
  19. Rules concerning the use of the certification mark;
  20. Overview of documents for the actual examination to be organized, including overview of candidates, examination schedule, name and address of the examination location;
  21. CB’s requirements for the examination organization;
  22. CB’s method of assessing the contracted examination organization (if applicable);
  23. Organization description and schedule of the examination organization;
  24. Agreement with an external examination agency.

Documents to be supplied for application ISO/IEC 17025 – Testing laboratories

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual or similar documentation and general management system procedures;
  4. A cross-reference between the requirements from ISO/IEC 17025 and your quality system;
  5. Internal audit report (not older than 6 months);
  6. Management review report (not older than 6 months);
  7. Work instructions for all requested tests;
  8. Validation or verification reports for all requested tests;
  9. Results of quality control checks for all requested tests (not applicable to applications for sampling activities);
  10. Statement and results of inter-laboratory comparisons (Ring tests, Proficiency testing, etc.) participated in (see RvA-T030) (not applicable for applications for sampling activities);
  11. Uncertainty calculation(s) in accordance with EA-4/02 for all quantities (not applicable for applications for sampling activities);
  12. Sample reporting to customer (not applicable for applications for sampling activities);
  13. If external scheme manager, own assessment of the scheme, as explained in RvA-T033 in combination with an application for scheme evaluation (F207) according to policy rule RvA-BR012; if applicable for the new activity(ies). If you consider it not applicable, please explain why;
  14. If the specific version of the scheme for which accreditation is sought is included in the list of schemes for which the RvA can grant accreditation (see policy rule RvA-BR010 list), a new application for scheme evaluation is not necessary;
  15. Declarations of competence (matrix and requirements);
  16. Any additional documentation in accordance with SAP for the parts of the scope in question.

Documents to be provided for ISO/IEC 17025 – Calibration laboratories

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual and general management system procedures;
  4. A cross-reference between the requirements from ISO/IEC 17025 and your quality system;
  5. Internal audit report (not older than 6 months);
  6. Management review (not older than 6 months);
  7. Technical implementation requirements for all requested calibration quantities;
  8. Validation reports for all requested calibration quantities;
  9. Uncertainty calculation(s) in accordance with EA-4/02 for all requested calibration quantities;
  10. Listing of inter-laboratory comparisons (Ring studies, Proficiency testing, etc.) in which participated (see RvA-T030);
  11. General procedures which have been developed or modified (and not included in manual);
  12. An example of a calibration report and calibration certificate to be issued.

Deliverable documents for ISO/IEC 17029 – Validation & Verification

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual and general management system procedures;
  4. A cross-reference between the requirements from EN-ISO/IEC 17029 and your quality system;
  5. Report of an internal audit (not older than 6 months);
  6. Management review report (not older than 6 months);
  7. Internal working procedures and regulations used in validation/verification;
  8. General procedures which have been developed or modified (and not included in manual);
  9. A sample validation/verification report and validation/verification statement (qualified and unqualified where applicable);
  10. Your own review of the validation or verification scheme, as explained in RvA-T033; if applicable for the new activity(ies). If not considered applicable, please explain why;
  11. An application for scheme evaluation (F207) according to policy rule RvA-BR012 if an external scheme manager is involved;
  12. If the specific version of the scheme for which accreditation is sought is included in the list of schemes for which the RvA can grant accreditation (see policy rule RvA-BR010 list), a new application for scheme evaluation is not necessary;
  13. Overview of qualifications that makes it clear that sufficient competent personnel are available such as verifiers, reviewers, etc.

Documents to be supplied ISO/IEC 17065 Product certification

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual and general management system procedures;
  4. A cross-reference between the requirements from EN ISO/IEC 17065 and your management system;
  5. A cross-reference between the requirements from the certification scheme (scheme, guideline, regulation) and your management system. This concerns the requirements for the certification body and the implementation of certification;
  6. Report of internal audit (not older than 6 months);
  7. Report of management review (not older than 6 months);
  8. Internal working procedures and regulations used in certification;
  9. General procedures which have been developed or modified (and not included in handbook);
  10. Competency requirements and qualification procedure;
  11. An example of a certificate;
  12. Your own assessment of the certification scheme, as explained in RvA-T033, if applicable for the new activity(ies). If you consider it not applicable, please explain why;
  13. An application for scheme evaluation (F207) according to policy rule RvA-BR012 if external scheme manager is involved;
  14. If the specific version of the scheme for which accreditation is sought is included in the list of schemes for which the RvA can grant accreditation (see policy rule RvA-BR010 list), then a new application for scheme evaluation is not necessary;

Documents to be provided for EMAS

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual and general management system procedures;
  4. A cross-reference between the requirements from ISO/IEC 17021-1: 2015 and your quality system;
  5. Internal audit report (not older than 6 months);
  6. Management review report (not older than 6 months);
  7. General procedures which have been developed or updated (and not included in handbook);
  8. Internal operating procedures and regulations used in verification;
  9. A sample verification statement, in accordance with Annex VII of the EMAS Regulation.

Documents to be provided for ISO 17034 – Producers of reference materials

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual and general management system procedures;
  4. A cross-reference between the requirements from ISO 17034 your quality system;
  5. Internal audit report (not older than 6 months);
  6. Management review (not older than 6 months);
  7. The technical procedures and implementation requirements for all requested activities;
  8. Validation reports for the analytical methods and characterization procedures used;
  9. Indication of uncertainty budgets and results of studies on stability and homogeneity of materials;
  10. Indication of your experience in producing reference materials indicating type of materials, matrices, numbers, and number of years of experience;
  11. General procedures which have been developed or modified (and not included in handbook);
  12. A sample reference material certificate.

Documents to be provided ISO/IEC 17043 – Organisers of ring tests

  1. Proof of registration with the Chamber of Commerce (not older than 6 months);
  2. An organization chart and description of your organizational structure;
  3. Quality manual and general management system procedures;
  4. A cross-reference between the requirements from ISO/IEC 17043 and your quality system;
  5. Internal audit report (not older than 6 months);
  6. Management review (not older than 6 months);
  7. The technical implementation requirements for all requested activities;
  8. General procedures which have been developed or modified (and not included in manual);
  9. Validation data homogeneity tests;
  10. An example of a report to be issued on a competition.