Certification of Management Systems

The procedure for certification of management systems carried out by ECOHYNTOX CAB is established by P.9.3.02 Procedure for Certification of Management Systems (View) and includes the following main stages:

  • Submission and consideration of the application (download) for certification of the management system;
  • Preparation for assessment;
  • Preliminary assessment of the management system (first stage of the certification audit);
  • Final assessment of the management system (second stage of the certification audit);
  • Analysis of results and opinions of the certification audit and decision on certification of the management system;
  • Supervision audits of the certified management system in the first and second years of the certificate’s term;
  • Audit for re-certification (re-certification audit) for the third year (before expiration of the term of the certificate).

List of documents for preliminary assessment of the quality management system:

  1. Quality policy and objectives.
  2. Quality guidelines.
  3. Organisational structure and documents on allocation of duties and powers within the management system.
  4. Organisational structure and documents on elements of subcontracting process management (if any).
  5. Regulatory documents establishing requirements for products and services (except for State Standards of Ukraine (DSTU, GOST)).
  6. Documents necessary for operation and control of processes related to manufacturing and measurement.
  7. Record management procedure.
  8. Protocol management procedure.
  9. Non-conforming product management procedure.
  10. Procedure for taking and analysing corrective actions.
  11. Procedure for taking and analysing preventive actions.
  12. Internal audit procedure and programme.
  13. Internal audit reports.
  14. Latest management review report.

Additional documents furnished for preliminary assessment of conformity of the quality management system to the requirements of DSTU ISO 9001/ISO 9001 for health care institutions:

  1. Medical service planning procedure.
  2. Procedure for management of the patient within the organisation.
  3. Medical service plan (procedure).
  4. Design and development procedure (where necessary).
  5. Patient/client medical service charts with allocation of tasks, recommendations, protocols and methodologies.
  6. List of methodologies for controlling medical devices, tools, products etc. Critical analysis methodology and materials stock, with indication of quantity and quality.
  7. Medical equipment maintenance and calibration procedure.
  8. Reports on monitoring of administration of medicinal products. Error detection process.
  9. Patient’s/client’s record, instructions on drawing up records.
  10. Data review, collection and use procedure.

Additional documents furnished for preliminary assessment of conformity of the quality management system in accordance with the requirements of DSTU ISO 13485/ISO 13485:

  1. Risk analysis results.
  2. General description of the device.
  3. Product sterilisation procedures processes (if any).
  4. Procedures for device identification at any manufacturing stage.
  5. Documents on requirements to infrastructure management if such activity or its absence can affect the product quality.
  6. Documents on requirements to health, cleanness and clothing of personnel; conditions and methods for monitoring of manufacturing conditions; on special controls of contaminated or potentially contaminated products (if applicable).
  7. Design and development procedures.
  8. Procedures, compliance with which will ensure conformity of procured products to the established procurement requirements.
  9. Documents necessary for operation and control of processes related to manufacturing.
  10. Procedures containing requirements to maintenance of product conformity in the course of internal operations and supply.
  11. Documents necessary for operation and control of processes related to measurement.
  12. Feedback system procedure.
  13. Procedures for data identification, collection and analysis to demonstrate suitability and performance of the quality management system.

List of documents furnished for preliminary assessment of the food safety management system (FSMS) under DSTU ISO 22000/ISO 22000:

  1. Safety policy and objectives.
  2. Regulatory documents establishing requirements for products (except for State Standards of Ukraine (DSTU, GOST)).
  3. Description of the scope of application of the FSMS.
  4. Organisational structure and documents on elements of subcontracting process management (if any).
  5. Documents on allocation of duties and powers within the Food Safety Management System (FSMS).
  6. Order on establishment of the safety group (HACCP group) and data confirming their knowledge and experience.
  7. Record management procedure.
  8. Protocol management procedure.
  9. Management review report.
  10. Procedures for managing actions entered into precondition programmes.
  11. Descriptions of raw materials, ingredients and materials contacting the product.
  12. Descriptions of end products.
  13. Descriptions of intended use of products.
  14. Process charts, description of process stage and management actions.
  15. Report(s) on identification and assessment of hazardous factors.
  16. Methodology for assessment of hazardous factors.
  17. Methodology for and results of selection and assessment of management actions.
  18. Reports on confirmation of management action combinations.
  19. Operational precondition programmes (PP).
  20. HACCP plan(s).
  21. Report(s) substantiating selected critical networks.
  22. Procedures for and instructions on monitoring of critical management points.
  23. PP, operational PP and HACCP plan examination reports.
  24. Data on traceability protocols.
  25. Procedure(s) for carrying out and analysing adjustments.
  26. Procedure for taking and analysing corrective actions.
  27. Procedure for handling potentially hazardous products.
  28. Procedure for withdrawing (recalling) hazardous products.
  29. Registered information on the cause, extent and result of withdrawal of hazardous end-products (if applicable).
  30. Reports on checking performance of the withdrawal programme.
  31. Records on results of calibration and check of measuring equipment used.
  32. Internal audit procedure and programme.
  33. Internal audit reports.
  34. Reports on assessment and analysis of check action results.
  35. FSMS assessment and update reports.

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