1. General provisions
1.1. Purpose of regulation
1.1.1. The Procedure for Evaluating and Improving the Performance of the Quality Management System (hereinafter QMS) of the Estonian Maritime Academy (hereinafter EMERA) provides for the procedure for conducting internal audits, management reviews and external audits in EMERA and for handling of nonconformities, corrective actions and improvement in accordance with the international quality management standard ISO 9001.
1.2. Scope of regulation
1.2.1. The regulation applies within the scope of the EMERA QMS.
1.3. Bases of regulation
1.3.1. ISO 9000 standard – Quality management systems — Fundamentals and vocabulary;
1.3.2. ISO 9001 standard – Quality management systems — Requirements;
1.3.3. ISO 19011 standard – Guidelines for auditing management systems;
1.3.4. Statutes of the Estonian Maritime Academy.
1.4. Definitions and abbreviations
1.4.1. audit – a systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled
1.4.2. DHS – University document management system
1.4.3. EMERA – Estonian Maritime Academy
1.4.4. management review – determining the suitability, adequacy and effectiveness of the EMERA QMS for achieving planned objectives, conducted by the management of EMERA
1.4.5. QMS – quality management system
1.4.6. correction – action to eliminate a detected nonconformity
1.4.7. corrective action – action to eliminate the cause of a nonconformity and to prevent recurrence
1.4.8. nonconformity – non-fulfillment of a requirement
1.4.9. effectiveness – extent to which planned activities are realized and planned results are achieved
1.4.10. objective evidence – data supporting the existence or verity of something
1.4.11. improvement – activity to enhance performance
1.4.12. internal audit – a first-party audit performed by EMERA itself (or under the authority of EMERA) in accordance with the ISO 9001 standard for the purposes of this procedure. For the purposes of this procedure, an internal audit is not an internal audit within the meaning of the Auditors Activities Act.
1.4.13. performance – a measurable result
1.4.14. external audit – a second or third party audit performed by the customer (or other persons authorized by the customer), a government agency, an independent certification body, etc.
1.4.15. university – Tallinn University of Technology
2. Internal audit
2.1. The purpose of internal audit is and it is required to assess:
2.1.1. compliance of EMERA QMS with the requirements of the ISO 9001 standard;
2.1.2. compliance of EMERA QMS with the legal and regulatory requirements of the field of activity;
2.1.3. compliance of the activities of EMERA with the EMERA QMS (incl. regulations);
2.1.4. effectiveness and efficiency of EMERA QMS.
2.2. The internal audit process is described in the corresponding process map. The internal audit process must meet all the internal audit requirements of the ISO 9001 standard. It is recommended to follow the ISO 19011 standard when implementing the internal audit process. Internal audits are performed as partial audits across different processes.
2.3. Preparation and approval of the internal audit plan
2.3.1. The internal audit plan is approved by the EMERA Director on the proposal of the EMERA Quality Manager.
2.3.2. A regular internal audit must be carried out at least once a year. Extraordinary internal audits may be carried out if necessary.
2.3.3. The internal audit plan must include:
18.104.22.168. the period of the audit;
22.214.171.124. the purpose of the audit;
126.96.36.199. the audit criteria (e.g. standard, regulation, contract, agreement, etc. for which compliance is assessed);
188.8.131.52. the scope of the audit (including the processes and staff/units to be audited);
184.108.40.206. members of the audit team.
2.3.4. The objectivity and impartiality of the audit process must be ensured in the selection of internal auditors and in the conduct of audits. Internal auditors must have completed internal auditor training.
2.3.5. In addition to the internal auditors, the audit team may include experts with specific knowledge or skills in the field being audited, as well as observers.
2.4. Preparation of an internal audit
2.4.1. During the preparation of an internal audit, the audit team leader must be selected, the division of labor of the audit team must be defined, an audit questionnaire must be prepared and the time and place of the audit must be agreed.
2.5. Carrying out an internal audit
2.5.1. An internal audit begins with an introduction to the audit team, which is guided by the inaugural chapter of the ISO 19011 standard.
2.5.2. Methods used to conduct internal audits include interviews, observations, and reviews of documented information. An internal audit is essentially a conformity assessment.
2.5.3. The auditees are responsible for providing the audit team with all necessary materials and assistance.
2.5.4. An internal audit concludes with a summary of the audit team, which is guided by the chapter on the final meeting of the ISO 19011 standard.
2.6. Preparation and dissemination of internal audit reports
2.6.1. Based on the results of the internal audit, the audit team shall prepare an internal audit report (Form V1/20.1) within 5 working days, which shall be digitally signed by the audit team leader.
2.6.2. Upon completion, the internal audit reports must be submitted to the audited persons and the quality manager.
2.6.3. After performing all audits, the quality manager prepares a summary report of the internal audit and signs it digitally. Internal audit summary reports are maintained in the DHS.
2.6.4. The quality manager presents the internal audit summary report to the directorate and EMERA staff.
3. Management review
3.1. The purpose of the management review is to determine and ensure the continued suitability, adequacy and effectiveness of the QMS and its alignment with the strategic direction of EMERA.
3.2. The management review process is described in the corresponding process card. The management review process shall meet all the requirements for management review in the ISO 9001 standard. All inputs must be considered and outputs must include the required decisions and actions. Data should be relied upon and referenced when considering inputs from the management review (apparent estimates are not sufficient).
3.3. The management review should be performed at least once a year.
3.4. The management review is carried out by the members of the EMERA management (as laid down in the EMERA Quality Manual) by preparing a management review report, which is signed by the EMERA director. The management review reports are filed in the DHS.
3.5. The management will present the management review report to the directorate and to EMERA staff.
4. External audit
4.1. The purpose of the external audit is to assess the implementation of the EMERA QMS, including its effectiveness, and/or the compliance of EMERA and its activities with national and international requirements.
4.2. EMERA’s administration and co-operation in the certification of the EMERA QMS and the conduct of external audits are organized by the Quality Manager.
4.3. External audit reports are filed in the DHS.
5. Nonconformities and corrective actions
5.1. The process for handling nonconformities and corrective actions are described on the corresponding process maps.
5.2. All nonconformities detected during operations must be reported in writing by EMERA staff to the Quality Manager, with a description of the nonconformity, the date of its identification, objective evidence and the title and requirement of the relevant source document. Nonconformities can be reported in the same manner by other EMERA interested parties.
5.3. Nonconformities detected during audits and day-to-day operations (including any complaints), as well as corrective actions, must be recorded in an electronic register (Form V1/20.2) maintained by the quality manager, which is open to all EMERA staff.
5.4. All stages related to the nonconformity and the corrective action must be reported to the quality manager, who will then complete the electronic register of nonconformities and corrective actions.
5.5. When a nonconformity is detected, a root cause analysis and, if applicable, correction and corrective action planning must be carried out within two weeks.
5.6. The quality manager checks the analysis of the root causes of nonconformity, corrections and implementation of corrective actions by the deadline. If the deadline is exceeded, the quality manager informs the immediate manager in charge of the process, who must ensure the immediate implementation of the planned activities.
6. Continual improvement
6.1. The process of continual improvement of the EMERA quality management system is described on the corresponding process map.
6.2. Observations made during external audits and opportunities for improvement identified during internal audits and management reviews must be recorded in an electronic register (Form V1/20.3) maintained by the Quality Manager, which is open to all EMERA staff.
6.3. The implementation of the observations made during the external audits and the opportunities for improvement identified during the internal audits and the management review must be planned within three weeks.
7. Executors and responsible persons
7.1. All EMERA employees are responsible for complying with the regulations in accordance with their responsibilities and authority.