Organization of Quality Management System Documentation of the Estonian Maritime Academy

Responsible department:
Document Reference: V6/1
Version Number: 2
Manager: Quality Manager
Approved: by the Director's order dated 05.03.2020, no. 1-24/69

1.1. Purpose of the regulation

This document defines the procedure for preparing, coordinating, issuing, managing, amending, approving and introducing the quality management system regulations of the Estonian Maritime Academy (hereinafter referred to as “EMERA”).

1.2. Scope of the regulation

The guidelines apply to regulations forming part of the quality management system that lay down the procedure for the execution of the work to be performed and specify the persons responsible for the execution of work.

1.3. Basis of the regulation

1.3.1 EVS-EN ISO 9001:2015 Quality management systems. Requirements
1.3.2 Records Management Rules of Tallinn University of Technology (hereinafter referred to as “the university”)

1.4 Definitions and abbreviations

1.4.1 “DMS” means the electronic document management system.
1.4.2 “Legislative act” means a document of external origin that lays down binding rules which must be adhered to.
1.4.3 “Core process” means EMERA’s main activities (management, degree studies, continuing education, research and development).
1.4.4 “Regulation” means a quality management system document (manual, procedure, statute, guidelines, rules and operating principles) that must be prepared and managed in compliance with the principles set out in the ISO 9001 standard. Regulations may include annexes (such as diagrams and forms).
1.4.5 “Management of a regulation” means ensu ring the preservation of a copy of the regulation and periodically evaluating it in order to determine whether the regulation needs to be amended, updated or repealed.
1.4.6 “Version of a regulation” means that the amendments made to the regulation are set out in an order of the Director of the Estonian Maritime Academy establishing the regulation.
1.4.7 “Regulation identifier” consists of EMERA’s identifier in the university system (V), the number denoting the core or support process (1-7) and the sequence number in the process (for example, regulation V2/6 “Internship Rules of the Estonian Maritime Academy” under the degree studies (V2) core process.). A form annexed to a regulation is identified by a number after the period (e.g., form V2/6.2 “Application for internship” annexed to the regulation  “Internship Rules of the Estonian Maritime Academy”).
1.4.8 “Support process” means activities supporting the core processes (e.g., human resources management, financial management, document management and administration, including supporting processes that monitor the effectiveness of processes, such as internal audit, etc.).

2. Preparing, coordinating and approving regulations

2.1 The necessity to prepare a regulation is determined either by the quality manual or by an actual need for a document to regulate an operation. Drafting a regulation may be initiated by a relevant unit or as a management decision, which may be communicated orally or formalized as a record of management review, a revision proposal or an order.
2.2 A drafter shall be assigned to each regulation. The drafter shall be the area director and/or persons (working group) appointed by the area director.
The following shall be indicated in a draft:
2.2.1 the purpose of the regulation;
2.2.2 the legislative acts and requirements that must be taken into account when drafting the regulation;
2.2.3 the units and persons with whom the regulation must be coordinated;
2.2.4 the deadline for drafting the regulation.
2.3 The drafter of a regulation (working group) shall collect the necessary materials and information and prepare a draft document on the basis thereof.
2.4 The drafter shall submit the draft regulation electronically to the Quality Manager and include his/her proposals regarding the approvers.
2.5 The approvers shall review the draft document to eliminate errors in matters within their area of expertise. If necessary, the drafter must provide explanations to the approvers and present the underlying materials.
2.6. The drafter (working group) shall review all the comments and proposals and, if necessary, discuss them with the person who assigned the task of preparing the document. In the case of failure to reach a common solution, the person who assigned the task of preparing the document will make the decision. The person’s decision is final.
2.7 After final verification, the drafter submits the draft document to the Quality Manager, who checks its compliance with the requirements of the quality management system and forwards the document for approval. If necessary, comments and proposals are also reviewed during the approval process.
2.8 The quality management system regulations are approved and amended by an order of the Director of the Estonian Maritime Academy.
2.9 The original copies of approved regulations are stored following the consolidated list of EMERA regulations. It is not required to store draft documents, notes and proposals.

3. Formalisation of regulations

3.1 As a rule, the format and structure of regulations are as follows:
Header: logo, document identifier, version number, person managing the regulation, references to the approval/enforcement of the regulation and any amendments thereto.
3.1.1 General provisions (why and for what purpose the regulation has been drawn up);
3.1.2 Scope of the document (the limits within which the regulation applies);
3.1.3 Basis (references to documents that served as the basis for drafting the regulation);
3.1.4 Definitions and abbreviations;
3.1.5 The body text of the regulation;
3.1.6 Executors and persons responsible;
3.1.7 Annexes (diagrams, etc.).
3.2 Operating principles shall be drawn up for EMERA centres. The operating principles lay down the responsibilities, structure, management, etc. of a centre.
3.3 A regulation exceeding 10 pages must include a table of contents; the front page can be designed as a title page.
3.4 The regulations shall be drawn up using the Calibri font, size 11.

4. Amending and repealing a regulation

4.1 A regulation may be amended or repealed based on the following:
4.1.1 non-conformities detected, observations, and comments;
4.1.2 changes planned or carried out in the organisation;
4.1.3 amendments to the legislative acts on the basis of which the document was drawn up;
4.1.4 revision proposals.
4.2 Amendments to a regulation shall be made by the Quality Manager in accordance with the requirements laid down in the university’s Records Management Rules. The header of a regulation shall include references to its approval and amendment.
4.3 The validity of a regulation can be verified using the EMERA’s consolidated list of regulations in the ‘Quality documents’ folder on drive V on the university’s intranet, which includes a list of regulations in force, with references to the basis for their approval and amendment (if possible, available in the public view of the DMS).
4.4 If it is necessary to store an invalid regulation, it must contain a conspicuous note indicating its invalidity.

5. Issuing and providing access to regulations

5.1 The process of issuing quality management system regulations involves document editing, preparation of the original copy, approval, making the approved copy available to the users and protection from unintentional changes.
5.2 EMERA’s quality management system regulations are available in the ‘Quality documents’ folder on drive V on the university’s intranet.
5.3 The full texts of the university’s legislation are published on the university’s intranet site under “Documents and forms”.

6. Executors and persons responsible

6.1 The drafter:

6.1.1 prepares the draft regulation, e-mails it to the Quality Manager, who stores a digital copy of the regulation.

6.2 The approvers:

6.2.1 assess whether the draft regulation submitted for approval is suitable for use and makes sure it does not contain non-conformities in their field of expertise;
6.2.2 provide comments and recommendations for the elimination of the non-conformities should non-compliances be detected.

6.3. The regulation manager:

6.3.1 A manager is assigned to a quality management system regulation, whose position is indicated in the header of the document;
6.3.2 monitors that the regulation is updated and proposes amendments if necessary.

6.4. The head of the unit:

6.4.1 arranges introduction of the regulation to employees who have responsibilities directly related to the document and/or if the document has an impact on the employee’s work procedure.

6.5 An employee:

6.5.1 Employees are required to read and comply with the quality management system regulations;
6.5.2 EMERA employees are required to comply with the university’s internal procedural rules when performing their duties.

6.6 The office manager:

6.6.1 submits documents for approval via the document management system.

6.7 The Quality Manager:

6.7.1 coordinates and organises the preparation of regulations, monitors compliance with the requirements for the format and management of regulations;
6.7.2 makes amendments to regulations;
6.7.3 makes the approved regulations available in the “Quality documents” folder on drive V on the university’s intranet.