Implementation of a Quality Management System (QMS) in accordance with STN EN ISO 9001:2016 (Slovak Technical Standard)
Quality Management System (QMS) in accordance with STN EN ISO 9001:2016 (hereinafter also referred to as the “standard”) is one of the tools for improving the quality of provided products or services. Unlike, for example, the CAF framework, QMS is a strictly requirements-based system in which the standard precisely defines all requirements that an organization must meet. The standard also defines control mechanisms (audits) that ensure that an organization with a certified QMS continuously improves it and, as a result, improves the products or services it provides to customers/citizens.
QMS implementation is divided into five phases. The first phase is the preparation for implementation, the second is the analysis of the current state, and the third is the implementation of the standard’s requirements. This is followed by the certification of the implemented QMS, and the final phase is the maintenance and improvement of the implemented QMS.
PHASE 1: PREPARATION FOR QMS IMPLEMENTATION
Step 1: Decision on QMS Implementation
What should not be forgotten in this step:
- The management’s decision to implement QMS in the organization, documented in an appropriate form (e.g. a written decision recorded in the minutes of a management meeting).
- The decision on the scope of implementation, i.e. whether QMS will be applied to the entire organization or only to a part of it.
- The appointment of key implementation roles – the Guarantor and the Quality Manager. The Guarantor is a member of the organization’s top management who provides support to the Quality Manager and the implementation team during QMS implementation. The Quality Manager is the person responsible for coordinating the implementation and for the subsequent maintenance and improvement of the implemented QMS.
- The preparation of an implementation plan, including the timeframe, assigned responsibilities, and required resources (human, time, and material).
Recommendations for Step 1
Step 2: Establishment of the Implementation Team
What should not be forgotten in this step:
- Informing all employees about the intention to implement QMS in the organization.
- The selection of candidates for the implementation team. Members of the implementation team participate in describing individual organizational processes and in adapting, or where appropriate creating, new activities and documentation in accordance with the requirements of the standard.
Recommendations for Step 2
PHASE 2: ANALYSIS AND ASSESSMENT OF THE CURRENT STATE
The objective of the current state analysis is to compare the actual state with the requirements of the standard prior to the start of QMS implementation. The output of the current state analysis is an assessment of which requirements of the standard the organization already meets and a list of tasks that need to be carried out in order to achieve compliance with all requirements of the standard.
Step 3: Mapping All Organizational Processes and Provided Services
What should not be forgotten in this step:
- Determining the method by which individual activities and processes of the organization will be identified. A process is understood as a sequence of precisely defined activities which, using given inputs, produce the required outputs.
- Summarizing all processes carried out within the organization and dividing them into three groups:
- Processes through which the organization creates products or provides services – the so-called main processes, sometimes also referred to as “value-creating”, “operational”, or “key” processes. These are the activities for which the organization has been established.
- Processes aimed at ensuring the functioning of the main processes and the operation of the organization as a whole – the so-called support processes. These include, for example, asset management, public procurement and financing, human resources administration, management of information and communication tools, etc.
- Management processes, sometimes also referred to as “managerial” processes. These are activities through which the organization plans, organizes, coordinates, and manages its operations. These include, for example, strategy, planning and management of the organization, quality management, management of human and financial resources, control processes, etc.
- Defining the organization’s customers, i.e. identifying for whom the organization creates products and provides services.
Step 4: Preparation of the Current State Analysis
What should not be forgotten in this step:
- Assessing the level of compliance with the requirements of the standard and identifying the organization’s weaknesses – insufficient or no compliance with the requirements of the standard.
- Preparing a summary report with proposals for eliminating the identified weaknesses.
- Preparing the implementation plan.
PHASE 3: IMPLEMENTATION OF THE QUALITY MANAGEMENT SYSTEM
Step 5: Training of Implementation Team Members
What should not be forgotten in this step:
- Familiarizing the implementation team members with the requirements of the standard, with process management, measurement of process performance, and with the requirements for document control.
Step 6: Defining the Method of Document Control
What should not be forgotten in this step:
- Defining the structure of the organization’s QMS documentation.
- If not already established within the organization, defining the method of document control and of all documented information in accordance with the requirements of the standard and applicable legislative requirements.
Step 7: Implementation of the Requirements of the Standard
What should not be forgotten in this step:
- Describing processes and creating a process map, or adapting the organization’s processes to the requirements of the standard and the adopted principles of document control, and updating the documentation so that it complies with the requirements of the standard.
- Maintaining the required documented information.
- Within this step, the organization identifies its processes and, if they do not exist, subsequently introduces new processes or activities in order to meet the requirements of the standard. This may include, for example, the introduction of an internal audit process for the quality management system, quality control of provided products and services, management of nonconformities and corrective actions, measurement of customer satisfaction, etc.
- Adopting a quality policy and defining quality objectives.
- Defining metrics for measuring process performance, and monitoring and evaluating the achievement of quality objectives.
- Selecting and training quality management system auditors.
PHASE 4: CERTIFICATION OF THE QUALITY MANAGEMENT SYSTEM
Step 8: Selection of a Certification Body and Conduct of the Certification Audit
What should not be forgotten in this step:
- An organization may apply for certification of the implemented QMS once it is able to demonstrate compliance with all requirements of the standard.
- It is important and recommended that QMS certification be carried out by an accredited certification body.
- To obtain QMS certification, the organization must undergo a certification audit that verifies compliance with the individual requirements of the standard and, upon successful certification, the certification body issues a quality management system certificate.
- The certification audit first involves a review of documentation, followed by an on-site audit. The certification body usually requests the organization to provide its organizational structure, quality manual (if applicable), and possibly documents from management reviews. Subsequently, during the on-site audit, the certification body verifies compliance with the requirements of the standard in the organization’s actual operations.
- The duration of the certification audit depends on several factors, such as the number of employees in the organization and the number of sites.
- For the successful completion of the certification audit, it is necessary that no systemic nonconformity (non-fulfilment of any requirement of the standard) is identified during the audit.
PHASE 5: MAINTENANCE AND IMPROVEMENT OF THE IMPLEMENTED QMS
Step 9: Activities Related to the Maintenance and Improvement of QMS
What should not be forgotten in this step:
- Certification of the QMS does not mark the end of the improvement process; on the contrary, it marks the beginning of the maintenance and continual improvement of the implemented QMS.
- In the period following the certification audit, the organization works on eliminating nonconformities identified during the certification audit (if any), and, where applicable, on implementing recommendations for improvement.
- The organization also continues to carry out internal audits.
- Based on identified deficiencies, implemented organizational changes, or decisions of the organization’s management, the organization continuously modifies and improves the implemented QMS.
- Good practice includes regular refresher training of employees on the implemented QMS, as well as training of new employees as part of induction training upon commencement of employment.
Step 10: Surveillance and Recertification Audits
What should not be forgotten in this step:
- The validity of the QMS certificate is three years from the date of its issuance.
- In the first and second year after the certificate is issued, the certification body carries out a surveillance audit within the organization. The surveillance audit verifies the sustainability of the QMS. A surveillance audit is not as comprehensive as a certification audit. During a surveillance audit, compliance with all requirements of the standard is not assessed within a single audit, as is the case with a certification audit. If a systemic nonconformity is identified during a surveillance audit, there is a risk that the certificate may be withdrawn.
- After three years from the issuance of the certificate, the organization undergoes recertification of the entire QMS.