Within the health sector, both health professionals and patients require and demand a certain level of services. In the past, we have applied the premise that things are done properly, but this is no longer enough and it is necessary to demonstrate that a sufficient level of quality is offered. Quality Management Systems (QMS) provide the tools to evaluate how we are working and what our previsions are at any time.

This article discusses the topic of QMS and quality certification and explains the process to follow to create a QMS and obtain ISO certification, based on the experience of the dermatology department of the Hospital General Universitario in Alicante (HGUA), in Spain.

What is ISO 9001:2015?

ISO 9001:2015 (the most recent version of ISO 9001) establishes the requirements to comply with a QMS and is applicable to any organization, regardless of size and geographic location. It covers the infrastructure, procedures, processes, and resources necessary to help organizations control and improve their performance and guide them towards efficiency, client service, and product excellence. QMS is based on the Deming cycle of plan, do, check, act (PDCA), to implement continuous improvement (Fig. 1).9–11

Figure 1.

Deming cycle for continuous improvement.

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Health care is one of the sectors in which quality, training of personnel, technological development, and collective work capacity have an impact on health and patient care.9,12 ISO certification can be applied globally to institutions or health centers, whether public or private, or partially, to services or laboratories, and represents a seal of quality for users or patients who are served by them.

In 2014, the dermatology department of the HGUA decided to obtain ISO 9001:2015 certification with the objective of improving its services.

In the article, we will explain the steps necessary to obtain certification and share some of our reflections on the experience.

To implement a QMS according to the requirements of UNE-EN-ISO 9001:2015 (the most recent version of the ISO standard)11 several stages are required:

1. Training. First, it is necessary to train the professionals in the principles and requirements of the ISO 9001:2015 standard through training sessions in the ISO process with the aim of familiarizing all personnel with the concepts and principles of quality, terminology, and requirements necessary for the process. On this point, it is often necessary to seek support from quality experts. Table 1 shows the main definitions and terminologies used in this system.

2. Quality committee. An internal quality committee should be set up within the dermatology department, with different professionals such as qualified dermatologists and residents, nursing staff from both the clinics and operating rooms, and administrative personnel. As with any committee, a president or secretary should be named. The quality committee should meet regularly. In the first working sessions, an in-depth analysis should be undertaken of the activity of the department, identifying the basic processes performed. Subsequently, a register should be made available for all members of the department to record incidents. These will be analyzed by the committee to identify lack of compliance and establish corrective actions and improvements.

3. Initial diagnosis. The initial diagnosis is made though a SWOT (strengths, weaknesses, opportunities, and threats) analysis, detailing the different areas and activities of the department. This approach provides an overview of the current situation, and can be used to decide the scope of the activity to be certified. In our center, it was decided that the scope of the activity would be based on the diagnosis, treatment, teaching, and research in dermatology within the HGUA. Then, the main processes that occur in the department were to be identified. These include those denoted operational or strategic, and are common to any type of organization and enable its objectives to be defined. The key processes, that is, those corresponding to a given organization, are also identified. Finally, the support processes necessary for ensuring the sustainability and reliability of the equipment used for providing a service are identified. In our department, we identified 12 operational or strategic processes, 9 key processes, and 5 support processes (Table 2).

Strategic processes should be accompanied by corresponding registers. For example, in the process of operation of the quality committee, the functioning should be explained precisely and registers attached; these are used to record noncompliance, complaints, etc. For the processes related to client satisfaction and interested parties, it is necessary to record satisfaction and work environment surveys (see Fig. 2 for an example). The key processes should be analyzed with a failure mode and effects analysis (FMEA). This means that, for each process, it is necessary to know all the possible associated risks and the relevance of each one. Alongside the basic processes, the protocols for functioning of different activities can also be noted.

Figure 2.

Example of satisfaction survey administered to dermatology patients.

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4. Task timelines. It is necessary to consider the different phases to be followed so that each person accountable for a certain process can elaborate the corresponding documentation. This will then be reviewed by members of the quality committee, with modification and adaptation as appropriate according to the consensus of all attendees. This process is also a means for disseminating information to other members of the department. The process is quite a painstaking one; thus, in our department, although the initial prevision was to perform the certification process in 2 years, this timeline was later extended by another year.

5. Quality system documentation. All the processes identified are documented in writing, following the design established by the standard, always mentioning the scope, process definitions, implementation of the process, and the associated indicators and registers. A date and version number are included, as well as a list of changes with respect to previous versions. All process documents are ordered and archived both as physical copies and electronically in a private space, housed in the web page of the department to which all accredited members have access with a password. The strategic processes, as well as the key and support ones, are integrated in a process map (Fig. 3), which represents a snapshot of the workings of the department. All this work is reflected in the quality policy and quality manual.

Figure 3.

Process map for the dermatology department.

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The quality policy is a definition that briefly covers the basis for the quality principles of the organization. In our case, it is expressed in the form of a small poster, visible everywhere within the dermatology department (Fig. 4).

Figure 4.

Quality policy.

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The quality manual is the basic document of the QMS. It includes the vision and mission of the dermatology department, the quality policy, and the planning of objectives to implement that policy. The quality manual should be elaborated with reference to standards and comprises 10 chapters, which reflect the principles of ISO QMS based on the plan, do, check, act cycle. The first 3 chapters correspond to the introduction and should include the objectives, scope, and presentation of the organization, the pertinent standards, and the terms and definitions of the QMS. Chapters 4, 5, and 6 then cover the planning of the organization, with mention of context, leadership, and planning, respectively. Chapters 7 and 8, referring to support and the organization, are related to doing. Checking is addressed in chapter 9, which covers the execution. The manual closes with the actions for improvement. Table 3 shows the structure of the quality manual with the sections developed in each chapter, as well as the all processes, indicators, protocols, or registers included therein.

6. Piloting the indicators and implementation of the requirements. The number of indicators that can be identified can be related to processes, outcomes, and structure. Structural indicators are those that confirm the existence of a certain procedure or protocol, which should be well structured, documented, and readily available. Process indicators show compliance with a certain aspect of the protocol and the outcome indicators are numerical and are intended to measure and compare. They serve to measure changes over time.

There may be numerous indicators and they may be dynamic. In our process, we identified 32 outcome indicators, 12 process indicators, and 19 structural indicators. Table 4 shows some of these indicators.

7. Conduct of an internal audit. Once the information has been collected, all processes should undergo an internal audit, which consists of a simulation of the definitive audit process with the aim of detecting possible failures. In our case, this process detected several points of lack of compliance that were corrected before the external audit, in October 2017.

8. Conduct of the external certification audit. The external audit is a 2-phase process. In the preliminary phase, the documentation is checked. In the final phase, on 2 consecutive days, the auditors review and compare all documentation produced and perform a physical check of all areas of the clinics, operating rooms, specialty centers, with interviews with different members of the department, to verify the authenticity of the processes documented.

Once this audit is complete, a report is issued. In our case, we received a positive opinion on January 30, 2018, and ISO 9001:2015 certification was awarded for the care, research, and teaching of the dermatology department of the HGUA (Fig. 5).

Figure 5.

ISO Certification.

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9. Annual review and renewal of the certificate every 3 years. After obtaining the initial certificate, all procedures should be reviewed annually and the certificate should be renewed every 3 years.

Finally, the Conselleria de Sanitat de la Comunitat Valenciana (Valencian Health Authority) has a registry of quality certifications. In our case, after the appropriate paperwork, the quality certificate of the dermatology department of the HGUA was included in this registry in May 2018.

After the experience of implementation of QMS in the dermatology department and obtaining the ISO 9001:2015 certification, we would like to comment on the following aspects:

In our experience, implementation of the QMS has not essentially changed the working methods of our department but it has enabled a reorganization of the system. The main processes have been identified and put in writing, assisting in compliance and supervision of the stages and the personnel involved.

The system improves the safety of the patients through an increased control of the activity performed,13 allows a greater satisfaction for all interested parties, internal recognition at the institutional level of the hospital or other fields of health care, increased visibility to other sectors of the society, and, above all, recognition from the patients, who feel encouraged to place their confidence in us when they are attended in the department that they know has been subject to an exhaustive quality assessment.

ISO certification of a dermatology department that provides patient care and performs research and teaching activities in the public health sector is also cause for satisfaction, bearing in mind the high demands for complying with ISO quality standards.

In short, a department that embarks on a quality certification process such as ISO 9001:2015 has to be firmly convinced of the need to provide quality service in the public health sector.

The authors declare that they have no conflicts of interest.