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ISO 9001 certification in healthcare

For a number of years, ISO 9001 has been an internationally recognised quality management system (QMS) standard in a number of different industries.

What is ISO 9001:2015 for healthcare?

ISO 9001:2015 for healthcare and community service providers is designed to ensure standardised levels of quality are applied across all levels of an organisation. It provides a clear framework that documents an organisation’s operations, allowing for the consistency of processes, and providing evidence of the achievement of objectives and goals.

Adhering to the standard helps organisations working in the health and community service industries to implement a foundation for development and continuous quality improvement, whilst also minimising waste and inefficiencies. It places a significant focus on patient and client satisfaction and ensuring their service experience is wholly positive.

Put simply, it is a commitment to quality and safety.

What is a quality management system (QMS)?

A quality management system (QMS) refers to the policies, procedures and other records that guide an organisation in the delivery of its products and services. It is designed to set the standards of practice within an organisation.

An organisation’s QMS will illustrate its systems for the planning and execution of projects, and how these are designed to deliver maximal customer satisfaction. It is effectively an internal manual that explains how quality is maintained throughout the organisation over the course of its operations.

ISO 9001 specifies what is required of an organisation to create and implement an effective quality management system.

Patient-centered care

Patient-centered care refers to the practice of ensuring care is tailored to suit the preferences, needs, and values of each patient. It is responsive to each individual and is instrumental in guiding all clinical decisions.

Patient-centered care is generally considered to be a prominent practice that is identifiable in leading healthcare providers. ISO 9001:2015 guides organisations in their efforts to adopt a process approach focused on patient-centered care.

What are the benefits of ISO 9001:2015 certification to my organisation?

As well as being a helpful tool in complying with relevant national and international legal and regulatory requirements, healthcare and community service providers that are certified to ISO 9001 enjoy a host of benefits.

  • It assists in identifying and managing risk to patients and staff. Best practice procedures are implemented, and complex processes can be more easily determined, managed and improved. Enhanced operational efficiencies will naturally prevent undesirable incidents from occurring, and consequently offers considerable health and safety improvements.
  • ISO 9001:2015 requires a system be in place to consistently identify areas for improvement within the organisation, as well as continuous enhancement of the quality management system itself. Implementing a continual improvement approach will benefit healthcare and community service providers as they will be better placed to monitor, assess and improve their procedures and practices on an ongoing basis.
  • Certification also provides assurance to patients and other stakeholders that you have implemented a well-functioning management system and are committed to continual improvement. As well as enhancing the organisation’s reputation, it also provides international and industry recognition, and may even provide a competitive advantage.
  • Staff will be introduced to an entirely new operating philosophy based on the ‘Three Cs’ of ISO 9001:2015: consistency, customer (patient) satisfaction and continual improvement. They will be required to consistently maintain a high level of quality in their care for patients, which in turn will enhance the patient/client experience.
  • Undergoing the certification process is a daunting and sometimes tasking process. However, the collation of all QMS documents and the strict document control required for certification will lead to greater integration and streamlining of internal policies and procedures. Organisations can use certification to assist in the structure and organisation of official and essential documentation.
  • Lastly, and perhaps most important, it provides a model for an effective QMS. An ISO 9001 quality management system will enhance an organisation’s ability to consistently deliver high-quality care that meets patient needs, and therefore deliver patient-centered care.

What does it involve?

As an internationally recognised and esteemed standard, ISO 9001:2015 does have a specific documentation list designed to illustrate certain requirements. It should be noted that the ISO 9001:2015 Standard brought some significant changes from ISO 9001:2008. The ISO 9001:2015 requirements mean the following four areas must be properly accounted for:

  1. Scope of the organisations’ QMS
  2. Quality policy
  3. Quality objectives, and
  4. Criteria for the evaluation and selection of suppliers.

The full scope of the organisation’s quality management system must be described in detail, and every requirement of the Standard in relation to the organisation must also be explained.

The quality policy involves a brief statement that defines the goals and objectives of the organisation. The organisation should ensure the documented information explains their commitment to meeting these, and how it can be done alongside their quality management system.

Quality objectives refer to the measurable steps planned to achieve the quality policy. Perfection may not always be possible, and consequently, an organisation often has to be realistic and define an acceptable tolerance for mistakes/errors.

The criteria for the evaluation and selection of suppliers will detail elements such as the quality of the goods or services and the credibility and reliability of delivery. It may also reference quantities, commitment to prices, and various parameters (such as the willingness to solve quality problems or the ability to train personnel).