Standards Development

Scope

This document specifies additional competence requirements for personnel involved in the audit and certification process for healthcare quality management systems and complements the existing requirements of ISO/IEC 17021 -1

Purpose

Healthcare Organizations of all sizes and structures must embrace a culture of quality and continual improvement with the objective of providing timely, safe, effective, efficient, equitable, and peoplecentred care. Given the current and future challenges in healthcare, more than ever it is vital to improve service user experience, quality of care, and provide sustainable solutions.

Healthcare organizations around the world have been facing significant risks for several years such as decreasing financial resources, workforce shortages, an increase in number of people needing care as a result of ageing populations, increasing rates of chronic disease, lack of data for decision making, scarcity of, or inadequate, medical equipment and medications, and an absence of clear healthcare system governance. Many countries have embarked on universal health coverage, while others struggle with rising healthcare costs. To compound this, a global pandemic has highlighted the importance of virtual healthcare, new technologies, and the need to create and adapt approaches to healthcare management and delivery. These health and organizational challenges require that we take bold steps to improve healthcare quality around the world.

The “high-impact” designated MSS, ISO/DIS 7101 Healthcare Quality Management systems - Requirements was written with a focus on providing requirements for healthcare quality management systems. In as such, its targeted audience is broad, including any healthcare system, organization, or entity that aims to increase the quality of its healthcare delivery and care outcomes. This includes ministries of health, public and private health systems, hospitals, clinics, non-governmental organizations and agencies that provide healthcare services, and more. 

Healthcare organizations implementing this standard will want to be recognized with certification by an accredited agency. The proposed new standard describes the competencies required for those who will be assessing compliance with ISO/DIS 7101. There are many levels upon which poor healthcare quality can have detrimental consequences. It is imperative that the experts who are assessing healthcare quality systems have not only proven knowledge of the requirements, but also experience working in the sector. Following are examples of sections from ISO/DIS 7101 where advanced expertise is fundamental to human health and safety. 

Section 8.1.2 Patient Safety

Patient safety is a large and complex field that touches patients in their journey from admission to discharge. Medication safety, surgical safety, infection prevention and control, diagnostic safety, patient identification measures, and blood transfusion requirements are just a few examples where an auditor without specialized healthcare knowledge would not be qualified to make crucial decisions about conformity to ISO/DIS 7101 requirements. In fact, the WHO stated this month of September 2022 that, “Unsafe medication practices and medication errors are a leading cause of avoidable harm in health care across the world.” We must ensure the integrity of the patient safety requirements of the standard by verifying auditors are equipped to make these judgement calls.

Section 6.1 Actions to address risks and opportunities

Without a doubt risk management in general is crucial. ISO 31000 does an excellent job of outlining requirements. Nonetheless, healthcare is an area where the risks could not be greater. Between financial risks, resource risks, patient risks, caregiver risks, visitor risks, infrastructure risks, and those related to natural disasters, wars, violence, and civil unrest, healthcare risks are numerous. In order to accurately determine if an organization has a well-developed and comprehensive risk management program the auditor must have advanced healthcare risk expertise. 

Section 8.10 People-centred care

Around the turn of the 21st century, a big cultural shift began to take place, as the concept of peoplecentred care began to permeate healthcare research and delivery. The WHO defines people-centred care as:

An approach to care that consciously adopts the perspectives of individuals, families, and communities, and sees them as participants as well as beneficiaries of trusted health systems that respects and responds to their needs and preferences in humane and holistic ways. [SOURCE: WHO global strategy on integrated people-centred health services 2016-2026. Available at: https://interprofessional.global/wp-content/uploads/2019/11/WHO-2015-Global-strategy-on-integratedpeople-centred-health-services-2016-2026.pdf]

Gradually, health care providers started to listen to the voice of patients and families. Little by little, health organizations came to realize patients and their families were the most under-utilized of all health resources and took steps to remedy this situation. The provision of people-centred care involves multiple principles as required in ISO/DIS 7101 such as service user experience, compassionate care, inclusivity and diversity, health literacy and co-production of care. Knowledge of these concepts and how they operate only come from study and practice in the area of healthcare. This is another reason why the proposed new document must outline additional requirements to ensure that auditors can effectively assess this important area of the standard.

General 

Healthcare is an area, unlike many industries or organizations, where multistakeholder communications, collaborations, and accountabilities can be large and complex. For example, in a health system, stakeholders include, but are not limited to, government agencies on both national and local levels, relief organizations, NGOs, suppliers and vendors, advocacy groups, payer systems, patients, caregivers, and even communities. It is important than an auditor assessing to DIS 7101 have a broad understanding of how health systems work and how each stakeholders plays an integral part of the whole.

The above examples are some of many areas of healthcare quality that require specialized knowledge and practice. It is not only important to the integrity of the standard, but also to the trust and reputation of accreditation and certification bodies that requirements are set to ensure competencies are defined and in compliance. However, most important of all is that healthcare organizations are effective, efficient and people-centred, and that service users are provided with safe, high-quality care. The creation of an ISO/IEC 17021 -15 sector specific standard will help achieve these goals.