How Asian Healthcare Leaders Can Benefit From ISO 9001:2015

Robert Burney, ISO 9001 expert, US

This article details the key elements of ISO 9001:2015 that Asian healthcare leaders should be aware of, detailing how this standard can have a positive impact on future hospital performance. This standard represents a significant change in structure and content and healthcare administrators will have until September 2018 to transition.

Against a backdrop of rising incomes and an increasing population, the healthcare system in Asia faces a landscape of major opportunities and challenges. Navigating that landscape can be made easier by incorporating ISO 9001, a popular quality management system standard used around the world, which provides more efficient ways of working, better cost control and more effective implementation of new practices.

That’s especially important as more than 60 per cent of Asian companies, including healthcare firms, say they have increased their investment in quality—including technology, training, equipment and personnel—over the past three years, according to a new ASQ Global State of Quality study.

Asia has been a leader in ISO 9001 adoption, based on an annual ISO Survey, with China and Japan consistently in the top 10 destinations for many years. Studies from the United Nations Industrial Development Organization, or UNIDO, show that effective ISO 9001 implementation and accredited certification has brought clear economic benefits to Asian developing countries and 98per cent of the certified organisations surveyed from various industries considered ISO 9001 implementation and certification to have been a ‘good’ (73 per cent) or ‘very good’ (25 per cent) investment. That’s a positive sign for Asian healthcare organisations.

Recently, the ISO published its updated ISO 9001:2015 standard that represents a significant change in structure and content healthcare administrators will need to carefully review and adjust to over the next three years. Healthcare organisations that are currently registered to the ISO 9001:2008 quality management system standard will have until September 2018 to make the transition to the ISO 9001:2015 version. This provides time to transition to the new standard or acquire ISO 9001 registration and certification under the new standard.

At initial review, the new ISO 9001 standard doesn’t look that different and, to some extent, it merely spells out requirements that were implied in the previous version. Basic principles remain — things like customer focus, leadership, engagement of people and using a process approach. Digging deeper, however, one sees that the standards introduce fundamental changes in thinking about quality management systems, adding new terminology and approaches to these key principles that can be more applicable to service industries like healthcare. They are also less prescriptive, giving organisations more freedom to innovate.

Leadership vs. Management

ISO 9001:2015 provides an opportunity for healthcare organisations to monitor and constantly improve key processes helping leaders to provide clear direction so that team members can spotlight real and potential problems. ISO 9001:2015 ensures a management system that produces consistent results from patient care processes, and aims for a system heavily focused on patient satisfaction and improvement.

Healthcare administrators familiar with ISO should note that the requirement for a management representative has disappeared in ISO 9001:2015 and the term ‘management responsibility’ has been replaced by an emphasis on responsibility of senior leaders for implementation of the quality management system, or QMS.

The previous standards always noted that the management representative had to be a member of management, but this was not always the case in practice. Now, it is very clear that the duties of the management representative belong to senior management or the chief executive. Healthcare leaders must now be personally involved in the hands-on implementation of the quality management system including determining quality policy and defining quality objectives. However, some clerical and administrative duties may still be delegated.

Risks and Opportunities

Thus far, few healthcare organisations have actually performed Failure Mode and Effects Analysis, so the standards now talk about ‘risks and opportunities,’ which the organisation must identify and address. No specific risk methodology is prescribed, but organisations must show some effort. This should not be a challenge, since even a retrospective technique like a Cause & Effect analysis can produce systemic change to a process that will prevent future errors. Risks, therefore, may be positive as well as negative. The term ‘risk’ just means the outcome is uncertain or not fully under the control of the organisation.

While healthcare organisations are quite accustomed to monitoring environmental factors that affect their business, now they will have to demonstrate this process to auditors according to the new ISO 9001:2015 standard. So they must have mechanisms to identify risks and opportunities and a plan to address them.

There are no specific requirements in ISO 9001:2015 for a Quality Manual or for key written procedures. However, it’s perfectly fine to continue to have a set procedure for tracking documents, performing internal audits etc. The message is to focus on bigger issues and know that specific procedures are no longer required. Written procedures may thus be more relevant to the needs of the organisation.

Technology and data collection bring opportunities to every phase of healthcare, but these are accompanied by some risk. One important question is what to do with important data related to quality objectives or required by regulations. One easy answer is to feed the results back to employees who will use the feedback to alter processes to produce better outcomes, thus demonstrating the improvement required by ISO 9001.In healthcare that means including data on complaints and near misses. For example, that might mean the wrong medication was sent out but caught before delivery to a patient.

Also, not every unhappy patient will register a formal complaint, and employees must be trained to recognise situations that need to be changed. For example, a patient request for a blanket translates into a complaint that the patient is cold. Perhaps the temperature needs to be increased in that area, or perhaps blankets/robes need to be issued pre-emptively to forestall heat loss.

Making patient data more widely available in electronic format carries the risk that such data might be accessed by unauthorised individuals. Physicians may want information about their hospitalised patients in their office, in their home, or in the parking lot on their cell phone. This is an opportunity for improved care and efficiency but also a risk for data loss. Preventive strategies are available, but they must be used, and they must be effective. One frequent problem is the loss of an unencrypted laptop containing patient data. This situation is easily prevented.

Electronic devices throughout the hospital report data to the medical record system, but that same data is also accessible to the sales representative in the lobby. There’s an example of a medical student who found he could write orders in patient charts with his phone from the sidewalk outside the hospital. While one doesn’t want to be so risk averse as to not take advantage of new opportunities, the key is to be aware of the risks and use ISO 9001:2015 to create a plan for dealing with undesirable outcomes so you are never surprised.

Considering the Customer

According to the ASQ Global State of Quality 2 Research, 56 per cent of Asian organisations say enhancing the customer experience is a top priority. So it’s positive that customer needs remain a central focus in ISO 9001: 2015 revision, including anticipation of problems before they occur. The term ‘customer’ now includes other interested parties. In healthcare, this might mean family members, employees, medical staff, payers, suppliers, and even the local community. All have an interest in the local healthcare organisation, but their interests are different and sometimes conflict.

The healthcare organisation must consider these varied demands and develop a system to satisfy as many as possible. As healthcare systems move more to preventive care, organisations will need to demonstrate this new demand is being met in addition to care for illness and injury.

Internal Audits

This is a hidden strength of the ISO 9001 management system. Various employees from all sections of healthcare organisations can audit sections where they do not work against the ISO 9001 standards. This, of course, requires some training, which means that knowledge of the standards will be widely dispersed within the organisation. Internal auditors must be trained not only in the ISO 9001:2015 standards, but also in the skills of auditing. By auditing another section, these employees become familiar with another aspect of the company, and better understand where they fit in the overall process. These employees also become local champions for the QMS within their own section. There is some direct cost for the training and time investment for the auditing, but these balance against the improvements mentioned. It is a good practice to schedule internal audits so that every key process is audited once a year, although problem processes may require auditing more frequently. Results of internal audits go to management for use in management review, improvement efforts, and overall assessments.

More Attention to Process

This new ISO 9001:2015 standard emphasises process even more and healthcare organisations must monitor key processes and demonstrate their use of data to make improvements. There is also a requirement to look at processes from the standpoint of risks and opportunities. Think about what inputs are required and what outputs are expected. Then consider what has to happen within the process to make that transition. Are there metrics to monitor processes and does the organisation use those metrics for improvement? Don't forget processes performed outside the organisation that should also be monitored. For example, if you are purchasing, assembling and sterilising operating room supplies outside of your facility, make regular visits to that facility to confirm the quality of their processes.

Make a short list of the key processes in your organisation. Supplies, IT, and medical records contribute widely to processes in any healthcare institution, but these are support processes and not the main focus of the organisation. To look at any high level process, establish specific objectives and related metrics to demonstrate progress. Review these metrics at specific intervals, and invite the various process owners to discuss ways to make their process operate more efficiently.

In looking at process metrics, don't forget processes performed outside the organisation that also need to be monitored. Some of these may affect your internal processes or interact directly with patients or other customers.

Changes in Terminology

When reviewing ISO 9001:2015, healthcare administrators will notice some changes in terminology, partly to make the standards more applicable to service industries, like healthcare. For example, ‘products and services’ replaces ‘products’. ‘Records’ are now ‘documented information,’ and a ‘supplier’ has become an ‘external provider.’ These changes are mainly a new way of looking at things, and use of the exact terminology is not required for compliance.

‘External provider’ might be a more meaningful way of thinking about an outside entity that furnishes goods or services to the organisation. In any case, organisations are free to continue to use existing terminology.

For this revision, all terms are included within the ISO 9001 standard. There is no need to refer to another list of definitions. Terminology within ISO 9001 is also compatible with similar terminology in other standards, such as environment, health and safety, etc.


There is, of course, value to the organisation in having a clear vision and direction for leaders and employees. Under the discipline of ISO 9001: 2015, processes will be monitored and constantly improved. The organisation will run efficiently, and leaders will know where real and potential problems are. The standards require those things. Registration to the ISO 9001:2015 standards also announces to the world that you have a management system in place that produces consistent results from your patient care processes, and that the system is heavily focused on patient satisfaction and improvement. That should be reassuring to prospective customers from other regions who do not know you well.

In summary, if ISO 9001:2015 is seen as part of the organisation's culture, all of the changes outlined here should be relatively easy to implement. A positive outcome of these revisions is healthcare leaders will now be required to use the standards as the powerful management tool they were designed to be. Ultimately, the key is for a healthcare organisation to be able to say, "This is the way we do things here, and everyone from the CEO down knows it."

For more information on ISO 9001:2015, visit ASQ Quality Management Standards and learn more about the ASQ Global State of Quality study at

                                                                                                                                                                                                                                                                       -- Issue 34 --


Author Bio

Robert Burney

Robert Burney, is a quality consultant and ISO 9001 expert who is co-author of "Using ISO 9001 in Healthcare: Applications for Quality Systems, Performance Improvement, Clinical Integration, and Accreditation." Burney, a member of the American Society for Quality, was previously Director, Quality Improvement, Medical Services for the US State Department.

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