Sentara Healthcare believes patients, the clinical staff and suppliers deserve nothing less than ISO-9001 certification
How do you know if your supply chain team is doing a good job?
How do you ensure that you keep getting better?
The answer to the first might be provided with a snapshot – a point in time. So, costs may be low, fill rates and customer satisfaction good; inventory turns OK. Any number of indicators.
But the answer to the second one, well, that calls for a journey. One that never ends. And it’s a journey that Sentara Healthcare – including supply chain – has undertaken.
Sentara began its quality journey in 2010, when Sentara Williamsburg Regional Medical Center piloted the DNV accreditation process and ISO certification, explains Brian Gadsby, supply chain, director of operations and optimization. Supply chain became engaged in the effort in 2013. Today, all 12 Sentara hospitals as well as supply chain are ISO-9001-certified.
Who is ISO?
ISO – the International Organization for Standardization – is an independent, international organization. Since its founding in 1946, ISO has published more than 22,000 standards covering technology and manufacturing, including healthcare. Headquartered in Switzerland, ISO has members from 161 countries and 778 technical committees and subcommittees.
ISO 9001 is a quality management standard, based on seven principles:
- Customer focus
- Leadership
- Engagement of people
- Process approach
- Improvement
- Evidence-based decision-making
- Relationship management
The principles themselves are simple, but implementing, maintaining and monitoring them introduce a certain amount of rigor to the quality management process, says Gadsby.
Leading the quality initiative
Gadsby has been with Sentara for 29 years, though not in supply chain. In fact, he was a social worker and nursing home administrator for six years. He participated in some think-tank and project work before turning his attention to quality in the supply chain in 2013. His current position was created in 2016. “My primary focus is on customer service, communications and leading the quality initiative for the supply chain,” he says.
Every part of the Sentara organization is involved in the ISO 9001 quality process. Each of its 12 hospitals, for example has an accreditation coordinator or lead.
“Historically, there was never an expressed interest in how services and goods were procured from a quality or audit [perspective],” he says. “This process was an exciting time to lay a foundation that could be used across the supply chain to improve customer service, reduce variability of service, identify best practices, and challenge reasons why we followed certain practices or made certain decisions. Now, all levels of the supply chain know that as decisions are made, we must consider our customers’ needs and wants.” Sentara identifies its customers as its clinicians and patients who come for care.
ISO certification isn’t a full-time job for Gadsby, but it does require a level of commitment, he says. A quality team of eight to 10 people routinely review risk assessments and change-management assessments. For example, when Sentara makes a change that may impact its vendors or processes – e.g., a change in distribution, vendor credentialing or delivery of care – the quality team assesses its potential impact on the organization.
“We do customer service surveys, audit our processes at all hospitals as well as corporate functions,” he continues. “All of this has resulted in a need to develop dashboards and metrics to enable all levels of supply chain staff to have a line of sight to how their functional areas are performing in relation to goals that have been set.”
The ISO standard is not prescriptive, that is to say, it doesn’t dictate how the organization should set up its quality management system, or even what that system should look like, says Gadsby. It does, however, demand that the organization adhere to the quality management principles. “In the end, it comes back to the three Cs: consistent service, customer service and continual improvement,” he says. “And as we implement it, we need to document what we do, do what we document, prove it and improve it.”
Suppliers are involved
Suppliers are an essential part of the ISO process, says Gadsby.
“Requirements are being actively worked on with our key suppliers that are actively engaged on the ISO journey with us,” he says. “These are specific to the relationship and services provided.
“An example of a metric we could track for the benefit of both Sentara and the supplier is ‘the perfect order,’ that is, the percentage of orders processed correctly and through proper channels to minimize touches and deviations from the system.
“Another example is jointly looking at backorders. Oftentimes, backorders are a supplier’s issue. However, we have seen that our order process can lead to backorders due to ordering unexpected amounts, stocking up without prior discussion or preparing for the absence of someone.
“Supply chain analytics can carry over from supplier to internal supply chain to customer” he continues. “The important aspect is to know what the data is showing and using it to improve.”
In time, Sentara expects all of its major suppliers to be ISO-certified or ISO-compatible. And why not? Plenty of other industries – as well as many medical manufacturers – already are, he says. “I have reviewed several of our suppliers who have ISO certifications that are specific to their industry. That is acceptable, as long as their quality management system mirrors what we are looking to achieve.”
Last year, Sentara hosted an ISO retreat for its top vendors, which collectively represent 40 percent of the IDN’s spend. A follow-up session is planned for this year. In addition, Sentara is planning to host another conference with a new set of vendors.
“This leads to joint performance metrics,” he says. “So, we will work with our analytics team to figure out how we can measure our vendors’ performance and how they can measure ours. This will demonstrate the sustainability of our quality management system, and theirs.”
A question of trust
“Currently, we can say that we have begun the journey to ensure products and services meet the level of service required by our customers,” says Gadsby. “Also, we have identified opportunities and gaps in service that we have been actively working on over the past several years. We have implemented risk and change assessment processes to guide us with vendor changes, supply changes or product outages similar to what occurred in 2017 during several of our natural disasters.
“If you ask ‘Why ISO in healthcare?’ I state ‘Why not?’ As an individual, you rely and trust industries not realizing that they are ISO certified. You purchase vehicles, fly on airlines, take cruises, buy technology, use energy. The customers of all of these industries expect a certain service to have high reliability that their products and services will work as intended. From my perspective, we should expect the same thing of the products and services used in healthcare today.
“Next time you use healthcare, do you expect the products and services to meet your needs and expected outcomes? If so, then the supply chain and healthcare system must have processes and expectations in place to meet them.”
Quality management principles
ISO 9001 and related ISO quality management standards are based on the following seven quality management principles:
- Customer focus. Sustained success is achieved when an organization attracts and retains the confidence of customers and other interested parties. Every aspect of customer interaction provides an opportunity to create more value for the customer. Understanding current and future needs of customers and other interested parties contributes to sustained success of the organization.
- Leadership. Creation of unity of purpose and direction and engagement of people enable an organization to align its strategies, policies, processes and resources to achieve its objectives.
- Engagement of people. To manage an organization effectively and efficiently, it is important to involve all people at all levels and to respect them as individuals. Recognition, empowerment and enhancement of competence facilitate the engagement of people in achieving the organization’s quality objectives.
- Process approach. The quality management system consists of inter-related processes. Understanding how results are produced by this system enables an organization to optimize the system and its performance.
- Improvement. Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.
- Evidence-based decision-making. Decision-making can be a complex process, and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause-and-effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decision-making.
- Relationship management. Interested parties influence the performance of an organization. Sustained success is more likely to be achieved when the organization manages relationships with all of its interested parties to optimize their impact on its performance. Relationship management with its supplier and partner networks is of particular importance.
Editor’s note: The quality management principles were developed and updated by international experts of ISO/TC 176, which is responsible for developing and maintaining ISO’s quality management standards. To view the principles, as well as their key benefits and actions your organization can take to achieve them, go to “Quality management principles,” an online ISO resource, at https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/pub100080.pdf