Implementation of a Quality Management System in the Sentara Supply Chain ISO to ISO

Sentara began its new quality journey in 2010, when Sentara Williamsburg Regional Medical Center piloted the DNV accreditation process and ISO certification.  Supply Chain became engaged in the effort in 2013. Today, all 12 Sentara hospitals as well as supply chain are ISO-9001-certified.

ISO - the International Organization for Standardization - is an independent, international organization founded in 1946, 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.

Historically, there was never an expressed interest of the supply chain from a quality or audit process on how services and goods were procured.  This process was implemented 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 you must consider the customers' needs and wants.   Sentara Supply Chain identifies its customers as its clinicians and patients who come for care.

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.   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.   As we implement it, we need to document what we do, do what we document, prove it and improve it.

Suppliers are an essential part of the ISO process!

Requirements are being actively worked on with our key suppliers that are actively engaged on the ISO journey with us.

An example of a metric we could track for the benefit of both Sentara and the supplier is 'the perfect order,' which is, measuring 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.  The important aspect is to know what the data is showing and using it to improve.

Sentara expects all of its major suppliers to be ISO-certified or ISO-compatible in the next 2 years.  Plenty of other industries - as well as many medical manufacturers - already are and what Sentara expects is a  quality management system that mirrors what we are looking to achieve.

This leads to joint performance metrics.  Sentara Supply Chain analytics team will work with vendors to determine  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.

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. 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.

If you want to partner with Sentara your organization will be ISO certified or have a quality management system that is compliant with the ISO standards.  The intent is to ensure:

• purchased service/product is purchased from a qualified vendor
• the service/product purchased is adequately sourced
• the received service/product conforms to requirements, is correct and free from damage