ISO 13485:2016 and Supplier Management – A Reflection of the World Around Us

ISO 13485:2016 and Supplier Management – A Reflection of the World Around Us

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

The global economy is often the topic of blogs, articles, and macroeconomic discussions. It’s no surprise that it’s become a leading consideration in the field of Quality as well. The global economy has added complexity to our supply chains making it more important than ever to assess and control supplier risk. Lengthy supply chains make it more difficult than ever to manage suppliers and remain compliant with the plethora of regulatory requirements around the world. The updates to ISO 13485:2016 reflect this reality.

It’s All About Risk

The supplier management and purchasing processes within ISO 13485:2016 have extensive updates, all aimed at reducing risk: supplier, product, and patient. ISO 13485 has been expanded to specify requirements for supplier approval, monitoring and reevaluation of suppliers, and supplier records. As more and more organizations outsource their activities, there is much stronger emphasis on supplier quality management. Lack of supplier deliveries, or delivery of product that does not meet required specifications, is not only costly, it puts patients at risk because it threatens the availability of life-saving products in the supply chain.

Supplier Evaluation is Key

To manage this risk, organizations are required by ISO 13485 to monitor and reevaluate their existing suppliers. Reevaluation must include measurement of the supplier’s performance in meeting the requirements for the products purchased from them. Non-fulfilment of purchasing requirements must be addressed in a manner that is proportionate with the risk associated with the purchased product, and in compliance with applicable regulatory requirements.

Documentation of these activities: evaluation, approval, monitoring, and reevaluation must be maintained. Undergoing due diligence in the selection and monitoring of supplier performance over time saves overall time and money by reducing the volume of product returns, reducing rework, improving product quality, and increasing customer satisfaction. This supports a “right the first time” mentality which is always more cost-effective than doing it over.

John Wooden, legendary basketball coach and leadership mentor would ask, “If you don’t have the time to do it right, when will you have time to do it over?” Life Sciences organizations must get it right the first time, and this means that our suppliers must get it right the first time. Proper supplier evaluation and monitoring is key to reducing risk, and now it’s part of a very impactful standard.

Additional Purchasing Changes in ISO 13485:2016

Additional changes in ISO 13485 aim to further reduce supplier-related risk and improve quality. Purchasing information has been reworded and clarified in the standard to ensure that purchasing requirements are being met, including specifications, product acceptance, supplier personnel qualifications, and quality system requirements. Similar to the FDA Quality System Regulation (QSR), a written agreement must be established stating that changes in the purchased product must be communicated prior to the implementation of any changes. ISO has strengthened the wording associated with verification of purchased products to ensure that it is appropriate based on the supplier evaluation and proportionate to the risks associated with the purchased part. Communication with your suppliers is key. Your suppliers near and far need to know that the changes they make impact the products you make. Written agreements aid in that understanding between your organizations.

The Bottom Line

What does all of this mean to Life Sciences organizations? It means that Quality Management Systems need to include suppliers and outsourcers by keeping them up to date on product specifications and requirements, and ensuring that they collaborate and communicate any relevant changes. It means that the Quality Management System must be fully integrated with properly structured data to ensure that all supplier activities, incoming material inspection results, supplier nonconformances, supplier corrective actions, and audit results continuously feed into the supplier performance monitoring and reevaluation process. This is key to achieving the preventive and predictive signals that will drastically improve your organization’s quality and achievement of customer expectations.

Quality Management must reflect the reality of our world; it must venture into our extended supply chains to reduce risk, improve patient safety, and aid our efforts to get it right the first time.


ISO 13485:2016

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Kari Miller

Regulatory & Product Management Leader, Pilgrim Quality Solutions

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