How Quality Agreements can boost your Suppliers’ Performance

What is a Quality Agreement?

Quality Agreements are written agreements between MedTech Companies and Suppliers/ Service Providers. Their purpose is to ensure that all purchased activities that impact product quality and safety meet regulatory compliance. Quality Agreements are a legal requirement. Some regulatory authorities require them explicitly, others implicitly.

1. ISO 13485: 16 section 4.1.5

2. FDA 21 CFR Part 820.50 - Purchasing Controls

3. ISO 9001:2015 section 8.4

4. MDR requires QM system (see point 1)

Content of a Quality Agreement

Roles, responsibilities and authorities must be clearly defined and regularly updated in a written agreement between the parties involved in order to control and monitor external processes.

A Quality Agreement should set out clear objectives, scope and designated contacts. It should also establish communication guidelines, response times and escalation levels. The agreement must specify the supplier's requirements, including quality management system, audit obligations and supplier management. Finally, it should define the client's obligations to ensure a smooth and effective working relationship.

Is the mere existence of a Quality Agreement a measurable indicator of the quality of processes and products?

Thinking outside the box

In less regulated industries, it is performance that matters. Service Level Agreements (SLA’s) or Master Service Agreements (MSA’s) set out clear arrangements and objectives. These are measured against agreed Key Performance Indicators (KPI’s). The supplier's performance and the quality of their products can therefore be evaluated using quantifiable measures.

QM meets Performance

QM is not interested in performance and efficiency of business processes. Neither is Procurement interested in compliance with normative requirements - too bad! Extending quality agreements to include mutually agreed Key Performance Indicators (KPI’s) helps to effectively evaluate the quality of products and processes. Metrics such as on-time delivery, scrap rates, products meeting specifications and mean downtime can provide measurable insights.

And your distributors?

Please note! Unlike suppliers, distributors do not literally require Quality Agreements. However, they do need to have contracts or formal agreements that clearly define the GMP responsibilities of each party to ensure product quality and safety.

If you have any questions, we will be happy to help!