The role of Quality Management System in Software Validation and Development

A quality management system (QMS) is the set of processes, procedures and responsibilities an organization follows to meet customer requirements and work more effectively, including when it develops software. Software development is demanding, and validating and maintaining that software is a long process of its own. This article looks at how much a QMS affects software validation and how to apply it effectively.

What does a quality management system do?

Many organizations hesitate to spend time and money on a QMS that seems to involve endless procedures. Yet of the many QMS standards in use, ISO 9001 is the most widely applied.

A QMS supports a range of activities:

• lowering costs and reducing waste;
• improving the quality of systems and processes;
• providing quality training;
• setting direction so the organization can reach long-term goals.

In short, a QMS touches every part of how an organization works, from overseeing quality to keeping to the standards set in its own procedures and instructions.

What does ISO 13485 require for software validation?

For software quality, the relevant QMS standard is ISO 13485:2016, which replaced ISO 13485:2003. A key requirement of ISO 13485:2016 is that software must be validated before its first use.

There are several ways to make software validation take less time and cost while improving quality at the same time. The sections below cover three of them.

How do vendor audits support validation?

Auditing your software vendor is one of the most effective ways to apply the QMS. The audit gives you confidence in the quality of the vendor’s development and testing process, and it strengthens the customer-vendor relationship.

Once you trust the vendor’s work, you can rely on its testing instead of repeating it yourself.

Why use a risk-based approach?

Another way to strengthen the QMS is to assess risk throughout software development and validation. Tracking changes and setting standard milestone checks each time the software is revisited lowers the risk in the development process.

A risk-based approach is especially useful when the software is changed again and again, for example when a customer asks for improvements.

Which processes need to be validated?

It helps to focus on critical business processes (CBPs). Not everything in your development process needs full validation. Validation drags on when every small part of the software is validated repeatedly, even when there is no need.

Give priority to the functions and activities that affect the safety, quality and consistency of your products and services. Focusing on CBPs shortens validation and helps your products and services stay stable and competitive in the market.

Key takeaways

A QMS has become a central way to address quality and security issues in software development. A development process backed by a strict QMS consistently improves software validation, which leads to better quality and functionality with fewer technical problems.

• Validate software before first use, as ISO 13485:2016 requires.
• Audit vendors so you can rely on their testing.
• Use risk-based checks when software changes often.
• Focus validation on critical business processes.