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What Is A Process In ISO 13485? Ask Your Audit Expert!

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What Is A Process In ISO 13485? Ask Your Audit Expert!


One of the ISO terminologies that often leaves readers confused is “process.” Today’s post sheds light on the meaning of process and discusses how it differs from procedures with the help of professional ISO 13485 audit experts.

Popularized by ISO 9001, the approach of process management has been around for a long time.

Still, the term often leaves people confused. Many even confuse it with similar terms like “procedures” and “policies”.

However, if your organization desires to pass the ISO 13485 audit in one go, familiarizing yourself with these terms is essential.

To help you, today’s post describes “processes” and highlights how it’s different from other similar terms.

So, continue reading!

What Is Process In ISO 13485?

According to the definitions of ISO 9001 and ISO 13485, a process is a set of interacting or corresponding activities that convert intakes or inputs into outputs or outcomes.

In a quality management system, almost any activity you perform can be a process. For instance, you will have a process for gathering resources to operate the ISO medical device quality management system. Similarly, you will have a process for hiring suppliers, keeping track of your medical devices, and identifying risks before going through an ISO 13485 audit.

Processes essentially involve taking an input and performing activities to turn it into the desired output.

For example, before hiring a supplier, you will have to perform adequate due diligence, craft contracts, conduct a risk assessment, and interviews.

Furthermore, there are different types of processes, such as processes for the management of an organization, processes for managing resources, operational processes and measurement, analysis, and improvement processes.

What Are The Benefits Of Process Approach?

Taking a process-based approach to your quality management system can have multiple benefits.

• It will allow you to integrate and align processes to achieve desired outcomes.

• It will enable you to focus your effort on the efficiency and effectiveness of each process.

• It will help maintain transparency throughout the operations of your organization.

• Taking a process approach can help you shorten the cycle of operations and effectively utilize available resources.

• It will allow you to obtain consistent and predictable results.

What Is A Procedure In ISO 13485?

ISO 13485 audit experts define the procedure as a specific way to carry out an activity or process. Many confuse procedures with processes. However, procedures refer to the steps that describe how you will perform a process.

For example, you may set up specific methods to review the process of evaluating supplier contracts.

It’s noteworthy that every process needs a procedure. For instance, you may have a process for hiring a supplier. However, if you don’t have a procedure for it, you will be unaware of how to select the correct supplier for your company.

However, whether you need to document every procedure is another argument.

How Policies Relate To Processes?

Policies are the guidelines that drive an organization as well as its processes and procedures. For instance, ISO 13485 requires organizations to establish a quality policy that offers a framework for establishing and reviewing quality objectives.

Understanding The Jargon Of ISO Is Important

Whether your organization is preparing for an ISO 13485 audit or ISO 9001 certification, learning about the fundamental terms of ISO management system standards is essential.

It’s even more critical when the term is “process.’’ The process approach is one of the eight quality management principles of ISO quality management system standards. It allows organizations to understand the relations between their operations and create necessary procedures.

Author Bio

Blue Wolf Certifications is a business partner to various accredited certification bodies. To put it another way, we are one of their auditors, a regional office.

Our auditors have been described as transparent, open, fair and supportive. And even easy to talk to and helpful.

Our audits have been described as nonthreatening, relaxing, straightforward, orderly, professional and painless.

Take the advice of our clients, we will make your ISO certification journey easier and less stressful.

We can audit and provide accredited certifications for ISO 9001, ISO 14001, ISO 27001, ISO 37001, ISO 45001 and other certifications.

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