ISO: Everything You Need to Know (Ultimate Guide + Free Templates)

isoISO means standards. A standard is just a set of requirements, decided by experts, for doing something specific.

A lot of standards exist under the banner of ISO, for all sorts of things, from quality management, to environmental and social responsibility guidelines, to how to design medical devices.

They’re useful because they help you to write good processes; how to structure, organize, implement, and improve on them.

At the heart of ISO is the principle of systematizing your approach to process management in your company – simple as that! You might be scared of ISO, but there’s really no need to be intimidated. What’s more, recent changes have made it easier than ever to get started with ISO standards.

In this Process Street article, we’ll look at everything ISO, including (but not limited to):

Let’s start with the basics. What exactly is ISO?
Continue Reading

ISO 13485: Basics and How to Get Started (QMS for Medical Devices)

iso 13485 checklist

In today’s business world, owners are constantly grappling with concerns and surmounting obstacles, the least of which is actually staying afloat financially in what can be an unforgiving economy.

However, the struggle to turn a profit pales in comparison to some of the harsher consequences of failing to comply with certain regulatory requirements.

Take HRIS broker Zenefits for example. Failure to comply with several licencing regulations issued by the California Department of Insurance landed them a $7million fine.

That’s just the tip of the iceberg; more severe penalties extend to include government bodies compelling you to dissolve your company, and ultimately the endangerment of the lives and well-being of individuals your organization is servicing.

“On a global scale, we are all being asked to do more with less—and for less. At some point soon, the current internal systems will not be able to hold back the deluge, and companies will be faced with a stark decision—consistently improve or perish” – Erik Myhrberg and Joseph Raciti, Practical Field Guide for ISO 13485

Often, these kinds of requirements take the form of the ISO 13485 standard for medical device manufacturers.

In this article, I’ll break down the ISO 13485 standard, from a basic introduction to suggestions and resources for implementing it in your business or organization.

Continue Reading

What is ISO 9001 Certification? How to Get Certified (For Beginners)

ISO 9001 certification

ISO 9001 is an international standard for defining a quality management system (QMS). It outlines various criteria (or standards) to define quality management principles such as focusing on the customer, optimizing leadership and management within the organization, improving and fine-tuning internal processes, and general methods of continuous improvement.

Let’s break down each of the components of and ISO 9001 certification.

Continue Reading

Get a free Process Street account
and take control of your workflows today.

No Credit Card Required