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?
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ISO 9001: The Ultimate QMS Guide (Basics, Implementation, ISO Templates)

Consumer Reports publishes an annual reliability survey, which includes data on over 470,000 cars.

In this report, owners of Tesla’s Model 3 experienced a number of problems, including chassis hardware, paint and trim related faults, indicative of a build quality that fell far shorter than expected standards set across the automotive industry. The Model 3 represents Tesla’s first real attempt at a mass-market electric vehicle, and the issues surrounding its launch created much frustration and controversy among electric vehicle enthusiasts.

This lack of quality assurance has lost at least one major $5 million order of Model 3 vehicles from a rental company, in relation to problems with the service and performance of previously purchased vehicles.

In an email, NextMove wrote:

“Tesla Model 3 vehicles, which NextMove was supposed to take over after payment and only a short examination, sometimes had serious defects: defective tires, paint and body damages, defective charge controllers, wrong wiring harnesses or missing emergency call buttons. Such quality defects would have endangered the safety of the customers and the profitability of NextMove.”

Stefan Moeller, Managing Director of NextMove, went on to say:

“We had to insist on compliance with general quality standards and processes in order to protect our renters and our business model.”

Why did Tesla have so many problems? Crucially, Tesla made the decision to deliver the product to market and sort out the issues later.

Basically, they didn’t have a strong enough system for managing quality.

We call these Quality Management Systems (QMS) – and they work.

The rest of the auto-industry follows a specific quality management system structure. It’s called ISO/TS 16949:2009 and it’s a variant of ISO 9001.

People follow quality management systems for various reasons; they improve quality first and foremost. But they also have a positive impact on the bottom line.

The return on investment (ROI) of a quality management system is typically impressive:

As a guide, a recent study undertaken through the American Society for Quality (ASQ) showed that for every $1 spent on your QMS, you could expect to see an additional $6 in revenue, a $16 reduction in costs, and a $3 increase in profits. On average, they saw that quality management reduced costs by 4.8% – ASQ

In this Process Street article, we’ll be looking at how ISO 9001 can be used to assure quality control across all types of organizations, with benefits like improved company performance, higher demand for products, and a competitive advantage towards increasing market share.

What we’ll cover:

For the uninitiated, what is ISO 9001, as simply as possible?
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ISO 50001: The Ultimate Guide to Energy Management Systems (EnMS)

What is ISO 50001 the ultimate guide to energy management systems (EnMS)

If there was a list of the “Top Ten Problems” facing humanity in the next few decades, what do you think would be at the top?

Well, it turns out Richard E. Smalley made such a list in 2003, and placed predictions about a looming global energy crisis at the top.

His prediction focused on the problem of the amount of energy being consumed, against the amount of energy being produced (as well as available sources of energy production) alongside the projected boom of human population to around 8-10 billion by 2050.

In recent years, there has been a resurgence of attention placed on the topic of energy efficiency and the relationship between energy consumption and climate change.

It is an undeniable fact that our global climate is rising in temperature. The science is there to prove it; the United Nations Intergovernmental Panel on Climate Change (IPCC) and many other international organizations have acknowledged that recent years have been the hottest since records began.

As a result, intense weather like heat waves, hurricanes, heavy rains, tropical storms, and rising sea levels all becoming more and more commonplace.

Despite the rising tide of climate crisis, the demand for energy supply is at an all-time high. The global economy is insatiable in its demand for energy to sustain economic growth and development.

How should organizations prepare themselves for the inevitable challenge of sustainable adaptation, and for ensuring they have the tools in place to facilitate the systematic energy management approach that will be the core of efforts to improve energy efficiency in the future.

“Energy efficiency is the most promising means to reduce greenhouse gases in the short term,” – Yvo de Boer, Former Executive Secretary of the United Nations Framework Convention on Climate Change (UNFCCC).

A systems-scale approach is necessary if organizations want to seriously engage with difficult problems facing sustainable business and adapt for the future of energy management.

ISO 50001 is a standard designed to help organizations establish efficient and effective energy management systems (EnMS) and improve energy performance.

Based on the principles of continuous improvement and popularized by the ISO 9001 and ISO 14001 management system standards, by implementing these standards companies stand to reduce energy efficiency costs, lower carbon dioxide emissions and prioritize the preservation and sustainable engagement with the environments in which they operate.

This article will provide an introduction to the ISO 50001 standard, with a simple explanation and tips for getting started with an implementation of your own using Process Street.

Thankfully, recent changes have made it easier than ever to implement ISO 50001 (and any ISO management system standard), so that will be a big focus of this article.

Here’s a breakdown of what I’ll be covering here:

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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.

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