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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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What is ISO 9001? The Absolute Beginner’s Guide (Free Templates!)

what is iso 9001

ISO 9001; you may have heard of it. You may be somewhat afraid of it. And, if you’re reading this article, chances are you’re probably at least somewhat confused about how to actually implement it.

It’s possible you even Googled something like “what is ISO 9001?”. Perhaps you felt you knew at one point, but the important bits never really stuck.

Well, with the 2015 updates to a whole range of ISO standards, it’s a lot less scary.

Before now, if you wanted to implement any ISO standard, you’d have to undertake a lengthy process involving unwieldy paper manuals and cumbersome bureaucratic procedure.

In short, ISO 9001 was hardly agile.

Now, you have far more flexibility to implement ISO 9001 the way that works for you best; with BPM software like Process Street to make things streamlined and simple.

This is why we’re presenting you with this handy overview of ISO 9001, including all of the essentials you need to get started.

We’ll cover how to combine structured compliance with the rapid process improvement of a startup, including:

Before we dive in, here’s some free templates to help you hit the ground running!
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Compliance Audit: What It Is, How to Prepare, and Why You Should Care

compliance audit

Quis custodiet ipsos custodes? (Who watches the watchmen?)” – Decimus Junius Juvenalis (Juvenal), Roman satiric poet

We’ve spoken before about the importance of meeting high standards with your work.

We’ve also covered, in detail, how failure to comply with industry standards and bad processes cost Zenefits $7,000,000.

This all happened because they weren’t meeting the standards they should have been with their internal processes.

To help stop you from falling afoul of the same fate, we here at Process Street will be covering compliance audits in this post. These are the guidelines that you will need to follow to avoid penalties from external sources for not doing your work satisfactorily.

It doesn’t matter what business you’re in – compliance audits are there to make sure that your customers are getting a satisfactory (or, at least reasonable) service.

We’ll cover:

Let’s get right into it.

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What is ISO 9000? The Beginner’s Guide to Quality Management System Standards (Free ISO 9001 QMS Template)

What is ISO 9000? The Beginner's Guide to Quality Management System Standards (Free ISO 9001 QMS Template)

In 2018, Apple rolled out their brand new iPad Pro; top-of-the-line, cutting-edge, very slightly bent- wait, slightly bent?

Customers on social media and several on the MacRumors forums have discovered their iPad Pros exhibited this slight bend straight out of the box.

Of course, Apple’s response was that this was completely normal, and absolutely not a defect.

Despite the publicity Apple gives its “ultra precise” quality manufacturing process, more and more issues like these are appearing. The bendy iPad Pro is looking less like an exception, and more like an increasingly problematic trend.

Here’s a comprehensive quality breakdown (quite literally) of the iPad Pro in question:

It’s interesting to note that while Apple is bragging about premium materials such as the sapphire camera lens cover, tests like the scratch durability test done in the video above pose glaring questions to Apple’s quality standards.

Other quality management blunders from Apple’s recent track record include:

  • iPhone X: Major factory defect on phone screen making it unresponsive to touch;
  • iPhone XS/XS Max: A repeat of antennagate, except this one might be un-fixable with software;
  • Apple Watch: Batteries will swell and crack or detach the screen.
  • iPad Pro 2017: An older iPad model sold until November 2018 reportedly develops strange screen glitches;
  • MacBook Pro: Users have reported and Apple has admitted to serious defects (resulting in data loss and failure) with the solid-state drives inside 13-inch models, as well as severe performance issues with i9 CPUs and sound distortion at low volume;
  • Macbook/Macbook Pro: Defective keyboards in models from 2015 to 2017.
  • That’s a lot of issues for a company that continues to charge top dollar, push prices up, and boast a reputation as a pioneer in quality assurance.

    Obviously, and for whatever reason, there is a problem somewhere in Apple’s quality management process.

    Quality control and management is important to ensure the customer gets the value they deserve, and quality management standards like those defined by the ISO 9000 family exist to make quality management work better.

    Although Apple has received certification for ISO 27001 (an information security management standard), it doesn’t appear that they have any ISO 9000 certification for quality management. Who knows, if they had, perhaps they wouldn’t have so many QC issues?

    In this article, I’ll be looking at the ISO 9000 family of quality management standards, breaking down the basics and giving you a few free checklist templates to get you started with your own quality management system.

    Here’s exactly what I’ll be covering:

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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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    What is CGMP? Current Good Manufacturing Practices and How to Use Them

    cgmpIf you’re manufacturing food, drinks, or medicine, you know you have a sea of regulations and standards which you need to hit and adhere to.

    You knew that starting out.

    But it does leave you with two questions:

    1. What are the regulations and standards that I should adhere to?
    2. How do I get my organization to run in an effective manner so that we consistently adhere?

    Lots of companies are very good at asking the first question, but the second sometimes gets overlooked.

    This is how we end up with malpractice and lawsuits and all kinds of bad things.

    You don’t just have to know what the standards are, or intend to reach those standards, but you have to consistently hit those standards in order to be the successful safe business you want to be.

    That’s why in this Process Street article we’ll be looking at:

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    The Ultimate Risk Management Guide: Everything You Need to Know

    Image showing the introduction to an article titled, "The Ultimate Risk Management Guide: Everything You Need to Know"

    Organizations face a wide array of uncertainties that can disrupt operations, threaten profitability, and damage reputation. Whether it’s market volatility, technological disruptions, or regulatory changes, the ability to anticipate, assess, and mitigate risks has become a crucial part of successful management. This is where risk management comes into play.

    Risk management is the structured process of identifying potential threats, evaluating their likelihood and impact, and developing strategies to minimize or eliminate their adverse effects.

    By integrating risk management into their decision-making processes, organizations can not only safeguard their assets but also seize opportunities that arise from taking calculated risks.

    In this article, we explore the fundamentals of risk management, its various types, and why proactive risk mitigation is essential for businesses to thrive in uncertain times.

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    What Is ISO 31000? Getting Started with Risk Management

    what is iso 31000? Getting started with risk management

    We analyze and manage risks every day.

    From crossing the street, correctly preparing food, fastening seat belts, to coordinating a journey via public transit. Each of these is an example of a risk management process happening in our heads; sometimes the result of “common sense”, sometimes these decisions are made unconsciously.

    When it comes to business management, a more rigorous, formalized approach is needed.

    One such strategy for managing risk is to utilize standards for risk management, like ISO 31000. This approach is useful in pretty much any situation, for organizations of all shapes and sizes, to manage risk in their everyday operations.

    Managing risk effectively is essential to ensure businesses succeed and thrive in an environment of constant uncertainty. This post covers everything you need to know about ISO 31000; here’s a quick rundown of the article structure:

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    ISO 19011:2018 Basics (8 Free Management System Audit Checklists)

    internal audit

    What exactly is an “audit“?

    The International Organization for Standardization defines it as:

    “[the] systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” – ISO, from ISO 19011:2018 – Guidelines for Auditing Management Systems

    That’s another way of saying someone takes a look at what you’re doing, gathers some evidence, and compares that evidence to what you’re supposed to be doing (in other words, a set of clearly documented requirements).

    In the case of ISO, these requirements are known as standards. ISO 9001 is a standard. ISO 14001 is a standard.

    Importantly, this understanding of audit implies that there are a few main things being considered by the auditor:

    • What’s documented by the company (e.g. internal processes, policies, and SOPs)
    • Evidence gathered to support how these policies, procedures, and SOPs are implemented in practice
    • The requirements defined by the ISO standard being audited against (e.g. ISO 9001)

    Audits performed by companies to assess and analyze their own management systems are known as internal audits. Many resources for guiding companies on how to perform internal audits exist, and foremost of these is the ISO 19011 standard.

    For most management system standards, internal audits are an important requirement. Even guideline standards like ISO 26000 for social responsibility depend on reports to evidence the success of their implementations.

    As such, ISO 19011 defines a set of guidelines; a framework for companies to plan, implement, and improve upon their audit programs, for auditing the implementation of management systems.

    Since the first edition of ISO 19011 was published in 2002, many new management system standards have been published.

    These standards often share a common structure, including certain requirements, terms, and definitions being used. That means ISO 19011 can be used to devise highly economic audit programs, wherein knowledge and processes can be shared and applied across various management systems.

    By considering how they might take a broader approach to management system auditing and integration, companies implementing ISO management systems stand to save time, money, and confusion when preparing for and implementing internal audits.

    The goal of this post is to provide a spring-board for understanding ISO 19011, and how to get started with internal ISO auditing. In this post, I’ll cover:

    • What is ISO 19011
    • 7 principles of ISO auditing
    • Different types of ISO audit
    • Key elements of an ISO audit
    • 8 free ISO audit templates

    If you just want the free ISO audit templates, then here they are:

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