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

What is ISO 9000? The Beginner’s Guide to Quality Management System Standards (Free ISO 9001 QMS Template) process.st/iso-9000 October 21, 2019

Oliver Peterson October 21, 2019

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: 1/12

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:

What is ISO 9000?

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ISO 9000 is a family of quality management system standards created to

help organizations build, maintain, and continuously improve their quality management systems in order to provide the best product or service possible for relevant stakeholders and customers.

A quick introduction to ISO The International Organization for Standardization (also known as ISO) is a standard-setting body with headquarters in Switzerland. It is formed of a number of different representatives from many standards organizations of all types.

ISO is the organization responsible for creating and maintaining standards like those found in ISO 9000.

What is the difference between ISO 9000 and ISO 9001?

Confusingly, ISO 9000 refers to both a single standard (ISO 9000) as well as the entire 9000 family of standards. They are all designed for quality management and quality assurance.

The ISO 9001 standard is one of many in the 9000 family.

What about ISO 9001?

ISO 9001 is a specific standard, perhaps the most famous of all of the ISO standards. It is specifically designed to help companies implement and maintain quality management systems.

It’s basically a standard that is supposed to help organizations be more efficient and successfully meet the needs of their customers.

At least one million companies and organizations in 170+ countries are certified to ISO 9001, and even more will informally utilize the standard in one way or another.

ISO 9000 for quality management systems Quality management is the process of making sure products or services are up to scratch, and that the recipient of those products or services are satisfied.

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Simply put, the goal of quality management is to achieve and maintain a desired level of quality. That’s what ISO 9000 is all about – putting a system in place that ensures a consistent level of quality.

What is a QMS? This is perhaps the most important concept of ISO 9000. A QMS, or quality management system, can be understood as a set of best practice principles for standard operating procedures.

The goal of this kind of system is to ensure reliable, predictable outputs for a given input.

With a QMS in place, it’s possible to quantifiably measure the quality of the various aspects of a business with techniques such as auditing.

A QMS at its core is a collection of documented policies and procedures that clearly define the ideal way you want the product or service delivered to your customers. Think of it like a business process management system with a focus on quality control.

No two quality management systems will be the same, and all companies will want to implement ISO 9000 standards in their own way, according to their own needs and goals.

Despite this, there are unifying principles that ISO 9000 quality management systems are designed around, such as the PDCA/PDSA framework.

PDCA (Plan, Do, Check, Act) or PDSA (Plan, Do, Study, Act) are both variants of the Deming cycle, which is a methodology of continuous improvement.

Certain standards in the ISO 9000 family, such as ISO 9001:2015 were updated to be more readily functional alongside the PDSA framework.

These changes come alongside other similar structural changes designed to simplify ISO 9000 implementation.

Annex SL and the management system standard (MSS) structure Another change to ISO standards has been the introduction of a new, commonly shared structure known as Annex L (previously known as Annex SL).

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Made up of 10 clauses, Annex L is shared by many ISO management system standards, such as ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018.

It replaces ISO’s previous Guide 83 standard, which provided base structure and format for management system standards.

What this means is, now many different ISO management system standards can be crossimplemented and integrated together very easily, as they all share the same core structure.

Understanding ISO’s management system standards is an important step towards improving efficiency in your organization, especially if you’re already using an ISO standard.

But why else would you consider implementing any of the ISO 9000 standards?

Why is ISO 9000 important?

ISO 9000 is a family of quality management standards, and quality management, in the form of a properly enforced QMS, can help an organization to: Market their business more effectively Exploit new markets Streamline onboarding processes Manage growth more efficiently Implement and reap the rewards of continuous improvement Reduce error in production processes Improve product or service efficiency Reduce waste Improve customer and stakeholder satisfaction

Why do I need ISO 9000?

Apart from being an internationally recognized symbol of prestige, a quality management system implemented with ISO 9000 standards for quality assurance can be assumed to have reached a consistently high level of customer satisfaction and product quality.

ISO 9000, specifically standards like ISO 9001, should be seen as ways to systematically and reliably implement functional quality management systems.

As well as being reliable and proven standards for the general purpose of implementing a QMS, there are a number of specific benefits that come with using ISO 9000.

Benefits of ISO 9000 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 5/12

revenue, a $16 reduction in costs, and a $3 increase in profits. On average, they saw that quality management reduced costs by 4.8%.

Benefits of ISO 9000 standards hit all sectors of an organization, and I’ve outlined the main benefits below.

How ISO 9000 can benefit your business For all recurring processes, you ISO 9000 will help to reduce the rate of error.

By utilizing a respected international standard, your brand image and credibility will increase.

Manual work is reduced with process integration and process automation.

By using data and evidence from auditing and detailed records, you will improve organizational efficiency and effectiveness.

You will save more time from more efficient management of resources.

You will increase profit potential and market share overall as a result of the cumulative effects of implementing ISO 9000 standards.

How ISO 9000 can benefit your customers Customer satisfaction will rise as you will be equipped to quickly and efficiently act on feedback.

ISO 9000 standards for quality management encourage preventative thinking and planning, meaning you will address issues before they have a chance to arise and cause problems for customers, or any other sector of business.

Customers will see ISO 9000 certification as a badge of a high-quality, reliable vendor.

Customer satisfaction is a core focus of ISO 9000 standards, so any effective implementation should see improvements to customer satisfaction.

How ISO 9000 can benefit your employees When done right, ISO 9000 standards will help to foster a company culture of continuous improvement.

Process ownership and accountability is an important concept of ISO 9000 standards, and as such employees will become more engaged with and feel responsible for their processes. This in turn improves process quality.

Improved business performance means more secure jobs.

Higher workplace happiness and job satisfaction due to roles being clearly defined and streamlined.

Onboarding and training becomes more streamlined thanks to improved planning and organizational structuring for ISO 9000 requirements.

ISO 9000 certification 6/12

ISO certification isn’t necessary; you can implement any standard without

getting officially certified and still reap the benefits.

However, certification carries some exclusive benefits, some of which have been mentioned above. You may also require ISO certification for specific situations, such as when a client or government body requests it.

To be clear, you can only achieve ISO certification as the result of a successful 3rd party audit. To succeed in a 3rd party audit, you need to have: 1. Built and implemented a quality management system in accordance with the principles of the relevant standard.

2. Have an audit performed by a Certified Body (CB or Registrar) to assess the performance of your QMS against the relevant standard.

3. If you are successful, the certificate will need to be recertified after three years (and every subsequent three years) to make sure you’re still up to standard (as well as any new changes to the standard).

That said, there are other reasons you may want to perform an ISO audit.

ISO 9000 audit process

ISO audits are generally made up of these stages: Audit management Audit preparation Audit process Gathering evidence Evaluation of audit evidence against audit criteria Closing the audit Following up Competence and evaluation of auditors

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Each stage will involve sub-tasks and requirements of its own, depending on the specific standard being audited to.

Different types of ISO audit

There are three main types of ISO audit, split into two distinct categories: Internal audits First-party External audits Second-party Third-party The important distinctions are between first, second, and third-party audits.

First-party These are simply internal audits.

Internal audits are conducted by, or on behalf of the organization itself. They’re typically used for assessing conformity, evaluating effectiveness, analyzing processes, and identifying areas for improvement.

They can also be done as part of requirements for certain ISO standards, where it is specified that internal audits need to be carried out.

First party audits can never result in an ISO certification, but they can be used to prepare for a third-party audit.

Second-party “External audits� refers to both second and third-party audits.

Second-party audits are done by, or at the request of any organization or interested party outside of the organization being audited. For example, a customer or a contractor might request a second-party ISO audit.

They will usually be more formal than first-party audits, because the outcome will more directly impact the relationship between the organization and the relevant interested party 8/12

requesting the audit.

Third-party Third-party audits are done by external organizations that don’t have any vested or conflicting interests in the organization being audited.

For example, a third-party audit will typically be done by a certified body or registered government agency.

The important factor is the independence of the audit organization. They must be separate from the organization being audited.

Customers can also request third-party audits, usually to make sure certain requirements are adhered to.

Third-party audits are the only way to get ISO certified. Just so, failing a third-party audit may lead to a fine or a citation being issued.

ISO has never been easier Recent changes to ISO standards across the board mean it’s easier than it’s ever been to get started with implementing ISO in your business.

These changes mean you can use Process Street to build and maintain your ISO management systems like those using ISO 9000 standards.

Using Process Street to implement ISO 9000 standards If you want to practically implement ISO 9000 standards, you will save yourself time and money by choosing a BPM software tool to keep everything organized and streamlined.

Process Street is one such tool, and you can use it to get started with a quality management system using ISO 9000, as well as managing all of your other workflows and business processes.

Since 2015 revisions of ISO standards, Process Street has been an ideal solution for building, managing, implementing, and optimizing standard operating procedures and ISO standards.

Features like form fields, conditional logic, and task assignments make building out your management system a breeze.

Check out this video for a quick rundown on how to get started with Process Street:

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Free ISO 9000 templates If you’re still wondering how to get started with ISO 9000, you could do worse than to take a look at some example templates for a better understanding of how these kinds of quality management systems might look in practice.

Here are some ISO 9000-related checklist templates for you to browse and use at your leisure.

If you want any of them for yourself, all you have to do is sign up for a free Process Street account and add them to your account.

ISO 9001 Internal Audit Checklist for Quality Management Systems

Arguably ISO’s most popular standard, ISO 9001 defines the requirements for implementing, maintaining, and improving quality management systems.

This template is for performing internal audits on ISO 9001 quality management systems, and is based on the auditing principles laid out in ISO 19011.

Click here to get the ISO 9001:2015 Audit Checklist for Quality Management Systems.

ISO 9001:2015 and ISO 14001:2015 Integrated Management System (IMS) Checklist

Integrating multiple different management system standards (MSS) can help save you time and money while reaping the rewards of both systems.

For example, two of the most common ISO management systems are quality management (ISO 9001) and environmental management (ISO 14001).

With this integrated management system (IMS) checklist, you can streamline the whole process of integrating the two systems and save yourself tons of effort in the long run.

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Click here to get the ISO 9001 and ISO 14001 Integrated Management System (IMS) Checklist.

ISO 9004:2018 Self-Audit Checklist ISO 9004 is a set of guidelines (as opposed to requirements) for achieving sustained success in quality management systems.

It’s basically a supplementary standard to go alongside ISO 9001, to help organizations implement better quality management systems.

Below you’ll find a self-audit checklist you can use in accordance to the 2018 revision of the ISO 9004 standard.

Click here to get the ISO 9004:2018 Self-Audit Checklist.

ISO 9001 QMS Mini-Manual Structure Template The Process Street template below provides you with a framework for building your own Quality Management System mini-manual (essentially a process and procedures library) to supplement an ISO 9001:2015 QMS. Click here to get the ISO 9001 QMS Mini-Manual Structure Template.

ISO 9001 Marketing Procedures (Mini-Manual Example) This template is a fully filled-out version of the structure template above. You can use it as a reference for how you might want to build out your own mini-manual.

Click here to get the ISO 9001 Marketing Procedures (Mini-Manual Example).

Relevant ISO/SOP articles For more of our ISO and standard operating procedure resources, check out the following articles: Disclaimer:

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1. Process Street is not affiliated or in partnership with the International Organization for Standardization (ISO). The materials on Process Street’s website are provided on an as-is basis and are for educational purposes. Process Street makes no warranties, expressed or implied, and hereby disclaims and negates all other warranties including, without limitation, implied warranties or conditions of merchantability, fitness for a particular purpose, or non-infringement of intellectual property or other violation of rights.

2. Further, Process Street does not warrant or make any representations concerning the accuracy, likely results, or reliability of the use of the materials on its website or otherwise relating to such materials or on any sites linked to this site.

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