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.
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:
- Free ISO 9001 Templates
- What is ISO 9001? The most popular QMS standard
- Benefits of implementing ISO 9001
- Quality management with ISO 9001: Key principles
- ISO 9001 certification: Is it necessary?
- Agile ISO 9001 in 5 simple steps
- More ISO resources
Free ISO 9001 Templates
The first step to understanding how to utilize ISO 9001 for your company is to look at an example of how a successful QMS works when in practice.
This Process Street template provides an easy-to-follow outline of a QMS Mini-Manual up to the standard of ISO 9001:2015:
Here’s a list of all of our ISO 9001 templates, to make things easier for you:
- ISO 9001:2015 and ISO 14001:2015 Integrated Management System (IMS) Checklist
- ISO 9001 Marketing Procedures (Mini-Manual Example)
- ISO 9001 Internal Audit Checklist for Quality Management Systems
- ISO 9001 QMS Mini-Manual Structure Template
- ISO 9004:2018 Self-Audit Checklist
What is ISO 9001? The most popular QMS standard
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.
What does ISO 9001 look like?
So what is ISO 9001, exactly? ISO 9001:2015 follows the Annex L management system standard (MSS) and is structured into 10 sections, three of which are introductory and of little importance when trying to understand the core principles of ISO 9001.
That leaves 7 main sections:
- Context of the organization
- Performance evaluation
There’s a lot of ground to cover for each of these; if you’re interested you can head over to my article on quality management for an in-depth look at each section.
Benefits of implementing ISO 9001
An ISO 9001 certification can open up a lot of business opportunities for you and your company. For instance, when bidding for contracts, an ISO 9001 certification is commonly a requirement.
It was shown in a recent study by the American Society for Quality, that every $1 invested into your QMS results in an average increase of $6 in revenue, $3 in profits, and a reduction of $16 in QMS costs.
When a company implements a strong quality management system, it can help to:
- Boost product efficiency
- Lower the overall waste of resources, money, and time
- Execute better production consistency for products and services
- Better customer satisfaction and retention
- Allow for companies to market themselves more successfully
- Improve employee onboarding
- Strengthen company growth
- Regularly improve upon company processes and products
Quality management with ISO 9001: Key principles
Quality management is central to ISO 9001. The heart of quality management is the quality management system (QMS).
Simply put, a QMS is a set of standard operating procedures (that’s a fancy way of saying processes) for measuring the level of quality of all kinds of aspects of your business.
It’s basically like a system for business process management, except with a focus on quality control.
No two QMS will be the same. Each business will have different needs, as well as a different definition of “quality”. That’s fine! That’s how things should work. It’s also how ISO 9001 works; being flexible in how each company defines its own requirements for a QMS.
What ISO 9001 does, is provide a set of guidelines to help you build and implement a successful QMS.
ISO 9001 is designed around the principles of continuous improvement; one of the most important concepts to understand here is PDCA (sometimes written PDSA).
Plan, Do, Check, Act. (Or: Plan, Do, Study, Act).
There are some important differences (expanded in our article on the Deming cycle) between PDSA and PDCA, but they’re both frameworks for continuous improvement, and they’re both ways of understanding ISO 9001.
To understand how to build a QMS, it’s important to understand continuous improvement. PDCA/PDSA aren’t the only ways you can implement continuous improvement, but they’re a great start.
For a more detailed look into the inner workings of a QMS, check out our quality management system article.
ISO 9001 certification: Is it necessary?
ISO 9001 certification is like a badge of honor, that basically communicates to your clients that you’ve gone through the rigour of being certified by an ISO lead auditor or inspector.
However, it’s only necessary in certain situations. Simply put, if you don’t know if your company needs ISO 9001 certification or not, you probably don’t need it.
Rather it’s an assurance that your company is able to perform to a specific quality standard, consistently, and will help you leverage new clients as well as certain government contracts.
So, you can implement a QMS without needing an ISO 9001 certification! Certification is basically an extra step you can take to validate your QMS.
How to self-audit with ISO 9001
An ISO 9001 audit is basically a way of making sure the requirements of the standard have been properly implemented. There are two main types of audit:
- Internal audits (informal audits performed inside of an organization to measure internal strengths and weaknesses)
- External audits (formal audits, often performed by request of a client, or in order to obtain ISO certification)
If you’re looking to implement a QMS, it’s worth looking into performing a self-audit (or internal audit).
For a more in-depth look at ISO audits, check out our ISO audit piece.
If you’re looking for a complete, actionable, and totally free ISO 9004:2018 self-audit checklist, you can grab that here:
ISO 19011:2018—Guidelines for Auditing Management Systems standard defines an audit as:
“[the] systematic, independent and documented process for obtaining audit evidence [records, statements of fact or other information which are relevant and verifiable] and evaluating it objectively to determine the extent to which the audit criteria [a set of policies, procedures or requirements] are fulfilled.” – ISO 19011:2018 – Guidelines for Auditing Management Systems
Agile ISO 9001 in 5 simple steps
Since the 2015 changes to ISO standards, you can do agile ISO. In other words, you can use a BPM software like Process Street to build and manage your QMS.
Agile ISO is all about breaking free from the shackles of old-fashioned ISO and empowering your standard operating procedures with the digital tools for rapid process improvements.
To understand how the new ISO changes allow you to be more flexible with your QMS, check out our piece on agile ISO.
How to use Process Street to implement ISO 9001
Before we go any further, watch this quick video introduction to Process Street:
Now you’re primed with the Process Street basics, let’s unpack how that can help you with ISO 9001.
Process Street makes it easier for you to build processes, and it’s even easier for your employees to start using them. It’s literally as simple as following a checklist.
First you create a template, and then run checklists from those templates. The templates are the “process model”, and the checklists are each individual instance of the model.
You can also hook all of these processes into your other digital tools by using the third party automation platform Zapier (there are over 1500+ apps you can connect with).
So here’s what you need to do to start using Process Street for agile ISO compliance:
- Step 1: Build your processes in Process Street
- Step 2: Create your folder architecture
- Step 3: Design your meta processes
- Step 4: Write your policies
- Step 5: Create your first official document
Figure out what processes you’re using internally, and have your team members (the ones using them) build them out in Process Street themselves. It’s quick and easy, and by doing it this way you cultivate a sense of process ownership. Keep things simple, and focus on the most important steps. You can improve things over time.
Check out our post on process libraries for inspiration on this one, but the basic idea is to use folders, subfolders and tags to keep things organized and easily readable. Permissions also help to keep sensitive data private. You can move the templates your team has created into the relevant folders.
This can be stuff like processes for improving other processes, risk assessment processes, how to create new processes, process style guides etc. Your meta-processes are for managing your other processes.
Here are some examples:
This may be boring, but it’s important. Context of the Organization, Operations, Support, etc. The best way to do this is by drafting a simple structure and getting feedback from relevant individuals in your company.
What you’ll end up with is a folder in your Process Street process library where you store your policies in the form of Process Street templates. You won’t run these templates as checklists, but it makes sense to keep all of your QMS documents in the same system. You can export process templates (as well as individual checklists) to PDF, in case you want to present the documents physically at any point. The first official document you will create might be your QMS mini-manual. Check out our structure template for help building it.
And that’s it! Agile ISO is as simple as that.
When you use Process Street for ISO 9001, you don’t have to update each physical copy of your procedure documents every time you want to make a small improvement.
Instead, you can do it in seconds by editing and creating new and improved processes that are easy to follow and completely ISO compliant!
More ISO resources
If you’re interested in more resources for ISO and standard operating procedure, I’ve listed some great articles below:
- What is an ISO Audit? Free ISO 9000 Self-Audit Checklist (ISO 9004:2018)
- Processes, Policies and Procedures: Important Distinctions to Systemize Your Business
- ISO 26000 for Corporate Social Responsibility: How to Get Started
- Agile ISO: How to Combine Compliance with Rapid Process Improvement
- 20 Free SOP Templates to Make Recording Processes Quick and Painless
- What is Quality Management? The Definitive QMS Guide (Free ISO 9001 Template)
- What is ISO 9001 Certification? How to Get Certified (For Beginners)
- How to Write an Actionable Policy and Procedure Template (ISO Compliant!)
We also have even more ISO checklists beyond ISO 9000:
- ISO 19011 Management Systems Audit Checklist
- ISO 45001 Occupational Health and Safety (OHS) Audit Checklist
- ISO 27001 Information Security Management System (ISO 27K ISMS) Audit Checklist
- ISO 14001 Environmental Management Self Audit Checklist
- ISO 14001 EMS Structure Template
- ISO 14001 EMS Mini-Manual Procedures
- ISO 26000 Social Responsibility Performance Assessment Checklist
- FMEA Template: Failure Mode and Effects Analysis
- SWOT Analysis Template
- 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.
- 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.
Have any questions about implementing any of the standards of ISO 9000? Leave a comment below, and we’ll get back to you!