Implementing a quality management system (QMS) is an important investment companies cannot overlook.
One Harvard Business Review study found that companies with an ISO 9001 certification have much higher rates of “corporate survival, sales, employment growth, and wage increases than a matched group of non-adopters.”
For instance, 65% of companies save $25,000 or more in costs within their first year of implementing a QMS.
Adopting a QMS software can also boost efficiency and consistency of work, increase customer satisfaction, raise product value, and reduce unnecessary costs and overall risks.
A good quality management system is all about achieving a quality-driven culture within your company, and as a result, making your product better and marketing it faster. But in order to access these benefits, it’s important that you choose the right QMS solution for you and your company.
In this Process Street article, we’ll be going over the foundation of everything you need to know before choosing your quality management system software.
We’ll be covering:
- What is a quality management system (QMS)?
- Agile QMS
- Best QMS software
- Build your agile QMS with Process Street
What is a quality management system (QMS)?
A quality management system (QMS) can be defined as a set of rules that inform companies and organizations how to build and deliver their product or service to customers at a high standard of quality.
When a company implements a QMS, it’s important that the system has been customized to fit your company’s needs. It should be distinctly focused on what product or service your company provides.
Having said that, it’s also critical that you don’t overlook any valuable qualities of a successful system when implementing a QMS. So it can be incredibly helpful to follow an existing guideline to ensure that your efforts will pay off.
ISO 9001 is one of the best examples of a foundational guideline that was built to standardize how a QMS is put together.
ISO 9001 for QMS
ISO 9001 is an international standard that lists particular requirements for companies to follow in order to build a strong quality management system.
These requirements can serve as a great foundation for any company to get started with building their QMS, especially when starting from square one. It’s a standard that was developed specifically for quality management to help companies run more efficiently and meet their customer needs.
An agile QMS involves the implementation of software(s) to help encourage company-wide transparency and adaptability, whilst maintaining compliance with ISO, or any other international quality standard. Agile QMS promotes an ongoing closed-loop quality management process to boost customer satisfaction, reduce company waste, and significantly improve product/service quality.
The use of a strong QMS software can really help streamline any transitions your company may go through, such as building your quality management system for the first time, or scaling your business, without being too structured or limiting flexibility.
But it’s important to note that not all QMS software are created equal. Choosing the wrong software for your company could potentially end up making your quality management system even more clumsy and unmanageable than ever before.
Not every QMS software is designed to be agile QMS software. The key is a system that is easy to use and provides the framework necessary to build simple and painless processes, but also encourages organizational flexibility to allow for your company processes to continually improve and evolve.
For companies that operate in fast-paced industries with a regularly changing market, an agile QMS is crucial to make sure that the company processes aren’t too locked in place and arduous to make changes to.
Some specific features to look for when choosing an agile QMS software include:
- Ability to build, manage, and update policies and processes
- Intuitive and easy to use
- Report generation with synthesized data to encourage regular improvement of company processes
What is Agile ISO?
Agile ISO is a reinterpretation of the standard ISO operating procedures where digital tools are implemented to allow for QMS processes to be built and continuously expanded upon for more organizational agility.
The most recent revision of ISO 9001:2015 introduced many changes with the intention of promoting companies and organizations to adapt a more flexible approach when establishing their QMS.
QMS software: Benefits of being agile
Implementing an agile QMS software has its many benefits, including:
1. Easy-to-follow processes reduce compliance risks
One of the key principles of the agile methodology reads “simplicity…is essential.” Clarity and simplicity in processes put a stop to company risks such as employee resistance and inefficiency, wasted time and resources, and more.
Some reasons why following straightforward, simple processes can reduce your company’s compliance risks include:
- Convoluted processes can be very difficult (and in some cases, impossible) to regularly update and maintain as is necessary
- If processes are inefficient, employees are more likely to make mistakes or simply resist following them
- Reviewing company processes and results can be significantly more difficult if the processes are complex
2. Adopt an agile culture
The agile methodology emphasizes company-wide teamwork, employee relationships, and equal contributions when creating a good product, and adopting these principles is just as important as adopting a QMS software.
While it’s important to meet regulatory quality standards, an agile QMS can also help your company move towards a culture that is quality-driven. Implementing the right software can create a more efficient business with a happier team.
3. Concise software (not bloated software)
Bloated software describes software that has an overload of features to the point where it’s just getting in the way of productivity and usability.
Not only can an overcomplicated process waste company time, it also demands higher budgets for training, documentation, and authorization; all things that would simply be avoided with a more concise and straightforward QMS software.
When developing your agile QMS, simplicity is key and your software should reflect that same principle.
4. Emphasis on quality
When a company places more value on compliance rather than quality, it isn’t running at its full potential. A compliance-focused company will typically practice meticulous control over data, documentation, and standards, without building an understanding on the bigger picture behind these actions. It isn’t uncommon to find companies that comply with international quality standards, but don’t actually offer much product/service quality.
A QMS that solely focuses on compliance also risks the loss of flexibility. Agencies such as the FDA, ISO, or EU periodically update their standards and regulations and as a result, companies need to be able to easily make changes to their processes to adapt.
An agile QMS embraces change and regards its flexibility as a strong advantage. Focusing your company’s culture on producing quality means always being a step ahead of compliance standards and taking advantage of any opportunity to improve.
Best QMS software
Below I’ll be covering some of the best quality management system software available to date. Our choices for the best QMS software are:
- Process Street
Process Street is a BPM software that allows you to build highly customizable and easy-to-follow checklists using templates to keep everything tidy and efficient. It’s a great tool to get started with building your quality management system, as well as managing any of your other business processes.
You’re able to create your own processes from scratch, or pick from Process Street’s library of free templates. Using these templates, you can streamline all of your company’s workflow processes and save your time and money.
Process Street is an ideal solution for creating, managing, and enhancing standard operating procedures and quality standards, because it uses features like task assignments, form fields, and conditional logic to make building your QMS as simple as possible. It also allows you to schedule your checklists to run and recur at any interval you may need.
Here’s a great intro video to get started with Process Street:
Pilgrim is a software that was developed under the ISO 9001 standard to offer document management and business workflows. It puts to use features such as audits, analytics, and electronic signatures to help make your job easier.
This software offers administrative dashboards with management features, high functionality, and the ability to streamline company data organization. But it’s important to note that it requires investment and could take significant time to implement its changes.
It was primarily designed for enterprise organizations in the life sciences industries, which could include: medical devices, pharma, or blood and tissue service companies.
Qualityze is a QMS solution that is actually built on the Salesforce platform. It offers QMS features for managing documents, customer complaints, suppliers, audits, and others to help your company comply with international quality standards.
This can be a great option for companies that are already using Salesforce and it’s one of few QMS softwares on the market that offer support for TGA and PMDA regulations. Qualityze makes it easy for you and your team to get started because of its intuitive interface. It supports the release of modules if needed and users have reported a high-value gain for the cost, so it’s definitely worth trying out if you or your team is already familiar with Salesforce.
Mastercontrol is one of the most adopted solutions within the life sciences industry, and for a good reason. It offers solutions built for compliance and quality management in product development, supplier management, clinical trials, and manufacturing.
This software offers excellent communication between modules, collaboration and administrative features, and an intuitive design.
If your company demands a customizable, complex QMS and can invest significant time and resources towards the implementation, then Mastercontrol might be right for you.
TrackWise is a QMS software built for companies that need to abide by GMP requirements to boost visibility and improve efficiency.
This software offers a large range of workflows and modules within its flexible design, and the option to merge into a complex software system. TrackWise has the ability to integrate with systems, such as: ERP, CRM, LIMS, and MES.
Build your agile QMS with Process Street
Process Street has a number of checklist templates in its library of premate templates, all of which are ready to use and can really come in handy when building your agile QMS.
Feel free to use any that catch your eye or dive in and sign up for free to see our full selection!
ISO 9000 Structure Template
This is an ISO 9000 Structure Template that was built to help make following the ISO 9001:2015 standard a breeze:
ISO 9000 Marketing Procedures
This ISO 9000 Marketing Procedures template is similar to the last, but was written using a fictional marketing company as an example:
ISO 9001 Internal Audit Checklist for Quality Management Systems
This ISO 9001 Internal Audit Checklist for Quality Management Systems template was created to make sure that basic requirements are covered and all evidence is recorded when performing an audit:
Process street features:
- Dynamic due dates
- Stop tasks
- Task assignments
- Task permissions
- Role assignments
- Embed widget
- Conditional logic
Here are some more QMS related checklists that may interest you:
- ISO 14001 EMS Structure Template
- FMEA Template: Failure Mode and Effects Analysis
- ISO 26000 Social Responsibility Performance Assessment Checklist
- ISO 27001 Information Security Management System (ISO 27K ISMS) Audit Checklist
- ISO 45001 Occupational Health and Safety (OHS) Audit Checklist
- ISO 14001 Environmental Management Self Audit Checklist
- ISO 19011 Management Systems Audit Checklist
- SWOT Analysis Template
- ISO 14001 EMS Mini-Manual Procedures
And for more QMS resources, feel free to check out the following articles:
- How to Write an Actionable Policy and Procedure Template (ISO Compliant!)
- Agile ISO: How to Combine Compliance with Rapid Process Improvement
- Processes, Policies and Procedures: Important Distinctions to Systemize Your Business
- ISO 26000 for Corporate Social Responsibility: How to Get Started
- What is ISO 9001 Certification? How to Get Certified (For Beginners)
- What is Quality Management? The Definitive QMS Guide (Free ISO 9001 Template)
- 20 Free SOP Templates to Make Recording Processes Quick and Painless
- What is an ISO Audit? Free ISO 9000 Self-Audit Checklist (ISO 9004:2018)
Have you implemented a QMS software for your company? Do you have any personal recommendations? Leave a comment below and let us know!