Posted by Mike Hansen ● 2/21/19 8:10 AM
What is ISO 9001? And how a cloud QMS software can get you certified
ISO 9001 Meaning
In a nutshell, ISO 9001 is the standard that outlines the requirements that an organization’s quality management system must meet or exceed to be certified.
To give you a bigger picture, the ISO 9001 standard is one part of the group (or “family”) of ISO 9000 standards. This ISO family is focused on quality management systems (QMS) that help organizations “ensure that their products and services consistently meet customer’s requirements and that quality is consistently improved.”
However, ISO 9001 is the only standard that lists actual requirements and is also the only one that needs to be certified. The rest of the 9000 standards only provide supporting guidelines and information.
The ISO 9000 Family
It’s impossible to talk about ISO 9001 without mentioning the rest of the ISO 9000 standards: ISO 9000, ISO 9002, ISO 9003, and ISO 9004.
Of these, ISO 9000 is the most important because it’s the base for all of the other ISO 9000 standards.
ISO 9000 provides guidelines on the concepts that make up a quality management system. It contains two sections: fundamentals, which lays out the basic principles of quality management, and vocabulary, which is pretty much a dictionary of QMS terminology. This standard is crucial because it provides the background information on how to properly implement a QMS and, in turn, achieve an ISO 9001 certification.
The ISO 9000 standard is based on quality management principles. In case you’re curious what exactly they are, these principles include:
- A customer focus
- Leadership from top management
- Internal engagement
- A process approach
- Continuous improvement
- Evidence-based decision making
- Relationship management
Despite its importance, ISO 9000 is only a guideline and doesn’t outline any requirements. So, anyone claiming to be “ISO 9000 Certified” has probably fallen victim to a typo.
What is a quality management system (QMS)?
It has been mentioned a few times already but not really explained. What exactly is a quality management system? In the eyes of ISO, a quality management system is a way for organizations to define how they can meet the requirements of their customers and other stakeholders who are affected by their work. To put this type of system in place, organizations need to align their structure, planning, processes, and resources to meet their quality objectives.
It’s worth noting that ISO 9001 quality management system standards are not product standards. Instead, they’re focused on good management practices that will ensure high levels of quality.
To avoid some confusion later on, you may have noticed that a lot of technology companies (AODocs included) offer software that is branded as a “quality management system” or a "cloud based quality management system". So, what’s the deal?
It’s best to think of this QMS software as the technical systems that allow organizations to make the conceptual processes outlined in ISO’s definition of a QMS a reality. For example, if you defined a change request process to meet your ISO 9001 requirements, you would use AODocs’ QMS to put that process in place.
Regardless of your preferred definition, the benefits of QMS software doesn’t end at ISO 9001. They also help you comply with other regulations like GxP (which includes GMP, GCP, GLP, and more).
Learn more about cloud QMS software for life sciences
What are the requirements of ISO 9001?
Generally speaking, the ISO 9001 requirements are quite generic. That’s because they’re meant to be able to be applied to any organization, big or small, in any industry. It explains why there are over a million organizations in more than 170 countries holding this certification.
The most important concept of ISO 9001 is the idea of continuous improvement. That’s why you won’t find any specific requirements of what “quality” is. Instead, companies are made to define their objectives themselves and then work to improve their processes to meet those objectives. However, a certified QMS still needs to do the following:
- Meet the requirements of other stakeholders. For example, customer requirements and regulatory standards
- Ensure that employees receive a training course outlining the quality requirements
- Determine and document the processes, their interactions, and their results
- Be able to produce records to prove that system requirements have been met
- Constantly monitor QMS performance
- Address any risks that could result from changes
- Perform internal audits and correct any issues
- Continuously improve the QMS
With that in mind, ISO 9001’s purpose is to evaluate whether a QMS does a good job of managing your processes while also being able to help you identify areas that need improvement. In simple terms, ISO 9001 helps companies and organizations who were making an excellent product most of the time, make an excellent product every time.
How can cloud QMS software help you get your ISO 9001 certification?
Creating processes that will adhere to ISO 9001 quality management standards is just the first step. Next, you actually have put them into action. That’s where AODocs and other QMS software comes into the picture. The QMS software helps you put all of your quality management processes into action.
How exactly does QMS software help? ISO existed long before the cloud or even the internet, for that matter. Well, QMS systems, especially those that are based in the cloud, provide features that help to simplify the ISO 9001 certification process.
In our experience, a cloud-based QMS is your best bet to get up and running quickly. First, the cloud makes implementation a whole lot easier. Secondly, a QMS should be easily accessible to everyone regardless of whether they work in an office or at a production site. With cloud-based systems, employees are able access the QMS from anywhere.
Automated document lifecycles and version control
The document lifecycle is a big part of the ISO 9001 requirements. From creation through to disposal, documents need to follow specific processes. First of all, many important QMS documents need to be properly reviewed and approved. Furthermore, only the most recent versions of those approved documents should be available; previous editions should be hidden away. That can be extremely hard to do manually.
With cloud QMS software, like AODocs, workflows can help you to automate the review and approval processes by automatically sharing documents with the right reviewers. Then, after the document has been approved, the changes will automatically be applied to the new master document while the obsolete version is archived, helping to remove any chance of it being accidentally used after the update.
Easily find documents
Ensuring that documents are easily searchable is another benefit of QMS software (and another requirement of ISO 9001). Rather than having to sort through hundreds of paper files or click through thousands of folders, QMS software helps make finding documents much quicker.
AODocs is especially good at this. It’s already integrated with Google Drive and you’re probably aware of what Google is most famous for. However, AODocs adds even more functionality by allowing you to assign custom metadata to documents.
What is metadata? Metadata is just extra information that helps to define a document. If you’re a Windows user, metadata is the “Date Modified”, “Type”, and “File Size” columns that you see in File Explorer (It’ll be “Size”, “Kind”, and “Date Added” for Mac users). With AODocs, you can add custom metadata fields to make documents easier to find. For example, you can add an “expiration date” field that allows you to look up policies based on their expiration dates.
To pass any ISO 9001 audit (or internal audit, for that matter), you will need to produce a complete audit trail of your documents’ activity history. That doesn’t only apply to active documents, it applies to earlier versions of documents as well.
Cloud QMS software helps make this simple. With AODocs and Google Drive, every single change to a document, regardless of whether it’s the current or past version, is tracked. When combined with AODocs workflows, you’re able to produce a precise log of every change and every approval made by every user.
Advanced user permissions and central file ownership
Last but not least, there’s the issue of security. Many of the problems related to security can be solved with user permissions. Managing who can access what, edit what, and approve what is essential. With advanced user permissions, QMS software is able to automatically assign the proper view, edit, and approval rights. Not only does it ensure that that the new junior accountant won’t be able to approve their own pay raise, but automation also eliminates any potential for human error as well.
Then, there’s also central file ownership. Since all documents are owned and managed by the company, you will never need to worry about losing important files or having key documents accidentally deleted. It also limits the abilities of malicious third-parties or disgruntled employees to destroy or transmit important documents.