The most recent requirements for ISO 9001: 2015 documentation are simpler than previous versions of the standard. Businesses now have considerably more flexibility on what to document and how.
Required ISO 9001 documentation
Previous versions of this standard had a much longer list of required documentation. In the latest version, there are documents you must maintain (plans, policies and documents that are subject to change) and documents you must retain (records that don’t change after they’re released).
The documents that must be maintained for ISO 9001 compliance are:
- the scope of your QMS
- documented information to support the operation of processes
- quality policy
- quality objectives.
It’s wise to maintain more than just the bare minimum, especially when some of the documents used by staff or management might be required to support or qualify the above documents.
For example, if quality management is important to your business, you probably have a quality manual. This manual could be invaluable to help auditors understand your quality management system.
ISO 9001 documents to retain
The list of documentation that a company should retain will vary depending on the type of business.
These are some of the records that should be kept in case they need to be referenced in future for compliance and audits:
- calibration records for monitoring and measuring equipment
- records of training, skills, experience and qualifications
- product or service requirements review records
- records of design and development of products or services
- product and service requirements
- records about customer property
- change control records
- records of conformity of product or service with acceptance criteria
- records of nonconforming outputs
- results of the quality objective data
- internal audit reports
- management review meeting minutes
- results of corrective actions (CAPA).
It’s up to each business how and exactly what they document. Many of these documents are already created and retained by most businesses, so the real challenge is deciding how to organize, store and communicate the documentation.
Using a digital QMS for ISO 9001 documentation
A digital QMS makes it easy to manage your ISO 9001 documentation by ensuring the most up-to-date versions are safely stored on the cloud where they’re accessible to the relevant staff. There are many benefits of using a digital QMS.
Consistency
A cloud-based system means everyone is working with the same version of a document. This is one of the biggest problems of paper-based or non-centralized QMSs.
Accessibility
An online system is accessible from any browser anywhere in the world if the user is authorized and has the correct login details.
Waste reduction
A digital system cuts down almost completely on paper use, which is eco-friendly.
Reduced costs
Cloud-based QMSs don’t require any hardware upgrades in order to be implemented. Their subscription-based modular systems also reduce unnecessary spending.
Automation
Many processes can be automated with a digital quality management system, so there’s less chance of steps being forgotten.
Streamlined processes
Processes and procedures, especially those between multiple different departments, are more streamlined.
Improved security
Cloud-based QMS software has excellent security. The risk of a data breach is extremely low. Data security is an important aspect of quality management compliance.
What isoTracker offers
isoTracker offers simple and affordable digital quality management solutions designed to streamline ISO certification. The cloud-based system ensures your ISO 9001 documentation is always centralized, accessible and up to date.
In addition to document management software, our modules include non-conformance management software, complaints management software, audit management software, corrective action software, risk management software and training software.
Our subscription service is based on the number of users and modules you choose so you only pay for what you need, when you need. Contact us to discuss your document management needs or sign up for a free 60-day trial.
