ISO 9001:2015 requires businesses to keep accurate and up-to-date documentation, but it doesn’t provide guidelines for how often to review documents.

Most businesses decide to include a review schedule when they set up their document control and other ISO 9001 procedures. Many of our customers choose to review documentation about once a year.

While this isn’t an ISO 9001 requirement, it is a good frequency for most businesses. You can review documents more often if you choose, but this could be a waste of resources.

How often you decide to review your ISO 9001 documents depends largely on how often your ISO 9001 procedures change.

Is it necessary to schedule formal ISO 9001 document reviews?

Most organisations update and change their ISO 9001 procedures at some point to stay compliant, especially as they grow and start offering more products or services.

If you review your documents every time these procedures are updated, additional review processes might not be necessary. In this case, it might be a waste of resources to implement yearly reviews.

On the other hand, if your procedures don’t change frequently or reviews aren’t automatically done every time there is a change, then a separate, structured document review schedule is a good idea.

Factors affecting how often to review documents for ISO 9001

As mentioned, there is no official ISO 9001 requirement to review documentation, only that you keep accurate documentation.

This means the frequency of a review process should be based on what you think is reasonable for your business and your ISO 9001 procedures.

If you don’t update your procedures very frequently, you might decide that an annual review is sufficient.

This might be reduced to six months or less if your company’s procedures change frequently and reviewing isn’t a part of this process.

If you run your management systems diligently but processes don’t change often, once every two years might be sufficient.

So, there’s no set-in-stone answer. In fact, the answer might change over time from when you first set up your document control system.

However, no matter how frequently you decide to review documents, a centralised document management system will help you ensure reviews are done properly and on schedule.

How Compliants on going support  Document Management software can help

Our document management software module helps you ensure that documents are properly reviewed and managed.

The system makes it easy to:

• find, review, update, and approve documents
• ensure that only the correct, most up-to-date versions of documents are used
• record and track all changes to documents

• 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 organise, 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-centralised QMSs.

  Accessibility

  An online system is accessible from any browser anywhere in the world if the user is authorised 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.

  sure your systems comply with ISO 9001:2015.