Both large and small organisations have gained from using Management Systems standards to improve their quality and compliance and achieve efficient reliable processes – amongst multiple other improvement factors.
Documentation and Document Control supports all ISO Management Systems. For instance: in a Quality Management System, adequate documentation and document control ensures that documented processes and related controls are consistently implemented across an organisation and helps to identify and deal with non-compliance issues quickly and effectively.
Changes to the requirements for documentation have attracted a lot of attention in the latest versions of the ISO Management Systems standards. People are asking: “Can I get rid of documented procedures?” and “Are there no longer requirements for documents and records?”
Before going into Document Control here’s a brief look at the new ISO Management Systems standards’ requirements for Documented Information.
ISO MANAGEMENT SYSTEMS REQUIREMENTS FOR DOCUMENTED INFORMATION ISO
Documents that are directive in nature, such as policies, procedures, instructions, templates and documents that contain historical information, previously termed records, are now collectively called Documented Information, but what is the difference?
The latest ISO standards have replaced the terms documented “procedures” and “records” with “Documented Information”. According to ISO, Documented Information is:
“meaningful data that is required to be controlled and maintained by the organisation and the medium on which it is contained.”
The difference between a record and a document is that records are Documented Information that are “retained” and documents are Documented Information that are “maintained”. A form is a document; when the form is filled out it becomes a record, which you will “retain” to provide ease of retrieval.
THE OLD VS THE NEW DOCUMENT REQUIREMENTS
While the ISO 9001:2008 version was explicit about documentation, ISO 9001:2015 allows more freedom in how, what, and when to document a Quality Management process (such as specific procedures). This allows an organisation the flexibility to use appropriate information, maintain current versions easier, provide broader access/distribution and reduce costs associated with documentation, as long as it conforms to the requirements pertaining to their Management System.
So, adequate documentation, maintenance and control of documents remain very important in the latest versions of the ISO Management Systems standards because Documented Information:
- Provides evidence of conformance to the ISO Management Systems standard
- Is an important consideration for auditing purposes
- Provides a ‘single point of truth’ in how a process is carried out
- Assists with staff training
Prevents the loss of institutional knowledge
But what is Document Control according to ISO and how do you control documented information?
THE ISO DOCUMENT CONTROL ARRANGEMENTS
When dealing with ‘Maintaining Documented Information’, previously referred to as document control. The intent of the revised ISO standards is that once you decide on the need for a document — the means to convey critical information or a template to collect data, for example — then you will want to make it available to the staff who need it. You will also want to make sure that the information is always up-to-date and correct.
In short, Maintaining Documented Information, or Document Control, entails setting up arrangements to ensure that Documented Information of the ISO Management System remains relevant, up-to-date, accessible and aligned to the organisation’s strategy.
Unfortunately, what goes into setting up, executing and managing the Document Control process often leaves people confused.
Document Control Software, for example, can potentially provide you with a simple way of controlling important documentation. But, first, you need to ask yourself: What type of Document Control Software do I need, and will it provide me with a secure, cost-effective solution to managing my Document Control process?
Want to find out more? Click here to Download our FREE Guide — Automated Document Control: A Key Component of ISO Management Systems.
WORKING WITH RISK ZA
We have many years of experience with various Document Control Software Solutions, which means we are able to give you good, solid advice on which route is best for you and your organisation. Give us a call to chat about how these Document Control Software options can streamline the way that you:
- Maintain important documentation
- Review, Approve, Share and Control Change of documents
- Archive and retrieve information
Don’t forget to download our FREE Guide on Automated Document Control: A Key Component of ISO Management Systems.