Documented Information – the new Document and Records Control
Have you ever felt overwhelmed by the management of documents and records? By the sheer tediousness and volume of administrative work required to manage and maintain all of the documents and records needed to demonstrate conformance to your management system?
Well, you are not alone. This is a common frustration by all management system administrators. To top it all off, you have to rely on everyone else to also follow the rules.
I am sorry to say, the new 2015 versions of ISO 9001 and ISO 14001 do not provide you with any real relief. The new standards are less restrictive with what they require to be documented information. However, it also opens you up for more scrutiny by your auditors as to what is required to have an effective management system. The one thing that you need to remember is that a management system is a tool for your organization to use not a burden. When it comes to determining what documentation you should have, consider the following:
- Does the control in place require a documented instruction? Typically, this could be a regulatory requirement, such as a confined space procedure, or a customer requirement, such as a quality test plan.
- Will training be more effective? For some operations, they are so complicated that they require on the job or classroom training, or even apprenticeships. Do you hire people for this specific knowledge?
- Is there already another tool in place to effectively manage this process? A common example is a work maintenance program or database. This is where the database is set up to include all of the regular tasks and activities for inspections and maintenance of equipment. It also maintains the resulting information to demonstrate that the work was completed as required.
- Is there an alternative to a typical work instruction? Would a flow chart, pictorial or checklist do a better job providing information? An example is an evacuation map, this method of communicating is much more effective than providing a description of the evacuation route.
The requirement for procedures has drastically decreased in the new standards. ISO 9001:2015 no longer requires a manual and the 6 procedures (document control, records control, internal audit, nonconforming product and corrective and preventive actions). Now both documents and records are both covered under the term “documented information”. With the continued use of databases and data and the blurring line between documents and records, it only made sense to merge them.
How do you know whether or not you need to keep a document or record? A simple tool is to look for the term “maintain” or “retain”. If you read “maintain” in reference to documented information, then this is referencing a procedure, a piece of information that can be referred to and must be kept up to date. If you read “retain” in reference to document information, then this is referencing a record, a piece of information that must be kept and not changed. We prepared a simple cheat sheet for both ISO 9001:2015 and ISO 14001:2015, that you can use to reference to know what your minimum requirements are for maintaining your documented information.