If you’ve ever worked for a large corporate, it’s likely you’re familiar with those cheesy motivational posters of tanned, muscular people running up hillsides alongside an ‘inspirational’ quote. Chances are you’ve seen the one that goes like this:
“The past cannot be changed. The future is yet in your power.”
Not the most original observation in the history of man, granted. And not the most comforting when you’ve just royally screwed up in front of the boss.
However, this phrase is absolutely key for ISO 9001, and for making the crucial distinction between documents and records.
For the purposes of ISO 9001, a ‘document’ consists of written information that helps you run your company. This is planning information – ‘the future is yet in your power’, so plans can, and should, change.
Documented information required by ISO 9001 are: Scope of the Quality Management System, Quality Policy, Quality Objectives, and Criteria for Evaluation and Selection of Suppliers. Bear in mind that, depending on the size and scope of your business, some documents may not be mandatory. The 2015 update to ISO 9001 is more focussed on what an organisation decides they need, rather than prescribing what the ISO thinks they should have. For example, you no longer need a quality manual if you think you can communicate the information well without it.
However, any documents you do have will evolve with your company as you gather information, evaluate performance and procedures, and learn from mistakes.
In stark contrast, a ‘record’ is created or written down when something is done. Records are evidence of a past event. ‘The past cannot be changed’, and therefore, records should not change.
Some 20 clauses require records in ISO 9001 2015, largely in monitoring, measurement, design and control of processes. Other clauses leave the choice up to you, with forgiving terminology such as ‘to the extent necessary’, ‘as applicable’, or ‘monitor and review’. While your records must not change, the number you decide to create over time probably will.
The control of these items are very different.
Because the future is ‘yet in your power’, documents must be regularly reviewed, approved, and kept up to date as your business evolves. All of your people must know of, and understand, their content, and know where to access these documents when needed, too.
Records, however, are different. They must be labelled appropriately so that they are immediately identifiable. They need to be stored securely, so that they may both be retrieved when required and protected from change or corruption. They must be backed up to prevent unforeseen data loss. And lastly, and perhaps most crucially, records should be disposed of when they become obsolete. So, through ‘the past cannot be changed’ you can bin it when the time is right.
If only that were true of real life!Tags: Document Control, documented information, documents, ISO 9001, iso 9001:2015, Quality Management, record control, records