Alex Woods offers a guide to the documented information requirements in ISO 9001:2015.
One of the more eagerly discussed differences between ISO 9001:2015 and its predecessor is the absence of the terms “documents” and “records”. The six mandatory documented procedures are gone, so too has the requirement for a documented quality manual. Instead, throughout the standard there are specific references to documented information.
ISO 9000:2015, 3.8.6, provides a definition of documented information as information, meaningful data, where data are facts about an object, that an organisation is required to control and maintain, and the medium on which it is contained.
Documented information is a means by which an organisation demonstrates compliance. It communicates what we do and how we do things, it communicates what happened and what results were achieved. It is, essentially, a tool for communication.
There are many different formats in which communication can happen and ISO 901:2015 makes allowances for organisations to use what suits them best. Documented information can be in any format, any media, from any source, 3.8.6 Note 1.
While some may be wedded to pieces of paper, the medium used can be anything: paper, electronic, photographic, samples. The possibilities are not quite endless, but certainly varied. If an organisation would find it useful and appropriate, a wall-painting or mosaic may well achieve the required result.
Organisations are not obliged to relegate their quality manuals and documented procedures to the dustbin. While there is no requirement for an organisation to have or use either, where such documentation exists, and is of use to the organisation they should continue to use it.
A good quality manual is a tool which is used throughout an organisation, not a tome which sits on a shelf gathering dust, the only purpose of which is to satisfy the requirements of ISO 9001:2008. If organisations do have a quality manual and documented procedures that perform a useful function, there is no reason to renumber or rename them to correspond with new clause references unless there is benefit in them doing so. Nor are they required to refresh existing documentation to use the new terms and definitions contained within ISO 9000:2015.
Consider the requirement to “maintain documented information”, where it occurs, as being equivalent to a document in 2008 speak; and to “retain documented information” as being equivalent to a record.
Removing reference to documents and records is not just an attempt to baffle and confuse. It is a deliberate effort to develop a standard that is applicable to businesses of all sizes and in all sectors. Organisations may have the detail and volume of documentation that they need, rather than enough to satisfy an auditor’s checklist.
They have been given more freedom in terms of what they choose to hold and format they choose to hold it in. The implications of these changes are significant to all those involved in implementing, maintain, and assessing quality management systems.
For quality managers and implementers, the big opportunity is to enhance their management system and the documented information they maintain or retain. This may involve a quality manual, it may involve documents and records, where they are beneficial to the organisation, and is likely to involve less documentation than previously.
Auditors and management system assessors are posed with a slightly greater challenge.
Auditors have to determine whether the requirements of the standard are being met. Documented information can be in any medium so auditors cannot depend on being presented with a single or series of bits of paper to review.
Auditors are going to have to build evidence by talking to many different people and investigating different forms and sources.
Attribute to original publisher/ publishing organization: Alex Woods, professional networks manager at the CQI and IRCA, https://www.quality.org/knowledge/%E2%80%8Biso-90012015-documented-information