There's no getting around it - an ISO 9001 certification will require time, effort and improvement from many areas of the business. However, the steps that must be taken are worth it for any company. The whole point of putting in a quality management system is that it will benefit business owners, employees and customers alike.
If you are considering becoming ISO 9001 certified, it's important to learn as much as possible about the certification and about the process. Rather than simply leave everything to a consultant, it's always a good idea for you to know exactly what you must do to get the certification.
In simple terms, ISO 9001 requires organisations to ‘say what they do, and do what they say’. They ‘say what they do’ by detailing their operating procedures, explaining how quality is monitored and controlled. They must then demonstrate that they ‘do what they say’ as they operate their quality systems. This usually involves keeping records of quality checks, tests and other activities, so that the system can be audited.
In previous iterations of ISO 9001 (before 2015) there was an emphasis on writing down your operating procedures and having a written manual detailing how your quality management was monitored and controlled. No longer - the 2015 standard has a distinct absence of the terms “documents” and “records”.
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 9001:2015 makes allowances for organisations to use what suits them best. Documented information can be in any format, any media, from any source.
While some may be wedded to pieces of paper, the medium used can be anything: paper, electronic, photographic, samples, etc. The possibilities are not quite endless, but certainly varied. If an organisation would find it useful and appropriate, a wall-painting or mosaic may also 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.
I still believe in an organisation having a Quality Manual, even though this is not a requirement under the standard. My experience shows that a good Quality Manual can be a vital a tool when referred to properly throughout an organisation - if it’s just a tome which sits on a shelf gathering dust, the only purpose of which is to satisfy the requirements of a standard (as far too many used to be), then this is clearly a waste of time and effort.
But I find that the benefits of having a Quality Manual are wide and varied and applicable to most businesses. They:
This will really help you as your system will consist of the following elements and a properly-managed Quality Manual will help to keep tabs on things:
That's it for this month, next month we'll be taking a look at how internal audits work.
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