If you are considering becoming ISO 9001 certified, it's important to learn as much as possible about the certification and about the process.
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:
Communicate management’s expectations to employees
Demonstrate the organisation’s plan to conform to the standard
Demonstrate that organisational roles, responsibilities, and authorities have been assigned, communicated, and understood
Provide company context for internal and customer requirements (you need to consider the needs of your own company and your clients or customers in setting up your management system - yes, this is a requirement of the standard, but it also makes fundamental business sense)
Guidance in increasing efficiency and improving processes
Guidance on having clear and concise communication throughout the organisation’s documents and between functions or departments
And yes, not a main reason but certainly a useful by-product, it makes audits easier (both internal and any external ones you might have) as it shows how you are aiming to comply with each clause of the standard
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:
a quality plan, and written Quality Policy which is understood, implemented and maintained at all levels of the organisation;
a definition of the responsibilities of all those who affect quality (an organisation chart is a good idea here);
a review of accepted orders to ensure that customers’ requirements are clear, and procedures which control the design of goods or services to ensure that these requirements are met;
procedures to ensure that purchased goods and services conform to the requirements of the organisation and that their progress can be traced through to delivery;
systems that ensure the suitability for use of any materials or services supplied by a customer;
demonstration that processes are carried out under specified conditions;
the control, calibration and maintenance of all measuring and testing equipment;
a system which identifies and segregates all non-conforming goods and services and which specifies corrective action and identifies root causes for these;
processes for any servicing operation to document and verify that it satisfies customers’ requirements;
records which provide objective evidence that the work is being carried out in accordance with procedures and customers’ requirements;
processes which identify training needs and carry out and record training for employees
the use of statistical techniques;
self-policing through internal audits and reviews (e.g. Senior Management meetings).
Article origniated in Ideas Distillery blog
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