What does the ISO 9001 standard require?

​​ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organisation.

​The standard requires that there is a quality management system in place with certain control mechanisms that guarantee quality of provision.  These appear under general headings:

• Requirements for a quality management system, including documented information, planning and determining process interactions
• Responsibilities of management
• Management of resources, including human resources and an organisation’s work environment  
• Product realisation, including the steps from design to delivery
• Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action

Although no longer a requirement in the 2015 version of the standard, in essence it’s a good idea to have a quality manual to set out everyone’s role in relation to quality. This should contain a list of procedures to be followed in the organisation in performing its functions including detailed work instructions for someone to follow when doing any particular task.

Where the organisation is small and procedures are straightforward, the procedure itself can contain the work instructions. It is simply formalising what most businesses do anyway, particularly when they are expanding and new staff come on board.  

How do you become accredited?
Once all of the elements of the standard are in place and you have conducted an audit of them to ensure that everything is working satisfactorily, it is then necessary to arrange an external audit of your organisations quality system by an approved accreditation organisation. 

There are many organisations in this field. When the external auditors visit if everything is up to standard they can award the quality mark on the spot.

If there are minor faults they can still award the accreditation on the spot together with a requirement for alterations to correct the faults within a specified time limit. 

If there are major faults they will point then out in writing and a reassessment will be necessary. 

Once the quality mark has been awarded the external auditors will return each year and sample areas of the quality system to ensure that it is still running as required. 

In the third year, they will check out the entire system again. If on one of the routine visits the external auditors find flaws have developed in the system or procedures are not being carried out as stated they can allow you to continue using the quality mark subject to repairs to the system within a specified timescale or they can suspend you use of the quality mark until they are satisfied that everything is ok. 

Every visit of an external auditor has to be paid for so it pays to shop around for your external auditors.