ISO 9001:2015

ISO 9001:2015 came into force September 2015. The standard replaces the old ISO 9001:2008 which becomes obsolete on 15th September 2018.

To achieve the new standard there are some key changes that companies need to do, The following areas are significant changes and the companies need to address them.

Context – This new requirement requires companies to consider all of the internal and external issues that can affect the business strategic direction and to achieve intended results from its Quality Management System. Typically companies do a Strength, Weakness, Opportunities and Threats (SWOT) analysis, or a basic risk assessment listing all foreseeable business risks and opportunities.
Some of the core business risks that have been identified maybe 1 – Ageing workforce, 2 – Reliance on major customers, 3 – Reliance on major suppliers,
Some of the risks that often get over looked may be legislation changes, loss of skills, IT failure etc.
All these areas should be considered when creating an analysis of the business risk and opportunities and a method of reducing the risk or increasing the opportunities.

As well as identifying the risks and opportunities, the business needs to identify all of its interested parties internally and externally. So a list should be created of the interested parties and the expectations of the parties.

Both these areas should be considered when setting quality planning Clause 6.0. Methods of determining which is most important issues to be addressed should be detailed and implemented. It is worth considering making some of the issues Quality Objectives / Targets which are measurable.


This was in the old 2008 standard, but was not as forcefully checked or audited. It is clearly a requirement in the new standard, and the top management i.e. CEO, MD or similar should be very involved with the creation, implementation and promoting of the ISO system.
Simply signing a policy is not enough. The company senior management should play an active role in overseeing the inputs and outputs of the management system. They should be monitoring and measuring its success and driving continual improvements.
An external auditor should interview the senior management during the audit process to make sure the top management are aware of the system and its importance.

Other changes of the standard can be discussed with QSC Ltd

Andy Adams
t: 01889 881887
m: 07900 558547
LinkedIn: – Andy Adam