Can you tell us about the context of your organisation?

This is generally a question directed at senior management. Your auditor will be looking for
you to include the internal and external issues that are relevant to your organisation’s
purpose, strategy, and the goals of your Quality Management System in your answer.

Who are the interested parties in your organisation?

This can appear to be a broad question, but you will be required to know this information and
provide it to your auditor. Interested parties pertains to internal and external people that are
relevant to your Quality Management System. Examples are employees, customers,
suppliers and regulators.
What are their requirements?

This can be described as part two of the previous question, as even-though you know who
your interested parties are, you will also need to know what their corresponding
requirements are. Careful planning is required here to understand the individual
requirements of each party and evidence will need to be provided in your audit.

Have risks and opportunities been identified and how are you addressing them?

This is one of the major clauses in ISO 9001:2015 and it would be safe to say it is one of the
most important. Your auditor will ask you to provide evidence that you have carried out an
assessment of all the risks and opportunities that may affect your Quality Management
System and the plans you have in place to manage them.

What plans have been put in place to achieve your Quality Management System
objectives?
Your auditor will need to determine what plans you have put in place to make it all happen.
So if you can show that you are taking the SMART (Specific, Measureable, Actionable,
Realistic and Time-Based) approach and show how you are implementing the plans
throughout the organisation, this is a great place to start. You should also provide evidence
that your employees are aware of how they can contribute to the objectives and that they are
familiar with the action plans.

How will your Quality Management System be integrated in to your business

processes?

With this question, your auditor is simply looking to define how you will use your ISO
9001:2015 Quality Management System to operate your business. Again, this question will
be directed at Senior Management as it places an emphasis on how the business will be run
and what plans are in place for continual improvement as part of the business strategy.
How will your organisation manage change?

This is a very important question as change will always come into an organisation and you
need to be prepared to address it. You will need to have identified changes that need to be
made and provide evidence on how you will manage these changes. Some of the changes
may include, changes to employees roles, products, suppliers and changes in customer
requirements.

Your auditor will seek evidence on how you are planning to manage these changes and that
they will meet the requirements for ISO 9001:2015.