Tips for staff undergoing an ISO 9001:2015 audit

What tips do you provide your front-line staff who are going to be interviewed for either an internal or external ISO 9001:2015 audit?

If the personnel already has experience of passing the ISO 9001:2008 certification audit, give them the following advice:

1. Employees should prepare the answers to the following auditor’s questions:
1.1. Risk based thinking (cl.4.4.1.f, cl.6.1):

• Demonstrate examples of risk assessment (identification, analysis, evaluation) in the activities that you are performing (in the Process).
• Demonstrate examples of risk treatment.
• What projects to improve QMS (to enhance desirable effects or to prevent undesired effects) were initiated as a result of Risk treatment.

Note: An example of a methodology for addressing risks and opportunities

1.2. Organizational knowledge (cl.7.1.6):

• How do you access the knowledge of the Organization?
• Demonstrate examples of using the Organization's knowledge in the activities that you are doing (in the Process).

Note: you can find examples of arranging the control of Organizational knowledge activities in the ISO 9001:2015 Quality Manual

2. Managers should prepare the answers to the following auditors questions:
2.1 Context of the Organization (cl.4.1):

• Where do you get information about the external and internal context of the organization?
• Provide examples of use of information about the external and internal context of the organization when making decisions.

Note: the examples of gathering, transfer, and use of information about the external and internal context of the organization can be found in ISO 9001:2015 Quality Manual

2.2. Understanding the needs and expectations of interested parties (cl.4.2):

• Who are the interested parties?
• Give examples of considering the requirements of interested parties in your activities.

Note: the examples of gathering, transfer, and use of information about the needs and expectations of interested parties can be found in ISO 9001:2015 Quality Manual

3. Production personnel should prepare answers to such questions of auditors (cl.8.5.1.g):

• Give an example of human error prevention activities in your processes.