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How to Prepare for Your ISO 9001:2015 Audit?

It is obvious ISO 9001:2015 comes with extended ways to elevate the usefulness of your entire management system. It has the capabilities to discover many hidden strengths of your organization and define new opportunities for further progress.

Yes, you may have successfully transited to new standard ISO 9001:2015 and modified your Quality Management System (QMS) according to the requirements of that new standard. But here the question will arise that how to ensure that your organization is perfectly implementing the needs of this revised standards or how any Auditor (internal or external) can apprehend that your organization is following the new requirements of ISO 9001:2015? If you can answer this question then you are prepared for Your ISO 9001:2015 Audit?

Refreshing and Re-arranging your QMS is a proven way to have more compliance and better management system for your organization and the good news is the new ISO 9001:2015 gives you the structure of that. With this standard you can now ensure quality throughout the organization in a minimal demonstrative approach. So Auditors will just estimate your whole system to confirm that every processes performing as expected to generate desired outcomes for the organization.

This new standard focuses on enhanced involvement of the leadership, so auditing will be started from here. Management gets highest advantages from this approach as it makes sure that quality is focused among the decision makers from where guidelines of the organization come from. Auditing can even access seminar or meeting room at the top decision making meeting also according to the new ISO 9001:2015 approach. It is beyond saying that leadership engagement into the quality management system is really vital for every organization to ensure that the decisions or processes made by them are compatible with the compliance while focusing on highest profits. A simple example of leadership involvement is the Meeting minutes of the management review Email series.

Without ensuring the fact that the processes running into your organization are aligned with the strategic direction, the new standard cannot be implemented perfectly. Internal Audit team will ensure this fact by auditing all the workflow of the processes and thus errors as well as the new opportunities and improvement will be found. As ISO 9001:2015 is an approach focused on continual improvement the internal audits will not be looking like examination for the process managers or employees any more. As an example check the question below that differentiate the old and the new approach. The internal audit team may ask any process manager this particular question.


Previous approach: Did you observe all the guidelines during the process?
New Approach: Does this process come with the intended results?

According to the new Standard the internal auditors also must include the following things into their checklist:

1. In which context the organization is running?
2. Who are the stakeholders of the organization?
3. Existing customers expectations and demands


As we know this new standard is needed risk based thinking, it is now proved practically that this Risk Based Thinking approach can improve the overall success of the organization thus increase not only the stakeholder’s confidence but also employee’s satisfaction. So audit team will focus on risks highly to confirm more scopes of improvement into the organization. To be mentioned, the ways to prove processes have risked based thinking, are not complex or need any external tools. In summery confirming the following things can determine risk based thinking is perfectly integrated into the system. Most QMS software now have Risk Management Module for that currently.

Risk Assessment: How risks are assessed within the system?
Root Cause Analysis (RCA): Why risks are happening?
Risk Mitigation: What measures should be taken to reduce risks and stop risks from happening?

Also read, Important Mistakes Executives Should not Make in Risk Management

So, you may have assured these practices already into your organization according to new ISO 9001:2015 standard. But if not yet perform a full review of your Quality Management System to make sure Risk based thinking, Leadership involvement into the QMS and Alignment of the processes with the strategic direction of the organization

Michael Prior

Michael is a Certified Quality Auditor and has a Bachelor of Science from Texas State University. Michael has over 34 years of corporate experience with 6 years of QMS field in Fortune 100 companies. He has published several articles related to ISO 9001-2008 and 9001-2015.

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