12 Tips to Help you get Ready for your Quality Audit

Audit’s play a vital role in ensuring organisational effectiveness, compliance, and sustainability in a business environment. They are crucial for several reasons such as; Ensuring Compliance, Identifying Areas for Improvement, Risk Management, Enhancing Quality, Monitoring Performance, Building Trust and Credibility, and Continuous Improvement.

Getting Audit Ready

Preparing for a quality audit involves several key steps to ensure that the organisation is ready to demonstrate compliance, effectiveness, and efficiency in its operations. Below, Claire Holohan Dataworks Quality Process Lead, gives a comprehensive guide on what to consider when preparing for a quality audit (internal or external) in your business:

  1. Understand the Audit Scope and Requirements: Review the audit scope, objectives, and criteria to understand what will be assessed during the audit. Ensure clarity on relevant regulations, standards, and internal policies that the audit will evaluate against.
  2. Document Management: Have the main evidence ready, (Quality Manual, Quality Policy, Non-Conformances, Change Control’s etc.) and familiarise yourself with them. This will save time during the audit and help you to be prepared.
  3. Communication and Collaboration: Be polite, professional, co-operative.
  4. Training and Competence: Ensure that staff involved in the audited processes are adequately trained, competent, and aware of their roles and responsibilities.
  5. Process Review and Gap Analysis: In order to identify any weaknesses or inefficiencies in the existing processes, conduct a thorough review of the audited before the audit. Understanding the gaps or weaknesses allows for a better assessment of risk.
  6. On the day of the audit, answer only the questions asked by the auditor. This is crucial because it helps address specific concerns and objectives for the audit process. It also ensures that the information provided is accurate and that discussions remain relevant and on track, reducing the likelihood of distractions that could detract from the audit’s objectives.
  7. Assist the auditor with their specific requests. The longer it takes the auditor to complete their work the longer the audit will take.
  8. It’s ok to not know something off the top of your head, if this is the case just tell them that you will find out and get back to them.
  9. Follow through! If the auditor wants to know something they always write it down somewhere so it’s not missed. If requests are missed auditors may incorrectly sense that something must be wrong or that you are hoping they forgot.
  10. Don’t forget to follow up – ensure that follow up actions are taken promptly after the audit to address any findings or recommendations.  Ignoring follow up can undermine the effectiveness of the audit process.
  11. Don’t worry about awkward silences.
  12. And above all Be Positive!


By following these steps, organisations can effectively prepare for quality audits, demonstrate compliance with applicable standards and regulations, and drive continuous improvement in quality management practices.

At Dataworks our processes are audited annually to ensure we comply to our regulations. We are proud to hold ISO 9001:2015 certification.  This certification is awarded by the NSAI (National Standards Authority of Ireland), and demonstrates our commitment to quality management systems and continuous improvement. In return this ensures that the products and services offered meet the required quality standards by evaluating processes and procedures within the organization.  Internal audits help maintain consistency and reliability, thus enhancing customer satisfaction.  Overall, internal audits play a crucial role in safeguarding customer interests and ensuring their continued satisfaction and trust in Dataworks offerings.

Get In Touch with Us

Contact us today to learn about how Dataworks can help transform your organisation.

To stay up to date with Dataworks Limited news and events, connect with us via the links below or call us on 051 878 555 today.

DATAWORKS – Driving Digital Transformation in the worlds’ Leading Life Science Company