How to prepare for an audit
Sooner or later, every life sciences, biotech, pharma, or medical device manufacturer will prepare to face an audit.Planning, preparation and proactive steps all are necessary to successfully pass an audit. The right tools and guidance can help make the path to audit success clear and achievable.
Ready the team
The entire team must be prepared on-paper and off-paper for interactions with the auditors. Never assume that an auditor won’t engage with someone because their role or project “isn’t important,” or their documentation is in order. Train the team to answer auditors carefully and refer to SOPs when needed. No auditor expects your employees to have your QMS documents fully committed to memory. Instead, they expect employees to know how to access, follow, and understand the quality documents that prescribe procedures.
View the audits as a helpful event
Ultimately, the ISO auditor is there to help. Their job is to measure the company against an objective standard by shining light on shortcomings. Take full advantage of internal audits as an opportunity for improvement and ask colleagues to provide detailed feedback on where the work fell short. When the external auditor arrives, the team will be better prepared to answer questions.
Use a comprehensive checklist
Companies are often unprepared to pass an ISO audit because their internal audit activities weren’t a simulation of the real thing. Sometimes, internal auditors perform superficial assessments that don’t uncover missing documentation or other small errors. There’s a lot that can go wrong when an ISO auditor steps on-site, especially if internal auditors are winging it or rushing through audits.
Both experienced and inexperienced internal auditors need a checklist to avoid common pitfalls and biases. This audit readiness checklist walks you through 12 aspects of quality procedures and systems to ensure your company's audit success, including documentation, laboratory, controls, training, and more.
The key to achieving a pain-free certification is effective communication with the team, a learning mindset, and comprehensive internal audits. With these key components in place, your organization will be in the best position to pass the inevitable audit with flying colors.
Follow the tips below to get started on your road to audit success, and get a free audit prep checklist here.
Sumatha Kondabolu is a Senior Quality Specialist at Qualio. She has more than 18 years of quality and regulatory experience in the medical device and pharmaceutical industries implementing quality management systems. She holds a master’s degree in chemistry, and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, ISO 17025, and ISO 9001.