Qualio ISO 13485 Internal Audit Checklist Free

An internal quality management system (QMS) audit is an essential process to ensuring your processes comply with ISO standards. While single instances of non-conformance should be expected, any repeat issues must be dealt with swiftly to avoid delays to certification.

Qualio, a cloud-based software company, offers an ISO internal audit checklist free to any team interested in conducting an effective audit.

Identify the Areas to be Audited
To pass your next ISO audit, it is imperative that your internal quality assurance department be strong. Qualified individuals must conduct internal audits and help meet the standard’s requirements.

Audits provide an in-depth examination of your business’s management system from start to finish – from documented information and records, through actual procedures carried out in the field, with auditors reviewing these elements as well as controls in place to implement ISMSs, and interviewing staff members.

The Document and Records Audit Checklist checks whether your company can identify, store, protect and make accessible documents and records to staff and auditors. In addition, procedures must exist for creating, controlling distributing or disposing documents and records.

Start here as this section of the audit is essential to both FDA and ISO compliance. To avoid failing this section, ensure your training and record keeping are centralized.

Documentation Requirements
Qualio offers fully editable ISO 13485 internal audit checklists that can assist your organization in both external and internal audit preparation, or process improvement efforts. They allow for efficient planning, conducting and reporting. They help minimize nonconformities by shortening planning time while cutting effort required for record keeping.

Documents such as quality plans, work instructions, inspection records, charts of test results and PPAP forms will be scrutinized by auditors. Furthermore, auditors will investigate how you identify risks and controls in each area of operation.

An ISO audit involves looking for corrective and preventive actions taken by management, and checking how effective the system is at achieving quality objectives and customer requirements. Any recurring problems should be corrected quickly as this could delay attaining ISO certification; additionally this provides an ideal opportunity to review and update your Quality Policy to reflect any alterations that may have taken place since certification.

Risk Assessment
Risk evaluation encompasses reviewing existing policies, procedures, and controls as well as records of training and qualifications verification. Audits often examine this key area.

Planning activities and broad system requirements will also be studied carefully, by conducting gap analyses that compare current quality management systems with ISO 9001 standards – commonly referred to as gap analysis – this allows companies to identify any nonconformities or oversights in ISMS policies, procedures, documents or security controls which need remediating prior to certification audits.

This will give the company a better chance at success during certification audits conducted by third-party auditors, which tend to be far less intense than on-site inspections from government agencies such as FDA. Still, employees should remain cognizant of potential consequences should anything inappropriate come up during these interactions.

Process Improvement
At the conclusion of an audit, process improvement will be the focus. Questions will examine your business’s use of the PDCA cycle in terms of materials utilization efficiency and interface between departments functioning optimally.

Once the process audit is completed, you can begin making any necessary modifications and setting a timeframe to revisit it and see how your processes are progressing compared with prior audit results. This allows you to compare where they started before audit with where they stand now, motivating employees towards continued improvements.

Though an ISO audit can only end in failure if you ignore all of its auditor’s suggestions for improvement, it is still wise to prepare as best you can in order to reduce the number of recommendations made by auditors. Qualio’s cloud-based QMS makes managing ISO audits simple so you can avoid costly mistakes and remain compliant year-round.