Audits
Internal, external and supplier audits – from the plan and report to nonconformities linked to CAPA.
The Audits module covers three kinds of audits: internal, external (e.g. a notified body audit) and supplier audits, plus the auditor list. For internal and supplier audits you prepare a plan and a report, and you link the nonconformities and observations from every audit to a CAPA record. NexiMed AI suggests the nonconformity type based on the criteria from your procedure.
Why Your Team Needs This Module
The main benefits this module brings to your team’s day-to-day work.
Three audit registers
Internal, external and supplier audits are kept in separate registers. Each audit is numbered according to your scheme, and the register shows its date, status and the number of nonconformities and observations.
Audit plan and report
The audit plan sets out the objectives, scope, criteria and an hourly schedule, and the audited department receives it with a notification. In the plan you also set the audit status, e.g. “planned” or “completed”, and after the audit you draw up its report.
Nonconformities linked to CAPA
You link an audit nonconformity directly to a CAPA record. The record’s status is shown in the audit register, and the CAPA automatically stores the number of the audit report the nonconformity comes from.
Nonconformity type with NexiMed AI
Based on the criteria from your procedure, NexiMed AI analyses the content of a nonconformity and suggests its type: minor, major or critical nonconformity, or observation. The auditor chooses the final type.
Key Features of the Module
What exactly this module can do.
Internal audit
You create an audit for a selected department, set a date or date range and assign a status, e.g. “planned” or “completed”. The system numbers the audit automatically according to the adopted scheme.
External audit
You record external audits, e.g. by a notified body: the auditing body, scope, legal requirements and audited devices. You attach the report and link the nonconformities found to a CAPA record.
Supplier audit
The supplier to be audited is picked from the list provided by the integration with the Purchasing module. You prepare the audit plan and draw up the report afterwards.
Audit team
You assign a lead auditor, technical auditors and observers to the audit. The system does not let you appoint a person who works in the audited department. The audit plan is created by a user with the lead auditor role.
Audit plan
Audit objectives, scope and criteria, a representative of the audited department and an hour-by-hour schedule. The finished plan reaches the audited department with a notification and can be edited until the report is created.
Audit report
Participants, the audit team, the course of the audit, evidence gathered, a summary and attachments. An internal audit report can be generated as a PDF.
Auditor list
A register of internal auditors with their competence and authorisation to carry out audits. It makes it easier to manage the audit team and choose the right people for each audit.
Cloud Security & EU Compliance
AWS architecture & GDPRHow this Module Connects with Other QMS Processes
NexiMed modules work together. Below are the processes related to this module.
CAPA
You link audit nonconformities to CAPA records, and the status of the actions is shown directly in the audit register.
Purchasing
You pick the supplier to audit from the qualified suppliers in the register kept in the Purchasing module.
NexiMed AI
Suggests the nonconformity type based on the criteria from your procedure, which makes classification easier.
Module Implementation FAQ
Can an auditor audit their own department?
No. When an internal audit plan is created, the system prevents assigning a person who works in the audited department, ensuring the independence of the audit process.
How are audit nonconformities linked to CAPA?
A nonconformity identified during an audit can be linked to an existing CAPA record, or a new one can be created. The status of the linked record is visible in the audit register, and the audit report number is saved in the CAPA documentation.
Can the application record notified body audits?
Yes. Notified body audits can be recorded as external audits. The application lets you enter the auditing body’s details, the report number, legal requirements and audited devices, as well as attach the report and link the identified nonconformities to CAPA records.
Does NexiMed AI classify nonconformities on its own?
No. NexiMed AI analyses the content of the nonconformity based on the criteria set out in the procedure and suggests its type. The final classification decision rests with the auditor.
See Audits in Action
Schedule an online demo with NexiMed specialists and see how this module can support the processes in your company.
Have questions?
Let's talk about your processes.
Not sure which package to choose? Or maybe you need a custom integration? Our engineers will be happy to help.