iso 134852016 fda qsr internal audit checklist

#Iso 134852016 fda qsr internal audit checklist iso

Define audit objectives, scope, and criteria. This is an important step.If you work for a small company, that might be you! This person will be responsible for all phases of the audit. Appoint the lead auditor. The first basic step is to figure out who will lead the audit team.However, the process of initiating the audit is vital to assure the audit process is comprehensive and successful. When planning an audit, it is tempting to skip some of the steps below and go immediately to creating a checklist and schedule.

Determine whether or not the QMS has been properly maintained.Determine if the QMS has been effectively implemented.

#Iso 134852016 fda qsr internal audit checklist iso

Determine whether or not the QMS has been documented in accordance with applicable requirements also known as audit criteria (e.g., ISO standard, applicable regulations, contracts).

Determine the extent to which the QMS has been established.

The focus of the documentation audit centers on whether the QMS has been established and documented, while the on-site audit looks at whether there is sufficient objective evidence within the QMS to confirm it has been implemented and maintained. The difference between the two usually is in the approach and depth to which each of these audit components is conducted. A thorough QMS audit includes both components. While documentation and on-site audits may seem like two entirely different animals, they are not.

Confirming that the organization has implemented and is maintaining the QMS documentation commonly called an “ on-site audit.”.

Confirming that the organization’s QMS documentation conforms to the standard and any applicable regulatory requirements commonly called a “ documentation audit.”.

ISO 13485 talks about two main components of internal audits (section 8.2.4): Audits are planned, systematic processes carried out according to prepared working documents and audit plans.