Internal Auditing Service

There are many aspects involved in maintaining your ISO 9001 and 13485 Quality Management System (QMS). One critical area which requires regular attention is your internal audits.

It is a standard requirement for internal audits to be performed on the systems, processes, procedures, and records within your QMS.

For small to medium sized businesses, it is advised the entire system is audited each year. For larger businesses, it may be justifiable to spread out the internal audit schedule over the course of 2-3 years, if the schedule is clearly defined. It is important to set your schedule with a risk-based mindset; this ensures the most important elements are audited as a priority and potentially more frequently than less critical aspects.

It can be challenging to recruit suitably qualified professionals within an organisation to perform Internal Audits. Additionally, it is important to ensure a lack of bias when auditing, as ISO compliance auditors are unable to audit their own work.

Employing Patient Guard’s Quality Assurance (QA) team to perform the Internal Audit for you will assist your compliance against ISO 9001 and/ or ISO 13485. The service will be finalised with a detailed audit report which will include any continual improvements and non-conformances for your records.

Here are a few commonly asked questions regarding our Internal Audit services:

Q: How is this service delivered? Are you able to assist overseas clients with internal audits?

A: Internal audits can be completed either virtually (UK and overseas) or on-site (if based in the UK) to suit your business’s needs.

Q: Can you perform supplier evaluation audits?

A: Our auditors can carry out supplier evaluation audits for your manufacturers, distributors etc… This can be performed either on-site in the UK or virtually.

We are flexible and responsive and can work around your Internal Audit needs and schedules.

If you require more information on our Internal Audit service, please contact us for more information.

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