Types of ISO 13485 Audit and how they are executed?

There are two main ISO 13485 audit types are internal and external audits. The key element of ISO 13485 Audit, and to become certified you must have internal audits and pass a 2-stage registrar audit conducted by an external party in order to become ISO 13485 certified. The different ways of ISO 13485 Audit can be conducted and discuss the differences between internal, external and certification audits.

There are three ways audits can be conducted are:

1. On-site audits: On-site audits are performed in full days. The number of days required for an audit depends on various factors including size, complexity, risk and nature of an organization. The International Accreditation Forum (IAF) has provided guidelines for registrars to calculate audit time.
2. Remote audits: Remote audits may be performed through web meetings, teleconferencing or electronic verification of processes. Remote audits are less common and typically not as essential as on-site audits.
3. Self-audits: Self-audits do not always mean an internal audit but self-audit can be requested of your customer to get rid of the requirement for them to use their resources and still offer some commitment that you are meeting requirements.

Types of audit

1. Internal ISO 13485 audit:

Internal ISO 13485 audit is audit that executed by your organization and are self-examination of your organization of QMS, performed on-site. Internal audits have many benefits including preparing your organization for external audits.

The internal ISO 13485 auditors must not be dependent of the area being audited to make sure objective results. Internal audits are an ISO 13485 the requirement and they are critical to the success of your QMS. Internal audits will be used to evaluate conformity and effectiveness as well as identify opportunities for improvement.

When you perform an internal audit, you will be able to compare your quality management system (QMS) to the requirements and understand if there are any non-conformances. This will allow you to correct your QMS and make sure that your organization will meet the requirements for the external auditor and allow for certification.

2. External ISO 13485 Audit:

External audits are included customer, supplier, certification and surveillance. A customer audit is where an existing, or potential customer, audits your organization to prove that you are meeting their requirements. If you are auditing an existing or potential supplier, we consider this as a supplier audit. Supplier audits can be one of the methods which are used to meet the requirements around control of external providers.

3. ISO 13485 Certification Audit:

The ISO 13485 certification audit is the audit your selected registrar will conduct to verify conformance with the reference of the ISO 13485 standard before they issue your official ISO 13485 certificate.

Two Stages of ISO 13485 Certification Audits:

Stage-1 audit is performed to decide an organization’s preparation for stage two of the audit. Stage-1 is oftentimes conducted remotely in order to not spend additional costs on travel. If the auditor decides you meet the minimum criteria for the stage-1 audit, your organization will proceed with the stage-2 audit.

Stage-2 audits will always be on-site audits. This is where the auditor will evaluate your staff and review your documented information (procedures, records, etc.) to check you are meeting all the ISO 13485 requirements. Certification audits are typically conducted every three years.

After certification, your registrar will check-up on your periodically using surveillance audits to check you are still upholding your QMS and the ISO requirements. Surveillance audits are very much such as certification audits, with the exception that they are not issuing or re-issuing a certificate.

Today, readymade ISO 13485 documents that include audit checklist are available on internet, companies can download them and audit their existing quality system based on ISO 13485 requirements.

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