How to Prepare for ISO 13485 Audit

No matter how confident you are in your QMS (Quality Management System), as a medical device manufacturer, you cannot be complacent about quality audits in the future. New global regulations like ISO 13485 imply that you need a tighter grip over the QMS in your facility.

The new regulations stretch widely through the QMS, particularly for those managing huge networks of vendors and suppliers. Preparing for an audit is a crucial step for your organization. The process culminates with a 3rd party registrar conducted an external audit for gaining 13485 Certification.

Auditors have many objectives. These are:

  • To verify that your documentation adheres to all standards and needs
  • To ensure that employees realize their role in the QMS and know about ISO 13485 needs as regards their role in the firm
  • Correct following of procedures and processes

Being audited is costly and time-consuming, so you may desire to be well prepared.

Following are some tips for a successful audit:

Give Time to Prepare

Much time and effort are involved in preparing your facility for audit. After deciding for getting certified, you must set goals and spare time for meeting the needs of the standard.

Prepare Employees

Before the audit, you will need to appraise all your employees about the time and scope of the audit. Every employee must know the quality objectives of the organization and how they can contribute. You can prepare most employees through ISO 13485 training online.

Documented Information

This is another crucial aspect of preparing for an audit. During this process, you must ensure that record lists and documents have been updated. All documents must be subject to review, approval, communication and followed by all. Also, ensure that there is the use of outdated documents.

Procedures and Processes

They need to be followed carefully. Your organization must make sure that all processes are adhering to the planned arrangements that you set out to accomplish and that they are being performed and followed in the right fashion by all employees.

Preparation of Facility

While preparing for an audit, your organization must be cleaned and well organized. A messy facility can weigh heavily. You must have a wide understanding of the facility to avoid any hidden issues. While getting organized for the audit, check drawers, counters, bulletin boards, etc. for uncalibrated measuring and monitoring instruments and unknown supplies or parts.

Internal Audit

An internal audit must be conducted by the firm. This is not only vital for ISO 13485 certification but also to spot non-conformances. You must take internal audits seriously. They are a good way to prepare staff for certification interviews. The aim of an internal audit is to spot weaknesses as well as areas requiring improvement.

Management Review

This should take place soon after an internal audit. As per this step, past internal audit findings must be reviewed, and corrective actions must be taken, where needed.

Review of Past Findings Of Internal Audit

Following an internal audit, findings must be reviewed in a close meeting with everyone involved. The objective of an internal audit is to correct areas of weaknesses in the path to ISO 13845 certification.

These are the major steps towards preparing for ISO 13845 certification. Additional steps are required such as review of past internal audit findings, review of corrective action process, pre-assessment audit, 2-Stage certification audit and finally, a professional, 3rd party audit.