, Published 3 May 2019
What is ISO 13485:2016?
ISO 13485:2016 is an international standard for the Quality Management System (QMS) of organizations involved in the manufacturing, distribution, servicing, and disposal of medical devices. Organizations with ISO 13485:2016 certification are recognized to produce medical devices that are at par with industry standards.
ISO 13485 Audit Checklist
An ISO 13485 audit checklist is utilized by quality managers to determine if the organization’s QMS is aligned with the ISO 13485:2016 standard. It helps evaluate an organization’s readiness for a third-party ISO 13485:2016 certification audit. With SafetyCulture (formerly iAuditor), quality managers can:
- Identify processes that don’t adhere with the corresponding ISO 13485:2016 requirement/s.
- Create notes for corrective actions related to specific gaps discovered.
- Assign corrective actions with deadlines.
- Generate and submit reports using mobile devices.
- Download this converted checklist to suit the needs of the business for ISO 13485 certification.
In this article
- What is an ISO 13485:2016 Audit Checklist?
- 5 Steps to Prepare for ISO 13485:2016 Certification
- FAQs About ISO 13485 Audit
- ISO 13485:2016 Audit Tool
- ISO 13485 Audit Checklists
What is an ISO 13485:2016 Audit Checklist?
An ISO 13485:2016 audit checklist is a tool used by quality managers to determine if the QMS of organizations align with the ISO 13485:2016 standard. This checklist is useful in evaluating readiness for a third-party ISO 13485:2016 certification audit.
5 Steps to Prepare for ISO 13485:2016 Certification
- Obtain a copy and gain an understanding of the ISO 13485:2016 standard.
- Identify areas for improvement in the current QMS by conducting a gap analysis or a readiness audit to ensure compliant to ISO 13485:2016 regulatory requirements.
- Perform quality monitoring audits and maintain a record of results.
- Define your organization’s competencies and determine training requirements for ISO 13485:2016 certification based on the internal audit results.
- Ensure competence needs are met and that all parties involved are kept in the loop.
FAQs About ISO 13485 Audit
An ISO 13485 audit is an assessment process that allows organizations to ensure their compliance with the current QMS standard for medical devices. This process is also performed to help businesses obtain ISO 13485 certification.
After obtaining the initial ISO 13485 certification, regular surveillance audits are conducted at least once a year to ensure the organization’s continued compliance with the standard. Recertification audits, on the other hand, are performed every three years.
Third-party or external auditing organizations conduct the audits for the actual ISO 13485 certification. The initial audits, however, are performed by internal auditors—mostly those in the quality assurance team—in preparation for the subsequent and more formal assessments.
ISO 13485:2016 Audit Tool
Paper-based audits can be burdensome and time-consuming. Time spent on documentation and manual filing of records can be better spent working on gaps found in the current QMS and working towards getting certified for ISO 13485. SafetyCulture, a cloud-based auditing app, can help organizations meet ISO requirements and maintain the quality of medical devices. Be ready for third-party ISO certification by doing the following:
- Create a mobile-ready ISO 13485 checklist.
- Empower teams to conduct efficient monitoring procedures and analysis using a smartphone or tablet.
- Save time with a mobile app that generates comprehensive ISO 13485 reports as you finish an audit.
- Save the ISO 13485 template online and automatically share reports with members of the organization. Preview a sample ISO 13485 PDF report here.
- Use for free with small teams. Unlimited reports and storage for premium accounts.
Here is a collection of our carefully prepared ISO 13485 audit checklists you can browse and use as part of achieving ISO 13485 certification and ongoing compliance.
ISO 13485 Audit Checklists
ISO 13485:2016 Standard Checklist
An ISO 13485:2016 standard checklist can help quality managers find gaps in the organization’s current processes. This digital checklist is divided into 5 sections following ISO 13485:2016’s key clauses:
4) Quality management system
5) Management responsibility
6) Resource management
7) Product realization
8) Measurement, analysis, and improvement
Each section assesses your organization’s preparedness in implementing an ISO-certified Quality Management System. This digitized checklist allows you to select “Done,” “In Progress,” “Not Started,” and, for sections 6, 7, & 8, “Not Applicable.”
