By The Pro QC Quality Assurance Team
1. What is ISO 13485?
ISO 13485 is the global international standard for establishment and maintenance of a documented quality management system in the medical device industry. If a manufacturer has implemented ISO 13485, it will have a foundation upon which to certify for regional medical device regulations such as the EU Medical Device Directive (MDD), the EY Medical Device Regulation (MDR), US FDA 21 CFR 820, as well as other regulations that demonstrate a commitment toward the quality and safety of medical devices.
2. COVID-19 highlights sanitation requirements.
Manufacturers of medical devices and medical products should consider prevention of risk of contamination of the device during the production process. Sources of contamination come not only from incorrect handling of the devices by people, but also from a list that includes raw materials, airborne particles, and dirty machines, among other things.
On April 16th, the International Organization for Standardization (ISO) published an updated standards list for PPE and Medical Devices, as part of their COVID-19 response effort. These product standards define guidelines for the manufacturers to follow to ensure a proactive role in the fight against the spread of the virus.
3. What is required for ISO 13485 certification?
To ensure medical products will pass certification, here are the key objectives the project should follow:
- Define the scope– What is the medical device, and what is its purpose, intended market, classification? What is the collection related ISO product standard, and what are the regional regulations for this product?
- Conduct an ISO 13485 Audit & Gap Analysis– This is an audit that determines the level of compliance versus the standards that are being held.
- Develop a project plan– After the audit and gap analysis, define a corrective plan which lists all non-conformities, including how to fix problems to comply with ISO 13485 requirements and related regional standard implementation.
- Develop documentation– Put together the mandatory documentation that includes a Quality Manual, procedures, work instructions and documentation with evidence of proof of implementation.
- Develop & conduct training– This is one of the most important steps in this checklist. Provision of training to anyone who will be involved in any stage of the production of the medical device is mandatory. The first training educates the team on applicable requirements of the ISO 13485 standards, including those relevant to regional and product certifications. The next training is to set in place a Quality Management System that provides a standard for complying with work instructions and necessary sanitary procedures, as well as recording of proof of implementation on specific documentation.
- Implementation– A period of three to six months is given to implement the new Quality Management System and preparation of documentation to demonstrate compliance.
- Conduct an internal audit– The supplier should conduct an internal medical device audit to measure compliance and correct any noted deviations. This internal audit can also be conducted by a third-party auditor, such as Pro QC.
- Conduct a management review– If the Quality Management System is not implemented according to ISO 13485 procedure, and does not meet the defined policy and objectives, it must be adjusted to meet the necessary requirements.
- Apply for ISO certification– An external audit of ISO 13485 is the final step. This external audit is typically conducted by certification bodies. Based on the readiness of your organization, the certification body will issue the ISO 13485 certificate if you pass, or issue a non-conformance report that will require corrective actions. In the case of a non-compliance, Pro QC can advise and assist the applicant in implementing and validating those corrective actions. Once all non-conformance items are closed, the company can then re-apply for certification.
4. What goes into the external ISO 13485 audit?
When Pro QC goes into a factory to conduct an audit, we have a specific checklist to follow that helps us make sure the manufacturer is following correct procedure. Our technical supervisor comes in to train the on-site auditor (if there is one), to ensure that there is a complete understanding of the ISO 13485 compliance requirements.
5. What are the common pitfalls associated with ISO 13485 certification?
Being ISO 13485 compliant requires being detail oriented. Pro QC has seen a number of common pitfalls in the road toward compliance, including a lack of control for the medical device file (clause 4.2.3), an insufficient record for each medical device or batch that provides traceability (clause 7.5.1), and others. It’s important to follow the steps and ensure you conduct either an internal or external ISO 13485 audit in order to prevent any holdup in manufacturing and shipping your medical devices.
A free, read-only version of the ISO 13485:2016 standard can be accessed here.