The ISO 13485 Checklist for Medical Device Manufacturers

Are you preparing for ISO 13485 certification? If so, the process can be overwhelming.

Keep reading to learn more about how to make the experience easier for your medical device company.

What is ISO 13485?

ISO 13485 outlines the unique requirements for a quality management system (QMS). To comply, organizations need to demonstrate their ability to produce medical devices that meet customer and regulatory requirements.

Without proper certification preparation and documentation, you could end up wasting valuable time, energy, and capital.

Having a proven and systematized process helps streamline the entire certification process.

For this reason, we've created a simple ISO 13485 checklist for medical device manufacturers.

Consult this helpful guide as you prepare for ISO 13485 certification.

The ISO 13485 Checklist for Medical Device Manufacturers

As an industry-leading quality management system partner, we've helped hundreds of life science organizations orient towards rapid ISO 13485 success.

"Without Qualio, we would have not been able to achieve our critical milestone of ISO 13485 certification before the end of 2015. We are now prepared to take next steps towards compliance with European regulatory requirements," said Jonas T., Quality Manager.

Every five years, ISO standards are reviewed to determine whether a revision is required in order to keep it current within the marketplace. ISO 13485:2016 is the most up-to-date standard built-in response to the latest quality management processes.

Follow this checklist to receive ISO 13485 certification and comply with the latest standards.

1. Identify Certification Requirements

Start by familiarizing yourself with ISO 13485 regulations.

This enables you to know the exact requirements necessary to maintain compliance. As a best practice, consider investing in an electronic quality management systems (eQMS) that delivers the following features:

  • Quality manuals
  • Device master records (DMR)
  • Quality procedures
  • Work instructions
  • Forms, specifications, and drawings
  • Quality records
  • Design history files (DHF)
  • Device history records (DHR)

RELATED: 5 Tips to Get ISO 13485 / ISO 14971 Certification

2. Define Quality Processes and Procedures

Next, define the quality processes and procedures that your life science organization currently abides by. By doing so, you can identify any significant gaps that might be preventing your organization from aligning with ISO 13485 requirements.

Keep in mind that the quality management system documentation consists of both the mandatory documents and other documents specified by regulatory bodies. These documents ensure that quality systems are understood and repeatable across the entire ecosystem. As such, the less complicated the process, the easier it will be to ensure that all stakeholders can produce routine quality outcomes.

3. Activate Internal Training Programs

ISO 13485:2016 includes a subtle expansion of training requirements.

Effective training is an important component of any quality management system. However, ISO 13485:2016 makes it clear that training activities should be more rigorous than simply checking a box.

In fact, it's no longer enough to document that employees have completed their training requirements. Organizations also need to quantify and measure an employee's ability to perform in their role.

As such, organizations are required to create a list of skill requirements for each position, establish criteria for successful training, and produce evidence that employees have met minimum requirements for training, testing, and certification.

RELATED: The 7 Best Online Quality Management Training Courses

4. Validate the eQMS

Validation is a critical first-step toward eQMS software adoption, implementation, and ISO 13485:2016 certification. It's the process and supporting documentation to ensure that your software meets regulatory requirements and guidelines.

During the validation phase, it's important to develop appropriate change controls to monitor the validated state. You may need to revisit documented procedures to determine whether or not a software update is required. You should also document any changes released by the provider and assess potential impacts on the validated state.

Qualio provides a simple, easy-to-use validation pack to guide your validation efforts. There are three components required during the validation phase:

  • Installation Qualification (IQ): Are the servers installed and configured?
  • Operation Qualification (OQ): Does the product work as intended?
  • Performance Qualification (PQ): Does the product perform as expected?

5. Perform Stage 1 and 2 Certification Audit

Finally, you'll need to perform appropriate certification audits.

The objective of the Stage 1 Audit is to determine an organization's readiness for Stage 2 Certification Audit. During the first phase, auditors will review your quality management system, evaluate site-specific conditions, and activate discussions with key stakeholders.

The Stage 2 Audit evaluates the implementation and effectiveness of the organization's quality management system. During this phase, auditors will identify any issues of nonconformance. If the Stage 2 Audit is successful, your organization's quality management system will be certified.

Streamline ISO 13485 Compliance with Qualio

An eQMS designed specifically for medical device manufacturers can simplify the process of achieving highly specific requirements for data capture, retention, and documentation.

This is why Qualio is a favorite eQMS vendor among growing medical device manufacturers, biotech companies, and contract service providers.

Qualio enables you to easily unite teams, processes, and data so you can get your products to market quickly and scale successfully.

Before you get started, we recommend downloading our free guide: 12 Questions to Ask Before You Buy an eQMS.

Read it to find out more about the questions you need to ask as you evaluate your eQMS options. This guide is designed to help you confidently select the option that:

  • Is tailored to your company's growth stage
  • Provides the level of support you need
  • Delivers the tools to help you comply with industry-specific regulations
  • Fits your current budget
  • Offers flexibility and level of customization your company requires
  • Your team will enjoy using