ISO 13485 in Canada

About ISO 13485 in Canada

ISO 13485:2016 outlines the parameters for a Quality Management System that demonstrates an organization’s capacity to supply medical devices that meet the device’s regulatory requirements and, if applicable, patient safety goals. ISO 13485:2016 is applicable to all organizations involved in the design and manufacturing of medical devices, including device manufacturers and service providers. 

ISO 13485

What does it mean to be ISO 13485 Certified?

The ISO 13485 standard is a stand-alone specification. It is based on the ISO 9001:2015 structure, but it contains medical device-specific standards such as risk analysis, sterile production, rework, and traceability. An organization that has established an ISO 13485 Quality Management System (QMS) and has successfully completed all applicable requirements, as assessed by the certification body, is referred to as an “ISO 13485-certified company.” 

How to Prepare Your Organization for ISO 13485 Certification

ISO 13485 documentation: A crucial component of most quality systems is a Quality Manual. In addition to the Quality Manual, a company should define the commitment it will make to create an environment and culture that prioritizes ISO 13485 quality in all activities. A policy or objective statement might be used to express this commitment. The standard has highly specific requirements for both operations and records that must be met:

  • The creation of a medical device should be accompanied by a file that contains product details as well as for instructions for use.
  • Make a plan for document control.
  • Make a plan for keeping track of your records.

Management Accountability: Management must demonstrate their commitment by demonstrating that they can be held accountable for their organization’s operations. They must guarantee that their focus does not diverge from the needs of the end customer and that all production laws are followed. Management is solely responsible for supporting the ISO 13485 quality policy, ensuring that it complies with local regulations, and communicating the objective to staff. They must plan ahead of time, delegate power, and communicate clearly. They are also in charge of the Management Review, which is a periodic review of the organization’s operations and progress.

Resource Management: It is the responsibility of top management to guarantee that the Quality Management System complies with ISO 13485 and meets local regulatory standards. Top management must guarantee that appropriate resources are available to fulfill the work provided by the firm, as stipulated by ISO 13485. Personnel, infrastructure, materials, equipment, succession planning, and risk avoidance are all examples of providing resources. This might be as specific as preventing pollutants in the daily workflow or ensuring that operations run smoothly in the years ahead.

Product Realization: An organisation must prepare for the transition from concept to ISO 13485 implementation. This can include creating a process for documenting how ideas are generated, concepts are validated, and products are planned and developed. Communication is essential for the device’s design and development. In order to realize a product, it’s important to transfer ideas, control the design, document any required adjustments, and keep track of all files involved in the process. A procedure should explicitly specify defining and tracking suppliers, keeping key information linked with each ISO 13485 product, and establishing how to validate these products.

Cleaning, installing, performing the necessary service, and meeting the ISO 13485 standards related to medical devices are all part of the process that must be monitored. Product realization also includes effectively monitoring and maintaining equipment, as well as ensuring that the device’s identification needs are met. Finally, evaluating the ISO 13485 product’s effectiveness in terms of traceability, maintaining customer property, and guaranteeing product preservation would aid in ISO 13485 compliance.

Measuring, analyzing, and improving: You have a responsibility now that your product has been developed and distributed for general usage to ensure that the consumers get what they want according to ISO 13485 standards. So, how do you go about doing that? It’s simple: you’re looking for feedback. Developing a system for proper monitoring and measuring product success must contain the following steps:

  • Dealing with grievances
  • Submitting information to regulatory agencies
  • Internal auditing and continuous process and product evaluation
  • Identifying and regulating items that do not satisfy the initial design criteria on an internal level (nonconforming product)
  • Assessing data gathered and refining the process on a continuous basis

Hire a Certification Body: Once your organization has implemented ISO 13485 in Canada, it’s time to look for a certification body to grant ISO 13485 certification. The certification body will inspect ISO 13485 compliance. During this process, the certification body will assess procedures for meeting ISO 13485 standards, ISO 13485 personnel training, and ISO 13485 system performance. The certification body will conduct two external audits: 

  • Stage One (Preliminary Audit): Auditors from your selected certification body will check to determine if your paperwork meets ISO 13485 requirements and conduct a preliminary audit to ensure ISO 13485 is effectively implemented.
  • Stage Two (Implementation Audit) – The certification body auditors will examine your paperwork, records, and corporate processes to verify if your actual activities are in compliance with ISO 13485. Any non-conformities discovered during the first Stage 1 audit will be reviewed to see if they have been addressed. Once your company passes the stage 2 audit, ISO 13485 certification for medical devices will be awarded.

Advantages of ISO 13485 in Canada

ISO 13485 certification is valuable because it demonstrates to the rest of the world that your company’s products are manufactured in compliance with ISO standards, allowing you to earn worldwide commercial prospects. When it comes to certifying manufacturing enterprises all around the world, ISO has a strong reputation for excellence and expertise. Some of the advantages of ISO 13485 certification are as follows:

  • Gain a competitive advantage by making new business relationships.
  • Boost efficiency while decreasing costs
  • Make safer and more efficient medical equipment available.
  • More knowledgeable and empowered staff 
  • Increased client satisfaction

Contact IAS today to learn more about ISO 13485 in Canada, or visit our ISO 13485 in Canada frequently asked questions page!