ISO 13485 QMS Consulting for Medical Devices in Canada

ISO 13485 QMS Consulting for Medical Devices in Canada

Also see our web page in the Regulatory Affairs pull-down menu, titled Medical Device consulting for medical device licence (MDL) applications and for medical device licence applications (MDELs)

What is the ISO 13485 Standard?

Who Needs to Follow this Standard?

Implementation, Training and Coaching Services

Specific Assistance With Implementation

Internal Audits of Your QMS

Third-Party Audits of Your Supplier’s QMS

Validation Studies

ISO 13485 QMS consultant

What is the ISO 13485 Standard

This Quality Management System (QMS) is regulated under Health Canada’s “Therapeutic Products Programme” (TPP) via the Medical Device Regulations (MDR). It is quite similar to the European Union’s EN 46000 Standard. It is now a requirement in Canada, in order to harmonize with other parts of the world. It ensures that the manufacturer has objective evidence that the device meets specific requirements for safety and effectiveness.

ISO 13488 is the same as ISO 13485, with the exclusion of the requirements for “Design Control”.

Who Needs to Follow this Standard

Manufacturers who export medical devices to the U.S.A. and the European Union and who require the E.U. “CE Marking”.

To sell a medical device in Canada, manufactures must meet the regulatory requirements as defined in the Medical Devices Regulations.

Implementation, Training and Coaching ServicesISO 13485 QMS Auditing services

We can:

  • conduct an assessment of your present Quality Management System and procedures;
  • perform a “Gap Analysis” to determine the deficiencies;
  • provide a general overview for Management and Staff;
  • assist with writing and revising the policies, procedures, validations and forms;
  • select and coach personnel involved in the implementation process;
  • provide detailed training to individual departments, regarding specific ISO 13485 requirements;
  • conduct the internal quality audit, and assist with implementing the required corrective actions;
  • liaise with the Health Canada Inspector;
  • be present and provide consultation during the Inspection Audit;  and
  • perform regular follow-ups, thereafter.

Specific Assistance With Implementation

We can help you to:

  • define and document a Quality Policy;
  • appoint a Management Representative, and define his or her authority;
  • develop a Quality Manual defining the policies, scope and structure of the Quality System;
  • develop procedures instructing how to carry out activities;
  • implement the documented Quality System;
  • establish a file with manufacturing and quality assurance specifications;
  • validate the design to ensure that product conforms to defined user needs and requirements;
  • establish a document control system and define the types of controlled documents;
  • evaluate subcontractors and monitor their quality performance;
  • perform Validation Studies of equipment and critical processes;
  • determine the requirements for health, cleanliness and clothing of personnel;
  • determine the requirements for the environment to which the product is exposed;
  • specify the required inspection and testing program, using previously developed quality plans and procedures;
  • develop procedures to calibrate measuring and test equipment;
  • set up a system to document and investigate customer complaints and returned devices;
  • set up a system to investigate quality system nonconformances;
  • develop procedures for product recall;
  • set up a system to index and organize quality records;
  • develop batch production records;
  • perform internal audits of the quality management system;
  • identify training needs for all personnel; and
  • perform the required training.

Please refer to our QA Implementation & Training web page for further details.

Internal Audits of Your QMS

ICS can provide an objective and unbiased review, to assess conformance to the Standard and to determine the level of implementation and effectiveness of the quality system requirements. This is done using our extensive checklists, which have evolved and are continually improved over time We can then identify opportunities for improvement, within the scope of the quality system, and provide recommendations, based on our vast experience.

A report summarizing the audit findings and results is then submitted. This report is then used as an official quality record to aid in management review, customer approval, continuous improvement and registration decisions. Please refer to our Auditing services web page.

Third-Party Audits of Your Supplier’s QMS

ICS can let you know whether your suppliers are meeting their contractual agreements, no matter where they are located throughout the world. These suppliers may include contract manufacturers and/ or testing laboratories.

No matter where your suppliers are located, we can most likely provide these services at less travel expenses. This is due to our network of strategic alliances or subcontracted auditors, or we may also have other clients in the city that your supplier is located.

Validation Studies

This is the documented act of demonstrating that any of your critical procedures, processes, equipment, materials, activities, or systems will consistently lead to expected results. We can perform:

  • InstaMedical Device QMS consultantllation Qualifications;
  • Operational Qualifications;
  • Performance Qualifications;
  • Retrospective Validations; and
  • Prospective Validations.

ICS can review of the documentation, or perform the actual work. Please refer to our Validation services web page.

Why use a consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house?  Please see our web pageWhy Use a Consultantas part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.


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