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ISO 13485
What is the ISO 13485 Standard?Who Needs to Follow this Standard?
What is a Medical Device?
Establishment Licence applications
Device Licence applications
Implementation, Training and Coaching Services
Specific Assistance With Implementation
Internal Audits of Your QMS
Third-Party Audits of Your Supplier's QMS
Validation Studies
What is the ISO 13485 Standard
This standard is presently regulated by Health Canada's "Therapeutic Products Programme" (TPP). It is quite similar to the European Union's EN 46000 Standard. It is soon to be 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.
(TPP's Draft Policy on CMCDAS, Q1R15: 1999-11-02)
After July 1, 2002 Canadian manufacturers of medical devices must satisfy the requirements of either ISO 13485 or ISO 13488.
What is a Medical Device
These devices can be invasive to the body (syringes, dental fillings or other orthodontic appliances, medical implants such as a heart valve, arthroscope, or contraceptive devices such as a diaphragm), or they can be non-invasive (stethoscope, intravenous pump, X-ray machine, MRI, or contact lens cleaners).
Establishment Licence applications
We can provide assistance with:
- completing the application forms to ensure that the correct device classifications are selected; and
- calculations of the initial and annual fees, including requests for fee reductions or adjustments.
Device Licence applications
We can provide guidance with completing the application forms to ensure that the correct activities and device classifications are selected.
We can also provide you with calculations of the initial and annual Licence fees, including requests for fee reductions or adjustments.
Implementation, Training and Coaching 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 product;
- 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.
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.
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:
- Installation Qualifications;
- Operational Qualifications;
- Performance Qualifications;
- Retrospective Validations; and
- Prospective Validations.
ICS can prepare all of the required documentation and perform the actual work, when requested.