ISO13485 – Quality Associates

Medical Devices - QMS Requirements

K&S Quality Associates can assist organizations that are seeking to become certified to ISO13485. K&S Quality Associates can provide gap analysis/pre-assessments, internal audit service, on-site training, procedure writing, implementation/consulting and other services

ISO 13485

The ISO 13485 standard is for organizations that design and manufacture medical devices and need to demonstrate its ability to provide services and medical devices that constantly meet customer and regulatory requirements. Compliance with ISO 13485 is the first step in achieving compliance with European regulatory requirements. ISO13485 is harmonized with ISO 9001, however medical device regulatory requirements for quality management systems are incorporated into the standard and ISO13485 excludes some of the requirements of ISO 9001 that are not appropriate to the regulatory requirements. K&S Quality Associates can help your organization to become ISO 13485 certified with services like procedure writing, internal auditor training, on-site training, gap analysis, consulting and other services.

For ISO 13485, a comprehensive QMS for design and manufacture of medical devices needs to be implemented. Regardless of the type or size of an organization, all requirements of ISO13485 are specific to organizations providing medical devices. Due to the nature of the medical device(s) and service(s) provided, many organizations take exclusion to design and development requirements and other requirement(s) in Clause 7 of ISO13485 by properly documenting justification statements for each exclusion. Additional requirements of ISO13485 include the promotion and awareness of regulatory requirements (21 CFR 820 Quality System Regulation for Medical Devices sold in the United States), risk management, requirements for sterilization, inspection and traceability for implantable devices.

With the help of qualified QMS professionals in our organization, we are able to build and put into practice a Quality Management System that factor in all the aspects of your organization. One can be assured of the ISO 13485 certification after receiving our comprehensive services. K & S Quality Associates will work out a viable approach that is best suited for your organization to function in the most productive and effective manner.

Our services for organizations seeking ISO 13485 certification include –

  • Policy Manual prepared by seasoned experts in the field.
  • Providing Procedures Manual by the same or similar experts.
  • Assistance in writing Work Instructions.
  • On-site assistance for implementing the quality management system.
  • Gap Analysis
  • Internal Audits and Auditor Training

With such a comprehensive approach to ISO 13485 compliance and certification in place, organizations that manufacture and design medical devices have benefitted from achieving higher levels of consistent performance in their operations and products. Our clients not only get the ISO 13485 certification, which is what they sought, but their profitability also increases by the enhanced efficiency of manufacturing and business operations.