Blended Business Solutions, Centurion

We specialize in assisting medical device manufacturers, wholesalers and distributors in achieving compliance with ISO 13485 standard, which pertains to quality management systems (QMS) for the medical device industry. Achieving ISO 13485 certification for your medical device company demonstrates a commitment to quality and patient safety. But navigating the intricacies of the standard and building a compliant Quality Management System (QMS) can be daunting.
Apart from our expertise in the ISO 13485 standard, we offer specialized ISO 9001 services tailored to companies spanning various sectors, encompassing medical devices, pharmaceuticals, engineering consulting, manufacturing, construction, mining, and beyond.

We are here to assist through the following services.
QMS Development
• Gap analysis: We assess your current practices against the ISO 13485 & ISO 9001:2915 requirements, identifying gaps and areas
needing improvement.
• Documentation development: We create or refine your QMS documentation, including policies, procedures, work instructions, and
records.
• Training: We provide comprehensive training for your staff on ISO 13485 & ISO 9001:2015 requirements and your QMS procedures.
QMS Implementation and maintenance
• Process Implementation: We guide you in implementing the documented QMS processes within your organization.
• Change Management: ll
• Internal Audits: We conduct regular internal audits to assess the effectiveness of your QMS and identify areas for improvement.
• Non-Conformance Management: Consultants guide you in addressing and resolving any non-conformances within the QMS.
QMS Internal Audit
• Audit Planning and Scoping: We work with you to define the scope and objectives of your internal audits.
• Audit Execution: We conduct thorough audits of your QMS, following established audit methodologies and document audit findings, and prepare audit reports.

• Consultants
• Quality
• Internal Audit
• Expert
• Templates
• Quality Management Systems
• Iso 9001
• Iso
• Sytems
• Qms
• ISO Certification
• Gap analysis
• ISO13485

• English
• isiZulu
• isiXhosa
• Tonga
• Shona