Overview
A certification-scheme documentation package for bodies certifying ISO 13485:2016 medical device quality management systems under ISO/IEC 17021-1:2015. ISO 13485 certification underpins market access for medical device manufacturers and their suppliers, and certifying it demands scheme documentation that reflects regulatory context — this package provides it: a Quality Manual establishing the certification body's management system and impartiality architecture; the ISO 13485 scheme document; fourteen procedures governing application review and audit-time determination for device manufacturers by risk class and process complexity, audit programme design, Stage 1 and Stage 2 execution — including evaluation of design and development controls, risk management per ISO 14971 linkage, sterile and software processes, and post-market feedback — technical review and certification decision, surveillance and recertification, special audits, suspension and withdrawal, appeals, complaints, auditor competence in medical device technologies, internal audit and management review; and fourteen forms covering the certification life cycle. With 48 controlled documents including an ISO 13485:2016 certification audit checklist, a CB compliance checklist against ISO/IEC 17021-1, medical-device audit guidance and auditor training materials, the editable kit equips certification bodies to operate an accreditation-ready medical device QMS scheme.
Included: 48 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).
License: single-organization license; delivered electronically as a ZIP archive.
From purchase to audit-ready
Buy & download instantly
Pay securely by card. Your ZIP download link appears immediately on the confirmation page and in your email.
Edit & brand as your own
Open the native Word & Excel files, add your logo and details, and adapt everything to your organisation.
Implement & get audit-ready
Roll out the manuals, procedures, forms and checklists to build a working, certification-ready system.
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
Because these are digital products delivered instantly, all sales are final once downloaded. If you have any issue with your files, contact us and we'll make it right. See our Refund Policy for full details.