Overview
This Integrated Management System is designed for inspection and conformity-assessment bodies operating in the medical-device sector, where independence and technical rigor are paramount. It combines ISO/IEC 17020 for inspection bodies, ISO 13485 medical-device quality management, ISO 9001, and ISO 31000 risk management into one authoritative framework. The documentation establishes the impartiality, competence, and consistency that accreditation bodies and regulators require of organizations judging product and system conformity. A master Quality Manual defines independence safeguards, inspection policy, and organizational structure, supported by procedures for inspection planning and execution, competence and authorization of inspectors, handling of complaints and appeals, reporting, and management of impartiality risks. Forms and records document inspection evidence, decisions, and traceability, while checklists convert ISO/IEC 17020 and ISO 13485 requirements into repeatable inspection routines. Training modules build and evidence inspector competence — a decisive accreditation criterion. The ISO 31000 layer embeds structured risk thinking across impartiality, technical judgment, and operations. This kit is ideal for bodies seeking ISO/IEC 17020 accreditation, notified-body activities, or contracts requiring demonstrable independence and device expertise. Every document is fully editable to your inspection scope, schemes, and structure, saving months of drafting effort. By systematizing impartiality management, competence control, and consistent decision-making, it strengthens the credibility of your inspection outcomes and accelerates accreditation. The result is a conformity-assessment body whose determinations are trusted by manufacturers, regulators, and the market — protecting your accreditation, your reputation, and the safety of the devices you assess.
Included: 66 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.