IMS Medical Device Inspection & Conformity Assessment Bodies (ISO 13485, ISO/IEC 17020, ISO 9001, ISO 31000)
IMS Medical Device Inspection & Conformity Assessment Bodies (ISO 13485, ISO/IEC 17020, ISO 9001, ISO 31000)
An inspection body is judged less on what it finds than on whether it can be trusted to find it.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 2 |
| Policies | 1 |
| Procedures & SOPs | 20 |
| Forms & Records | 25 |
| Checklists & Audit Tools | 9 |
| Job Descriptions & Organisation | 1 |
| Training & Awareness | 3 |
| Guides & Work Instructions | 4 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-IMS-QM-001 | Integrated Management System Manual | Word |
| AGS-IMS-SC-001 | Medical Device Inspection Scheme | Word |
| AGS-IMS-PR-09 | Medical Device Inspection and Conformity Assessment Process | Word |
| AGS-IMS-F-13 | Medical Device Inspection Report | Word |
| AGS-IMS-F-14 | Inspection Certificate | Word |
| AGS-IMS-CL-01 | IMS Gap Analysis Checklist | Word |
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Overview
Inspection and conformity assessment bodies in the medical device sector are assessed on two things at once: technical command of the devices in front of them, and visible independence from the people who make them. This system answers both, combining ISO/IEC 17020 for inspection bodies with ISO 13485 medical device quality management, ISO 9001 and ISO 31000 risk management. A dedicated Medical Device Inspection Scheme sits beside the manual, so the inspection activity itself is defined rather than implied.
Independence here is engineered rather than declared: conflict of interest procedures, signed confidentiality and impartiality declarations, a documented impartiality risk assessment and a standing impartiality review. Competence gets the same rigour, through inspector authorisation records and witnessed monitoring in the field. The operational chain then runs from review of requests, tenders and contracts, through method validation and the conformity assessment process, to the inspection report and certificate, with complaints and appeals registered, resolved and closed on the record. Guidance on professional judgement addresses what no procedure can fully script.
What this system covers
- Impartiality, independence and conflict of interest — declarations, risk assessment and periodic review
- Inspector competence and authorisation — qualification and witnessed monitoring of inspectors at work
- Inspection methods and their validation — consistent application across the team
- Medical device inspection and conformity assessment — planning, evidence and the conformity decision
- Reports and certificates — content, technical review and release
- Complaints and appeals — registration, resolution and closure of challenges to a determination
- Risk management to ISO 31000 — risk applied to impartiality, judgement and operations
- Facilities, equipment and external providers — calibration and control of outsourced work
Who it's for
Quality managers, technical managers and consultants in inspection and conformity assessment bodies serving the medical device sector. The trigger is normally an application or reassessment for ISO/IEC 17020 accreditation, notified body related activity, or a client contract requiring demonstrable independence. Editable to your own inspection scope and schemes, it leaves impartiality, competence and each conformity decision evidenced by a record an assessor can inspect.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
One purchase covers everyone in your organisation. No per-seat fees.
Built by people who run real audits, so the content matches what assessors check.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
Full refund if your files are faulty, incomplete or not as described and we can't put it right
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?
These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
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