IMS Medical Device Manufacturing (ISO 13485, ISO 9001, ISO/IEC 17020, ISO 31000)
IMS Medical Device Manufacturing (ISO 13485, ISO 9001, ISO/IEC 17020, ISO 31000)
ISO 13485 device controls, the ISO/IEC 17020 inspection layer and ISO 31000 risk management, held in one quality manual and audit programme.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 3 |
| Policies | 1 |
| Procedures & SOPs | 20 |
| Forms & Records | 23 |
| Checklists & Audit Tools | 8 |
| Registers, Logs & Matrices | 1 |
| Job Descriptions & Organisation | 1 |
| Training & Awareness | 3 |
| Guides & Work Instructions | 4 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-IMS-QM-001 | Integrated Quality Manual | Word |
| AGS-IMS-PR-13 | Production and Process Validation | Word |
| AGS-IMS-PR-14 | Identification Traceability and UDI | Word |
| AGS-IMS-PR-17 | Advisory Notices and Product Recall | Word |
| AGS-IMS-F-13 | Device Master Record DMR Index | Word |
| AGS-IMS-F-14 | Device History Record Batch Record | Word |
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Overview
An integrated management system for manufacturers placing medical devices on regulated markets. The four standards interlock rather than run in parallel: ISO 9001 supplies the process approach and PDCA, ISO 13485 the device-specific regulatory controls, ISO/IEC 17020 the inspection activity behind conformity decisions, and ISO 31000 the risk method for product and organisational risk. An Integrated Quality Manual carries device-quality policy and regulatory responsibility across all four, and a correlation guide maps clauses between them.
The documentation follows the device lifecycle: design and development planned and reviewed on record, purchasing through supplier evaluation and incoming inspection, production qualified by IQ, OQ and PQ under calibration and work-environment control. Identification, traceability and UDI tie into the Device Master Record index and Device History Record, so batch release rests on documented evidence, while complaints, vigilance, advisory notices and recall feed into CAPA and change control. Every document is editable to your devices, processes and facilities.
What this system covers
- Design and development controls — planned design, recorded review, outputs traceable into the technical file.
- Risk management to ISO 31000 — a product risk management file, plus organisational risk and opportunity.
- Process validation and production control — IQ, OQ and PQ, equipment calibration, contamination and cleanliness control.
- Traceability, UDI and labelling — Device Master Record and Device History Record evidence behind batch release.
- Purchasing and supplier control — evaluation and approval of external providers, incoming inspection.
- Inspection under ISO/IEC 17020 — the device inspection scheme, professional judgement and impartiality.
- Post-market surveillance — complaints and vigilance, advisory notices and product recall.
- Audit readiness and competence — internal audit against each standard, certification gap check, workforce competence.
Who it's for
Written for quality and regulatory managers at medical-device manufacturers facing ISO 13485 certification, CE marking or equivalent market access, or OEM supplier approval. You edit it to your devices and facilities, work the gap check, and meet the notified body with design, validation, traceability and post-market evidence under document control.
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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