Certification Scheme - ISO/IEC 17021-1:2015 & ISO 13485:2016
Certification Scheme - ISO/IEC 17021-1:2015 & ISO 13485:2016
Market access for a device manufacturer rests on its ISO 13485 certificate, so the scheme behind that certificate has to be documented to the same standard.
Couldn't load pickup availability
Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 2 |
| Procedures & SOPs | 16 |
| Forms & Records | 16 |
| Checklists & Audit Tools | 3 |
| Registers, Logs & Matrices | 5 |
| Training & Awareness | 3 |
| Guides & Work Instructions | 3 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-QM-01 | Quality Manual | Word |
| AGS-SCH-01 | Certification Scheme ISO 13485-2016 | Word |
| AGS-CL-01 | ISO 13485-2016 Certification Audit Checklist | Word |
| AGS-CL-02 | Stage 1 Readiness Review Checklist | Word |
| AGS-CL-03 | ISO 17021-1-2015 Internal Conformity Checklist | Word |
| AGS-P-06 | Initial Certification — Stage 1 and Stage 2 Audits | Word |
- Need the complete document list? Request it — same day
- Want to check the quality first? Preview free samples
Overview
Certification-scheme documentation for bodies certifying ISO 13485:2016 medical device quality management systems under ISO/IEC 17021-1:2015. Certifying device manufacturers and their suppliers is a regulated undertaking and the scheme has to reflect it. Audit time is determined by device risk class and process complexity. Stage 2 evaluation reaches into design and development controls, risk management through its ISO 14971 linkage, sterile and software processes, and the post-market feedback that shows whether the system responds after release.
A Quality Manual sets the management system and impartiality architecture, and the scheme document defines the ISO 13485 scheme. Procedures run the full cycle: application review, audit programme and planning, Stage 1 and Stage 2, the certification decision, surveillance and recertification, suspension, the extension or reduction of scope, complaints and appeals with panel records, and corrective and preventive action. Guidance on audit duration and on the grading and closure of nonconformities addresses where inconsistency between auditors is most visible to a client, alongside the ISO 13485:2016 audit checklist, a Stage 1 readiness review and an internal conformity checklist against ISO/IEC 17021-1:2015.
What this system covers
- Design and development controls, and risk management assessed through its ISO 14971 linkage
- Sterile and software processes, and the post-market feedback loop sampled during the audit
- Audit time by device risk class and complexity, and the three-year audit programme built from it
- Stage 1 readiness review, Stage 2 conduct, and the grading and closure of nonconformities
- Certification decision, certificate issue, surveillance, recertification and special audits
- Extension or reduction of scope, suspension and withdrawal, with appeal panels recorded
- Auditor competence in medical device technologies — qualification, authorisation and induction
Who it's for
Certification bodies that certify device manufacturers and their suppliers, and bodies extending an accredited scope into ISO 13485 for the first time. The trigger is usually a scope extension, or device-sector clients whose market access depends on the certificate and who will not wait for a scheme to be written from scratch. From here the body has a defined scheme, a stated basis for audit duration and nonconformity grading, and a cycle that leaves the record an assessor expects.
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.
More in Healthcare & Pharmaceutical
See all 61
Integrated Healthcare Quality, Safety & Risk Management System (ISO 7101, ISO 9001, ISO 31000)
Healthcare & Pharmaceutical67 documents $1,250USD
Professional Nutrition & Dietetics Management System
Healthcare & Pharmaceutical185 documents $1,350USD
Professional Dietitian Practice Toolkit
Healthcare & Pharmaceutical155 documents $850USD