What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
You check that device manufacturers meet the requirements before their products can be sold, working for the organisation that issues the certificate.
You audit quality management systems and technical documentation against the scheme your body is designated for, report findings, and feed a certification decision you do not make yourself.
You are the mechanism by which a market trusts products it has not itself inspected, and that trust depends on a separation between assessing and deciding that is easy to describe and hard to hold.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
Inside a designated body, facing manufacturers who need its certificate to place product on the market.
ASSESSMENT · AUTHORITY TO FIND, NOT TO FIX
Working across clients
The eight facets above describe a role inside one organisation. Notified Body Auditor is not in one, so these are the boundaries that replace a reporting line.
WHOSE SYSTEM GOVERNS
The manufacturer’s quality system, assessed against the scheme your body is designated for. Neither is yours: you apply requirements you did not write to a system you did not build, and stating both in the report is what makes it usable by the decision-maker.
AUTHORITY
- Findings, classified against the scheme’s own criteria
- Whether evidence presented supports the manufacturer’s claim of conformity
- Whether the certificate is granted, maintained or withdrawn — that decision is separated from the assessment by design
- How the manufacturer fixes a nonconformity, or which solution it adopts
- The scheme requirements themselves
BETWEEN ENGAGEMENTS
- Competence in the scheme and in the technologies within your qualified scope
- Audit method and the ability to test a claim against evidence quickly
- One manufacturer’s technical documentation, designs or findings, into another’s assessment
- Commercially confidential information of any kind between clients of the same body
- The audit report and nonconformity records held by your body and the manufacturer
- The assessment trail the designating authority may later examine
- Assessing a manufacturer you have consulted for — the prohibition is stricter here than for a contract auditor, because the body’s designation depends on it
- Advising a manufacturer how to resolve a nonconformity you raised, which converts assessment into consultancy
- Assessing outside your qualified competence scope, however obvious the subject appears
- A manufacturer’s application and its technical documentation
- The certification decision made by someone other than you
- Market access for the manufacturer
- Your own competence scope — you may only assess what you are qualified against
- Access to the manufacturer’s system, sites and documentation
- The scheme requirements your body is designated for
- The certification decision-maker
- Regulators relying on the body’s designation
- Patients, at the far end
- The findings and the evidence supporting each
- The accuracy of the assessment against the scheme
- The certification decision itself, which is deliberately separated from the assessment
- How the manufacturer remediates
- The scheme requirements, which you apply rather than set
- The certification decision-maker within your body
- The designating authority, where a matter goes beyond a single manufacturer
- Audit reports and nonconformity records
- Assessment of technical documentation against the scheme
WHAT THIS ROLE CAN EVIDENCE · 0
No published competency maps to Notified Body Auditor yet. 14 are published across the registry, and this role is not among the ones they name.
Read the standard and its stated coverage →A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Medical Device Quality pathway. No scenario exercises this role yet, so Practise comes later for it, then what any of it evidences. Skip any of them — the order does not change.
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- 21 CFR Part 820Quality Management System Regulation (QMSR) — 21 CFR Part 820FDA · last revised 2026-02-02
- ISO 13485:2016Medical Devices — Quality Management Systems — Requirements for Regulatory PurposesISO · last revised 2016-03-01
- ISO 14971:2019Medical Devices — Application of Risk Management to Medical DevicesISO · last revised 2019-12-01
- IEC 62304:2006+A1:2015Medical Device Software — Software Life Cycle ProcessesIEC · last revised 2015-06-01