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 make sure the certification body works properly: that its auditors are qualified, that decisions are fair, and that nobody certifies work they were involved in.
You manage competence records and scopes, allocate auditors to assessments without creating conflicts, operate the impartiality arrangements, and maintain the separation between assessment and decision that the body’s designation rests on. Scope is the detail that carries the weight: accreditation is granted per method and per matrix, so an auditor’s competence and a certificate’s coverage are both narrower than the organisation’s name suggests.
The body sells trust, and trust is a structural property rather than a cultural one. Your job is the structure — which is why it is a role and not a policy. The structural risk is gradual: an auditor who has assessed the same client for years, a decision-maker who was consulted during the assessment, a scope quietly extended by practice rather than by review. None requires anyone to act badly, and each erodes the separation the designation depends on.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
Inside the certification body, above individual assessments and behind the certificate.
- The body’s designation and the scheme requirements it operates under
- Every assessment the body performs
- Every certification decision it issues
- Accurate competence records for every auditor
- Disclosure of relationships that could compromise impartiality
- The designating authority’s requirements
- Auditors, for scope and allocation
- Decision-makers, for a clean assessment
- The designating authority
- Auditor competence, qualification and scope maintenance
- The impartiality mechanism and conflict screening
- Separation between assessing and deciding
- Individual findings
- Individual certification decisions
- The scheme requirements
- The body’s leadership and its impartiality committee
- The designating authority, for anything affecting the body’s own conformity
- Competence and qualification records
- Conflict screening and impartiality records
- Internal audit of the body itself
WHAT THIS ROLE CAN EVIDENCE · 0
No published competency maps to Certification Scheme Manager 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