Length: 2 Days
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ISO/TS 17012 — Conformity Assessment and Technical Competence Training by Tonex

Innovation Mindset & Leadership for Engineers (Medical Device Edition) Fundamentals Training by Tonex

Grounded in real-world practice, this program equips professionals to build, operate, and continually improve conformity assessment systems aligned to ISO/TS 17012. Participants translate requirements into actionable processes, metrics, and competencies across testing, inspection, and certification functions. You will learn how to evidence competence, assure impartiality, and maintain traceability while keeping documentation lean and audit-ready.

In connected enterprises, rigorous conformity controls also protect information assets and reduce operational risk. Strong record integrity, access governance, and validated digital workflows support cybersecurity resilience and incident forensics. Competent personnel, trusted data, and disciplined change control form a defensible foundation for secure, compliant operations.

Learning Objectives

  • Interpret ISO/TS 17012 clauses and map them to practical, auditable processes
  • Establish a competence framework covering roles, training, authorization, and performance evidence
  • Design risk-based conformity workflows with clear inputs, outputs, and decision criteria
  • Implement measurement control, method validation, traceability, and uncertainty documentation
  • Build an impartiality structure, address conflicts of interest, and protect decision integrity
  • Integrate conformity KPIs into management review and continual improvement cycles
  • Strengthen governance over test data and records so cybersecurity controls align with conformity requirements

Audience:

  • Quality Managers and Directors
  • Accreditation and Compliance Leads
  • Laboratory and Inspection Supervisors
  • Certification Body Personnel and Auditors
  • Operations and Process Improvement Managers
  • Cybersecurity Professionals
  • Regulatory Affairs and Risk Managers

Course Modules:

Module 1 — Standard Structure Essentials

  • Scope, terms, and definitions
  • Process approach and PDCA
  • Context and stakeholder needs
  • Risk-based thinking basics
  • Documentation architecture
  • Clause-to-process mapping

Module 2 — Competence and Authorization

  • Role profiles and matrices
  • Training plans and curricula
  • Qualification and authorization rules
  • Witnessing and on-the-job evidence
  • Periodic reassessment methods
  • Competence records lifecycle

Module 3 — Impartiality and Governance

  • Impartiality risk identification
  • Conflict of interest controls
  • Decision-making independence
  • Use of committees and oversight
  • Escalation and issue resolution
  • Governance KPIs and reporting

Module 4 — Methods, Validation, Traceability

  • Method selection and suitability
  • Validation and verification plans
  • Reference materials and standards
  • Metrological traceability chains
  • Measurement uncertainty analysis
  • Change control for methods

Module 5 — Records, Data Integrity, Security

  • Data integrity principles ALCOA+
  • Record creation and retention rules
  • Access control and segregation
  • Electronic systems validation basics
  • Audit trails and evidence reliability
  • Secure transfer and archival

Module 6 — Audits, NCs, Improvement

  • Internal audit program design
  • Risk-based audit planning
  • Nonconformity and root cause tools
  • Corrective and preventive actions
  • Management review effectiveness
  • Continual improvement roadmaps

Advance your organization’s credibility and reduce compliance risk with a competence-first conformity system. Enroll in ISO/TS 17012 — Conformity Assessment and Technical Competence Training by Tonex to turn requirements into reliable operations, defend decisions with robust evidence, and align quality governance with modern cybersecurity expectations. Secure your seat today and elevate assurance across your testing, inspection, and certification activities.

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