ISO 13485:2016 LEAD AUDITOR
This class addresses how quality management systems (QMS) and ISO 13485 apply to the medical device industry and how to develop a management system in conformity for ISO 13485 certification.
This ISO 13485 Lead Auditor Training is intended particularly for companies that produce or service medical devices or are part of an FDA regulated industry. It addresses the concerns specific to the medical device industry including risk management, software validation and supplier management.
- Interpret and apply the requirements of ISO 13485:2016
- Apply ISO 14971
- Use the QMS and ISO 13485 to ensure compliance to applicable regulations
- Implement regulatory issues with minimal impact upon operations
- Identify and implement the controls necessary for ensuring the QMS consistently meets requirements
- Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
- Determine and communicate the resources necessary for the system to work as planned
- Communicate the roles and responsibilities within the QMS to the organization
- Conduct and lead 1st, 2nd and 3rd party audits, particularly on undocumented systems and audit for process effectiveness against measurable objectives
- Relate the capabilities of the organization to the expectations of customers, top management and shareholders
- Use the QMS to work proactively and not reactively, manage risk, validate software and manage suppliers
- Medical device professionals
- Professionals from FDA regulated industries
- Quality professionals
- Individuals who want to become Exemplar Global (RABQSA) certified lead auditors
- ISO Managers/Management Reps
- Auditors (internal, 3rd party, and supplier)
- Process owners
- Systems professionals or people who want to understand how management systems work
- Improvement Specialists
- Buyers in FDA regulated industries
- Leaders/managers/professionals in the Medical Device industry
This class may be run in conjunction with a ISO 13485 Lead Auditor Training Course.
DAY 1
- Lecture: Intro to Management Systems
- Lecture: Quality Standards Including 13485
- Workshop: Terms and Definitions ISO 19011
- Lecture: ISO 13485
- Workshop: Analyzing Processes
DAY 4
- Workshop: Writing Nonconformity Statements
- Workshop: ISO 13485–Interviewing Auditees
- Workshop: Closing Meeting Preparation
DAY 2
- Exam: ISO 13485 Self Study
- Workshop: ISO 13485 Clauses
- Lecture: Auditing Management Systems
- Lecture: Developing Process-Based Management Systems
- Lecture: Audit Planning and Preparation
- Exam: 13485 Test
DAY 3
- Workshop: ISO 13485–Review System Docs and Prep Audit Schedule
- Workshop: ISO 13485–Reviewing Processes and Prep Checklists
- Lecture: Performing Lead Audit Investigation
- Workshop: Verifying Facts
- Lecture: Concluding the Audit
- Workshop: ISO 13485–Determining Nonconformities
- Interpret and apply the requirements of ISO 13485:2016
- Apply ISO 14971
- Use the QMS and ISO 13485 to ensure compliance to applicable regulations
- Implement regulatory issues with minimal impact upon operations
- Identify and implement the controls necessary for ensuring the QMS consistently meets requirements
- Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
- Determine and communicate the resources necessary for the system to work as planned
- Communicate the roles and responsibilities within the QMS to the organization
- Conduct and lead 1st, 2nd and 3rd party audits, particularly on undocumented systems and audit for process effectiveness against measurable objectives
- Relate the capabilities of the organization to the expectations of customers, top management and shareholders
- Use the QMS to work proactively and not reactively, manage risk, validate software and manage suppliers
- Medical device professionals
- Professionals from FDA regulated industries
- Quality professionals
- Individuals who want to become Exemplar Global (RABQSA) certified lead auditors
- ISO Managers/Management Reps
- Auditors (internal, 3rd party, and supplier)
- Process owners
- Systems professionals or people who want to understand how management systems work
- Improvement Specialists
- Buyers in FDA regulated industries
- Leaders/managers/professionals in the Medical Device industr
- This class may be run in conjunction with a ISO 13485 Lead Auditor Training Course.
DAY 1
- Lecture: Intro to Management Systems
- Lecture: Quality Standards Including 13485
- Workshop: Terms and Definitions ISO 19011
- Lecture: ISO 13485
- Workshop: Analyzing Processes
DAY 4
- Workshop: Writing Nonconformity Statements
- Workshop: ISO 13485–Interviewing Auditees
- Workshop: Closing Meeting Preparation
DAY 2
- Exam: ISO 13485 Self Study
- Workshop: ISO 13485 Clauses
- Lecture: Auditing Management Systems
- Lecture: Developing Process-Based Management Systems
- Lecture: Audit Planning and Preparation
- Exam: 13485 Test
DAY 3
- Workshop: ISO 13485–Review System Docs and Prep Audit Schedule
- Workshop: ISO 13485–Reviewing Processes and Prep Checklists
- Lecture: Performing Lead Audit Investigation
- Workshop: Verifying Facts
- Lecture: Concluding the Audit
- Workshop: ISO 13485–Determining Nonconformities
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