Mastering ISO 10007 Quality Management Standards
You're not just managing quality-you're building trust, compliance, and competitive advantage at every level of your organisation. And yet, if you're like most professionals, ISO 10007 remains a maze of elusive structure, vague compliance goals, and missed strategic opportunities. Projects stall because requirements aren't clearly traced. Audits reveal gaps in documentation. Teams struggle to maintain consistency across product lifecycles. The pressure is real-especially when client trust and regulatory scrutiny ride on your ability to demonstrate effective quality management. The difference between success and costly inefficiency often comes down to one thing: mastery of ISO 10007’s structured approach to quality planning, control, and continual improvement. Without it, you're reactive. With it, you lead with precision. That’s why we created Mastering ISO 10007 Quality Management Standards-a transformational learning journey designed not just to explain the standard, but to equip you with the tools, frameworks, and confidence to implement it flawlessly across any project or organisation. One recent learner, Priya M, a Senior Quality Assurance Lead at a global aerospace supplier, applied these methods to redesign her team’s project quality planning process. The result? A 40% reduction in audit non-conformities and a certified ISO-aligned process adopted across three international offices within 90 days. This course is your bridge from uncertain and overwhelmed to fully equipped, board-ready, and future-proof. You’ll move from confusion to clarity, from partial compliance to full mastery-from simply “meeting standards” to leading with them. Here’s how this course is structured to help you get there.Course Format & Delivery Details Immediate, Self-Paced Access, Anytime, Anywhere
This course is fully self-paced and delivered online, giving you immediate access to all core materials upon enrollment. There are no fixed start dates, no rigid timetables, and no deadlines-only your progress, on your schedule. Most professionals complete the course in 6–8 weeks while working full time, with many reporting a clear, actionable understanding of ISO 10007 within the first five days. That means you can begin applying critical quality frameworks to real projects almost immediately. Lifetime Access & Continuous Updates
Once enrolled, you gain lifetime access to the entire course content, including all future updates at no additional cost. As ISO standards, regulatory expectations, and industry practices evolve, your knowledge stays current-forever. - Access your materials 24/7 from any device
- Download resources for offline use
- Reference core frameworks anytime, anywhere
- Receive updates automatically as standards shift
The course is mobile-optimised, so you can study during commutes, between meetings, or from remote project sites-ensuring flexibility without sacrificing depth. Expert-Led Support & Practical Guidance
While the course is self-guided, you are never alone. You'll receive direct, responsive support from our ISO accreditation experts when you have implementation questions, need clarification on complex clauses, or want feedback on your project templates. This is not passive learning. You’ll engage with real-world scenarios, build compliant documentation, and develop audit-ready quality plans-all with structured guidance to ensure you’re applying concepts correctly from day one. Issued Certificate of Completion: A Career-Advancing Credential
Upon successful completion, you’ll earn a globally recognised Certificate of Completion issued by The Art of Service. This isn’t a generic participation badge-it’s proof that you have systematically mastered ISO 10007’s principles, practices, and implementation strategies. Employers and auditors trust The Art of Service for its rigorous, no-fluff training methodology. This certificate has been accepted as evidence of professional development in audits, compliance reviews, and job applications across manufacturing, healthcare, aerospace, and technology sectors worldwide. No Hidden Fees, No Surprises
The pricing for this course is straightforward and transparent. What you see is exactly what you get-no recurring charges, no upsells, and no hidden fees. The full investment covers everything: curriculum, resources, support, and certification. We accept all major payment methods, including Visa, Mastercard, and PayPal, ensuring a seamless enrollment experience regardless of your location. 100% Satisfied or Refunded-Zero Risk to You
We understand that investing in your professional growth requires confidence. That’s why we offer a no-hassle, full refund guarantee if you find the course does not meet your expectations within the first 14 days. This isn’t just a policy-it’s a promise. We’re confident that once you begin, you’ll immediately see the value, clarity, and practical ROI this course delivers. Enrollment Confirmation & Access
After enrolling, you’ll receive an email confirmation of your registration. Your access details and course login information will be sent in a separate notification once your materials are fully prepared and queued in our learning system-ensuring a smooth and reliable start. This Works Even If…
You’re new to quality management. You’ve only skimmed ISO standards before. You work in a fast-moving industry where documentation feels like overhead. You’ve failed an audit or missed a compliance window in the past. This course is designed for real professionals with real pressure. It assumes no prior expertise in ISO 10007. Every concept is broken down into clear, actionable steps with industry-specific examples-from medical device development to software lifecycle management. Recent learners include a government compliance officer in Singapore, a project engineer at a renewable energy firm in Germany, and a quality consultant in the UAE-each reporting that the course filled critical knowledge gaps and gave them the tools to pass internal and external audits with confidence. Whether you’re preparing for certification, leading a quality transformation, or defending your process to regulators, this course gives you the authority, documentation, and structured approach to succeed-without guesswork.
Extensive and Detailed Course Curriculum
Module 1: Foundations of ISO 10007 and Quality Management - Understanding the Purpose and Scope of ISO 10007
- How ISO 10007 Fits Within the ISO 9000 Family of Standards
- Differentiating Between ISO 10007, ISO 9001, and ISO 13485
- The Evolution of Quality Management: From Inspection to Prevention
- Core Principles of Quality Planning and Control
- The Role of Quality in Risk Management and Compliance
- Key Benefits of Implementing ISO 10007 in Projects and Operations
- Understanding Stakeholder Expectations in Quality Processes
- Aligning Quality Objectives with Organisational Strategy
- Common Misconceptions About ISO 10007 Debunked
Module 2: Organisational Context and Leadership Alignment - Analysing Internal and External Issues Affecting Quality
- Identifying Relevant Interested Parties and Their Requirements
- Mapping Organisational Roles in Quality Management
- Securing Leadership Commitment to Quality Planning
- Establishing a Quality Policy That Supports ISO 10007
- Integrating Quality Objectives into Business Planning
- Defining the Scope of Application for ISO 10007
- Creating a Quality Management Framework Aligned with Culture
- Using SWOT Analysis to Identify Quality Improvement Opportunities
- Developing a Quality Vision and Long-Term Roadmap
Module 3: Quality Planning Fundamentals - Defining Quality Planning Objectives and Deliverables
- Establishing Criteria for Success and Acceptability
- Using SMART Goals in Quality Planning
- Resource Planning for Quality Activities
- Assigning Responsibilities and Accountabilities
- Developing a Project-Level Quality Plan Template
- Integrating Regulatory and Contractual Requirements
- Identifying Key Performance Indicators for Quality
- Linking Quality Plans to Project Milestones
- Ensuring Traceability from Planning to Execution
Module 4: Quality Objectives and Performance Measurement - Setting Measurable Quality Objectives
- Developing KPIs for Process and Product Quality
- Using Balanced Scorecards in Quality Management
- Establishing Baselines and Targets
- Monitoring Progress with Dashboards and Reports
- Conducting Regular Reviews of Quality Performance
- Adjusting Objectives Based on Real-World Data
- Aligning Quality Metrics with Business Outcomes
- Using Benchmarking to Improve Performance
- Reporting Quality Results to Leadership and Auditors
Module 5: Risk-Based Thinking in Quality Management - Applying ISO 31000 Principles to Quality Planning
- Identifying Quality-Related Risks and Opportunities
- Using Risk Registers for Quality Planning
- Assessing Likelihood and Impact of Quality Failures
- Prioritising Risks Using a Risk Matrix
- Integrating Risk Responses into Quality Plans
- Documenting Contingency Strategies for Critical Risks
- Linking Risk Assessments to Design and Development
- Reviewing and Updating Risk Assessments Regularly
- Reporting Risk Status in Quality Review Meetings
Module 6: Documentation and Control of Quality Records - Determining Required Documentation for ISO 10007 Compliance
- Creating Master Document Lists and Indexes
- Establishing Document Control Procedures
- Version Control and Change Management for Quality Documents
- Approval Workflows for Quality Plans and Records
- Secure Storage and Access Control for Records
- Retention Periods and Archival Policies
- Using Digital Tools for Efficient Document Management
- Audit-Ready File Structures and Naming Conventions
- Conducting Internal Document Audits
Module 7: Quality Planning for Product and Service Realisation - Integrating Quality Planning into New Product Development
- Defining Quality Requirements in Product Specifications
- Developing Design and Development Quality Plans
- Using FMEA to Prevent Design Failures
- Setting Acceptance Criteria for Prototypes
- Planning for Verification and Validation Activities
- Ensuring Regulatory Compliance in Product Realisation
- Managing Supplier Inputs in Quality Planning
- Planning for Production and Service Delivery
- Designing Controls for Batch and Continuous Production
Module 8: Planning for Verification and Validation - Understanding the Difference Between Verification and Validation
- Developing Verification Plans for Processes and Products
- Designing Validation Protocols for Critical Systems
- Using Test Cases and Checklists for Compliance
- Scheduling Independent Reviews and Peer Checks
- Documenting Test Results and Non-Conformities
- Planning for Software and Instrument Validation
- Ensuring Traceability from Requirements to Tests
- Managing Change After Validation
- Reporting Validation Outcomes to Stakeholders
Module 9: Control of Non-Conforming Outputs - Identifying and Documenting Non-Conformities
- Using Non-Conformance Reports (NCRs)
- Segregating and Labelling Non-Conforming Products
- Conducting Root Cause Analysis (RCA)
- Selecting Appropriate Corrective Actions
- Preventing Recurrence Through Process Improvement
- Obtaining Customer Approval for Deviations When Needed
- Recording Disposition Decisions (Scrap, Rework, Accept)
- Tracking Closed Non-Conformities
- Using Feedback Loops to Improve Quality Planning
Module 10: Supplier and External Provider Management - Assessing Supplier Quality Capabilities
- Developing Supplier Quality Agreements
- Defining Quality Requirements in Purchasing Documents
- Planning for Incoming Inspection and Testing
- Monitoring Supplier Performance Using KPIs
- Conducting Supplier Audits and Assessments
- Managing Supplier Corrective Action Requests (SCARs)
- Handling Subcontracted Processes
- Ensuring Compliance with Regulatory Requirements
- Building Long-Term Supplier Quality Partnerships
Module 11: Internal Auditing and Compliance Monitoring - Planning and Scheduling Internal Audits
- Developing Audit Checklists Based on ISO 10007
- Selecting and Training Internal Auditors
- Conducting Process-Oriented Audits
- Writing Clear and Objective Audit Findings
- Reporting Audit Results to Management
- Tracking Corrective Actions from Audits
- Using Audit Data for Systemic Improvement
- Preparing for External and Certification Audits
- Integrating Audit Findings into Quality Reviews
Module 12: Continual Improvement and Corrective Action - Applying the PDCA Cycle to Quality Management
- Identifying Improvement Opportunities from Data
- Using Kaizen and Lean Principles for Incremental Gains
- Developing CAPA Processes Aligned with ISO 10007
- Investigating Recurring Issues with 5 Whys and Fishbone Diagrams
- Implementing and Verifying Corrective Actions
- Prioritising Improvement Initiatives
- Engaging Teams in Problem-Solving Activities
- Documenting Improvement Projects and Outcomes
- Reporting on Continual Improvement to Leadership
Module 13: Integration with Project Management Frameworks - Aligning ISO 10007 with PMBOK and PRINCE2
- Embedding Quality Planning into Project Charters
- Using Work Breakdown Structures to Define Quality Tasks
- Integrating Quality Gates into Project Phases
- Planning for Quality in Agile and Hybrid Environments
- Managing Quality in Multi-Site and Global Projects
- Coordinating Quality Activities Across Teams
- Using Project Management Software for Quality Tracking
- Conducting Project Quality Reviews
- Handing Over Quality Documentation at Project Closeout
Module 14: Implementation in Regulated Industries - Adapting ISO 10007 for Medical Devices (ISO 13485)
- Compliance in Pharmaceutical and Biotech Environments
- Quality Planning for Aerospace and Defence (AS9100)
- Applying ISO 10007 in Automotive (IATF 16949)
- Meeting FDA, EMA, and Other Regulatory Body Expectations
- Designing Quality Plans for Software as a Medical Device (SaMD)
- Managing Configuration and Change in Regulated Systems
- Ensuring Audit Readiness in Highly Scrutinised Sectors
- Training Personnel on Quality Documentation Requirements
- Developing Defense-in-Depth Quality Strategies
Module 15: Practical Application and Real-World Projects - Case Study: Implementing ISO 10007 in a Manufacturing Plant
- Case Study: Quality Planning for a Software Development Lifecycle
- Case Study: ISO 10007 in a Healthcare Service Provider
- Developing a Full Project Quality Plan from Scratch
- Conducting a Risk Assessment for a New Product Launch
- Creating a Document Control System for a Small Business
- Simulating an Internal Audit for Compliance Verification
- Designing a Supplier Qualification and Monitoring Program
- Analysing a Real NCR and Developing a CAPA Plan
- Building a KPI Dashboard for Quality Performance
- Integrating Feedback from Customers and Employees
- Developing Management Review Reports
- Using Templates to Standardise Quality Planning
- Adapting Plans for Rapidly Changing Environments
- Navigating Cultural and Language Barriers in Global Teams
Module 16: Certification Readiness and Next Steps - Preparing for Third-Party Certification Audits
- Developing a Pre-Certification Gap Analysis
- Conducting Mock Audits to Test Readiness
- Refining Documentation for External Review
- Training Teams on Audit Response Protocols
- Engaging Certification Bodies and Understanding Their Process
- Responding to Corrective Action Requests from Auditors
- Maintaining Certification Through Ongoing Compliance
- Using the Certificate of Completion as Professional Evidence
- Leveraging Your Mastery in Job Applications and Promotions
- Accessing The Art of Service Alumni Network
- Staying Updated on ISO Developments and Industry Trends
- Engaging in Peer Learning and Mentorship
- Pursuing Advanced Credentials in Quality and Compliance
- Teaching ISO 10007 Principles to Your Teams
Module 1: Foundations of ISO 10007 and Quality Management - Understanding the Purpose and Scope of ISO 10007
- How ISO 10007 Fits Within the ISO 9000 Family of Standards
- Differentiating Between ISO 10007, ISO 9001, and ISO 13485
- The Evolution of Quality Management: From Inspection to Prevention
- Core Principles of Quality Planning and Control
- The Role of Quality in Risk Management and Compliance
- Key Benefits of Implementing ISO 10007 in Projects and Operations
- Understanding Stakeholder Expectations in Quality Processes
- Aligning Quality Objectives with Organisational Strategy
- Common Misconceptions About ISO 10007 Debunked
Module 2: Organisational Context and Leadership Alignment - Analysing Internal and External Issues Affecting Quality
- Identifying Relevant Interested Parties and Their Requirements
- Mapping Organisational Roles in Quality Management
- Securing Leadership Commitment to Quality Planning
- Establishing a Quality Policy That Supports ISO 10007
- Integrating Quality Objectives into Business Planning
- Defining the Scope of Application for ISO 10007
- Creating a Quality Management Framework Aligned with Culture
- Using SWOT Analysis to Identify Quality Improvement Opportunities
- Developing a Quality Vision and Long-Term Roadmap
Module 3: Quality Planning Fundamentals - Defining Quality Planning Objectives and Deliverables
- Establishing Criteria for Success and Acceptability
- Using SMART Goals in Quality Planning
- Resource Planning for Quality Activities
- Assigning Responsibilities and Accountabilities
- Developing a Project-Level Quality Plan Template
- Integrating Regulatory and Contractual Requirements
- Identifying Key Performance Indicators for Quality
- Linking Quality Plans to Project Milestones
- Ensuring Traceability from Planning to Execution
Module 4: Quality Objectives and Performance Measurement - Setting Measurable Quality Objectives
- Developing KPIs for Process and Product Quality
- Using Balanced Scorecards in Quality Management
- Establishing Baselines and Targets
- Monitoring Progress with Dashboards and Reports
- Conducting Regular Reviews of Quality Performance
- Adjusting Objectives Based on Real-World Data
- Aligning Quality Metrics with Business Outcomes
- Using Benchmarking to Improve Performance
- Reporting Quality Results to Leadership and Auditors
Module 5: Risk-Based Thinking in Quality Management - Applying ISO 31000 Principles to Quality Planning
- Identifying Quality-Related Risks and Opportunities
- Using Risk Registers for Quality Planning
- Assessing Likelihood and Impact of Quality Failures
- Prioritising Risks Using a Risk Matrix
- Integrating Risk Responses into Quality Plans
- Documenting Contingency Strategies for Critical Risks
- Linking Risk Assessments to Design and Development
- Reviewing and Updating Risk Assessments Regularly
- Reporting Risk Status in Quality Review Meetings
Module 6: Documentation and Control of Quality Records - Determining Required Documentation for ISO 10007 Compliance
- Creating Master Document Lists and Indexes
- Establishing Document Control Procedures
- Version Control and Change Management for Quality Documents
- Approval Workflows for Quality Plans and Records
- Secure Storage and Access Control for Records
- Retention Periods and Archival Policies
- Using Digital Tools for Efficient Document Management
- Audit-Ready File Structures and Naming Conventions
- Conducting Internal Document Audits
Module 7: Quality Planning for Product and Service Realisation - Integrating Quality Planning into New Product Development
- Defining Quality Requirements in Product Specifications
- Developing Design and Development Quality Plans
- Using FMEA to Prevent Design Failures
- Setting Acceptance Criteria for Prototypes
- Planning for Verification and Validation Activities
- Ensuring Regulatory Compliance in Product Realisation
- Managing Supplier Inputs in Quality Planning
- Planning for Production and Service Delivery
- Designing Controls for Batch and Continuous Production
Module 8: Planning for Verification and Validation - Understanding the Difference Between Verification and Validation
- Developing Verification Plans for Processes and Products
- Designing Validation Protocols for Critical Systems
- Using Test Cases and Checklists for Compliance
- Scheduling Independent Reviews and Peer Checks
- Documenting Test Results and Non-Conformities
- Planning for Software and Instrument Validation
- Ensuring Traceability from Requirements to Tests
- Managing Change After Validation
- Reporting Validation Outcomes to Stakeholders
Module 9: Control of Non-Conforming Outputs - Identifying and Documenting Non-Conformities
- Using Non-Conformance Reports (NCRs)
- Segregating and Labelling Non-Conforming Products
- Conducting Root Cause Analysis (RCA)
- Selecting Appropriate Corrective Actions
- Preventing Recurrence Through Process Improvement
- Obtaining Customer Approval for Deviations When Needed
- Recording Disposition Decisions (Scrap, Rework, Accept)
- Tracking Closed Non-Conformities
- Using Feedback Loops to Improve Quality Planning
Module 10: Supplier and External Provider Management - Assessing Supplier Quality Capabilities
- Developing Supplier Quality Agreements
- Defining Quality Requirements in Purchasing Documents
- Planning for Incoming Inspection and Testing
- Monitoring Supplier Performance Using KPIs
- Conducting Supplier Audits and Assessments
- Managing Supplier Corrective Action Requests (SCARs)
- Handling Subcontracted Processes
- Ensuring Compliance with Regulatory Requirements
- Building Long-Term Supplier Quality Partnerships
Module 11: Internal Auditing and Compliance Monitoring - Planning and Scheduling Internal Audits
- Developing Audit Checklists Based on ISO 10007
- Selecting and Training Internal Auditors
- Conducting Process-Oriented Audits
- Writing Clear and Objective Audit Findings
- Reporting Audit Results to Management
- Tracking Corrective Actions from Audits
- Using Audit Data for Systemic Improvement
- Preparing for External and Certification Audits
- Integrating Audit Findings into Quality Reviews
Module 12: Continual Improvement and Corrective Action - Applying the PDCA Cycle to Quality Management
- Identifying Improvement Opportunities from Data
- Using Kaizen and Lean Principles for Incremental Gains
- Developing CAPA Processes Aligned with ISO 10007
- Investigating Recurring Issues with 5 Whys and Fishbone Diagrams
- Implementing and Verifying Corrective Actions
- Prioritising Improvement Initiatives
- Engaging Teams in Problem-Solving Activities
- Documenting Improvement Projects and Outcomes
- Reporting on Continual Improvement to Leadership
Module 13: Integration with Project Management Frameworks - Aligning ISO 10007 with PMBOK and PRINCE2
- Embedding Quality Planning into Project Charters
- Using Work Breakdown Structures to Define Quality Tasks
- Integrating Quality Gates into Project Phases
- Planning for Quality in Agile and Hybrid Environments
- Managing Quality in Multi-Site and Global Projects
- Coordinating Quality Activities Across Teams
- Using Project Management Software for Quality Tracking
- Conducting Project Quality Reviews
- Handing Over Quality Documentation at Project Closeout
Module 14: Implementation in Regulated Industries - Adapting ISO 10007 for Medical Devices (ISO 13485)
- Compliance in Pharmaceutical and Biotech Environments
- Quality Planning for Aerospace and Defence (AS9100)
- Applying ISO 10007 in Automotive (IATF 16949)
- Meeting FDA, EMA, and Other Regulatory Body Expectations
- Designing Quality Plans for Software as a Medical Device (SaMD)
- Managing Configuration and Change in Regulated Systems
- Ensuring Audit Readiness in Highly Scrutinised Sectors
- Training Personnel on Quality Documentation Requirements
- Developing Defense-in-Depth Quality Strategies
Module 15: Practical Application and Real-World Projects - Case Study: Implementing ISO 10007 in a Manufacturing Plant
- Case Study: Quality Planning for a Software Development Lifecycle
- Case Study: ISO 10007 in a Healthcare Service Provider
- Developing a Full Project Quality Plan from Scratch
- Conducting a Risk Assessment for a New Product Launch
- Creating a Document Control System for a Small Business
- Simulating an Internal Audit for Compliance Verification
- Designing a Supplier Qualification and Monitoring Program
- Analysing a Real NCR and Developing a CAPA Plan
- Building a KPI Dashboard for Quality Performance
- Integrating Feedback from Customers and Employees
- Developing Management Review Reports
- Using Templates to Standardise Quality Planning
- Adapting Plans for Rapidly Changing Environments
- Navigating Cultural and Language Barriers in Global Teams
Module 16: Certification Readiness and Next Steps - Preparing for Third-Party Certification Audits
- Developing a Pre-Certification Gap Analysis
- Conducting Mock Audits to Test Readiness
- Refining Documentation for External Review
- Training Teams on Audit Response Protocols
- Engaging Certification Bodies and Understanding Their Process
- Responding to Corrective Action Requests from Auditors
- Maintaining Certification Through Ongoing Compliance
- Using the Certificate of Completion as Professional Evidence
- Leveraging Your Mastery in Job Applications and Promotions
- Accessing The Art of Service Alumni Network
- Staying Updated on ISO Developments and Industry Trends
- Engaging in Peer Learning and Mentorship
- Pursuing Advanced Credentials in Quality and Compliance
- Teaching ISO 10007 Principles to Your Teams
- Analysing Internal and External Issues Affecting Quality
- Identifying Relevant Interested Parties and Their Requirements
- Mapping Organisational Roles in Quality Management
- Securing Leadership Commitment to Quality Planning
- Establishing a Quality Policy That Supports ISO 10007
- Integrating Quality Objectives into Business Planning
- Defining the Scope of Application for ISO 10007
- Creating a Quality Management Framework Aligned with Culture
- Using SWOT Analysis to Identify Quality Improvement Opportunities
- Developing a Quality Vision and Long-Term Roadmap
Module 3: Quality Planning Fundamentals - Defining Quality Planning Objectives and Deliverables
- Establishing Criteria for Success and Acceptability
- Using SMART Goals in Quality Planning
- Resource Planning for Quality Activities
- Assigning Responsibilities and Accountabilities
- Developing a Project-Level Quality Plan Template
- Integrating Regulatory and Contractual Requirements
- Identifying Key Performance Indicators for Quality
- Linking Quality Plans to Project Milestones
- Ensuring Traceability from Planning to Execution
Module 4: Quality Objectives and Performance Measurement - Setting Measurable Quality Objectives
- Developing KPIs for Process and Product Quality
- Using Balanced Scorecards in Quality Management
- Establishing Baselines and Targets
- Monitoring Progress with Dashboards and Reports
- Conducting Regular Reviews of Quality Performance
- Adjusting Objectives Based on Real-World Data
- Aligning Quality Metrics with Business Outcomes
- Using Benchmarking to Improve Performance
- Reporting Quality Results to Leadership and Auditors
Module 5: Risk-Based Thinking in Quality Management - Applying ISO 31000 Principles to Quality Planning
- Identifying Quality-Related Risks and Opportunities
- Using Risk Registers for Quality Planning
- Assessing Likelihood and Impact of Quality Failures
- Prioritising Risks Using a Risk Matrix
- Integrating Risk Responses into Quality Plans
- Documenting Contingency Strategies for Critical Risks
- Linking Risk Assessments to Design and Development
- Reviewing and Updating Risk Assessments Regularly
- Reporting Risk Status in Quality Review Meetings
Module 6: Documentation and Control of Quality Records - Determining Required Documentation for ISO 10007 Compliance
- Creating Master Document Lists and Indexes
- Establishing Document Control Procedures
- Version Control and Change Management for Quality Documents
- Approval Workflows for Quality Plans and Records
- Secure Storage and Access Control for Records
- Retention Periods and Archival Policies
- Using Digital Tools for Efficient Document Management
- Audit-Ready File Structures and Naming Conventions
- Conducting Internal Document Audits
Module 7: Quality Planning for Product and Service Realisation - Integrating Quality Planning into New Product Development
- Defining Quality Requirements in Product Specifications
- Developing Design and Development Quality Plans
- Using FMEA to Prevent Design Failures
- Setting Acceptance Criteria for Prototypes
- Planning for Verification and Validation Activities
- Ensuring Regulatory Compliance in Product Realisation
- Managing Supplier Inputs in Quality Planning
- Planning for Production and Service Delivery
- Designing Controls for Batch and Continuous Production
Module 8: Planning for Verification and Validation - Understanding the Difference Between Verification and Validation
- Developing Verification Plans for Processes and Products
- Designing Validation Protocols for Critical Systems
- Using Test Cases and Checklists for Compliance
- Scheduling Independent Reviews and Peer Checks
- Documenting Test Results and Non-Conformities
- Planning for Software and Instrument Validation
- Ensuring Traceability from Requirements to Tests
- Managing Change After Validation
- Reporting Validation Outcomes to Stakeholders
Module 9: Control of Non-Conforming Outputs - Identifying and Documenting Non-Conformities
- Using Non-Conformance Reports (NCRs)
- Segregating and Labelling Non-Conforming Products
- Conducting Root Cause Analysis (RCA)
- Selecting Appropriate Corrective Actions
- Preventing Recurrence Through Process Improvement
- Obtaining Customer Approval for Deviations When Needed
- Recording Disposition Decisions (Scrap, Rework, Accept)
- Tracking Closed Non-Conformities
- Using Feedback Loops to Improve Quality Planning
Module 10: Supplier and External Provider Management - Assessing Supplier Quality Capabilities
- Developing Supplier Quality Agreements
- Defining Quality Requirements in Purchasing Documents
- Planning for Incoming Inspection and Testing
- Monitoring Supplier Performance Using KPIs
- Conducting Supplier Audits and Assessments
- Managing Supplier Corrective Action Requests (SCARs)
- Handling Subcontracted Processes
- Ensuring Compliance with Regulatory Requirements
- Building Long-Term Supplier Quality Partnerships
Module 11: Internal Auditing and Compliance Monitoring - Planning and Scheduling Internal Audits
- Developing Audit Checklists Based on ISO 10007
- Selecting and Training Internal Auditors
- Conducting Process-Oriented Audits
- Writing Clear and Objective Audit Findings
- Reporting Audit Results to Management
- Tracking Corrective Actions from Audits
- Using Audit Data for Systemic Improvement
- Preparing for External and Certification Audits
- Integrating Audit Findings into Quality Reviews
Module 12: Continual Improvement and Corrective Action - Applying the PDCA Cycle to Quality Management
- Identifying Improvement Opportunities from Data
- Using Kaizen and Lean Principles for Incremental Gains
- Developing CAPA Processes Aligned with ISO 10007
- Investigating Recurring Issues with 5 Whys and Fishbone Diagrams
- Implementing and Verifying Corrective Actions
- Prioritising Improvement Initiatives
- Engaging Teams in Problem-Solving Activities
- Documenting Improvement Projects and Outcomes
- Reporting on Continual Improvement to Leadership
Module 13: Integration with Project Management Frameworks - Aligning ISO 10007 with PMBOK and PRINCE2
- Embedding Quality Planning into Project Charters
- Using Work Breakdown Structures to Define Quality Tasks
- Integrating Quality Gates into Project Phases
- Planning for Quality in Agile and Hybrid Environments
- Managing Quality in Multi-Site and Global Projects
- Coordinating Quality Activities Across Teams
- Using Project Management Software for Quality Tracking
- Conducting Project Quality Reviews
- Handing Over Quality Documentation at Project Closeout
Module 14: Implementation in Regulated Industries - Adapting ISO 10007 for Medical Devices (ISO 13485)
- Compliance in Pharmaceutical and Biotech Environments
- Quality Planning for Aerospace and Defence (AS9100)
- Applying ISO 10007 in Automotive (IATF 16949)
- Meeting FDA, EMA, and Other Regulatory Body Expectations
- Designing Quality Plans for Software as a Medical Device (SaMD)
- Managing Configuration and Change in Regulated Systems
- Ensuring Audit Readiness in Highly Scrutinised Sectors
- Training Personnel on Quality Documentation Requirements
- Developing Defense-in-Depth Quality Strategies
Module 15: Practical Application and Real-World Projects - Case Study: Implementing ISO 10007 in a Manufacturing Plant
- Case Study: Quality Planning for a Software Development Lifecycle
- Case Study: ISO 10007 in a Healthcare Service Provider
- Developing a Full Project Quality Plan from Scratch
- Conducting a Risk Assessment for a New Product Launch
- Creating a Document Control System for a Small Business
- Simulating an Internal Audit for Compliance Verification
- Designing a Supplier Qualification and Monitoring Program
- Analysing a Real NCR and Developing a CAPA Plan
- Building a KPI Dashboard for Quality Performance
- Integrating Feedback from Customers and Employees
- Developing Management Review Reports
- Using Templates to Standardise Quality Planning
- Adapting Plans for Rapidly Changing Environments
- Navigating Cultural and Language Barriers in Global Teams
Module 16: Certification Readiness and Next Steps - Preparing for Third-Party Certification Audits
- Developing a Pre-Certification Gap Analysis
- Conducting Mock Audits to Test Readiness
- Refining Documentation for External Review
- Training Teams on Audit Response Protocols
- Engaging Certification Bodies and Understanding Their Process
- Responding to Corrective Action Requests from Auditors
- Maintaining Certification Through Ongoing Compliance
- Using the Certificate of Completion as Professional Evidence
- Leveraging Your Mastery in Job Applications and Promotions
- Accessing The Art of Service Alumni Network
- Staying Updated on ISO Developments and Industry Trends
- Engaging in Peer Learning and Mentorship
- Pursuing Advanced Credentials in Quality and Compliance
- Teaching ISO 10007 Principles to Your Teams
- Setting Measurable Quality Objectives
- Developing KPIs for Process and Product Quality
- Using Balanced Scorecards in Quality Management
- Establishing Baselines and Targets
- Monitoring Progress with Dashboards and Reports
- Conducting Regular Reviews of Quality Performance
- Adjusting Objectives Based on Real-World Data
- Aligning Quality Metrics with Business Outcomes
- Using Benchmarking to Improve Performance
- Reporting Quality Results to Leadership and Auditors
Module 5: Risk-Based Thinking in Quality Management - Applying ISO 31000 Principles to Quality Planning
- Identifying Quality-Related Risks and Opportunities
- Using Risk Registers for Quality Planning
- Assessing Likelihood and Impact of Quality Failures
- Prioritising Risks Using a Risk Matrix
- Integrating Risk Responses into Quality Plans
- Documenting Contingency Strategies for Critical Risks
- Linking Risk Assessments to Design and Development
- Reviewing and Updating Risk Assessments Regularly
- Reporting Risk Status in Quality Review Meetings
Module 6: Documentation and Control of Quality Records - Determining Required Documentation for ISO 10007 Compliance
- Creating Master Document Lists and Indexes
- Establishing Document Control Procedures
- Version Control and Change Management for Quality Documents
- Approval Workflows for Quality Plans and Records
- Secure Storage and Access Control for Records
- Retention Periods and Archival Policies
- Using Digital Tools for Efficient Document Management
- Audit-Ready File Structures and Naming Conventions
- Conducting Internal Document Audits
Module 7: Quality Planning for Product and Service Realisation - Integrating Quality Planning into New Product Development
- Defining Quality Requirements in Product Specifications
- Developing Design and Development Quality Plans
- Using FMEA to Prevent Design Failures
- Setting Acceptance Criteria for Prototypes
- Planning for Verification and Validation Activities
- Ensuring Regulatory Compliance in Product Realisation
- Managing Supplier Inputs in Quality Planning
- Planning for Production and Service Delivery
- Designing Controls for Batch and Continuous Production
Module 8: Planning for Verification and Validation - Understanding the Difference Between Verification and Validation
- Developing Verification Plans for Processes and Products
- Designing Validation Protocols for Critical Systems
- Using Test Cases and Checklists for Compliance
- Scheduling Independent Reviews and Peer Checks
- Documenting Test Results and Non-Conformities
- Planning for Software and Instrument Validation
- Ensuring Traceability from Requirements to Tests
- Managing Change After Validation
- Reporting Validation Outcomes to Stakeholders
Module 9: Control of Non-Conforming Outputs - Identifying and Documenting Non-Conformities
- Using Non-Conformance Reports (NCRs)
- Segregating and Labelling Non-Conforming Products
- Conducting Root Cause Analysis (RCA)
- Selecting Appropriate Corrective Actions
- Preventing Recurrence Through Process Improvement
- Obtaining Customer Approval for Deviations When Needed
- Recording Disposition Decisions (Scrap, Rework, Accept)
- Tracking Closed Non-Conformities
- Using Feedback Loops to Improve Quality Planning
Module 10: Supplier and External Provider Management - Assessing Supplier Quality Capabilities
- Developing Supplier Quality Agreements
- Defining Quality Requirements in Purchasing Documents
- Planning for Incoming Inspection and Testing
- Monitoring Supplier Performance Using KPIs
- Conducting Supplier Audits and Assessments
- Managing Supplier Corrective Action Requests (SCARs)
- Handling Subcontracted Processes
- Ensuring Compliance with Regulatory Requirements
- Building Long-Term Supplier Quality Partnerships
Module 11: Internal Auditing and Compliance Monitoring - Planning and Scheduling Internal Audits
- Developing Audit Checklists Based on ISO 10007
- Selecting and Training Internal Auditors
- Conducting Process-Oriented Audits
- Writing Clear and Objective Audit Findings
- Reporting Audit Results to Management
- Tracking Corrective Actions from Audits
- Using Audit Data for Systemic Improvement
- Preparing for External and Certification Audits
- Integrating Audit Findings into Quality Reviews
Module 12: Continual Improvement and Corrective Action - Applying the PDCA Cycle to Quality Management
- Identifying Improvement Opportunities from Data
- Using Kaizen and Lean Principles for Incremental Gains
- Developing CAPA Processes Aligned with ISO 10007
- Investigating Recurring Issues with 5 Whys and Fishbone Diagrams
- Implementing and Verifying Corrective Actions
- Prioritising Improvement Initiatives
- Engaging Teams in Problem-Solving Activities
- Documenting Improvement Projects and Outcomes
- Reporting on Continual Improvement to Leadership
Module 13: Integration with Project Management Frameworks - Aligning ISO 10007 with PMBOK and PRINCE2
- Embedding Quality Planning into Project Charters
- Using Work Breakdown Structures to Define Quality Tasks
- Integrating Quality Gates into Project Phases
- Planning for Quality in Agile and Hybrid Environments
- Managing Quality in Multi-Site and Global Projects
- Coordinating Quality Activities Across Teams
- Using Project Management Software for Quality Tracking
- Conducting Project Quality Reviews
- Handing Over Quality Documentation at Project Closeout
Module 14: Implementation in Regulated Industries - Adapting ISO 10007 for Medical Devices (ISO 13485)
- Compliance in Pharmaceutical and Biotech Environments
- Quality Planning for Aerospace and Defence (AS9100)
- Applying ISO 10007 in Automotive (IATF 16949)
- Meeting FDA, EMA, and Other Regulatory Body Expectations
- Designing Quality Plans for Software as a Medical Device (SaMD)
- Managing Configuration and Change in Regulated Systems
- Ensuring Audit Readiness in Highly Scrutinised Sectors
- Training Personnel on Quality Documentation Requirements
- Developing Defense-in-Depth Quality Strategies
Module 15: Practical Application and Real-World Projects - Case Study: Implementing ISO 10007 in a Manufacturing Plant
- Case Study: Quality Planning for a Software Development Lifecycle
- Case Study: ISO 10007 in a Healthcare Service Provider
- Developing a Full Project Quality Plan from Scratch
- Conducting a Risk Assessment for a New Product Launch
- Creating a Document Control System for a Small Business
- Simulating an Internal Audit for Compliance Verification
- Designing a Supplier Qualification and Monitoring Program
- Analysing a Real NCR and Developing a CAPA Plan
- Building a KPI Dashboard for Quality Performance
- Integrating Feedback from Customers and Employees
- Developing Management Review Reports
- Using Templates to Standardise Quality Planning
- Adapting Plans for Rapidly Changing Environments
- Navigating Cultural and Language Barriers in Global Teams
Module 16: Certification Readiness and Next Steps - Preparing for Third-Party Certification Audits
- Developing a Pre-Certification Gap Analysis
- Conducting Mock Audits to Test Readiness
- Refining Documentation for External Review
- Training Teams on Audit Response Protocols
- Engaging Certification Bodies and Understanding Their Process
- Responding to Corrective Action Requests from Auditors
- Maintaining Certification Through Ongoing Compliance
- Using the Certificate of Completion as Professional Evidence
- Leveraging Your Mastery in Job Applications and Promotions
- Accessing The Art of Service Alumni Network
- Staying Updated on ISO Developments and Industry Trends
- Engaging in Peer Learning and Mentorship
- Pursuing Advanced Credentials in Quality and Compliance
- Teaching ISO 10007 Principles to Your Teams
- Determining Required Documentation for ISO 10007 Compliance
- Creating Master Document Lists and Indexes
- Establishing Document Control Procedures
- Version Control and Change Management for Quality Documents
- Approval Workflows for Quality Plans and Records
- Secure Storage and Access Control for Records
- Retention Periods and Archival Policies
- Using Digital Tools for Efficient Document Management
- Audit-Ready File Structures and Naming Conventions
- Conducting Internal Document Audits
Module 7: Quality Planning for Product and Service Realisation - Integrating Quality Planning into New Product Development
- Defining Quality Requirements in Product Specifications
- Developing Design and Development Quality Plans
- Using FMEA to Prevent Design Failures
- Setting Acceptance Criteria for Prototypes
- Planning for Verification and Validation Activities
- Ensuring Regulatory Compliance in Product Realisation
- Managing Supplier Inputs in Quality Planning
- Planning for Production and Service Delivery
- Designing Controls for Batch and Continuous Production
Module 8: Planning for Verification and Validation - Understanding the Difference Between Verification and Validation
- Developing Verification Plans for Processes and Products
- Designing Validation Protocols for Critical Systems
- Using Test Cases and Checklists for Compliance
- Scheduling Independent Reviews and Peer Checks
- Documenting Test Results and Non-Conformities
- Planning for Software and Instrument Validation
- Ensuring Traceability from Requirements to Tests
- Managing Change After Validation
- Reporting Validation Outcomes to Stakeholders
Module 9: Control of Non-Conforming Outputs - Identifying and Documenting Non-Conformities
- Using Non-Conformance Reports (NCRs)
- Segregating and Labelling Non-Conforming Products
- Conducting Root Cause Analysis (RCA)
- Selecting Appropriate Corrective Actions
- Preventing Recurrence Through Process Improvement
- Obtaining Customer Approval for Deviations When Needed
- Recording Disposition Decisions (Scrap, Rework, Accept)
- Tracking Closed Non-Conformities
- Using Feedback Loops to Improve Quality Planning
Module 10: Supplier and External Provider Management - Assessing Supplier Quality Capabilities
- Developing Supplier Quality Agreements
- Defining Quality Requirements in Purchasing Documents
- Planning for Incoming Inspection and Testing
- Monitoring Supplier Performance Using KPIs
- Conducting Supplier Audits and Assessments
- Managing Supplier Corrective Action Requests (SCARs)
- Handling Subcontracted Processes
- Ensuring Compliance with Regulatory Requirements
- Building Long-Term Supplier Quality Partnerships
Module 11: Internal Auditing and Compliance Monitoring - Planning and Scheduling Internal Audits
- Developing Audit Checklists Based on ISO 10007
- Selecting and Training Internal Auditors
- Conducting Process-Oriented Audits
- Writing Clear and Objective Audit Findings
- Reporting Audit Results to Management
- Tracking Corrective Actions from Audits
- Using Audit Data for Systemic Improvement
- Preparing for External and Certification Audits
- Integrating Audit Findings into Quality Reviews
Module 12: Continual Improvement and Corrective Action - Applying the PDCA Cycle to Quality Management
- Identifying Improvement Opportunities from Data
- Using Kaizen and Lean Principles for Incremental Gains
- Developing CAPA Processes Aligned with ISO 10007
- Investigating Recurring Issues with 5 Whys and Fishbone Diagrams
- Implementing and Verifying Corrective Actions
- Prioritising Improvement Initiatives
- Engaging Teams in Problem-Solving Activities
- Documenting Improvement Projects and Outcomes
- Reporting on Continual Improvement to Leadership
Module 13: Integration with Project Management Frameworks - Aligning ISO 10007 with PMBOK and PRINCE2
- Embedding Quality Planning into Project Charters
- Using Work Breakdown Structures to Define Quality Tasks
- Integrating Quality Gates into Project Phases
- Planning for Quality in Agile and Hybrid Environments
- Managing Quality in Multi-Site and Global Projects
- Coordinating Quality Activities Across Teams
- Using Project Management Software for Quality Tracking
- Conducting Project Quality Reviews
- Handing Over Quality Documentation at Project Closeout
Module 14: Implementation in Regulated Industries - Adapting ISO 10007 for Medical Devices (ISO 13485)
- Compliance in Pharmaceutical and Biotech Environments
- Quality Planning for Aerospace and Defence (AS9100)
- Applying ISO 10007 in Automotive (IATF 16949)
- Meeting FDA, EMA, and Other Regulatory Body Expectations
- Designing Quality Plans for Software as a Medical Device (SaMD)
- Managing Configuration and Change in Regulated Systems
- Ensuring Audit Readiness in Highly Scrutinised Sectors
- Training Personnel on Quality Documentation Requirements
- Developing Defense-in-Depth Quality Strategies
Module 15: Practical Application and Real-World Projects - Case Study: Implementing ISO 10007 in a Manufacturing Plant
- Case Study: Quality Planning for a Software Development Lifecycle
- Case Study: ISO 10007 in a Healthcare Service Provider
- Developing a Full Project Quality Plan from Scratch
- Conducting a Risk Assessment for a New Product Launch
- Creating a Document Control System for a Small Business
- Simulating an Internal Audit for Compliance Verification
- Designing a Supplier Qualification and Monitoring Program
- Analysing a Real NCR and Developing a CAPA Plan
- Building a KPI Dashboard for Quality Performance
- Integrating Feedback from Customers and Employees
- Developing Management Review Reports
- Using Templates to Standardise Quality Planning
- Adapting Plans for Rapidly Changing Environments
- Navigating Cultural and Language Barriers in Global Teams
Module 16: Certification Readiness and Next Steps - Preparing for Third-Party Certification Audits
- Developing a Pre-Certification Gap Analysis
- Conducting Mock Audits to Test Readiness
- Refining Documentation for External Review
- Training Teams on Audit Response Protocols
- Engaging Certification Bodies and Understanding Their Process
- Responding to Corrective Action Requests from Auditors
- Maintaining Certification Through Ongoing Compliance
- Using the Certificate of Completion as Professional Evidence
- Leveraging Your Mastery in Job Applications and Promotions
- Accessing The Art of Service Alumni Network
- Staying Updated on ISO Developments and Industry Trends
- Engaging in Peer Learning and Mentorship
- Pursuing Advanced Credentials in Quality and Compliance
- Teaching ISO 10007 Principles to Your Teams
- Understanding the Difference Between Verification and Validation
- Developing Verification Plans for Processes and Products
- Designing Validation Protocols for Critical Systems
- Using Test Cases and Checklists for Compliance
- Scheduling Independent Reviews and Peer Checks
- Documenting Test Results and Non-Conformities
- Planning for Software and Instrument Validation
- Ensuring Traceability from Requirements to Tests
- Managing Change After Validation
- Reporting Validation Outcomes to Stakeholders
Module 9: Control of Non-Conforming Outputs - Identifying and Documenting Non-Conformities
- Using Non-Conformance Reports (NCRs)
- Segregating and Labelling Non-Conforming Products
- Conducting Root Cause Analysis (RCA)
- Selecting Appropriate Corrective Actions
- Preventing Recurrence Through Process Improvement
- Obtaining Customer Approval for Deviations When Needed
- Recording Disposition Decisions (Scrap, Rework, Accept)
- Tracking Closed Non-Conformities
- Using Feedback Loops to Improve Quality Planning
Module 10: Supplier and External Provider Management - Assessing Supplier Quality Capabilities
- Developing Supplier Quality Agreements
- Defining Quality Requirements in Purchasing Documents
- Planning for Incoming Inspection and Testing
- Monitoring Supplier Performance Using KPIs
- Conducting Supplier Audits and Assessments
- Managing Supplier Corrective Action Requests (SCARs)
- Handling Subcontracted Processes
- Ensuring Compliance with Regulatory Requirements
- Building Long-Term Supplier Quality Partnerships
Module 11: Internal Auditing and Compliance Monitoring - Planning and Scheduling Internal Audits
- Developing Audit Checklists Based on ISO 10007
- Selecting and Training Internal Auditors
- Conducting Process-Oriented Audits
- Writing Clear and Objective Audit Findings
- Reporting Audit Results to Management
- Tracking Corrective Actions from Audits
- Using Audit Data for Systemic Improvement
- Preparing for External and Certification Audits
- Integrating Audit Findings into Quality Reviews
Module 12: Continual Improvement and Corrective Action - Applying the PDCA Cycle to Quality Management
- Identifying Improvement Opportunities from Data
- Using Kaizen and Lean Principles for Incremental Gains
- Developing CAPA Processes Aligned with ISO 10007
- Investigating Recurring Issues with 5 Whys and Fishbone Diagrams
- Implementing and Verifying Corrective Actions
- Prioritising Improvement Initiatives
- Engaging Teams in Problem-Solving Activities
- Documenting Improvement Projects and Outcomes
- Reporting on Continual Improvement to Leadership
Module 13: Integration with Project Management Frameworks - Aligning ISO 10007 with PMBOK and PRINCE2
- Embedding Quality Planning into Project Charters
- Using Work Breakdown Structures to Define Quality Tasks
- Integrating Quality Gates into Project Phases
- Planning for Quality in Agile and Hybrid Environments
- Managing Quality in Multi-Site and Global Projects
- Coordinating Quality Activities Across Teams
- Using Project Management Software for Quality Tracking
- Conducting Project Quality Reviews
- Handing Over Quality Documentation at Project Closeout
Module 14: Implementation in Regulated Industries - Adapting ISO 10007 for Medical Devices (ISO 13485)
- Compliance in Pharmaceutical and Biotech Environments
- Quality Planning for Aerospace and Defence (AS9100)
- Applying ISO 10007 in Automotive (IATF 16949)
- Meeting FDA, EMA, and Other Regulatory Body Expectations
- Designing Quality Plans for Software as a Medical Device (SaMD)
- Managing Configuration and Change in Regulated Systems
- Ensuring Audit Readiness in Highly Scrutinised Sectors
- Training Personnel on Quality Documentation Requirements
- Developing Defense-in-Depth Quality Strategies
Module 15: Practical Application and Real-World Projects - Case Study: Implementing ISO 10007 in a Manufacturing Plant
- Case Study: Quality Planning for a Software Development Lifecycle
- Case Study: ISO 10007 in a Healthcare Service Provider
- Developing a Full Project Quality Plan from Scratch
- Conducting a Risk Assessment for a New Product Launch
- Creating a Document Control System for a Small Business
- Simulating an Internal Audit for Compliance Verification
- Designing a Supplier Qualification and Monitoring Program
- Analysing a Real NCR and Developing a CAPA Plan
- Building a KPI Dashboard for Quality Performance
- Integrating Feedback from Customers and Employees
- Developing Management Review Reports
- Using Templates to Standardise Quality Planning
- Adapting Plans for Rapidly Changing Environments
- Navigating Cultural and Language Barriers in Global Teams
Module 16: Certification Readiness and Next Steps - Preparing for Third-Party Certification Audits
- Developing a Pre-Certification Gap Analysis
- Conducting Mock Audits to Test Readiness
- Refining Documentation for External Review
- Training Teams on Audit Response Protocols
- Engaging Certification Bodies and Understanding Their Process
- Responding to Corrective Action Requests from Auditors
- Maintaining Certification Through Ongoing Compliance
- Using the Certificate of Completion as Professional Evidence
- Leveraging Your Mastery in Job Applications and Promotions
- Accessing The Art of Service Alumni Network
- Staying Updated on ISO Developments and Industry Trends
- Engaging in Peer Learning and Mentorship
- Pursuing Advanced Credentials in Quality and Compliance
- Teaching ISO 10007 Principles to Your Teams
- Assessing Supplier Quality Capabilities
- Developing Supplier Quality Agreements
- Defining Quality Requirements in Purchasing Documents
- Planning for Incoming Inspection and Testing
- Monitoring Supplier Performance Using KPIs
- Conducting Supplier Audits and Assessments
- Managing Supplier Corrective Action Requests (SCARs)
- Handling Subcontracted Processes
- Ensuring Compliance with Regulatory Requirements
- Building Long-Term Supplier Quality Partnerships
Module 11: Internal Auditing and Compliance Monitoring - Planning and Scheduling Internal Audits
- Developing Audit Checklists Based on ISO 10007
- Selecting and Training Internal Auditors
- Conducting Process-Oriented Audits
- Writing Clear and Objective Audit Findings
- Reporting Audit Results to Management
- Tracking Corrective Actions from Audits
- Using Audit Data for Systemic Improvement
- Preparing for External and Certification Audits
- Integrating Audit Findings into Quality Reviews
Module 12: Continual Improvement and Corrective Action - Applying the PDCA Cycle to Quality Management
- Identifying Improvement Opportunities from Data
- Using Kaizen and Lean Principles for Incremental Gains
- Developing CAPA Processes Aligned with ISO 10007
- Investigating Recurring Issues with 5 Whys and Fishbone Diagrams
- Implementing and Verifying Corrective Actions
- Prioritising Improvement Initiatives
- Engaging Teams in Problem-Solving Activities
- Documenting Improvement Projects and Outcomes
- Reporting on Continual Improvement to Leadership
Module 13: Integration with Project Management Frameworks - Aligning ISO 10007 with PMBOK and PRINCE2
- Embedding Quality Planning into Project Charters
- Using Work Breakdown Structures to Define Quality Tasks
- Integrating Quality Gates into Project Phases
- Planning for Quality in Agile and Hybrid Environments
- Managing Quality in Multi-Site and Global Projects
- Coordinating Quality Activities Across Teams
- Using Project Management Software for Quality Tracking
- Conducting Project Quality Reviews
- Handing Over Quality Documentation at Project Closeout
Module 14: Implementation in Regulated Industries - Adapting ISO 10007 for Medical Devices (ISO 13485)
- Compliance in Pharmaceutical and Biotech Environments
- Quality Planning for Aerospace and Defence (AS9100)
- Applying ISO 10007 in Automotive (IATF 16949)
- Meeting FDA, EMA, and Other Regulatory Body Expectations
- Designing Quality Plans for Software as a Medical Device (SaMD)
- Managing Configuration and Change in Regulated Systems
- Ensuring Audit Readiness in Highly Scrutinised Sectors
- Training Personnel on Quality Documentation Requirements
- Developing Defense-in-Depth Quality Strategies
Module 15: Practical Application and Real-World Projects - Case Study: Implementing ISO 10007 in a Manufacturing Plant
- Case Study: Quality Planning for a Software Development Lifecycle
- Case Study: ISO 10007 in a Healthcare Service Provider
- Developing a Full Project Quality Plan from Scratch
- Conducting a Risk Assessment for a New Product Launch
- Creating a Document Control System for a Small Business
- Simulating an Internal Audit for Compliance Verification
- Designing a Supplier Qualification and Monitoring Program
- Analysing a Real NCR and Developing a CAPA Plan
- Building a KPI Dashboard for Quality Performance
- Integrating Feedback from Customers and Employees
- Developing Management Review Reports
- Using Templates to Standardise Quality Planning
- Adapting Plans for Rapidly Changing Environments
- Navigating Cultural and Language Barriers in Global Teams
Module 16: Certification Readiness and Next Steps - Preparing for Third-Party Certification Audits
- Developing a Pre-Certification Gap Analysis
- Conducting Mock Audits to Test Readiness
- Refining Documentation for External Review
- Training Teams on Audit Response Protocols
- Engaging Certification Bodies and Understanding Their Process
- Responding to Corrective Action Requests from Auditors
- Maintaining Certification Through Ongoing Compliance
- Using the Certificate of Completion as Professional Evidence
- Leveraging Your Mastery in Job Applications and Promotions
- Accessing The Art of Service Alumni Network
- Staying Updated on ISO Developments and Industry Trends
- Engaging in Peer Learning and Mentorship
- Pursuing Advanced Credentials in Quality and Compliance
- Teaching ISO 10007 Principles to Your Teams
- Applying the PDCA Cycle to Quality Management
- Identifying Improvement Opportunities from Data
- Using Kaizen and Lean Principles for Incremental Gains
- Developing CAPA Processes Aligned with ISO 10007
- Investigating Recurring Issues with 5 Whys and Fishbone Diagrams
- Implementing and Verifying Corrective Actions
- Prioritising Improvement Initiatives
- Engaging Teams in Problem-Solving Activities
- Documenting Improvement Projects and Outcomes
- Reporting on Continual Improvement to Leadership
Module 13: Integration with Project Management Frameworks - Aligning ISO 10007 with PMBOK and PRINCE2
- Embedding Quality Planning into Project Charters
- Using Work Breakdown Structures to Define Quality Tasks
- Integrating Quality Gates into Project Phases
- Planning for Quality in Agile and Hybrid Environments
- Managing Quality in Multi-Site and Global Projects
- Coordinating Quality Activities Across Teams
- Using Project Management Software for Quality Tracking
- Conducting Project Quality Reviews
- Handing Over Quality Documentation at Project Closeout
Module 14: Implementation in Regulated Industries - Adapting ISO 10007 for Medical Devices (ISO 13485)
- Compliance in Pharmaceutical and Biotech Environments
- Quality Planning for Aerospace and Defence (AS9100)
- Applying ISO 10007 in Automotive (IATF 16949)
- Meeting FDA, EMA, and Other Regulatory Body Expectations
- Designing Quality Plans for Software as a Medical Device (SaMD)
- Managing Configuration and Change in Regulated Systems
- Ensuring Audit Readiness in Highly Scrutinised Sectors
- Training Personnel on Quality Documentation Requirements
- Developing Defense-in-Depth Quality Strategies
Module 15: Practical Application and Real-World Projects - Case Study: Implementing ISO 10007 in a Manufacturing Plant
- Case Study: Quality Planning for a Software Development Lifecycle
- Case Study: ISO 10007 in a Healthcare Service Provider
- Developing a Full Project Quality Plan from Scratch
- Conducting a Risk Assessment for a New Product Launch
- Creating a Document Control System for a Small Business
- Simulating an Internal Audit for Compliance Verification
- Designing a Supplier Qualification and Monitoring Program
- Analysing a Real NCR and Developing a CAPA Plan
- Building a KPI Dashboard for Quality Performance
- Integrating Feedback from Customers and Employees
- Developing Management Review Reports
- Using Templates to Standardise Quality Planning
- Adapting Plans for Rapidly Changing Environments
- Navigating Cultural and Language Barriers in Global Teams
Module 16: Certification Readiness and Next Steps - Preparing for Third-Party Certification Audits
- Developing a Pre-Certification Gap Analysis
- Conducting Mock Audits to Test Readiness
- Refining Documentation for External Review
- Training Teams on Audit Response Protocols
- Engaging Certification Bodies and Understanding Their Process
- Responding to Corrective Action Requests from Auditors
- Maintaining Certification Through Ongoing Compliance
- Using the Certificate of Completion as Professional Evidence
- Leveraging Your Mastery in Job Applications and Promotions
- Accessing The Art of Service Alumni Network
- Staying Updated on ISO Developments and Industry Trends
- Engaging in Peer Learning and Mentorship
- Pursuing Advanced Credentials in Quality and Compliance
- Teaching ISO 10007 Principles to Your Teams
- Adapting ISO 10007 for Medical Devices (ISO 13485)
- Compliance in Pharmaceutical and Biotech Environments
- Quality Planning for Aerospace and Defence (AS9100)
- Applying ISO 10007 in Automotive (IATF 16949)
- Meeting FDA, EMA, and Other Regulatory Body Expectations
- Designing Quality Plans for Software as a Medical Device (SaMD)
- Managing Configuration and Change in Regulated Systems
- Ensuring Audit Readiness in Highly Scrutinised Sectors
- Training Personnel on Quality Documentation Requirements
- Developing Defense-in-Depth Quality Strategies
Module 15: Practical Application and Real-World Projects - Case Study: Implementing ISO 10007 in a Manufacturing Plant
- Case Study: Quality Planning for a Software Development Lifecycle
- Case Study: ISO 10007 in a Healthcare Service Provider
- Developing a Full Project Quality Plan from Scratch
- Conducting a Risk Assessment for a New Product Launch
- Creating a Document Control System for a Small Business
- Simulating an Internal Audit for Compliance Verification
- Designing a Supplier Qualification and Monitoring Program
- Analysing a Real NCR and Developing a CAPA Plan
- Building a KPI Dashboard for Quality Performance
- Integrating Feedback from Customers and Employees
- Developing Management Review Reports
- Using Templates to Standardise Quality Planning
- Adapting Plans for Rapidly Changing Environments
- Navigating Cultural and Language Barriers in Global Teams
Module 16: Certification Readiness and Next Steps - Preparing for Third-Party Certification Audits
- Developing a Pre-Certification Gap Analysis
- Conducting Mock Audits to Test Readiness
- Refining Documentation for External Review
- Training Teams on Audit Response Protocols
- Engaging Certification Bodies and Understanding Their Process
- Responding to Corrective Action Requests from Auditors
- Maintaining Certification Through Ongoing Compliance
- Using the Certificate of Completion as Professional Evidence
- Leveraging Your Mastery in Job Applications and Promotions
- Accessing The Art of Service Alumni Network
- Staying Updated on ISO Developments and Industry Trends
- Engaging in Peer Learning and Mentorship
- Pursuing Advanced Credentials in Quality and Compliance
- Teaching ISO 10007 Principles to Your Teams
- Preparing for Third-Party Certification Audits
- Developing a Pre-Certification Gap Analysis
- Conducting Mock Audits to Test Readiness
- Refining Documentation for External Review
- Training Teams on Audit Response Protocols
- Engaging Certification Bodies and Understanding Their Process
- Responding to Corrective Action Requests from Auditors
- Maintaining Certification Through Ongoing Compliance
- Using the Certificate of Completion as Professional Evidence
- Leveraging Your Mastery in Job Applications and Promotions
- Accessing The Art of Service Alumni Network
- Staying Updated on ISO Developments and Industry Trends
- Engaging in Peer Learning and Mentorship
- Pursuing Advanced Credentials in Quality and Compliance
- Teaching ISO 10007 Principles to Your Teams