Quality Management Systems Final Notes
Topic 4: ISO 14000
ISO 14000’s connection to ISO 9000
ISO 14000 extends quality principles to environmental management.
Integration aligns product and service quality with sustainability goals.
Global Movement towards Sustainability
is defined as a series of international environmental management standards, guides, and technical reports.
these standards were introduced by the International Organization for Standardization (ISO) in 1996 and were most recently revised in 2015.
Importance of Integration
Combining Quality (ISO 9000) and Environmental (ISO 14000) Management Systems enhances efficiency, transparency, and accountability.
This integration assists organizations in simplifying audits, reducing waste, and improving overall performance
Main Trigger for Integration:
Stakeholder and Market Pressure - Growing demand for sustainability and accountability.
Regulatory Compliance - Meets supply chain and legal requirements efficiently.
Operational Efficiency - Reduces waste, simplifies audits, and improves performance.
Environmental Management Systems (EMS)
Framework by ISO to manage environmental responsibilities through an EMS.
Covers planning, implementation, monitoring, and improvement.
Focus areas: Pollution prevention, resource efficiency, and compliance.
ISO 14001:2015 Core Standard
ISO 14001 is the core and certifiable standard of the ISO 14000 family. Built on the PDCA cycle for continuous improvement.
ISO 14000 objectives:
Minimize environmental impact
Ensure legal compliance
Promotes sustainable and efficient operations
Integration points:
Compatible with ISO 9001, enabling dual certifications.
Supports the Triple Bottom Line: economic, environmental, and social performance.
ISO 14001: Clauses
Clause 1: Scope
Clause 2: Normative Reference
Clause 3: Terms and Definitions
Clause 4: Context of Organization
Clause 5: Leadership
Clause 6: Planning
Clause 7: Support
Clause 8: Operation
Clause 9: Performance Evaluation
Clause 10: Improvement
The Annex SL
Annex SL is the common framework adopted by ISO for all new and revised management system standards (MSS) since 2012.
Purpose: To ensure consistency and facilitate integration across different disciplines (Quality, Environment, Health & Safety, etc.)
High-Level Structure (HLS): An identical, 10-clause chapter sequence.
Identical Core Text: The same wording is used for key requirements in each clause.
Common Terms and Definitions: Consistent terminology across all standards (e.g., ‘risk’, ‘interested parties’, ‘documented information’)
Responding to Stakeholder and Market Pressure
Shared Clauses 5 (Leadership) and 6 (Planning) align both goals.
Unified Policies = one mission for quality + environment
Customer demand both quality and responsibility.
Achieving Regulatory Compliance
Shared Clauses 4 (Context) & 9 (Performance Evaluation).
One process for compliance identification and reporting.
Streamlined audits and faster response to new regulations.
Operational Efficiency through Shared Systems
Shared Clauses 7 (Support), 8 (Operation), 10 (Improvement).
One audit, one documentation, one management review.
The Integration Process of ISO 9000 and ISO 14000:
Levels of Integration
Engineering the High-Efficiency Workshop
A Strategic Analysis of Integration Models for Our Quality (ISO 9001) and Environmental (ISO 14001) Toolkits.
Our Current Toolkit:
Current State: Our workshop is highly proficient, built around a world-class Quality toolkit (QMS) that ensures precision and reliability.
Objective: We must now integrate a new, specialized Environmental toolkit (EMS). The critical decision is not just what tools to add, but how we organize the entire workshop to accommodate them without losing efficiency.
Agenda: We will analyze three distinct workshop organization models to engineer the optimal layout for our needs.
Level 1: The Coordinated Workshop (Parallel Systems)
Separate Tool Lists: A distinct manual for the QMS toolkit and another for the EMS toolkit.
Shared Workbench Rules: A single, common procedure governs how all tools are managed, how we inspect the workshop (Audits), and how the foreman reviews all projects (Management Review)
Best Suited For: Workshops adding a new capability without wanting to disrupt long-established, efficient workflow for an existing one.
Level 2: The Shared-Drawer Workshop (Partial Integration)
Shared Resources: Common procedures for tasks like training, supplier evaluation (now including both quality and green criteria), and new employee orientation are combined into one.
Reduced Duplication: We no longer need two separate training programs or two different checklists for onboarding a new supplier.
Hybrid System: While many tools are now shared, highly specialized tools remain in their dedicated QMS or EMS toolboxes.
Best Suited For: Workshops where the same craftsmen frequently perform both quality and environmental tasks and can benefit from a common set of resources.
Level 3: The Unified Tool Chest (Full Integration)
Process-Centric: The system is organized by process, not by standard.
One Master Manual: A single guide explains how the entire workshop operates.
Maximum Efficiency: Craftsmen have everything they need for a task in one place, eliminating wasted motion and system redundancy.
Best Suited For: A brand-new workshop being designed from scratch or a workshop undergoing a complete "lean manufacturing" overhaul.
Tools and Techniques
IMS Software (Integrated Management System Software): Centralizes audits, records, and compliance tracking.
Risk-Based Thinking Matrix: Centralizes audits, records, and compliance tracking.
Cross-Functional KPIs (Key Performance Indicators): Shared metrics linking product quality and sustainability.
Strategic and Operational Benefits
Operational Efficiency: Streamlined processes, fewer audits, lower costs, and faster decisions.
Enhanced Risk Management: Unified risk control, prevents issues early, ensures compliance, and improves reliability.
Sustainability and Corporate Image: Improves brand trust, enhances reputation, attracts investors, and aligns with SDGs.
Continuous Improvement and Innovation: Uses PDCA cycle, encourages collaboration and process optimization.
Integration Challenges and Mitigation
Organizational Factors:
Challenges: Resistance, unclear accountability.
Mitigation: Leadership support, employee engagement, and clear communication.
Technical Factor:
Challenges: Different objectives and documents.
Mitigation: Use the Annex SL framework, joint audits, and integrated templates.
Resource and Training Factor:
Challenges: Increased workload and costs.
Mitigation: Phased rollout, cross-training, IMS software.
Industry Case Examples:
Toyota
Has 9001 and 14001
Integrated ISO 9001 & 14001 under the Toyota Production System (TPS).
Achieved 35% CO₂ reduction, near-zero landfill, and improved product quality.
Uses Kaizen to enhance both efficiency and sustainability
Mitsubishi
Has 9001 and 14001
Certified in ISO 9001 and ISO 14001 for its Sta. Rosa plant.
Implemented waste reduction, energy optimization, and “Green Manufacturing’ audits.
Improved supplier compliance and local sustainability practices.
Siemens
Has 9001, 14001, 45001, but not 22301
Unified management under a single Sustainability Management
Reduced carbon footprint by 46% and audit costs by 20%
Demonstrates balance between product reliability and environmental goals.
National Grid Corporation of the Philippines (NGCP)
Has 9001, 14001, 45001, and 22301
ISO 9001, 14001, 45001, and 22301 certified since 2012.
Streamlined operations, reduced waste, and improved service reliability.
Strengthened international reputation through integrated compliance.
Nestle
Has 9001 and 14001
Integrated QMS & EMS in all factories to ensure food safety and sustainability.
Reduced energy use per ton of product by 25% (2010-2020).
Uses ISO integration for lifecycle sustainability tracking.
San Miguel Brewery INC
Has 9001 and 14001
Integrates quality control with waste reduction and water recycling initiatives.
Demonstrates that food/beverage manufacturing can achieve both efficiency and eco-goals.
Topic 5: PDCA, PDSA, and SDCA in Quality Management Systems
The early 20th century marked a period of rapid industrialization and mass production, which created unprecedented challenges for businesses.
Factories produced goods on a large scale, but quality control was inconsistent and relied heavily on post-production inspection.
Walter A. Shewhart, a physicist and statistician at Bell Telephone Laboratories, observed that all processes inherently exhibit variation.
He distinguished between common cause variation (natural fluctuations) and special cause variation (irregular errors).
This led to the development of Statistical Quality Control (SQC) and the first feedback loop for process management, the Shewhart Cycle, emphasizing that quality should be built into processes rather than inspected afterward.
Shewhart’s feedback loop, originally called Plan–Do–See or Plan–Do–Check, introduced the concept of systematic process control.
By repeatedly planning, implementing, and reviewing, organizations could reduce variation and improve quality over time.
The Shewhart Cycle encouraged proactive problem-solving and marked a shift from inspection-focused quality to process-focused quality.
After working with Shewhart, W. Edwards Deming expanded these ideas and helped rebuild Japanese industry post World War II.
He taught statistical control and management principles to Japanese engineers and executives and introduced the PDCA (Plan–Do–Check–Act) cycle as a universal method for continuous improvement.
His philosophy emphasized that quality is the responsibility of management, not just workers, and profoundly influenced companies like Toyota, Sony, and Mitsubishi.
Deming’s teachings inspired the Japanese quality revolution, giving rise to Kaizen — the philosophy of continuous improvement.
Japanese companies systematically implemented PDCA to enhance efficiency, reduce waste, and encourage employee involvement in problem-solving.
Over the decades, Kaizen principles spread globally, making PDCA a core methodology in modern management and industrial practices.
While PDCA and PDSA focus on improvement and learning, SDCA (Standardize–Do–Check–Act) ensures that processes are stable and consistent before attempting improvements.
Standardization creates a foundation for reliable operations, so organizations only improve processes that are already controlled.
SDCA promotes discipline, consistency, and operational stability, which is essential for continuous improvement to be effective.
In practice, SDCA ensures that all workers follow the same best known method. Once stability is achieved, PDCA or PDSA can be applied to improve and innovate.
For example, Toyota’s production system relies on standard work procedures as a foundation for Kaizen activities. By stabilizing processes first, organizations reduce variability and create a safe environment for experimentation and improvement.
SDCA, PDCA, and PDSA form a hierarchical framework for continuous improvement. SDCA stabilizes the process, PDCA improves the process, and PDSA drives learning and innovation.
Together, they ensure that organizations achieve reliable, incremental, and sustainable progress, combining operational discipline with systematic experimentation and learning.
The evolution of process improvement cycles demonstrates a shift from controlling variation to fostering learning and innovation.
SDCA establishes stability, PDCA drives improvement, and PDSA encourages experimentation and knowledge creation. By understanding and applying these cycles, organizations can build a culture of continuous improvement, reduce errors, enhance efficiency, and innovate sustainably.
PDCA Cycle
PDCA (Plan-Do-Check-Act) is an iterative, four-stage approach for continually improving processes, products or services, and for resolving problems. It involves systematically testing possible solutions, assessing the results, and implementing the ones that have shown to work. It is based on the scientific method of problem-solving and was popularized by Dr W. Edwards Deming, who is considered by many to be the father of modern quality control.
The PDCA Cycle provides a simple and effective approach for solving problems and managing change. It enables businesses to develop hypotheses about what needs to change, test these hypotheses in a continuous feedback loop, and gain valuable learning and knowledge. It promotes testing improvements on a small scale before updating company-wide procedures and work methods.
Key Characteristics:
Iterative: PDCA repeats continuously; it’s not a one-time process but a repeating loop of learning and improvement.
Data-driven: Relies on evidence, measurements, and analysis.
Systematic: PDCA encourages discipline and consistency in problem-solving.
Collaborative: Requires cross-functional teamwork.
Flexible: Can be applied to manufacturing, services, administration, and even education or healthcare.
PDSA Cycle
The PDSA cycle (Plan-Do-Study-Act) is an iterative, four-step framework for continuous improvement of processes, products, or services. It was adapted from Deming’s original PDCA (“Plan-Do Check-Act”) cycle by emphasizing “Study” in place of “Check” to stress deeper learning and theory-building, not just simple verification.
In practice, a team plans a change, does a small-scale test of that change, studies the outcome by collecting and analyzing data, and acts on what was learned by either adopting the change, adapting it, or abandoning it.
Key Characteristics
Iterative: PDSA is a continuous, never ending loop of experimentation.
Data-driven: The “Study” step emphasizes data collection and analysis. Focus on prediction and evidence (rather than just “checking” pass/fail)
Controlled Experimentation: Only a limited portion of a process or system is altered initially, minimizing risk.
Innovative and Adaptive: Encourages testing new ideas in a structured way. It lets organizations try out novel solutions quickly and learn from failures safely.
Flexible: Widely used in diverse fields such as Healthcare and Education.
SDCA Cycle
The SDCA Cycle is a systematic approach used to maintain and control process stability through continuous standardization and evaluation. It ensures that the best-known methods are clearly defined, implemented, monitored, and improved when necessary.
This cycle emphasizes sustaining established standards to prevent performance decline and maintain efficiency. By applying the SDCA Cycle, organizations can achieve consistent quality, operational reliability, and a strong foundation for continuous improvement.
Objectives:
To establish and maintain process standards.
To promote stability and reliability.
To identify and correct deviations.
To support continuous improvement. To enhance overall operational efficiency.
Key Characteristics
Standardization-focused: The SDCA Cycle ensures that best practices are clearly documented and consistently followed to maintain process stability.
Continuous Monitoring and Control: It prioritizes sustaining performance by regularly checking if standards are met and addressing deviations promptly.
Prevents Performance Decline: The cycle helps avoid backsliding by continuously reinforcing and validating established standards.
Structure and Cyclical Process: SDCA uses a repetitive loop to keep processes stable, with updated standards serving as the new baseline.
Foundation for Continuous Improvement: It strengthens existing processes, providing a stable starting point for future PDCA improvements.
Sequential and Complementary Use: How the Three Cycles Work Together
SDCA provides a stable foundation by standardizing processes.
PDCA builds on that stability to drive gradual, data-based improvements.
PDSA introduces experimentation and innovation to test new ideas safely.
Together, they form a “spiral of continuous progress” — a system that maintains quality while fostering constant learning and development.
Integration: Applying the Cycles in Practice
A real-world example shows how the cycles integrate in an organization:
Standardize work instructions to ensure consistency and reliability (SDCA).
Optimize the standardized process by analyzing performance and reducing waste (PDCA).
Experiment with new technology or innovative methods, study the outcomes, and, if successful, incorporate them into the new standard (PDSA).
Importance of Integration:
Promotes balance between stability and change.
Encourages data-driven decisions and experimentation.
Builds a culture of continuous learning and improvement.
Three Improvement Cycles:
SDCA ensures stability and discipline by maintaining effective standards.
PDCA focuses on gradual, data-based improvement of existing processes.
PDSA promotes learning and innovation, allowing organizations to test and refine new ideas.
Together, they form a continuous system that balances consistency, efficiency, and adaptability for sustainable growth.
Application in QMS
PDCA as the Core of ISO 9001:2015
ISO 9001:2015 isn't just a set of rules; it's a dynamic system for continual improvement, and PDCA is its beating heart.
The standard's clauses are deliberately designed to follow the PDCA logic. This ensures every requirement—from leadership to operations—is part of a cycle of planning, doing, checking, and acting.
This model transforms the QMS from a static "certificate on the wall" into a living process that actively drives the organization toward its quality objectives and customer satisfaction.
How PDCA Drives the QMS:
PLAN (Clauses 4-6): Set the Strategy
Action: Define context, assess risks, set objectives.
Tool: SWOT Analysis, Risk Matrix.
CHECK (Clause 9): Monitor Performance
Action: Audit processes, measure against KPIs.
Tool: Internal Audits, Control Charts.
DO (Clauses 7-8): Execute the Plan
Action: Allocate resources, train staff, follow procedures.
Tool: SOPs, Training Plans.
ACT (Clause 10): Improve
Action: Fix root causes, update processes.
Tool: 5 Whys, CAPA.
SDCA: The Foundation of Stability
Core principle—you cannot improve an unstable process
SDCA creates the stable, standardized baseline needed for improvement
It is embedded in ISO requirements for Documented Information, Competence, and Operational Control
Example: A factory must first standardize a cutting method with SDCA before it can run a project to reduce material waste with PDCA
Topic 6: IATF 16949 & ISO 13485
IATF 16949: Automotive Industry
International standard for Automotive Quality Management Systems (QMS).
Developed by the International Automotive Task Force (IATF).
Fully aligned with ISO 9001; cannot be certified without it.
Purpose: Improve quality, consistency, and defect prevention in the automotive supply chain.
Focus: Customer-specific requirements (CSRs), process capability, risk management, and continual improvement.
Benefits: Reduced defects, improved OEM confidence, stronger supplier performance.
Key Principles:
Defect prevention as a core objective.
Reduction of variation and waste.
Integration of customer-specific requirements.
Risk-based thinking and contingency planning.
Data-driven decision-making.
Strong supplier and process control.
Continual improvement through structured problem-solving.
Scope and Applicability
Applicable to organizations involved in:
Automotive parts manufacturing and assembly
Design and development centers
Heat treatment, welding, coating, and painting
Material production (metal, rubber, plastics, etc.) Distribution and service-related operations
Applies across the global automotive supply chain.
List of Local Certified Companies:
Tsukiden Electronics PH:
EMS company (PCB assembly, automotive electronics) IATF 16949:2016-certified
First PH company certified by SGS under IATF 16949
Focus on continuous improvement, customer-supplier partnership, at high quality process control
Amkor Technology PH
Harada Automotive Antenna
Iriso Electronics PH
IATF 16949: 2016 Structure
Clause 1: Scope
This applies to design, development, production, and servicing of products
Clause 2: Normative Preference
This refers to ISO 9001:2015 as the basis for the requirements, along with customer-specific requirements applicable to the automotive industry.
Clause 3: Terms and Definitions
This includes automotive terms like special characteristics, control plan, product safety, traceability.
Clause 4: Context of the Organization
QMS Scope: define boundaries, document any exclusions, and account for customer-specific requirements
Process mapping: identify key processes and address risks and opportunities
Documented Information: maintain records to support operations, traceability, and product safety.
Clause 5: Leadership
Management commitment: accountability for QMS effectiveness
Customer focus: enhanced customer-specific requirements, continuous feedback, and metrics
Quality policy: communicate and maintain policy aligned with strategic direction
Roles and responsibilities: assign and document responsibilities, ensure authority and product conformity
Corporate responsibility: ethical behavior, anti bribery policies, employee code of conduct, whistleblower protection.
Clause 6: Planning
Risk and Opportunity
Quality Objectives
Contingency Planning
Change Management
Clause 7: Support
Competence and training
Equipment calibration
Infrastructure and maintenance
Documentation control
Awareness and communication
Clause 8: Operation
Operational Planning: define processes, sequence, resources; include risks & controls.
Design and Development: folow CSR, use FMEA, control plans, and validation.
Supplier Management: evaluate, select, and monitor suppliers
Production control: control processes, special characteristics, and traceability.
Product safety and traceability: manage safety requirements, regulations, and traceability.
Nonconforming output control: ISO 13485 detect, contain, and prevent shipment of nonconforming
Clause 9:
Monitoring and measurement
Customer satisfaction
Internal audits
Management review
Clause 10: Improvement
Corrective Action: address nonconformities, including root cause analysis; IATF requires structured problem solving QMS IATF 16949
Root Cause Analysis identify ISO 13485 underlying causes of issues; includes error proofing for defect prevention
Continual Improvement enhance QMS effectiveness, product quality, and customer satisfaction
Core Requirements:
Customer-specific requirements (CSRs)
Risk management and contingency plans
Product safety controls
Process capability (Cp, Cpk)
Supplier qualification and monitoring
Production validation and approval (PPAP)
Calibration and measurement systems
Control of nonconforming products
Error-proofing and preventive controls
Traceability requirements
ISO 13485: Medical Device Industry
Definition: ISO 13485 is an international standard for Quality Management Systems (QMS) specificaly designed for medical device organizations.
Purpose: Ensures medical devices are consistently designed, produced, and distributed in a safe and compliant manner.
Characteristics: The standard is harmonized with major regulatory frameworks such as the U.S. FDA, European Union MDR, and Health Canada regulations.
Focus: Emphasizes risk management, documentation, regulatory alignment, process control, and lifecycle quality.
Benefits:
Reduces product defects and recalls
Ensures strong regulatory compliance
Enhances patient safety
Promotes consistency and reliability in device quality
Key Principles:
Regulatory compliance as the foundation of the QMS
The QMS must fully align with medical device regulations, ensuring that all processes, documents, and decisions support legal and safety requirements.
Risk-based thinking and decision-making
Risks must be identified, evaluated, and controlled at every stage of the product lifecycle to ensure safe and reliable medical devices
Process approach and lifecycle control
All activities from design to production, distribution, and servicing must be managed as structured processes with clear controls and monitoring.
Traceability and data integrity
Organizations must maintain accurate, secure, and complete records, ensuring every device can be traced from materials to final use.
Continual improvement focused on safety (not efficiency)
Improvements should prioritize patient safety and product quality through audits, corrective actions, and ongoing performance evaluation.
Scope and Applicability
Applicable to organizations involved in:
Medical device design and development
Establish design controls, risk management, verification, validation, and design history documentation.
Production and assembly
Control of manufacturing processes, equipment, personnel qualifications, and work environment.
Sterilization and cleanroom operation
Validation of sterilization methods and maintenance of cleanroom conditions
Packaging, storage, distribution
Ensuring product integrity and safety during storage, handling, shipping, and transport.
Installation and servicing
Procedures for proper installation, maintenance, servicing, and functional verification of medical devices.
Suppliers of components and materials
Complaint handling, regulatory reporting, field corrective actions, and traceability in case of recalls.
List of Local Certified Companies
Toyoflex Cebiu Corporation
ISO 13485:2016 certified manufacturing facility in Cebu
Produces non-sterile and sterile guidewires and angiographic catheters
Includes EO-sterilized medical devices and metal components for guidewires
Certification issued by TÜV SÜD; valid until 2026
Integrated Micro-electronics Incorporated
Medsalv
ISO 13485: 2016 Structure
Clause 4: Quality Management System
General Requirements
The organization must document a QMS and maintain its effectiveness.
Crucialy, this includes applying a risk-based approach to hi the control of appropriate processes.
Documentation Requirements:
Quality Manual: The roadmap of your QMS.
Medical Device File: Specifics for each device type/family.
Control of Documents: Review, approval, and versioning.
Control of Records: Evidence of conformity and effective operation.
Practical Application:
Proportional Control: The stringency of process controls (e.g., supplier audits, training rigor) should match the risk associated with that process failing.
Alignment: Works in tandem with ISO 14971 (Risk Management for Medical Devices)
Clause 5: Management Responsibility
Leadership Commitment
Top management cannot delegate accountability. They must provide evidence of commitment through resource allocation and internal communication.
Customer and Regulatory Focus
Ensuring that customer needs and applicable regulatory requirements are determined and met is a primary function of leadership.
Quality Policy
A documented policy that provides a framework for establishing and reviewing quality objectives. Must be established, communicated, and understood at al levels.
Management Review
Regular reviews of the QMS to ensure its continuing suitability, adequacy, and effectiveness. This is a critical feedback loop for leadership
Clause 6: Resource Management
Competence and Training
Infrastructiure
Work Environment
Clause 7: Product Realization (Planning & Design)
Planning for Realization
Planning the processes needed for realization, including quality objectives, resource needs, and verification/validation activities.
Design and Development Control
A controled process for device design (Inputs → Outputs → V&V).
Purchasing and Supplier Management
Evaluate suppliers based on risk and ability to meet requirements.
Production & Process Controls
Manufacturing under controled conditions (instructions, suitable equipment).
Sterile Device Validation
IQ/OQ/PQ required for processes where output cannot be verified (e.g., sterilization).
Identification & Traceability
Identify product status and maintain UDI records where needed.
Preservation of Product
Protect product from damage/contamination during al handling/storage
Clause 8: Measurement, Analysis, Improvement
Monitoring and Management
Feedback Information: gathering on whether the organization has met customer requirements. This is a key input for risk management.
Complaint Handling: Formal procedures for receiving, reviewing, and evaluating complaints. Includes determining if a complaint requires reporting to regulatory authorities.
Internal Audit: Systematic, independent audits to determine if the QMS conforms to planned arrangements and ISO 13485 requirements.
Nonconforming Products
Strict procedures to ensure product that does not conform to requirements is identified
Controls to prevent unintended delivery. Options include: Eliminate detected nonconformity (rework), Authorize use under concession, or Scrapping
Corrective and Preventive Action (CAPA)
Corrective Action (CA)
Action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
Goal: To prevent recurrence.
Preventive Action (PA)
Action taken to eliminate the cause of a potential nonconformity or other undesirable potential situation.
Goal: To prevent occurrence.
Post-Market Surveillance and Feedback
Procedures must be in place to gather and review experience from the post-production phase. This feedback is essential for the risk management process.
Post-Market Actions:
Complaint Handling: Formal process for receiving, reviewing, and evaluating complaints, including determining reportability.
Regulatory Reporting: Documented procedures for timely reporting of adverse events or field actions to relevant regulatory authorities.
Data Analysis: Using feedback, nonconformities, audits, and CAPA data to identify opportunities for improvement.
Core Requirements of ISO 13485
Risk Management (ISO 14971 Alignment)
Integrated throughout product lifecycle
Linked with feedback, complaint data, and post-market surveilance
Required in QMS planning and process control
Design & Development Documentation (DHF, DMR, DHR)
Design History File (DHF): Ful design development records
Device Master Record (DMR): Manufacturing specs, procedures
Device History Record (DHR): Documentation of how each unit or device was made
Purpose: Ful traceability from design to production
Supplier Quality and Purchasing Controls
Evaluate and qualify your suppliers
Create quality agreements with suppliers.
Monitor supplier performance (incoming inspection, audits)
Use risk-based controls for outsourced processes / purchased products
Complaint Handling and Vigilance Reporting
Document procedures for complaint receipt and evaluation.
Investigate complaints, determine root causes
Report to the regulatory authority if required
Take corrective actions and track outcomes
Process Validation (IQ, OQ, PQ)
Installation Qualification (IQ): Verify correct instalation
Operational Qualification (OQ): Test that process operates within defined parameters
Performance Qualification (PQ): Confirm that the process produces desired output under real conditions
Validation is critical for processes that cannot be fuly verified by inspection.
Traceability and UDI Systems
Track al materials, sub-components, and final devices
Maintain Unique Device Identification (UDI) for devices Helps in product recals and regulation
Ensure ful traceability in the event of non-conformities
Document and Change Control
Procedures for document creation, review, approval, and distribution.
Control of records: Storing, retrieving, retention, and protection
Change control: Ensuring any change is reviewed, validated, and documented
Training and Competency Documentation
Define competency requirements per job or role
Maintain training records, assessments, and requalification evidence
Ensure staff are trained on risk management, change control, and critical processes
Challenges in Implementing ISO 13485
Heavy documentation requirements Quality
Manual, Medical Device File, records, design controls
Maintaining updated regulatory knowledge
FDA, EU MDR, Health Canada expectations
Supplier compliance and ongoing monitoring
Requires audits, verification, and performance tracking
Cleanroom/sterile process validation costs
IQ/OQ/PQ + environmental controls
Maintaining effective CAPA systems
Root-cause analysis, verification of effectiveness
Ensuring consistency in traceability
UDI records, lot control, post-market data
Benefits of ISO 13485
Demonstrates global regulatory readiness
supports approvals across major markets
Improves product consistency and safety
controled processes, validated equipment
Reduces defects, recalls, and compliance risks
CAPA + risk-based monitoring
Enhances customer trust and market competitiveness
recognized certification increases credibility
Strengthens supplier and process control
traceability + purchasing requirements