Heya all
Lately, I've have been thinking about some of the problems people usually have in designing a quality management system that fulfills ISO (such as ISO 13485) requirements.
I think that part of the problem is in a misconception - that standards such as ISo 13485 can be used to create a quality management system. Well, those types of standards are not created to design a QMS - they are created to verify a QMS. Thus, using standards such as ISO 13485 or ISO 9001 for such a task is not the best option to create a QMS (on the other hand, ISO 9004 and other ISo TC 176 documents such as ISO 10004 were created to help design QMS).
Also, another usual misconception is about the process approach, but this has been extensively discussed here many times.
So, with this is mind, I'm redesign my ISO 13485 course to focus more in process-based QMS design and development, with a heavy emphasis on ISO documents that were created to help design a QMS, such as ISO 9004, ISO 10002, ISO 10004, etc..). I've also used David Hoyle's approach to QMS conception and design as a basis.
The course outline at the moment is the one below. Feedback is appreciated!
Design and development of an ISO 13485 quality management system
1 - General overview of quality management and processes
1.1 - General overview of quality management and quality systems
Organizations and clients, products and services
Changes in quality concepts over the years
Quality planning, control, improvement and assurance
Some hsitorical quality concepts
Quality management as control of process variation
PDCA Cycle - Deming
Deming's 14 points & 7 Deadly diseases
Quality and management - Juran
Failure elimination x success management
1.2 – Processes - theory and design
What are processes
Functional/documental approach x process approach
Characteristics of processes
Process analysis and mapping
Design of a process-based quality management system
Design of controls
1.3 - What is a quality management system from the standpoint of laws and standards?
Laws and standards about quality management systems
Laws and standards don't define processes
Laws and standards define controls for processes
Quality management principles - ISO
Historical development of quality management systems in the medical devices field
2 – Process for the design of a quality management systems
2.1 – System conception process - define system requirements
Organizational goals
Organizational policies including quality policies
Business objectives including quality objectives
Quality management system scope
2.2 – System conception process - define system requirements
Context diagrams
System model
Business process
Functions and processes
2.4 – System conception process – identification the processes needed for the quality management system and process analysis
Identifying work processes from business processes
Using laws and standards to help in the identification of processes
Process design
KPIs
Process capability
Process flowcharts/turtle diagrams
Task analysis
Competencies
Resources
Process risk analysis
Process control definition and analysis
2.5 - Documentation from system conception
Process analysis reports
Quality manual
Process description
Process development plans
Quality plans
2.6 - Process development
Documentation
Process integration
System integration
System validation
System operation
3 – Topics related to the design of a quality management system that fulfills ISO 13485
3.1 - Process resources needed to fulfill process objectives
Financial resources
Infra-structure
Work environment
Resource control
3.1.1 - Human resources
Competence management
Responsibility and authority
Training process
Defining training needs
Training design and planning
Training provision
Evaluation of training results
3.2 - Monitoring, measurement, reviews
Process monitoring and measurement
Production and device information gathering
Monitoring and measurement of client satisfaction
Feedback and complaint handling process
Control of non-conformities
Preventive action and process risk analysis
Corrections and corrective actions
3.3 - Quality management system documentation
Reasons to document information
Reasons not to document information
Document creation process
Defining documentation objectives
Document approval and control
3.4 - Product realization - Design and development
Examples of design and development processes
Design and development controls
Design and development history and records
Product specifications
3.5 - Product realization - control of manufacturing process
Cleanliness
Special processes validation
Identification and traceability
Measurement equipment and systems
Lately, I've have been thinking about some of the problems people usually have in designing a quality management system that fulfills ISO (such as ISO 13485) requirements.
I think that part of the problem is in a misconception - that standards such as ISo 13485 can be used to create a quality management system. Well, those types of standards are not created to design a QMS - they are created to verify a QMS. Thus, using standards such as ISO 13485 or ISO 9001 for such a task is not the best option to create a QMS (on the other hand, ISO 9004 and other ISo TC 176 documents such as ISO 10004 were created to help design QMS).
Also, another usual misconception is about the process approach, but this has been extensively discussed here many times.
So, with this is mind, I'm redesign my ISO 13485 course to focus more in process-based QMS design and development, with a heavy emphasis on ISO documents that were created to help design a QMS, such as ISO 9004, ISO 10002, ISO 10004, etc..). I've also used David Hoyle's approach to QMS conception and design as a basis.
The course outline at the moment is the one below. Feedback is appreciated!
Design and development of an ISO 13485 quality management system
1 - General overview of quality management and processes
1.1 - General overview of quality management and quality systems
Organizations and clients, products and services
Changes in quality concepts over the years
Quality planning, control, improvement and assurance
Some hsitorical quality concepts
Quality management as control of process variation
PDCA Cycle - Deming
Deming's 14 points & 7 Deadly diseases
Quality and management - Juran
Failure elimination x success management
1.2 – Processes - theory and design
What are processes
Functional/documental approach x process approach
Characteristics of processes
Process analysis and mapping
Design of a process-based quality management system
Design of controls
1.3 - What is a quality management system from the standpoint of laws and standards?
Laws and standards about quality management systems
Laws and standards don't define processes
Laws and standards define controls for processes
Quality management principles - ISO
Historical development of quality management systems in the medical devices field
2 – Process for the design of a quality management systems
2.1 – System conception process - define system requirements
Organizational goals
Organizational policies including quality policies
Business objectives including quality objectives
Quality management system scope
2.2 – System conception process - define system requirements
Context diagrams
System model
Business process
Functions and processes
2.4 – System conception process – identification the processes needed for the quality management system and process analysis
Identifying work processes from business processes
Using laws and standards to help in the identification of processes
Process design
KPIs
Process capability
Process flowcharts/turtle diagrams
Task analysis
Competencies
Resources
Process risk analysis
Process control definition and analysis
2.5 - Documentation from system conception
Process analysis reports
Quality manual
Process description
Process development plans
Quality plans
2.6 - Process development
Documentation
Process integration
System integration
System validation
System operation
3 – Topics related to the design of a quality management system that fulfills ISO 13485
3.1 - Process resources needed to fulfill process objectives
Financial resources
Infra-structure
Work environment
Resource control
3.1.1 - Human resources
Competence management
Responsibility and authority
Training process
Defining training needs
Training design and planning
Training provision
Evaluation of training results
3.2 - Monitoring, measurement, reviews
Process monitoring and measurement
Production and device information gathering
Monitoring and measurement of client satisfaction
Feedback and complaint handling process
Control of non-conformities
Preventive action and process risk analysis
Corrections and corrective actions
3.3 - Quality management system documentation
Reasons to document information
Reasons not to document information
Document creation process
Defining documentation objectives
Document approval and control
3.4 - Product realization - Design and development
Examples of design and development processes
Design and development controls
Design and development history and records
Product specifications
3.5 - Product realization - control of manufacturing process
Cleanliness
Special processes validation
Identification and traceability
Measurement equipment and systems
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