株式会社イーコンプライアンス

CHAPTER 1　OVERVIEW OF ISO9001 AND MODULE I

1.　ISO standards
2.　Overview of ISO9001
2.1　Quality
2.1.1　Requirements
2.1.2　Quality in terms of product life cycle
2.1.3　Quality from the customer’s perspective
2.2　Management and management systems
2.2.1　Management （system） and quality management （system）
2.2.2　Study of the introduction of QMS
2.3　Assurance
2.3.1　Changes in requirement levels
2.3.2　Quality assurance in the process approach
3.　Outline of Module I
3.1　Configuration of Module I
3.2　Relationship between PV systems and quality systems
4.　Comparison between ISO9001：2008 and Module I
4.1　Similarities between ISO9001：2008 and Module I
4.2　Differences between ISO9001：2008 and Module I
5.　Documentation and recordkeeping
5.1　Documentation
5.2　Retention of records
6.　Management review


CHAPTER 2　Establishment of PV business management systems and construction of quality systems
1.　Mission, product, customer, interested party, environmental trend
1.1　PV product
1.2　Customer and interested party determination and understanding of expectations and requirements
1.3　Understanding the environment
1.4　Key points of the survey and analysis
2.　Quality policy and objectives
2.1　What is quality?
2.2　What is quality in PV regulations?
2.3　Quality policy and quality objectives
2.3.1　The role of quality policy and quality objectives
2.3.2　Setting quality objectives
2.3.2.1　Setting an appropriate timeline
2.3.2.2　Setting quality objectives
2.3.2.3　Means for achievement
2.4　Drafting an execution plan for quality objectives（quality plan）
2.5　Risk
2.6　Execution control of quality plan
2.6.1　Executing the plan
2.6.2　Gantt chart and arrow diagram
2.6.3　How to prepare an arrow diagram
3.　Process development
3.1　Difference between process and procedure
3.2　Management on an organizational basis and a process basis
3.3　Interaction between production process and other processes
3.4　Process development and arrangement
A）Clarification of PV system configuration
A）-1　Clarification of regulations and requirements
A）-2　Product clarification
A）-3　Clarification of the required process
A）-4　Clarification of input and products in required processes, and interrelationships in the processes
B）Product design
B）-1　Extraction of quality requirements for the product and process
B）-2　Quality planning and designing
B）-2.1　Quality function deployment
B）-2.2　Case of quality design
B）-2.3　Deployment of required quality according to a tree diagram
B）-2.4　Deployment to quality elements
B）-2.5　Preparation of quality table
B）-3　Examination of mechanism/parts group that constitute the product and elements work/parts thereof
C）Deployment to process and preparation of procedure
C）-1　Deployment to process
C）-1.1　Drafting of the process and peripheral information
C）-1.2　Turtle diagram
C）-2　Analysis of necessary technology and resources
C）-3　Key point for quality assurance in the process
C）-4　Preparation of procedural document
C）-4.1　Operation standard in PV
C）-4.2　Considerations in preparation
C）-4.3　Reviewing risks in procedures
4.　System and process operation
4.1　Resource management
A）Personnel
A）-1　Preparation of job description
B）Facilities, Equipment and Apparatus
C）External resources
4.2　Procedural training
4.2.1　Process operation to prevent procedure violation
4.2.2　Implementation of procedural training
4.3　Ensuring compliance with procedure
4.3.1　Case of an accident due to non-compliance with procedures（1）4）
4.3.2　Case of accident due to non-compliance with procedures（2）5,6）
4.4　Error measure
4.4.1　Error caused by human characteristics
4.4.1.2　Error by social loafing
4.4.1.3　Other factors
4.4.2　Error elimination 
4.5　Monitoring
4.5.1　Purpose of monitoring
4.5.2　Monitoring according to process characteristics
4.5.3　Control chart
4.5.3.1　X-R control chart
4.5.3.2　T-type matrix
4.6　Early process control
4.7　Variation point control
4.8　Change control
5.　Audit
5.1　Audit plan
A）Strategic level audit planning
B）Tactical level audit planning
C）Operational level audit planning
5.2　Implementation of audit
A）Preparation of an audit agenda
B）Opening meeting
C）Interviews and review of documents and records
D）Closing meeting
5.3　Reporting of audit results
5.4　Analysis of audit results
5.5　Training of auditor
A）Qualification
B）Qualities
C）Work experience
D）Knowledge
E）Skills
6.　Improvement（handling abnormalities, problems, and unfavorable situations：CAPA）
6.1　Problems in the preparation and management of CAPA
6.1.1　Problems in CAPA preparation
6.1.2　Problems in CAPA management
6.2　Understanding the actual situation and status of the problem
6.3　Correction
6.4　Root cause analysis and impact assessment
6.5　Corrective action
6.5.1Response to recurrence prevention
6.5.2　Addressing root causes
6.5.3　Planning and implementation of corrective action 
6.6　Preventive action
6.7　Execution of CAPA
6.8　Evaluation of CAPA effectiveness

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