第1章 ISO9001およびModule Iの概要

• 1. ISO規格
• 2. ISO9001の概要

  2.1 品質
  2.1.1 要求事項
  2.1.2 製品ライフサイクルの観点における品質
  2.1.3 顧客の視点から見た品質
  2.2 マネジメントおよびマネジメントシステム
  2.2.1 マネジメント（システム）と品質マネジメント（システム）
  2.2.2 QMS導入の検討
  2.3 保証
  2.3.1 要求水準の移り変わり
  2.3.2 Process approachにおける品質保証

• 3. Module Iの概要

  3.1 Module Ⅰの構成
  3.2 PV システムと品質システムの関係

• 4. ISO9001：2008とModule Iの比較

  4.1 ISO9001：2008とModule Ⅰの類似点
  4.2 ISO9001：2008とModule Ⅰの相違点

• 5. 文書化および記録の保管

  5.1 文書化
  5.2 記録の保管

• 6. マネジメントレビュー

第2章 PV business management systemの構築および品質システムの構築

• 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

• 4. System and process operation

  4.1 Resource management
  4.2 Procedural training
  4.3 Ensuring compliance with procedure
  4.4 Error measure
  4.5 Monitoring
  4.6 Early process control
  4.7 Variation point control
  4.8 Change control

• 5. Audit

  5.1 Audit plan
  5.2 Implementation of audit
  5.3 Reporting of audit results
  5.4 Analysis of audit results
  5.5 Training of auditor

• 6. Improvement（handling abnormalities, problems, and unfavorable situations：CAPA）

  6.1 Problems in the preparation and management of CAPA
  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
  6.6 Preventive action
  6.7 Execution of CAPA
  6.8 Evaluation of CAPA effectiveness