Introduction to "ISO9001 International Quality Management System" I. ISO9000 standard Overview
8 Management Principles
12 theoretical foundations
80 terms
Ii. Eight management principles
Principle 1: Focus on customers
Principle 2-leadership
Principle 3-full participation
Principle 4-process methods
Principle 5-Management System Method
Principle 6-Continuous Improvement
Principle 7-fact-based decision making
Principle 8-mutually beneficial relationship with suppliers
Iii. 12 theoretical foundations of Quality Management System
1. Theoretical Explanation of the quality management system (helping customers increase their satisfaction)
2 quality management system requirements and product requirements
3. Quality Management System Method
4 Process Method
5. quality policies and objectives
6. Role of top management in Quality Management
7 files
8. Quality Management System Evaluation
9. Continuous Improvement
10 Application of Statistical Technology
11 focus of quality management system and other management systems
12 relationship between quality management system and excellent Model
Iv. 80 terms
Quality terminology (5)
Management terms (15)
Organization terminology (7)
Terms related to processes and products (5)
Terms related to features (4)
Terms related to conformity (13)
Terms related to documents (6)
Terms related to checks (7)
Review terminology (12)
Terminology on quality assurance during measurement (6)
Structure Diagram (ISO9001) (23 Requirements)
V. Main stages of introduction and implementation of ISO9000 Standards
1. Standard publicity and system planning stage
Task: plan the standard publicity and Quality Management System
Organize training for all members to understand standards and unified understanding
Organize implementation and formulate plans
Establish quality policies and objectives
Status Quo Investigation and Analysis
Determine the quality system structure and allocate Quality Functions
System File planning and Task Arrangement
Ensure necessary resources
2. File preparation stage
Task: compile appropriate quality management system documents
Determine the document structure of the quality document system ~ Quality Manual ~ Program file ~ Other quality documents
Document Writing Training
Determine document writing principles
File formation program
3. Quality System Trial Run phase
Task: verify the suitability, coordination, and effectiveness of Quality System Documents
And adequacy, and take corrective measures for exposed/discovered problems
For improvement
Publicizing quality system documents (publishing → implementation)
Various preparations (documents, record tables, facilities ······)
Conduct effective information management, locate problems → corrective actions → improve
Internal Quality System Review
Internal Auditor Training
Appointment of qualified internal auditors
Implement internal quality system review
Management Review
Make full preparations (input)
Host by the top management (suitability, adequacy, and effectiveness)
Review output
4. Authentication phase
Task: Submit the system operation evidence that meets the standard requirements and obtain the certification certificate.
Select the certification authority and Contract Signing → confirm the authentication time
Submit Quality Manual → Certification Authority implementation document review → modify according to opinions
The Certification Authority conducts on-site audits (possibly issuing non-conformity reports)
Formulate corrective actions (disable non-conformities)
Formulate corrective actions
Submit evidentiary materials for corrective action implementation within the specified time
Receive authentication certificate
5. Quality Management System Operation stage
Task: maintain the stable operation and continuous improvement of the quality management system
Maintain Stable quality system operation
Implement internal audit as planned
Plan implementation management review
Accept supervision and review from certification bodies
The certificate is valid for three years.
1 time/year within three years (the first time is carried out within nine months, and then 1 time/year)
You must apply for a new review token after the expiration of the three-year warranty period.
