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Anonymous users2024-02-151. The requirements specified by the customer 2. The requirements implied by the customer 3. The requirements of laws and regulations 4. The additional requirements of the organization.
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Anonymous users2024-02-14There is a lot of content in this standard, so let's give a brief introduction:
On November 25, 1999, the International Organization for Standardization (ISO) published the 2000 version of the ISO 9000 family of international standards. The 9000 international standard includes:
9000 "Quality Management System Basic Principles and Terminology";
9001 "Quality Management System Requirements";
9004 Quality Management System Performance Improvement Guide.
The eight principles of the ISO9000 quality management system:
Principle 1: Focus on the customer.
Principle 2: Leadership.
Principle 3: Full participation.
Principle 4: Process approach.
Principle 5: A systematic approach to management.
Principle 6: Continuous improvement.
Principle 7: Fact-based decision-making.
Principle 8: Mutually beneficial supply-side relationship.
Catalogue of ISO9001
Preface. ISO Foreword.
Introduction. 1 Scope.
General. Apply.
2.Reference standards.
3 Terms and Definitions.
4. Quality management system.
General requirements. Documentation Requirements:
General. Quality Manual.
File control. Record control.
5 Management Responsibilities.
Management commitments. Focus on the customer.
Quality policy. Mastermind. Quality objectives.
Quality management system planning.
Responsibilities, Authority, and Communication.
Responsibilities and Authority.
Representatives of managers.
Internal communication. Management Reviews.
General. Review inputs.
Review the output. 6 Resource management.
Resource Provision. Human resources.
General. Competence, awareness and training.
Infrastructure. Working environment.
7 Product Implementation.
Planning of product realization.
Customer-related processes.
Determination of product-related requirements.
Review of product-related requirements.
Customer communication. Design and development.
Design and development planning.
Design and development inputs.
Design and develop outputs.
Design and development review.
Design and development validation.
Design and development confirmation.
Design and develop control of change.
Procurement. Procurement process.
Procurement Information. Verification of purchased products.
Production and service provision.
Control of production and service provision.
Validation of the production and service delivery process.
Identification and traceability.
Customer Property. Product Protection.
Control of monitoring and measuring devices.
8 Measurement, Analysis, and Improvement.
General. Monitoring and measurement.
Customer satisfaction. Internal Audits.
Monitoring and measurement of the process.
Monitoring and measurement of the product.
Non-conforming product control.
Data analysis. Improvement. Continuous improvement.
Corrective Actions. Precautionary measures.
According to the general enterprise:
Problem 1: Layer 1 Documents: Management Manuals.
Layer 2 files: program files.
Three and four layers of documents: departmental operation documents, work instructions, operating procedures, various inspection standards, technical documents, etc.
Question 2: The whole set of **, you should say that the record file, this thing is different in different industries and different product categories, so you should grasp the core of the standard and compile it according to the characteristics of your own products (the quality management system is particularly prominent, and the environmental safety of the enterprises is not very bad), so others can help you, but there must be a limit.
ISO9001 basically has 5 functions:
1. Expand sales and get bigger profits. >>>More
Improve the level of enterprise management.
The company has obtained ISO9001 certification, which means that a complete quality management system has been established. The effective operation of the quality system can continuously promote the standardized management of the enterprise, improve efficiency, reduce costs and obtain better benefits. >>>More
ISO 9001 is an international standard that defines an organization's quality management system. The aim is to ensure that organizations are able to deliver consistent, high-quality products and services, and that they are able to continuously improve their business processes and management systems. This standard applies to all types of organizations, regardless of size or type, including manufacturers, service providers, and nonprofits. >>>More
Purpose:1It can be confirmed that the company has the ability to provide products that meet customer requirements and applicable laws and regulations. >>>More
It was introduced more than 10 years ago So, it will be a long time!