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ISO Principles

The document outlines the main principles, requirements, and documents needed for an ISO 9001:2015 Quality Management System (QMS). It discusses the 7 main principles of ISO 9001:2015 including a focus on customers, leadership, engagement of people, a process approach, improvement, evidence-based decision making, and relationship management. It then lists the 13 mandatory requirements an organization needs to establish to meet ISO 9001, such as establishing procedures, conducting internal audits, and addressing nonconformities. Finally, it provides a list of 20 documents that are typically required as part of an ISO 9001:2015 compliant QMS.

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82 views4 pages

ISO Principles

The document outlines the main principles, requirements, and documents needed for an ISO 9001:2015 Quality Management System (QMS). It discusses the 7 main principles of ISO 9001:2015 including a focus on customers, leadership, engagement of people, a process approach, improvement, evidence-based decision making, and relationship management. It then lists the 13 mandatory requirements an organization needs to establish to meet ISO 9001, such as establishing procedures, conducting internal audits, and addressing nonconformities. Finally, it provides a list of 20 documents that are typically required as part of an ISO 9001:2015 compliant QMS.

Uploaded by

hasib
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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ISO 9001 2015 main principles 1.

Focus on the customer: Organizations need to understand


current and future customer needs and expectations, and meet them with the aim of exceeding
customer satisfaction. 2. Leadership: Top management should provide leadership and direction
to ensure that quality objectives are established, implemented, and maintained. 3. Engagement of
people: All personnel should be empowered to contribute to the effectiveness and efficiency of
the organization’s QMS. 4. Process approach: A process-based approach should be used to
identify and manage interrelated processes required to achieve the organization’s objectives. 5.
Improvement: Organizations need to continually improve the effectiveness of their QMS. 6.
Evidence-based decision making: Decisions should be based on the analysis and evaluation of
data and information. 7. Relationship management: Organizations should establish and maintain
mutually beneficial relationships with suppliers and other stakeholders.

ISO 9001 2015 QMS requirements 1. Establish a quality management system (QMS) that meets the
requirements of ISO 9001:2015. 2. Establish an effective quality policy and quality objectives. 3.
Communicate the quality policy and objectives throughout the organization. 4. Establish and maintain
procedures to ensure compliance with the requirements of ISO 9001:2015. 5. Establish and maintain a
process for internal auditing of the QMS. 6. Establish and maintain a process to review the performance
of the QMS. 7. Establish and maintain a process to address nonconformities and corrective and
preventive action. 8. Establish and maintain a process for the control of design and development
activities. 9. Establish and maintain a process for the control of purchased products and services. 10.
Establish and maintain a process for the control of production and service provision. 11. Establish and
maintain a process for the identification, traceability and control of products and services. 12. Establish
and maintain a process for the control of measuring and monitoring devices. 13. Establish and maintain
a process for the control of nonconforming products.

Documents required for ISO 9001 2015 QMS 1. Quality Management System (QMS) Manual 2.
Quality Policy 3. Quality Objectives 4. Quality Manual 5. Organizational Chart 6. Control of
Documents 7. Control of Records 8. Internal Audit Program 9. Risk Analysis 10. Process
Flowcharts 11. Job Descriptions 12. Training Records 13. Corrective and Preventive Action
Records 14. Nonconformance Reports 15. Management Review Records 16. Supplier Evaluation
Records 17. Customer Complaint Records 18. Performance Measurement and Monitoring
Records 19. Audit Reports 20. Design and Development Records.

ISO 9001 Mandatory Requirements — Documents and


Records
1. Monitoring and measuring equipment calibration records
2. Records of training, skills, experience and qualifications
3. Product/service requirements review records
4. Record about design and development outputs review
5. Record about design and development inputs
6. Records of design and development controls
7. Records of design and development outputs
8. Design and development changes records
9. Characteristics of product to be produced and service to be provided
10. Records about customer property
11. Production/service provision change control records
12. Record of conformity of product/service with acceptance criteria
13. Record of nonconforming outputs
14. Monitoring measurement results
15. Internal audit program
16. Results of internal audits
17. Results of the management review
18. Results of corrective actions

Non-Mandatory Requirements — But Often Included


1. Procedure for determining context of the organization and interested parties
2. Procedure for addressing risks and opportunities
3. Procedure for competence, training and awareness
4. Procedure of equipment maintenance and measuring equipment
5. Procedure for document and record control
6. Sales procedure
7. Procedure for design and development
8. Procedure for production and service provision
9. Warehousing procedure
10. Procedure for management of nonconformities and corrective actions
11. Procedure for monitoring customer satisfaction
12. Procedure for internal audit
13. Procedure for management review
ISO 9001 Clauses - PLAN
 1 Scope
 2 Normative references
 3 Terms and Definitions
 4 Context of the organization
o 4.1 Understanding the organization and its context
o 4.2 Understanding the needs and expectations of interested parties
o 4.3 Determining the scope of the quality management system
o 4.4 Quality management system and its processes
 5 Leadership
o 5.1 Leadership and commitment
 5.1.1 Leadership And Commitment For The Quality Management System
 5.1.2 Customer Focus
o 5.2 Policy
 5.2.1 Establishing the quality policy
 5.2.2 Communicating the quality policy
o 5.3 Organizational roles, responsibilities and authorities
 6 Planning
o 6.1 Actions to address risks and opportunities
o How to address risk in ISO 9001
o 6.2 Quality objectives and planning to achieve them
o 6.3 Planning of changes

ISO 9001 Clauses - DO


 7 Support
o 7.1 Resources
 7.1.1 General
 7.1.2 People
 7.1.3 Infrastructure
 7.1.4 Environment for the operation of processes
 7.1.5 Monitoring and measuring resources
 7.1.6 Organizational knowledge
o 7.2 Competence
o 7.3 Awareness
o 7.4 Communication
o 7.5 Documented information
 7.5.1 General
 7.5.2 Creating and updating documented information
 7.5.3 Control of documented information
 8 Operation
o 8.1 Operational planning and control
o 8.2 Requirements for products and services
o 8.3 Design and development of products and services
o 8.4 Control of externally provided processes, products and services
o 8.5 Product and service provision
o 8.6 Release of products and services
o 8.7 Control of nonconforming outputs

ISO 9001 Clauses - CHECK


 9 Performance evaluation
o 9.1 Monitoring, measurement, analysis and evaluation
 9.1.2 Customer Satisfaction
o 9.2 Internal Audit
o 9.3 Management Review

ISO 9001 Clauses - ACT


 10 Improvement
o 10.1 General
o 10.2 Nonconformity in ISO 9001
o 10.2 What is Non-conformance?
o 10.2 Corrective Action
o 10.3 Continual Improvement

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