Comparison between ISO 9001:2008 and ISO/DIS 9001:2015


ISO 9001:2008

ISO 9001:2015 DIS

Comments

0. Introduction

0. Introduction

 

1.1 General

1. Scope

 

1.2 Application

4.3 Determining the scope of the quality management system

 

2. Normative references

2. Normative references

There is no normative reference in the DIS

3. Terms and definitions

3. Terms and definitions

Definitions from ISO 9001:2014 DIS included

4. Quality Management System

4. Context of the organization

 

4.1 General Requirements

4.4 Quality management system and its processes

 

4.2 Documentation Requirements

4.4 Quality management system and its processes

Reduced requirements for documentation

4.2.1 General

 

 

4.2.2 Quality Manual

 

Quality Manual not required

4.2.3 Control of Documents

7.5 Documented Information

Records and Documents are now Maintain & Retain "Documented Information

4.2.4 Control of Records

7.5 Documented Information

Records and Documents are now Maintain & Retain "Documented Information"

5. Management Responsibility

5. Leadership

 

5.1 Management Commitment

5.1.1 Leadership and commitment for the quality management system

Top Management shall demonstrate - The risks which can affect conformity of goods and services and customer satisfaction are identified and addressed.

5.2 Customer Focus

5.1.2 Customer focus

 

5.3 Quality Policy

5.2 Quality policy

Available to relevant interested parties, as appropriate.

5.4 Planning

6. Planning

 

5.4.1 Quality Objectives

6.2 Quality objectives and  planning to achieve them

 

5.4.2 Quality Management System Planning

6.3 Planning of change

 

5.5 Responsibility, Authority, and Communication

5.3 Organizational roles, responsibilities and authorities

 

5.5.1 Responsibility and Authority

5.3 Organizational roles, responsibilities and authorities

 

5.5.2 Management Representative

 

MR not required for an individual person

5.5.3 Internal Communications

7.4 Communication

 

5.6 Management Review

9.3 Management Review

 

5.6.1 General

9.3.1 Management Review

 

5.6.2 Review Input

9.3.1 Management Review

 

5.6.3 Review Output

9.3.2 Management Review

 

6. Resource Management

7.1 Resources

 

6.1 Provision of Resources

7.1 Resources

 

6.2 Human Resources

7.1.2 People

 

6.2.1 General

7.2 Competence

 

6.2.2 Competence, Training, and Awareness

7.2 Competence

 

6.3 Infrastructure

7.1.3 Infrastructure

 

6.4 Work Environment

7.1.4 Environment for the operation of processes

 

7. Product Realization

8. Operation

 

7.1 Planning of Product Realization

8.1 Operational planning and control

Use of goods & services      instead of products

7.2 Customer-Related Processes

8.2 Determination of requirements for products and services

 

7.2.1 Determination of Requirements Related to the Product

8.2.2 Determination of requirements related to products and services

 

7.2.2 Review of Requirements Related to the Product

8.2.3 Review of requirements related to products and services

 

7.2.3 Customer Communication

8.2.1 Customer communication

 

7.3 Design and Development

8.3 Design and development of products and services

 

7.3.1 Design and Development Planning

8.3.2 Design and development planning

 

7.3.2 Design and Development Inputs

8.3.3 Design and development inputs

 

7.3.3 Design and Development Outputs

8.3.5 Design and development outputs

 

7.3.4 Design and Development Review

8.3.4 Design and development controls

 

7.3.5 Design and Development Verification

8.3.4 Design and development controls

 

7.3.6 Design and Development Validation

8.3.4 Design and development controls

 

7.3.7 Control of Design and Development Changes

8.3.6 Design and development changes

 

7.4 Purchasing

8.4 Control of externally provided products and services

 

7.4.1 Purchasing Process

8.4.1 General

 

7.4.2 Purchasing Information

8.4.3 Information for external providers

 

7.4.3 Verification of Purchased Product

8.4.2 Type and extent of control of external provision

 

7.5 Production and Service Provision

8.5 Production and service provision

 

7.5.1 Control of Production and Service Provision

8.5.1 Control of production and service provision

 

7.5.2 Validation of Processes for Production and Service Provision

8.5.1 Control of production and service provision

 

7.5.3 Identification and Traceability

8.5.2 Identification and traceability

 

7.5.4 Customer Property

8.5.3 Property belonging to customers or external providers

 

7.5.5 Preservation of Product

8.5.4 Preservation

 

7.6 Control of Monitoring and Measuring Equipment

7.1.5 Monitoring and measuring resources

 

8. Measurement, Analysis, and Improvement

9.1 Monitoring, measurement, analysis and evaluation

 

8.1 General

9.1.1 General

 

8.2 Monitoring and Measurement

9.1.1 General

 

8.2.1 Customer Satisfaction

9.1.2 Customer satisfaction

 

8.2.2 Internal Audit

9.2 Internal Audit

 

8.2.3 Monitoring and Measurement of Processes

9.1.3 Analysis and evaluation

 

8.2.4 Monitoring and Measurement of Product

9.1.3 Analysis and evaluation

 

8.3 Control of Nonconforming Product

8.7 Control of nonconforming process outputs, products and services

 

8.4 Analysis of Data

9.1.3 Analysis and evaluation

 

8.5 Improvement

10. Improvement

 

8.5.1 Continual Improvement

10.3 Improvement

Continual deleted

8.5.2 Corrective Action

10.2 Nonconformity and corrective action

 

8.5.3 Preventive Action

 

No requirement for  PA (risk based thinking)