[featured_image]
Download
Download is available until [expire_date]
  • Version
  • Download 214
  • File Size 478.99 KB
  • File Count 1
  • Create Date July 12, 2016
  • Last Updated January 8, 2017

ISO 9001:2015 Checklist (English)

ISO 9001:2015

ISO 9001:2015
0.1 General

0.2 Quality management principles

0.3 Process Approach

0.4 Relationship with other management system standards

ISO 9001:2015
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3. Determining the scope of the quality management system
ISO 9001:2015
4.4. Quality management system and its processes
5. Leadership
5.1 Leadership and commitment
5.1.1
5.1.2 Customer Focus
ISO 9001:2015
5.2 Quality Policy
5.2.1 Developing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
6. Planning
6.1 Actions to address risks and opportunities
6.1.1

6.1.2

ISO 9001:2015
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.l.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness

 

ISO 9001:2015
7.4. Communication
7.5. Documented information

7.5.1. General

7.5.2. Creating and updating

7.5.3. Control of documented information

8. Operation
8.1. Operational planning and control
8.2. Determination of requirements

for products and services

8.2.1. Customer communication

8.2.2. Determination of requirements related to products and services

8.2.3. Review of requirements related to products and services

ISO 9001:2015
8.3. Design and development of products and services
8.3.1. General
8.3.2. Design and development planning
8.3.3. Design and development inputs
8.3.4. Design and development controls

 

8.3.5. Design and development outputs
ISO 9001:2015
8.3.6. Design and development

changes

8.4. Control of externally provided

products and services

8.4.1. General

8.4.2. Type and extent of control

8.4.3. Information for external

providers

8.5. Production and service provision 7.5. Production and service provision

8.5.1. Control of production and service provision

8.5.2. Identification and traceability
There are now seven quality management principles:

• customer focus;

• leadership;

• engagement of people;

• process approach;

• improvement;

• evidence-based decision making;

• relationship management.

In the new version the Process Approach is now embedded in requirements.

It incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

The process approach ensures that not only will incremental improvement take place but that there will be innovative changes Risk management is in, preventive action out.

The standard emphasizes that by addressing both risks and opportunities it establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing undesirable effects.

The standard is in line with the framework developed by ISO to improve alignment among its International Standards for management systems.