1. Summary of changes between ISO 9001:2008 and ISO/CD 9001
New Clause No
1 Scope
Existing Clause
No
1
by Tala khalid Hasan
Summary of Changes
1.1 Unchanged apart form Note 1 b) – ‘realisation processes’ becomes ‘operational processes’
1.2 Removed
2 Normative References
2
ISO 9000:2005 becomes ISO 9000:2015
3 Terms & Definitions
3
Reference to ‘product = service’ removed
A list of common definitions included but may be removed later and put into ISO 9000:2015
4 Context of the
organisation
4.1 Understanding the organisation and its context – new clause
4.2 Determining the scope of the quality management system
4
4.1
4.4 Quality management system
4.4.1 General - Still a requirement establish, implement, etc a QMS
4.4.2 Process approach
5 Leadership
5.1 Leadership and commitment
5.1
5.1.1 This relates to commitment to the QMS
5.2
5.1.2 This relates to commitment to customers
5.3
5.2 Quality policy
5.5
5.3 Organisational roles, responsibilities and authorities
6 Planning
Whilst this is a familiar title, it is mostly a new section which relates to the establishment of the QMS.
6.1 Actions to address risks and opportunities
5.4
6.2 Quality objectives and planning to achieve them
5.4
6.3 Planning of changes
7 Support
This is a new title but it contains mostly what is currently in section 6 (resource management) plus some
additional requirements
6.1
7.1 Resources
6.3
7.1.2 Infrastructure
6.4
7.1.3 Process environment
7.6
7.1.4 Monitoring and measuring devices
7.1.5 Knowledge
6.2
7.2 Competence

2. 6.2
7.3 Awareness
5.5.3
7.4 Communication
4.2.3 & 4.2.4
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
8 Operation
7.1
8.1 Operational planning and control
7.2
8.2 Determination of market needs and interactions with customers
8.2.1 General
7.2.1
8.2.2 Determination of requirements related to the goods and services
7.2.2
8.2.3 Review of requirements related to the goods and services
7.2.3
8.2.4
7.1
7.4 & 4.1
7.4.1
8.3 Operational planning process
8.4 Control of external provision of goods and services
8.4.1 A simple statement that externally provided goods and services must conform to specified
requirements.
7.4.1
8.4.2 Type and extent of control of external provision
7.4.2 &7.5.4
8.4.3 Documented information for external providers
7.3
8.5 Development of goods and services
7.5
8.6 Production of goods and provision of services
7.5.1
8.6.1 Control of production of goods and provision of services
7.5.3
8.6.2 Identification and traceability
7.5.4
8.6.3 Property belonging to customers or external providers
7.5.5
8.6.4 Preservation of goods and services
7.2
4.2.3 & 5.4.2
8.2.4
8.6.5 Post delivery activities
8.6.6 Control of changes
8.7 Release of goods and services
8.3
9 Performance evaluation
8.8 Nonconforming goods and services
8.2
9.1.1 Monitoring, measurement, analysis and evaluation
8.2.1
8.4
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation of data

3. 8.2.2
5.6.1,2,3
10 Improvement
8.3 & 8.5.2
8.5.1
9.2 Internal audit
9.3 Management review
10.1 Nonconformity and corrective action
10.2 Improvement