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ISO and quality management

ISO 9001:2015 draft and ISO 9001:2008: archived clause comparison

2015-09-01 05:02:25 | Lượt xem: 12869 | ISO and quality management

This archived article presents a clause comparison prepared before ISO 9001:2015 was published in September 2015. The table reflects the draft used at that time and is retained for historical comparison, not as a current implementation checklist.

Archived comparison of the ISO 9001:2015 draft with ISO 9001:2008. Some draft headings and clause numbers differ from the published edition. Service scopes and timings below describe the offer made at that time.

Comparison of clauses in the ISO 9001:2015 draft and ISO 9001:2008

Clauses in
ISO 9001:2015 draft
Clauses in
ISO 9001:2008
0
Introduction
0
Introduction
1
Scope
1
1.1
1.2
Scope of application
General
Application
2
Normative references
2
Normative references
3
Terms and definitions
3
Terms and definitions
4
Context of the organisation
4
None
4.1
Understanding the organisation and its context
4.1
None
4.2
Understanding the needs and expectations of interested parties
4.2
None
4.3
Determining the scope of the quality management system
1.2
None
4.4
Quality management system
4
Quality management system
5
Leadership
5
Management responsibility
5.1
Leadership and commitment
5.1
Management commitment
5.2
Policy
5.3
Quality policy
5.3
Organisational roles, responsibilities and authorities
5.5.1
Responsibility and authority
6
Planning
5.4
Planning
6.1
Identifying risks and opportunities
 
None
6.2
Quality objectives and planning to achieve them
5.4.1
Quality objectives
6.3
Planning and controlling changes
 
None
7
Support
 
None
7.1
Resources
6
Resource management
7.1.1
General
 
None
7.1.2
Infrastructure and work environment
6.3
6.4
Infrastructure
Work environment
7.1.3
Monitoring and measuring equipment
7.6
Control of monitoring and measuring equipment
7.1.4
Knowledge requirements
 
None
7.2
Competence
6.2.2
Competence, awareness and training
7.3
Awareness
6.2.2
Competence, awareness and training
7.4
Communication
5.5.3
Internal communication
7.5
Documented information
 
None
7.5.1
General
 
None
7.5.2
Creating and updating
 
None
7.5.3
Control of documented information
4.2.3
Control of documents
8
Operation
7
Product realisation
8.1
Operational planning and control
 
None
8.2
Interactions with customers and interested parties
 
None
8.2.1
Determining customer requirements related to the product
7.2.1
Determining customer requirements related to the product
8.2.2
Review of requirements related to the product
7.2.2
Review of requirements related to the product
8.2.3
Customer communication
7.2.3
Customer communication
8.3
Operational readiness
 
None
8.4
Control of externally provided processes or products
 
None
8.5
Design control
7.3
Design and development
8.5.1
Definition
 
None
8.5.2
Analysis
 
None
8.5.3
Application
 
None
8.5.4
Verification and validation
7.3.5
7.3.6
Design and development verification
Design and development validation
8.5.5
Transfer and operation
 
None
8.6
Application and exclusions
1.2
Application
8.6.1
Control of production and service provision
7.5.1
Control of production and service provision
8.6.2
Validation of production and service provision processes
7.5.2
Validation of production and service provision processes
8.6.3
Identification and traceability
7.5.3
Identification and traceability
8.6.4
Monitoring and measurement of product
8.2.4
Monitoring and measurement of product
8.6.5
Control of nonconforming product
8.3
Control of nonconforming product
8.6.6
Control of external property
 
None
8.6.7
Preservation of product
7.5.4
Preservation of product
8.6.8
Post-delivery activities
7.5.1
Control of production and service provision
9
Performance evaluation
 
None
9.1
Monitoring, measurement, analysis and evaluation
8
Measurement, analysis and improvement
9.1.1
General
8.1
General
9.1.2
Customer satisfaction
8.2.1
Customer satisfaction
9.1.3
Data analysis
8.4
Data analysis
9.2
Internal audit
8.2.2
Internal audit
9.3
Management review
5.6
Management review
10
Improvement
8.5
Improvement
10.1
Nonconformity and corrective action
8.2.2
8.5.2
Internal audit
Corrective action
10.2
Continual improvement
8.5.1
Continual improvement
Illustration of document comparison and transition. The clause comparison above retains the original article data.
Illustration of document comparison and transition. The clause comparison above retains the original article data.

Services described during the historical transition

1. Awareness, standard interpretation and internal auditor training for ISO 9001:2015

Duration: three days — half a day for awareness, one and a half days for interpreting requirements, and one day for internal auditing.

Objective: help participants understand the revised standard and audit against its requirements so that the organisation can manage its own system transition.

2. Transition consulting

The scope described in the original article included:

  • Site review and gap analysis: two days.
  • Awareness training and interpretation of requirements: two days.
  • Guidance on revising and adding documents to meet the requirements.
  • Implementation guidance.
  • Internal auditor training and practical internal audits.
  • Guidance on corrective and preventive measures.

Indicative timeframe in the original offer: one to two months, depending on system size.

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