ISO 9001 2015 vs 2008 conversion tool
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0.1 General
0.2 Quality management principles
0.3 Process approach
0.4 Relationships with other management system standards
1 Scope
2 Normative references
3 Terms and definitions
4.1 Understanding organization and its context
4.2 Understanding needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5.1 Leadership and commitment
5.1.1 Leadership and commitment for the quality management system
5.1.2 Customer focus
5.2 Quality policy
5.3 Organizational roles, responsibilities and authorities
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of process
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
8.1 Operational planning and control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements related to products and service
8.2.3 Review of requirements related to products and services
8.2.4 Changes to requirement for product and services
8.3 Design and development of products and services
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
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 of external provision
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming outputs
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Annex A
Annex B
ISO 9001:2008 -
0.1 General
These clauses are almost the same; the new version explains the context of the organization and its influence on the structure of the quality management system (QMS), while pointing out that the standard does not imply a need for uniformity in the structure of the QMS. Additionally, enhancing customer satisfaction is pointed out in this clause.
ISO 9001:2008 - 0.2 Process approach
The clause name is the same, but the 2015 revision has three sections that explain the process approach, PDCA cycle, and risk-based thinking. For more information, read
Plan-Do-Check-Act
in the ISO 9001 Standard.
ISO 9001:2008 - 0.4 Compatibility with other m
anagement systems
This clause of the new version of the standard refers to ISO 9000, ISO 9004, and Annex B of the standard, which provides more details of other standards on quality management.
ISO 9001:2008 - 1 Scope
These clauses are almost the same for both versions of the standard.
ISO 9001:2008 - 2 Normative references
These clauses are almost the same for both versions of the standard.
ISO 9001:2008 - 3 Terms and definitions
The new version refers to ISO 9000:2015.
ISO 9001:2008 - 4.2.2 Quality manual
This requirement was related to the Quality Manual in the previous version. The Quality Manual is not mandatory anymore, but the requirement for determining and documenting the scope remains. For more information, read
What clauses can be excluded in ISO 9001:2015?
and
The future of the Quality Manual in ISO 9001:2015.
ISO 9001:2008 - 4.1 General requirements
The requirements from the previous version remain; the new requirements are related to determining the risks and opportunities and inputs and outputs of the processes, as well as assigning responsibilities and authorities for the processes.
ISO 9001:2008 - 5.1 Management commitment
The clauses are very similar; the emphasis in the new version is on promoting awareness and support of other persons who contribute to the effectiveness of the QMS. The main difference between the clauses is that the new version requires the top management to take accountability for the effectiveness of the QMS. For more information, read
How to comply with new leadership requirements in ISO 9001:2015.
ISO 9001:2008 - 5.4.2 Quality management system Planning
The clauses are very similar; the emphasis in the new version is on promoting awareness and support of other persons who contribute to the effectiveness of the QMS. The main difference between the clauses is that the new version requires the top management to take accountability for the effectiveness of the QMS. For more information, read
How to comply with new leadership requirements in ISO 9001:2015.
ISO 9001:2008 - 5.2 Customer focus
The old requirements remain the same. Determination of the risks and opportunities regarding conformity of products and services is a new requirement, as well as the consideration of the statutory and regulatory requirements.
ISO 9001:2008 - 5.3 Quality Policy
The requirements remain the same. An additional requirement is to be available to interested parties, as appropriate. See the sample document here:
Quality Policy.
For more information, read
How to Write a Good Quality Policy.
ISO 9001:2008 - 5.5.1 Responsibility and authority
The main difference is that the new standard does not require appointing a management representative; however, the new clause describes in more detail the roles, responsibilities and authorities within the QMS, implying that they can be allocated to different persons.
ISO 9001:2008 - 5.4.1 Quality objectives
The requirements remain the same, but are further elaborated in the new version. See the sample document here:
Quality Objectives
. For more information, read
How to Write Good Quality Objectives.
Iso 9001:2008 - 5.4.2 Quality management system planning
The new version of the standard defines how the changes in the QMS should be managed by considering the purpose of the change, the potential consequences, and availability of resources and allocation of responsibilities.
ISO 9001:2008 - 6.1 Provision of resources
The old requirements remain, but new version emphasizes consideration of capabilities and constraints of the organization, as well as resources obtained from external providers.
ISO 9001:2008 - 6.2.1 General
The requirements of both clauses are pretty much the same.
ISO 9001:2008 - 6.3 Infrastructure
The requirements of both clauses are pretty much the same.
ISO 9001:2008 - 6.4 Working environment
The requirements of both clauses are pretty much the same.
ISO 9001:2008 - 7.6 Control of monitoring and measuring equipment
The new version of the standard emphasizes the provision of resources for monitoring and measurement. The organization must retain the documented information as evidence of fitness for purpose of monitoring and measurement resources. The old standard only focuses on the measuring equipment. See the sample document here:
Maintenance and Calibration Record.
ISO 9001:2008 - 6.2.2 Competence, training and awareness
Competence and awareness are split into different clauses to emphasize their importance and provide more detailed requirements. See the sample document here:
Procedure for Human Resources.
For more information, read
Using Competence, Training and Awareness to Replace Documentation in your QMS.
ISO 9001:2008 - 5.5.3 Internal communication
The new clause includes both external and internal communication and requires definition of responsibility and methods of communication.
ISO 9001:2008 - 4.2.3 Control of documents
Documents and records now belong to the same category – documented information. The requirements of both versions are equivalent. See the sample document here:
Procedure for Document and Record Control.
For more information, read
New approach to document and record control in ISO 9001:2015.
ISO 9001:2008 - 4.2.4 Control of records
Documents and records now belong to the same category – documented information. The requirements of both versions are equivalent. See the sample document here:
Procedure for Document and Record Control.
For more information, read
New approach to document and record control in ISO 9001:2015.
ISO 9001:2008 - 7.1 Planning product realization
The requirements of both clauses are equivalent. See the sample document here:
Procedure for Production and Service Provision.
ISO 9001:2008 - 7.2 Customer-related processes
The requirements are almost the same, but the new version emphasizes communication about treatment of customer property. See the sample document here:
Notification to a Customer about Changes on his Property.
ISO 9001:2008 - 7.2.3 Customer communication
The requirements are almost the same, but the new version emphasizes communication about treatment of customer property. See the sample document here:
Notification to a Customer about Changes on his Property.
ISO 9001:2008 - 7.2.1 Determination of requirements related to the product
The requirements of both clauses are pretty much the same. See the sample document here:
Sales Procedure.
ISO 9001:2008 - 7.2.2 Review of requirements related to the product
The requirements of both clauses are pretty much the same. See the sample document here:
Customer Requirement Review Checklist.
ISO 9001:2008 - 7.3 Design and development
The requirements of both clauses are pretty much the same. See the sample document here:
Procedure for Design and Development.
ISO 9001:2008 - 7.3.1 Design and development planning
The requirements of both clauses are pretty much the same. See the sample document here:
Procedure for Design and Development.
ISO 9001:2008 - 7.3.2 Design and development inputs
The requirements of both clauses are pretty much the same. See the sample document here:
Project Task.
ISO 9001:2008 - 7.3.4 Design and development review
The new clause sublimates the requirements of the three old clauses, keeping the old requirements and emphasizing the consideration of nature, duration, and complexity of design and development activities. See the sample document here:
Project Plan and Review
. For more information read
ISO9001 Design Verification vs Design Validation.
ISO 9001:2008 - 7.3.5 Design and development verification
The new clause sublimates the requirements of the three old clauses, keeping the old requirements and emphasizing the consideration of nature, duration, and complexity of design and development activities. See the sample document here:
Project Plan and Review
. For more information read
ISO9001 Design Verification vs Design Validation.
ISO 9001:2008 - 7.3.6 Design and development validation
The new clause sublimates the requirements of the three old clauses, keeping the old requirements and emphasizing the consideration of nature, duration, and complexity of design and development activities. See the sample document here:
Project Plan and Review
. For more information read
ISO9001 Design Verification vs Design Validation.
ISO 9001:2008 - 7.3.3 Design and development outputs
The requirements of both clauses are pretty much the same. See the sample document here:
Design Review Minutes.
ISO 9001:2008 - 7.3.7 Control of design and development changes
The requirements of both clauses are pretty much the same. See the sample document here:
Change Review Record.
ISO 9001:2008 - 7.4.1 Purchasing process
Although the name of the clause has changed, the requirements are pretty much the same. See the sample document here:
Procedure for Purchasing and Evaluation of Suppliers.
ISO 9001:2008 - 7.4.3 Verification of purchased product
The requirements of both clauses are pretty much the same. See the sample document here:
Procedure for Purchasing and Evaluation of Suppliers.
For more information, read
How to control outsourced processes using ISO 9001.
ISO 9001:2008 - 7.4.2 Purchasing information
The requirements of both clauses are pretty much the same. The new version emphasizes the monitoring and control of external providers’ performance.
ISO 9001:2008 - 7.5 Production and service provision
The requirements are almost the same, but the new standard points out that the implemented controlled conditions are for delivery and post-delivery activities. See the sample document here:
Procedure for Production and Service Provision.
For more information, read
Understanding Product & Service Provision in ISO 9001.
ISO 9001:2008 - 7.5.1 Control of production and service provision
The requirements are almost the same, but the new standard points out that the implemented controlled conditions are for delivery and post-delivery activities. See the sample document here:
Procedure for Production and Service Provision.
For more information, read
Understanding Product & Service Provision in ISO 9001.
ISO 9001:2008 - 7.5.2 Validation of processes for production and service provision
The requirements are almost the same, but the new standard points out that the implemented controlled conditions are for delivery and post-delivery activities. See the sample document here:
Procedure for Production and Service Provision.
For more information, read
Understanding Product & Service Provision in ISO 9001.
ISO 9001:2008 - 7.5.3 Identification and traceability
The requirements of both clauses are pretty much the same. See the sample document here:
Record of Traceability.
ISO 9001:2008 - 7.5.4 Customer property
The requirements of both clauses are the same, but in the new standard the requirements are extended to property belonging to external providers as well. See the sample document here:
Notification to a Customer about Changes on his Property.
ISO 9001:2008 - 7.5.5 Preservation of product
The requirements of both clauses are the same.
ISO 9001:2008 - 8.3 Control of nonconforming product
The requirements are equivalent. See the sample document here:
Procedure for Control of Nonconforming Product.
ISO 9001:2008 - 8.2.3 Monitoring and measurement of processes
The new clause sublimates all requirements for processes and products or services monitoring and measurement.
ISO 9001:2008 - 8.2.4 Monitoring and measurement of product
The new clause sublimates all requirements for processes and products or services monitoring and measurement.
ISO 9001:2008 - 8.2.1 Customer satisfaction
The requirements are the same. See the sample document here:
Procedure for Measuring Customer Satisfaction.
ISO 9001:2008 - 8.4 Analysis of data
The requirements are equivalent. See the sample document here:
Data Analysis Report.
ISO 9001:2008 - 8.2.2 Internal audit
The requirements are equivalent. The main difference is that the new standard does not require a documented procedure. See the sample document here:
Procedure for Internal Audit.
For more information, read
Five Main Steps in ISO 9001 Internal Audit.
ISO 9001:2008 - 5.6 Management review
The requirements are equivalent. See the sample document here:
Procedure for Management Review
. For more information, read
How to Make Management Review More Practical.
ISO 9001:2008 - 8.5.2 Corrective action
The requirements are equivalent. See the sample document here:
Procedure for the Management of Nonconformities and Corrective Actions.
For more information, read
Understanding dispositions for ISO 9001 nonconforming product.
ISO 9001:2008 - 8.5.1 Continual improvement
The new standard points out the need to use all available information for continually improving the QMS. For more information, read
Complete guide to corrective action vs. preventive action.
Clarification of new structure, terminology and concepts
Annex A explains the new structure of the 2015 revision together with key new terms and concepts.
Other International Standards on quality management and quality management systems developed by ISO/TC 176
Annex B lists all ISO standards related to ISO 9001 and clauses to which each of the listed standards is referring.
The 2008 revision of the standard only mentions that the quality management principles are taken into consideration; the 2015 revision lists the quality management principles, pointing out that detailed descriptions of the principles are given in ISO 9000.
This is a completely new requirement; the organization will need to determine the external and internal context that affects the organization.
For more information, read
How to identify the context of the organization in ISO 9001:2015
.
This is a completely new requirement. When planning the QMS, the organization will need to determine the risks and opportunities affecting the organization.
For more information, read this article:
The Role of Risk Assessment in the QMS
.
Interested parties are introduced in the new version of the standard. The previous version was only focused on the customer.
This is a completely new requirement, which acknowledges the organizational knowledge as an important resource. The organization will need to determine the knowledge necessary to run its processes and achieve conformity of products and services.
This new clause defines requirements related to changes in requirements related to products and services.
The post-delivery activities are mentioned in several places in the old
version, but in the new standards they are set apart as a separate sub clause.
The control of changes is mentioned in several places in the old version; however, the importance of controlling changes is stressed in the new standard by defining a separate sub clause.
This is a new requirement, dealing with verification of product and ensuring that product or service meets requirements.
The requirements in the new standard explain what should be considered in the process of improvement.
1 Scope
These clauses are almost the same for both versions of the standard.
ISO 9001:2008 - 6.2.1 General
Contact Information