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Comparison between ISO 9001:2015 and ISO 9001:2008

Helping you transition from ISO 9001:2008 to ISO 9001:2015

 

General topic comparison between ISO 9001:2008 and ISO 9001:2015

ISO 9001:2008 ISO 9001:2015
Structure Eight clauses Ten clauses; reorganization of clause order and content to better align with other standards.
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Context of the organization No requirement An organization must determine, monitor and review internal and external issues as well as relevant interested parties and their requirements.
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Documented information Six required procedures Document the QMS scope, objectives, quality policy and any process the organization determines needs to be documented.
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Risk Based Thinking Preventative Actions Organizations must take actions to address risks and opportunities.
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Exclusions & requirements Excluding a standard requirement was specific to Product Realization Any requirement that cannot be applied may be excluded as long as it is justified.
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Objects, outputs, products and services Process Based Only The process model is expanded to include anything that affects quality.
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Terminology “Product”
“Supplier”
“Preventative actions”
“Documents and records”
“Products and services”
“External provider”
“Risks and opportunities”
“Documented information”
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Clause by Clause Comparison

ISO 9001: 2015 ISO 9001:2008 Discussion
4  Context of the organization 1.0  Scope
4.1  Understanding the organization and its context New clause Organizations must determine the external and internal issues that affect its purpose and strategic direction as well as relevant interested parties and their requirements.
4.2  Understanding the needs and expectations of interested parties New clause Relevant interested parties and their requirements must be determined and this information is to be monitored and reviewed.
4.3  Determining the scope of the quality management system 1.2  Application
4.2.2 Quality manual
The Quality Manual is no longer mandatory.  The requirement remains for determining and documenting the QMS scope.
4.4  Quality management system and its processes 4  Quality management system
4.1     General requirements
This requirements remains, but now includes risks, opportunities, and assigning authority for processes.
5  Leadership 5  Management responsibility
5.1  Leadership and commitment 5.1  Management commitment
5.1.1  Leadership and commitment for the quality management system 5.1  Management commitment The 2015 version requires top management to become accountable for the QMS’ effectiveness and integration with the organization’s business processes as well as ensuring the quality policy and objectives are compatible with the organization’s context and strategic direction.
5.1.2  Customer focus 5.2  Customer focus The 2015 version includes services (along with products) and also addresses statutory and regulatory requirements.
5.2  Quality policy 5.3  Quality policy The quality policy must now be appropriate to the purpose, strategic direction and context of the organization.
5.3  Organizational roles, responsibilities and authorities 5.5.1  Responsibility and authority
5.5.2 Management representative
The 2015 version requires top management to assign responsibility and authority for ensuring process are delivering their intended outputs.
6 Planning for the quality management system 5.4.2  Quality management system planning
6.1  Actions to address risks and opportunities 5.4.2  Quality management system planning 8.5.3 Preventive action Preventative action has been replaced by risks and opportunities.
6.2  Quality objectives and planning to achieve them 5.4.1  Quality objectives Quality objectives must now be monitored. There are also additional requirements for planning how the organization will achieve it’s objectives.
6.3  Planning of changes 5.4.2  Quality management system planning
7  Support 6  Resource management
7.1  Resources 6  Resource management
7.1.1  General 6.1  Provision of resources
7.1.2  People 6.1  Provision of resources
7.1.3  Infrastructure 6.3  Infrastructure
7.1.4  Environment for the operation of processes 6.4  Work environment
7.1.5  Monitoring and measuring resources 7.6  Control of monitoring and measuring equipment
7.1.6  Organizational knowledge 6.2.2 Competence, training and awareness The 2015 version makes a distinction between knowledge specific to the organization and general training or competence.
7.2  Competence 6.2.2 Competence, training and awareness Competence clause separated for clarity and focus.
7.3  Awareness 6.2.2  Competence, training and awareness Awareness clause separated for clarity and focus.
7.4  Communication 5.5.3  Internal communication Communication expanded in the 2015 revision to include eternal communication.
7.5  Documented information 4.2  Documentation requirements Documents and records are now referred to as “documented information“. Where “retain” is used this refers to records and where “maintain” is used this refers to documents.
7.5.1  General 4.2.1  General
7.5.2  Creating and updating 4.2.3  Control of documents
4.2.4 Control of records
7.5.3  Control of documented Information 4.2.3  Control of documents
4.2.4 Control of records
New requirement to protect records from unintended alterations.
8  Operation 7  Product realization
8.1  Operational planning and control 7.1  Planning of product realization New requirement to review the consequences of unintended changes and take actions to mitigate any adverse effects.
8.2  Determination of requirements for products and services 7.2  Customer-related processes
8.2.1  Customer communication 7.2.3  Customer communication
8.2.2  Determination of requirements related to products and services 7.2.1  Determination of requirements related to the product
8.2.3  Review of requirements related to the products and services 7.2.2  Review of requirements related to the product
8.3  Design and development of products and services 7.3  Design and development
8.3.1  General New clause Establish, implement and maintain a design and development process that is appropriate for your organization.
8.3.2  Design and development planning 7.3.1  Design and development planning Organization’s must now consider the need for involvement of customers and users in the design and development process.
8.3.3  Design and development Inputs 7.3.2  Design and development inputs
8.3.4  Design and development controls 7.3.4  Design and development review
7.3.5   Design and development verification
7.3.6  Design and development validation
8.3.5  Design and development outputs 7.3.3  Design and development outputs
8.3.6  Design and development changes 7.3.7  Control of design and development changes
8.4  Control of externally provided products and services 7.4.1  Purchasing process
8.4.1  General 7.4.1  Purchasing process
8.4.2  Type and extent of control of external provision 7.4.1  Purchasing process
7.4.3 Verification of purchased product
8.4.3  Information for external providers 7.4.2  Purchasing information
8.5  Production and service provision 7.5  Production and service provision
8.5.1  Control of production and service provision 7.5.1  Control of production and service provision
8.5.2  Identification and traceability 7.5.3  Identification and traceability
8.5.3  Property belonging to customers or external providers 7.5.4  Customer property Extends requirements for property belonging to external providers (as well as customers).
8.5.4  Preservation 7.5.5  Preservation of product
8.5.5  Post-delivery activities 7.5.1  Control of production and service provision The new standard separates post-delivery activities into its own sub-clause.
8.5.6  Control of changes 7.3.7  Control of design and development changes
8.6  Release of products and services 8.2.4  Monitoring and measurement of processes 7.4.3 Verification of purchased product
8.7  Control of nonconforming process outputs, products and services 8.3  Control of nonconforming product
9  Performance evaluation 8  Measurement, analysis and improvement  
9.1  Monitoring, measurement, analysis and evaluation 8.2  Monitoring and measurement
9.1.1  General 8.1  General
9.1.2  Customer satisfaction 8.2.1  Customer satisfaction
9.1.3  Analysis and evaluation 8.4  Analysis of data
9.2  Internal audit 8.2.2  Internal audit The new standard does not require a documented procedure for internal audit, but an internal audit program must be established.
9.3  Management review 5.6  Management review Management reviews now include review the QMS for alignment with the organization’s strategic direction. In addition, review inputs must include changes to internal and external issues, feedback from interested parties and the extend to which quality objectives have been met.
10   Improvement 8.5  Improvement
10.1  General 8.5.1  Continual improvement
10.2  Nonconformity and corrective action 8.3  Control of nonconforming product 8.5.2 Corrective action New requirement to review the effectiveness of correction actions and to update risks and opportunities.
10.3  Continual Improvement 8.5.1  Continual improvement