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Comparison between ISO 9001:2015 and ISO 9001:2008

Helping you prepare for the new ISO 9001:2015 standard


General topic comparison between the ISO 9001:2008 standard and the ISO 9001:2015 standard?

ISO 9001:2008 ISO 9001:2015
The Structure Compare the old Structure Preparing for Integrated Standards
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Context How the QMS relates internal issues to external issues 9001:2015 requires how an organization defines internal and external influences
Documented Information The documents are strictly defined The new standard loosens the definition to “information” and the quality manual requirements
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Risk Based Emphasis Risk was implicit in ISO 9001:2015 ISO 9001:2015 explicity expects risk assessment and avoidance
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Exclusions & Requirements Excluding a standard requirement was specific to Product Realization The new standard allows for a more general way to exclude specific requirements
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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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Clarifications From implementing, and auditing within ISO 9001:2008, there were a number of issues that needed clarification
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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 1.1  General A new requirement – the organization must determine the external and internal context that affects the organization
4.2  Understanding the needs and expectations of interested parties 1.1  General
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 its scope.
4.4  Quality management system and its processes 4  Quality management system 4.1     General requirements This requirements remains, the new
cover 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 new version requires top management to become accountable for the QMS’ effectivness.
5.1.2  Customer focus 5.2  Customer focus Virutally the same except the new version includes services (along with products) and also addresses government regulations.
5.2  Quality policy 5.3  Quality policy
5.3  Organizational roles, responsibilities and authorities 5.5.1  Responsibility and authority 5.5.2 Management representative The new version details the responsibilities, roles and authorities within the QMS.
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
6.2  Quality objectives and planning to achieve them 5.4.1  Quality 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 The 2015 version focuses the provision of
resources to monitor and measure. The organization must retain the evidence monitoring and measuring resources.
7.1.5  Monitoring and measuring resources 7.6  Control of monitoring and measuring equipment
7.1.6  Organizational knowledge New The organization must determine the
knowledge necessary to run the processes and achieve conformity of products and services
7.2  Competence 6.2.1  General 6.2.2 Competence, training and awareness The old version covered both competence and awareness in the same clause.  The new clause separates them.
7.3  Awareness 6.2.2  Competence, training and awareness Separated for clarity and focus.
7.4  Communication 5.5.3  Internal communication Internal and External communication responsibilities must be defined.
7.5  Documented information 4.2  Documentation requirements
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  Documents and records are now considered in the same category (i.e. documented information)
7.5.3  Control of documented Information 4.2.3  Control of documents 4.2.4 Control of records
8  Operation 7  Product realization
8.1  Operational planning and control 7.1  Planning of product realization
8.2  Determination of requirements for products and services 7.2  Customer-related processes The new version emphasizes documenting the treatment of customer property.
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  
8.3.2  Design and development planning 7.3.1  Design and development planning
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

The new clause aggregates of the three 2008 clauses, and emphasizes the
nature, duration of design and
development processes.
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 The 2015 version emphasizes monitoring and control of external providers.
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 Describes extending requiments 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 to a new clause.
8.5.6  Control of changes 7.3.7  Control of design and development changes A new separate clause is used to highlight the importance of change control.
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 New  
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  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
9.3  Management review 5.6  Management review
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
10.3  Continual Improvement 8.5.1  Continual improvement The 2015 standard emphasizes the use of all available information for continually improving the Quality Management System