DUV Transition Plan

 

ISO 9001 Quality Management Systems registration provides a set of uniform requirements for a quality management system. A number of quality management principles including a strong customer focus, support of top management, the process approach and continual improvement form the basis for the standard.

 

Changes to the Standard

 

ISO 9001:2015 was published on September 23, 2015.

The newly revised ISO 9001:2015 responds to the latest market developments, and is more compatible with other management systems, such as ISO 14001, thanks to an updated, higher-level structure.  The new standard is less prescriptive than the previous version; instead focusing on performance through a combination of risk-based thinking and a process approach, as well as employment of the “Plan-Do-Check-Act” cycle at all levels in the organization. 

Other updates include:

-           Increased importance has been given to risk

-           More emphasis has been placed on leadership and Top Management direction

-           Greater significance of communication and awareness

These updates, along with changes to other management system standard, include implementing similar terminology across all standards and matching sub-clauses to the top-level structure, ensuring fully integrated systems.

 

ISO 9001:2015 Transition

 

DUV  will be working with each of you (our clients) to provide a smooth transition over the next three years to the new International Standard for Quality Management. We are committed to ensuring that your organization understands the updated requirements and what steps your organization may need to take to achieve conformance. 

ISO 9001:2008 certificates will not be valid after the 3-year transition period.  Organizations looking for first-time ISO 9001 certification are encouraged to certify to ISO 9001:2015. Existing ISO 9001:2008 clients are encouraged to transition early to avoid a bottleneck at the end of the 3-year transition period, or any unforeseen challenges with maintaining certification.

 

ISO 9001: 2015 vs. ISO 9001: 2008 Comparison Table

 

New or Different in ISO 9001:2015

Covered in ISO 9001:2008

 

 

Clause in ISO 9001:2015

Equivalent Clause in ISO 9001:2008

1              Scope

1         Scope

1.1      General

4         Context of the organization

4         Quality management system

4.1      Understanding the organization and its context

4         Quality management system

4.2      Understanding the needs and expectations of interested parties

4         Quality management system

4.3      Determining the scope of the quality management system

1.2      Application

4.2.2  Quality manual

4.4      Quality management system and its  processes

4         Quality management system

4.1      General requirements

5          Leadership

5         Management responsibility

5.1      Leadership and commitment

5.1      Management commitment

5.1.1  General

5.1      Management commitment

5.1.2  Customer focus

5.2      Customer focus

5.2      Policy

5.3      Quality policy

5.2.1  Developing the Quality Policy

5.3      Quality policy

5.2.2  Communicating the Quality Policy

5.3      Quality policy

5.3      Organizational roles, responsibilities and  authorities

5.5.1  Responsibility and authority

5.5.2  Management representative

5.4.2  Quality management system planning

6         Planning

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

7.1.5  Monitoring and measuring resources

7.6      Control of monitoring and measuring equipment

7.1.5.1  General

7.6      Control of monitoring and measuring equipment

7.1.5.2  Measurement traceability

7.6      Control of monitoring and measuring equipment

7.1.6  Organizational knowledge

No equivalent clause

7.2      Competence

6.2.1  General

6.2.2  Competence, training and awareness

7.3      Awareness

6.2.2  Competence, training and awareness

7.4      Communication

5.5.3  Internal communication

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

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     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 products and services

7.2.2  Review of requirements related to the product

8.2.4  Changes to requirements for products and services

7.2.2  Review of requirements related to the product

8.3      Design and development of products and services

7.3Design and development

8.3.1  General

7.3.1  Design and development planning

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

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 processes, products and services

4.1 |  General requirements

7.4.1  Purchasing process

8.4.1  General

7.4.1  Purchasing process

8.4.2  Type and extent of control

7.4.1  Purchasing process

7.4.3  Verification of purchased product

8.4.3  Information for external providers

7.4.2  Purchasing information

7.4.3  Verification of purchased product

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

7.5.2  Validation of processes for 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

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

8.5.6  Control of changes

7.3.7  Control of Design and Development Changes

8.6      Release of products and services

7.4.3  Verification of purchased product

8.2.4  Monitoring and measurement of product

8.7      Control of nonconforming outputs

8.3     Control of nonconforming product

9         Performance evaluation

8        Measurement, analysis and  improvement

9.1      Monitoring, measurement, analysis and evaluation

8       Measurement, analysis and   improvement

9.1.1  General

8.1      General

8.2.3  Monitoring and Measurement  Processes

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

9.3      Management review

5.6     Management review

9.3.1  General

5.6.1 General

9.3.2  Management review input

5.6.2 Review input

9.3.3  Management review output

5.6.3 Review output

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

8.5.3   Preventive action