Transitioning from ISO 9001:2008 to ISO 9001:2015: Documentation

Are there any key points to remember in transitioning from ISO 9001:2008 to ISO 9001:2015 especially when it comes to documentation?


For the key points to remember in transitioning from ISO 9001:2008 to ISO 9001:2015 refer to the following sections

4.1. In the section 4.1 of Quality Manual, describe activities to monitor, analyze and communicate the information about the internal and external context including three components

• gathering of information and analysis of the components of internal and external context in QMS processes;
• communication of information about the context inside the Organization;
• use of information about the context of the organization. 

4.2. In the section 4.2 of Quality Manual, describe activities of interaction of the Organization with the interested parties that include:

• defining interested parties relevant to the QMS;
• monitoring and analysis of interested parties’ needs and expectations. 

4.3. In the section 4.3 of Quality Manual govern (in addition to the process approach implementation as per sec 4.1 of ISO 9001:2008) activities to address risks and opportunities in each QMS process. Provision should be made for keeping records of these activities as evidence of process operation.

6.1. Actions to address risks and opportunities. Develop and implement a risk management system considering (or even in compliance with) ISO 31000. Such system fits in well with the requirements of ISO 9001:2015. An example of this decision in a concise form, when risk management activation are described in the form of a quality procedure can be found in QSP 6.1-01 Actions to address risks and opportunities.

Other approaches to addressing risks and opportunities and more details on the subject find in Actions to address risks and opportunities: Planning.


6.2. It is necessary to plan achieving the quality objectives (not only define and monitor their implementation as required by ISO 9001:2008).
A good and practically proven methodology is to word quality objectives of the organization in the form of the Organization’s Annual Development Program.
Further details of quality objectives planning are given in the 2nd edition of ISO 9001:2015 Quality Manual.

7.1.5. Monitoring and measuring resources – is aimed at definition of requirements, ensuring availability and serviceability of the three components of resources for monitoring and measuring:

•  Measuring equipment (it was in the ISO 9001:2008 requirements);
•  Measuring and monitoring methodologies (new);
•  Competence of personnel conducting monitoring and measuring (new). 

Further details of quality objectives planning is given in the 2nd edition of ISO 9001:2015 Quality Manual.

7.1.6. Consider knowledge as an importance resource to operate processes and ensure products and services compliance. Control of organizational knowledge is aimed at:

• Definition of knowledge necessary to operate the processes and achieve products and services compliance;
• Obtaining and maintaining of knowledge
• Ensuring the availability of knowledge to the extent necessary
• Viewing the current knowledge and obtaining access to any necessary additional knowledge and the required updates in response to changing needs and trends. 

When documenting control of organizational knowledge it is enough to describe it in the section 7.1.6 of the Quality manual. It is a better practice to do it in the form of a quality system procedure. An example of the procedure: QSP 7.1-01 Control of Organizational knowledge

8.5. While providing and describing the controlled production conditions ensure the implementation of actions to prevent human error.