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.

Product updates: ISO 9001:2015 Quality Manual Template

We have incorporated 12 months’ experience of SO 9001:2015 compliant QMS operation, took into consideration the ISO 9002:2016 requirements and offer the 2nd edition of Quality Manual template.

The new Quality manual template is the detailed description of the QMS processes and their interaction.
The depth of the description is enough for the Organization to decide that this Quality Manual is the only QMS document, which summarizes all mandatory Procedures as well as the procedures that regulate processes in accordance with the existing good practices.
This could be a rational decision of the Organization that provides services for small and mid-size manufacturing companies.

ISO 9001:2015 Quality Manual template package includes:
Quality Manual Template 1st edition

• 54 pages MS Word document (Preview)
• Diagrams and models

Quality Manual Template 2nd edition

• 108 pages MS Word document (Preview)
• Diagrams and models

Please note that Quality Manuals’ sections are inter-changeable.

Having access to both editions, you have an opportunity to create your own unique Quality Manual, compile it using sections that are the most suitable for your organization.

ISO 9001:2015 Documents and Templates collection

Quality Objectives and Planning to achieve them

One of the requirements of the new version of ISO 9001 Standard is that there should be a plan to achieve quality objectives.

How would/have you come up with a plan for achieving quality objectives and how would/have you document(ed) them?

A good and practically proven practice is too word quality objectives of the organization in the form of the Organization’s Annual Development Program, which could have the following structure:

1. #
2. Quality objectives wording
3. Process name
4. Responsible for the implementation
5. Deadlines
6. Resources
7. Report type

Quality objectives of the Process (or structural subdivision) are set by the process owner (or structural subdivision manager), based on the analysis of two components:

• Tasks resulting from Organization’s Development Program for the year;
• Tasks aimed at the process (or subdivision) development, using own resources.

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

Numbering System for ISO documentation based on ISO 9001:2015

As far as I know ISO 9001:2015 do not mandates a specific numbering system for control documents.

Is it true that the organization is left open to adopt one that suits it's organizational needs?

Also I am interested to know the best practices for the numbering system.


Yes, that's right - ISO 9001:2015 does not mandate a specific numbering system for control of documents.

Here is an example of the documented information number structure that has been proven in practice:
1. Abbreviation that identifies the document type in accordance with the Documented information structure adopted by the Organization.
For example:

• QSP = Quality System Procedure. 
• QSF = Quality System Form

2. ISO 9001:2015 clause number the group of documents is relevant to.
Example: 7.1- , a group of documents relevant to resources.
3. Index number of the document in the group.
Example: -003 means this is a document #3 in the group.
4. Sometimes it is relevant to give the document’s year of approval in the last part of the id number.
Example: -2017.

QSP 7.5-01-2017 Control of Documented Information

You can find more examples of the QMS documented information numbering on our website in the ISO 9001:2015 Quality System Procedures section