Showing posts with label qms questions and answers. Show all posts
Showing posts with label qms questions and answers. Show all posts

Thursday, February 9, 2017

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.

Friday, February 3, 2017

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