Clause 4 procedure and department Quality objective

1. Is the clause 4. is in need of documentation or a procedure? specially the internal and external issues? Do I need to create a procedure for this?

Answer:

ISO 9001:2015 has no mandatory requirements concerning procedures for clause 4. Please check this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ . You will find that the only mandatory document is the scope statement. However, consider clause 4.4.2 about documents and records that organizations decide to use even if not mandatory according to the standard.

2. Is each department is in need to create their department Quality objective or not? are they require to create their department quality objective?

Answer:

Quick answer, no!

ISO 9001: 2015 does not refer to departments. ISO 9001: 2015 works with the process approach. According to clause 4.4, each process must have at least one indicator. Hence it is possible to create at least one objective per process based on each indicator.

Some organizations make the objectives of the processes also the objectives of the QMS. Personally, I don't share that approach. I prefer to look at the objectives of the QMS as umbrella objectives, objectives that require the contribution of the organization as a whole.

The following material will provide you more information:

• How to define Key performance indicators for a QMS based ISO 9001: https://advisera.com/9001academy/24/define-key-performance-indicators-qms-based-iso-9001/-iso-9001/
• How to Write Good Quality Objectives - https://advisera.com/9001academy/knowledgebase/how-to-write-good-quality-objectives/
• Please check this free webinar on demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/  - how to relate processes and objectives
• Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
• Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/