ISO 9001 - Clause 6 - Planning - Risk and opportunity, Quality Objectives and Planning of change

There are 3 sub clause. Clause 6.1, Clause 6.2 and Clause 6.3. 

6.1 - Risk and opportunity 

Organizations shall plan actions that address potential risks and opportunities, integrate them into their quality management system processes, and evaluate the effectiveness of these actions. It emphasizes a risk-based approach to enhance the system's ability to achieve its intended results, prevent undesirable effects, and achieve continual improvement. When identifying Risk and opportunity organization shall also consider internal and external issues. 

Template - Risk and opportunity 

6.2 - Quality Objectives

Organizations shall establish quality objectives at relevant functions, levels, and processes needed for the quality management system. These objectives must be SMART
S - Specific 
M - Measurable 
A - Achievable
R - Relevant 
T - Time Bound
Quality objectives should be communicated, updated as appropriate, and consistent with the quality policy. They should also take into account applicable requirements, be relevant to conformity of products and services, and aim at enhancing customer satisfaction.

Examples of Quality Objectives 

1. Reduce manufacturing defects by 20% by the end of year by implementing new quality control procedures and regular staff training.

2. Increase customer satisfaction by 15% over the next year by improving product quality and addressing customer feedback promptly.

6.3 - Planning of change

Organizations shall manage and control changes in a systematic manner, preventing unintended consequences. Changes may involve implementation of new systems, like ERP or SAP, or alteration to existing ones. Planning should be carried out in a way that maintains the integrity of the quality management system.