6.1.1、When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:
a. give assurance that the quality management system can achieve its intended result(s.;
b. enhance desirable effects;
c. prevent, or reduce, undesired effects;
d. achieve improvement.