6. PLANNING

6.1 Actions to Address Risks and Opportunities

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.

6.1.2 The organization shall plan:

a. actions to address these risks and opportunities;

b. how to:

1. integrate and implement the actions into its quality management system processes (see 4.4);

2. evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

NOTE 1: Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

NOTE 2: Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.

6.2 Quality Objectives and Planning to Achieve Them

6.2.1 The organization shall establish quality objectives at relevant functions, levels, and processes needed for the quality management system.

The quality objectives shall:

a. be consistent with the quality policy;

b. be measurable;

c. take into account applicable requirements;

d. be relevant to conformity of products and services and to enhancement of customer satisfaction;

e. be monitored;

f. be communicated;

g. be updated, as appropriate.

The organization shall maintain documented information on the quality objectives.

6.2.2 When planning how to achieve its quality objectives, the organization shall determine:

a. what will be done;

b. what resources will be required;

c. who will be responsible;

d. when it will be completed;

e. how the results will be evaluated.

6.3 Planning of Changes

When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4).

The organization shall consider:

a. the purpose of the changes and their potential consequences;

b. the integrity of the quality management system;

c. the availability of resources;

d. the allocation or reallocation of responsibilities and authorities.