6 Planning

6.1 Actions to address risks and opportunities

6.1.1 and 6.1.2
See ISO 9001:2015 requirements

6.1.2.1 Risk Analysis
The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls,
product audits, field returns and repairs, complaints, scrap, and rework.
The organization shall retain documented information as evidence of the results of risk analysis.

6.1.2.2 Preventive Action
The organization shall determine and implement action(s) to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the
severity of the potential issues.

The organization shall establish a process to lessen the impact of negative effects of risk including the
following:
a) determining potential nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of nonconformities;
c) determining and implementing action needed;
d) documented information of action taken;
e) reviewing the effectiveness of the preventive action taken;
f) utilizing lessons learned to prevent recurrence in similar processes (see ISO 9001, Section
7.1.6).

6.1.2.3 Contingency Plan
The organization shall:

a) identify and evaluate internal and external risks to all manufacturing processes and
infrastructure equipment essential to maintain production output and to ensure that customer
requirements are met;
b) define contingency plans according to risk and impact to the customer;

c) prepare contingency plans for continuity of supply in the event of any of the following: key
equipment failures (also see Section 8.5.6.1.1); interruption from externally provided
products, processes, and services; recurring natural disasters; fire; utility interruptions; labour
shortages; or infrastructure disruptions;

d) include, as a supplement to the contingency plans, a notification process to the customer and
other interested parties for the extent and duration of any situation impacting customer
operations;

e) periodically test the contingency plans for effectiveness (e.g., simulations, as appropriate);

f) conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team
including top management, and update as required;

g) document the contingency plans and retain documented information describing any
revision(s), including the person(s) who authorized the change(s).

The contingency plans shall include provisions to validate that the manufactured product continues to
meet customer specifications after the re-start of production following an emergency in which
production was stopped and if the regular shutdown processes were not followed.

6.2 Quality objectives and planning to achieve them

6.2.1 and 6.2.2
See ISO 9001:2015 requirements

6.2.2.1 Quality objectives and planning to achieve them – supplemental
Top management shall ensure that quality objectives to meet customer requirements are defined,
established, and maintained for relevant functions, processes, and levels throughout the organization.
The results of the organization’s review regarding interested parties and their relevant requirements
shall be considered when the organization establishes its annual (at a minimum) quality objectives
and related performance targets (internal and external).

6.3 Planning of changes
See ISO 9001:2015 requirements