ISO 9001 – Planning Overview Clause 6: 6.1 – 6.3

Need a better understanding of Clause 6 Planning of the ISO 9001 standard? In the next series of blog posts, we will be diving deeper to get a better understanding of Clause 6 Planning sections 6.1 – 6.3. We will start with an overview of the clause to understand what this clause is about and how you need to apply it to your organization.

Planning consists of 3 clauses:

6.1 – Actions to address risks and opportunities

6.2 – Quality objectives and planning to achieve them

6.3 – Planning of changes

Clause 6.1 Actions to address risks and opportunities

In this section, the main objective is to establish a structured approach to anticipate and manage potential risks and opportunities affecting the QMS. Some key aspects include:

· Opportunity Identification

· Risk Identification and Evaluation

· Actions to address risks and opportunities

· Integration into the QMS

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:

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.

Clause 6.2 Quality objectives and planning to achieve them

In this section, the main objective is defining clear, measurable quality objectives aligned with the organization’s quality policy and its strategic direction. Some key aspects include:

· Characteristics of quality objectives

· Establishing quality objectives

· Planning to achieve objectives

· Monitoring and reviewing

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:

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.

Clause 6.3 Planning of changes

In this section, the main objective is to manage changes to the QMS effectively to prevent unintended consequences and maintain organizational quality standards. Some key aspects include:

· Identifying changes

· Consideration of potential impacts

· Resource allocation and communication

· Documentation and Review

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:

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.

In Conclusion, Clause 6 Planning in ISO 9001:2015 standard highlights establishing and proactive framework for managing tasks, setting quality objectives, and implementing changes in a controlled manner. Organizations will improve performance and achieve continuous improvement. In the next series of blog posts, we will be diving deeper into each section of Clause 6 Planning. This includes 6.1 Actions to address risks and opportunities, Clause 6.2 Quality objectives and planning to achieve them and Clause 6.3 Planning of changes.

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