ISO 9001:2015, Clause 6, Planning

 Clause 6 on Planning has three sub-clauses:

6.1 Actions to Address Risks and Opportunities
6.2 Quality Objectives and Planning to Achieve Them
6.3 Planning of Changes

This article summarizes the ISO 9001:2015 requirements in sub-clauses 6.1, 6.2, and 6.3 and highlights the changes from ISO 9001:2008.

6.1 Actions to Address Risks and Opportunities
6.1.1 (untitled)

When planning for the quality management system (QMS), consider the issues in clause 4.1, and the requirements in 4.2.

Determine the risks and opportunities that need to be addressed to:

  • give assurance that the QMS can achieve its intended results;
  • enhance desirable effects;
  • prevent, or reduce, undesired effects;
  • achieve improvement.

6.1.2 (untitled)

  • plan actions to address these risks and opportunities;
  • plan how to:
    • integrate and implement the actions into QMS processes (see 4.4);
    • evaluate the effectiveness of these actions.

Take actions to address risks and opportunities that are proportionate to the potential impact on the conformity of products and services.

NOTE 1: Options to address risks and opportunities can include:

  • avoiding risk;
  • taking risk 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:

  • 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 organization or customer needs.

Changes:

  • This is a new clause on risks and opportunities
  • Expands on old clause 5.4.2 on Planning
  • Replaces old clause 8.5.3 on Preventive Action
  • Need methodology to identify and address risks
  • Could decide to accept risk and take no action

Note that ISO 9001:2008 in its requirement clauses 4 through 8 does not mention “risk”. ISO 9001:2015 in its requirement clauses 4 through 10, mentions “risk” 16 times.

6.2 Quality Objectives and Planning to Achieve Them
6.2.1 (untitled)

Establish quality objectives at relevant functions, levels, and processes.

The quality objectives must:

  • be consistent with the quality policy;
  • be measurable;
  • consider applicable requirements;
  • be relevant to conformity of products and services;
  • be relevant to enhancement of customer satisfaction;
  • be monitored;
  • be communicated;
  • be updated as appropriate.

Maintain documented information on the quality objectives.

6.2.2 (untitled)

When planning how to achieve the quality objectives, determine:

  • what will be done;
  • what resources will be required;
  • who will be responsible;
  • when it will be completed;
  • how the results will be evaluated.

Changes:

  • Replaces old clause 5.4.1 on quality objectives
  • Expands to set quality objectives for relevant “processes”
  • Adds that objectives must be relevant to services and customer satisfaction
  • Must consider objectives for applicable requirements
  • Adds planning (what, who, when, how) for achievement of quality objectives

6.3 Planning of Changes

Carry out changes in a planned manner (see 4.4) when the organization determines the need for changes to the quality management system.

Consider the:

  • purpose of the changes and their potential consequences;
  • integrity of the quality management system;
  • availability of resources;
  • allocation or reallocation of responsibilities and authorities.

Changes:

  • Replaces the old clause 5.4.2.b on QMS planning
  • Adds consideration of potential consequences, resources, and responsibilities

The ISO 9001:2015 Requirements and Transition Guidance course can taught at your location by contacting Larry Whittington at larry@whittingtonassociates.com or 770-862-1766.