ISO 9001:2015 Changes Offer New Opportunities for Leadership Engagement

July 2, 2016

ISO 9001:2015 was published in September 2015. We are nearly a year into the transition period for ISO 9001:2015, and affected organizations are busy assessing the gaps between their current processes and ISO 9001:2015’s requirements.

Common gaps include several areas related to input from top management. Although addressing these requirements will take some effort, they provide opportunities to increase top management’s engagement in the quality management system.

New Requirements for Top Management in ISO 9001:2015

ISO 9001:2015 Requirement: Context of the Organization (Clause 4)

Clause 4 sets the stage for the management system. It requires your organization to determine the external and internal issues that impact the organization, the results of the quality management system (QMS), the needs of interested parties, the scope of the QMS, and the necessary QMS processes.

Opportunity: The organization’s top management needs to use the organization’s vision and mission to help define and establish the scope of the management system, as well as determine which (if any) requirements cannot be applied. This emphasis on context offers management the opportunity to examine components – such as vision (i.e., desired future) and mission (i.e., why the organization exists) – and link them with the needs and expectations of interested parties who are relevant to the quality management system.

ISO 9001:2015 Requirement: Leadership (Clause 5)

This clause covers leadership and commitment, customer focus, the quality policy, and organizational roles.

Opportunity: Clause 5 states specific expectations for top management’s leadership and commitment to the QMS. The new requirements provide the opportunity for top management to step back and connect the QMS with the company’s strategy. Too often, organizations “work for ISO.” They work hard to maintain certification, but their certifications may not add value to the business. The new standard makes it easier – through greater top management engagement – to have ISO work for the organization.

ISO 9001:2015 Requirement: Planning (Clause 6)

The Planning clause includes actions to address risks and opportunities, how to achieve the quality objectives, and planning changes to the QMS.

Opportunity: This clause prompts organizations to consider the impact of both business risks and opportunities, a natural role for top management. To meet the requirements, the organization must plan the actions to address the risks and opportunities, integrate the actions into the QMS processes, and evaluate the effectiveness of the actions. This evaluation is important because it demands regular, ongoing input from top management.

What’s next?

A good first step in your effort to comply with ISO 9001:2015 is to perform a gap analysis of your current QMS against the revised standard.

Then, as you begin transitioning to ISO 9001:2015, we recommend stepping back periodically and identifying opportunities to use the changes to make your quality management system a strategic driver of performance and sustainability.

Author: Oriel STAT A MATRIX

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