Overview

Guidance for organizations that want to go beyond conformity with ISO 9001 and improve their overall ability to achieve sustained success, including a self-assessment tool for judging maturity.

ISO 9004:2018, Quality management — Quality of an organization — Guidance to achieve sustained success, is the guidance companion to ISO 9001. It is the fourth edition and cancels and replaces ISO 9004:2009, which it technically revised. Where ISO 9001 is about giving confidence in an organization's products and services, ISO 9004 is about confidence in the organization's ability to keep succeeding over time.

Two concepts define the 2018 edition. The first is the quality of an organization — the degree to which the organization's inherent characteristics fulfil the needs and expectations of its customers and other interested parties, not just customers. The second is the identity of an organization, made up of its mission, vision, values and culture, which the standard treats as the anchor for strategy and for consistent decision-making.

The document is structured as guidance rather than requirements, so its clauses use "should" throughout. It covers understanding the organization's context and interested parties, establishing and deploying identity and strategy, managing processes, resources and improvement, and analysing and evaluating performance. It also addresses learning, innovation and improvement as linked activities, and the leadership behaviours needed to sustain them.

A distinctive feature is the self-assessment tool provided in an annex. It lets an organization score its maturity against the concepts in the standard across several levels and identify where to focus. The output is a maturity picture rather than a pass or fail, which is why ISO 9004 is often used alongside business excellence models such as EFQM as a lighter-weight, standards-based alternative or complement.

ISO 9004:2018 is aligned with the concepts and terminology of ISO 9000:2015 and ISO 9001:2015 and refers to the quality management principles. It does not add requirements to ISO 9001, is not intended for certification, regulatory or contractual use, and is applicable to any organization regardless of size, type or activity.

Typical use is by organizations that already hold ISO 9001 certification and find that maintaining conformity no longer drives improvement. ISO 9004 gives them a broader agenda — interested parties beyond the customer, organizational identity and culture, longer planning horizons, and structured self-assessment — while keeping the vocabulary and principles their existing system is built on.

Purpose

To give guidance for enhancing an organization's ability to achieve sustained success in a complex, demanding and changing environment, based on the quality management principles, and to provide a self-assessment tool for reviewing how far those concepts have been adopted.

Key Benefits

• Extends attention from customers to the full set of relevant interested parties
• Provides a structured self-assessment for judging organizational maturity
• Links strategy, identity, culture and day-to-day process management
• Gives ISO 9001-certified organizations an improvement agenda beyond conformity
• Uses the same principles and vocabulary as ISO 9000 and ISO 9001, so no new language is needed
• Offers a standards-based alternative or complement to business excellence models
• Applicable to any organization regardless of size, sector or activity
• Supports longer-term thinking about resources, learning and innovation

Key Requirements

• Guidance only — ISO 9004 contains recommendations, not auditable requirements
• Understand the organization's context, interested parties and their relevant needs and expectations
• Define and deploy the organization's identity: mission, vision, values and culture
• Establish, deploy and review strategy, policy and objectives consistent with that identity
• Manage processes as an interacting system and align them with strategy
• Manage resources, including people, knowledge, infrastructure, technology and external providers
• Analyse and evaluate performance across the organization, not only product and service conformity
• Use the self-assessment tool to determine maturity and prioritise improvement
• Manage improvement, learning and innovation as connected activities

Who Needs This Standard?

Senior leadership teams, quality directors and business improvement functions in organizations that already have a functioning quality management system and want a broader framework for long-term performance. It also suits organizations that want a structured maturity self-assessment without committing to a full business excellence award process, and consultants advising on organizational development.

Related Standards