ISO 9001:20XX Status

ISO 9001:20XX Status

In August, the ISO TC 176 SC2 ballot on options for the future of ISO 9001 returned the following voting results:

Option a): 36 (revision)

Option b): 25 (affirm)

Abstention: 17

The results of voting showed a simple majority of members in favor of option a) “Start a revision with the scope aligned to the attached draft design specification” that was submitted with the voting documents.

  • Based on comments after voting the initial release of ISO 9001:20XX was scheduled to be 2030.
  • Current tentative date is 2026 based on additional feedback.
  • The IAQG (Aviation, Space and Defense) will be following the ISO revision with additional aerospace requirements added.
  • Once finalized and released, organizations would have 3 years to implement and transition.

The following is from the TC176 summary:

Demographic change

Relates to how populations develop and evolve in different places. Demographic change has a critical influence on the ongoing ability of organizations to act. Competence of employees is decisive for the success of an organization. Every loss of existing specialists means a loss of knowledge and competence to the organization. Securing knowledge in the organization and passing it on to new employees is crucial.

ISO 9001, 5.1.1, 7.1.2, 7.2

  • Add a new requirement(s) 5.1.1. Changing competence requirements need to be addressed in 7.1.2 and 7.2.

Change Management

A systematic approach to initiating, communicating and implementing a transition or transformation. An organization’s context is changing constantly and often very rapidly, however the type and extent of change, and therefore the level of change management needed, varies widely between organizations.

Potential application ISO 9001

  • Introduce change management as a new concept in ISO 9001, either as a standalone requirement or as part of the ‘risk-based thinking’ and/or ‘improvement’ requirements.

 

Integration

An integrated management system (IMS) integrates all systems and processes into one complete framework, drives integration at process level and creates a single aligned system that addresses all objectives and all relevant needs and expectations of interested parties.

ISO 9001 clause 0.4 or Annex

  • A paragraph based can be added either to the introduction or to the Annex.

Integration

An integrated management system (IMS) integrates all systems and processes into one complete framework, drives integration at process level and creates a single aligned system that addresses all objectives and all relevant needs and expectations of interested parties.

ISO 9001 clause 0.4 or Annex

  • A paragraph based can be added either to the introduction or to the Annex.

Integration

An integrated management system (IMS) integrates all systems and processes into one complete framework, drives integration at process level and creates a single aligned system that addresses all objectives and all relevant needs and expectations of interested parties.

ISO 9001 clause 0.4 or Annex

  • A paragraph based can be added either to the introduction or to the Annex.

Integration

An integrated management system (IMS) integrates all systems and processes into one complete framework, drives integration at process level and creates a single aligned system that addresses all objectives and all relevant needs and expectations of interested parties.

ISO 9001 clause 0.4 or Annex

  • A paragraph based can be added either to the introduction or to the Annex.

Emerging Technologies

Those that can or do impact quality include augmented reality, block chain, cloud computing, internet of things (IoT), collaborative robots, crowdsourcing, industry 4.0, artificial intelligence (AI -machine learning), smart products, digital layer, telemetry, quantum computing and autonomous agents and products.

Regardless of the technology that is being used, there are certain factors that must be considered and addressed, including: design, policies, processes, quality control (validation/tests), availability, security, privacy, organizational knowledge, competence.

ISO 9001 Clauses 4, 6.2, 7.5.3, 8.2, 8.3.2, 9.1.1

  • Take emerging technologies into account when revising ISO 9001, with particular emphasis on the clauses cited.

Ethics & Integrity

Those fulfilling leadership roles need to model ethical behaviors to ensure quality activities, and the QMS itself, are effective and trustworthy and cannot be perceived as lacking integrity or self-serving. Without top management commitment to ethical behavior, the organization will lack integrity and meeting customer and business requirements is unlikely to be fully effective.

It is not expected that adding requirements for ethics and integrity would yield a great number of nonconformities. It would help organizations determine how they govern ethics and integrity in dealings with interested parties.

ISO 9001 Clauses 4, 5, 7.3

  • The main impact of ethics would be introduced as part of the context of the organization (4.1) and subsequent risk-based thinking and planning. Leadership (5.1.1) should be expanded to set the tone. Awareness (7.3) should cover the need to ensure ethical behavior and attitude of integrity permeates the organization’s culture.

Organizational Culture

Refers to the collective beliefs, values, attitudes, manners, customs, behaviors, and artifacts unique to an organization. Leadership establishes the organizational identity through the culture it develops and promotes. The distinguishable characteristics of an organization’s identity are centered on its purpose, vision, values, and mission.

Factors that affect organizational culture include: importance of quality in different sectors and level of focus on quality within the organization, maturity of the organization, local/national culture, attitude of leadership, professional and financial status of workers.

ISO 9001 Clause 5.1

It is recommended that organizational culture concepts be added into the next revision of ISO 9001 (there is an existing reference to culture in 4.1 under NOTE 3)

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