Management system standards (MSS) are built on a harmonized approach (HA) described in ISO/IEC Directives, Part 1:2026 (Part 1), Annex Q (Annex Q).
The harmonized approach provides for:
- Justification Study (Q.3 to Q.5);
- Harmonized structure (ISO/IEC Directives, Part 1, Amd. 1);
- Using the harmonized structure (Q.6, Amd. 1).
The purpose of the harmonized approach is to promote integration across disciplines and make it easier for organizations to implement and, if desired, obtain certification for multiple management system standards.
Justification Study
The Justification Study (JS) helps TC/SC/PCs to define and expand the rationale behind the development of a new MSS.
The JS questionnaire contains 32 questions and covers topics such as market relevance, compatibility of the proposal with existing standards, the extent of the coverage, and the flexibility to apply it in various types of organizations. It also covers potential impacts on free trade, conformity assessment, climate change and the ease of use of the resulting standard.
The requirements to submit a JS are provided in Q.3.
The process and criteria of a JS are provided in Q.4 and Q.5.
Harmonized structure
The harmonized structure (HS) is a set of elements that constitute the common structure of every MSS and includes identical:
• clause numbers with the same sequence;
• clause titles;
• common terms and core definitions;
• core text, including requirements and notes.
The HS is available in a single document containing, on the left-hand side, the harmonized structure text (blue text) and, on the right-hand side, guidance for MSS writers for each clause, as well as examples.
Using the Harmonized structure
The harmonized approach provides a set of rules to use and apply the HS.
To enhance the HS for a specific MSS, the HA allows a level of flexibility so the TC/SC/PCs can:
• add requirements, recommendations and guidance specific to their discipline;
• use a definition of risk that is tailored to their context.
To foster interoperability, the HA provides a limited set of constraints, including the need to avoid:
• affecting harmonization or contradicting or undermining the intent of the HS;
• repetitions of the HS text.
Development of an MSS
The harmonized approach allows TC/SC/PCs to clearly define their intent and purpose and to use the harmonized structure as a basis to manage their discipline-specific area with a simple set of rules.
The development of an MSS follows a set of specific steps that enables TC/SC/PCs to leverage the harmonized approach in meeting market needs and expectations.
The figure on the right represents steps and responsibilities for developing, revising, or amending a MSS. Click the link below the figure to review full information.
Where to start?
A TC/SC/PC considering the development of an MSS should start by creating a shared understanding within its relevant working group(s) of the harmonized approach and its key components, as well as having a conversation with the TC/SC/PC Chair and Committee Manager to foster alignment with the Strategic Business Plan and integration with its current portfolio.
After that first step, the TC/SC/PC should consider either or both of the following:
• request an introductory presentation by the JTCG to validate their understanding or the process and ask specific questions related to their project;
• start drafting a Form 4 and a JS.
How to get help?
The JTCG team is here to support and provide insights to TC/SC/PCs during the inception, design, development and revision of MSS.
Understanding the specificities of each TC/SC/PCs, the team can help TC/SC/PCs with:
• the development workflow;
• the application of the harmonized approach;
• providing guidance on specific elements of the proposed MSS;
• identifying possible solutions to meet the needs of specific users or markets;
• collecting feedback on the harmonized approach and the development process.
Managing MSS
The complete article can be found here.