Guidance

Design and development

The ISO Navigator™ database hyperlinks the ISO 9000:2005 principles and the ISO 9001:2008 requirements; and explains them in plain English with practical guidance.

This guidance has been superseded by ISO 9001:2026 Clause 8.3.3 Design and Development Inputs. If you want to see a comparison matrix that correlates the requirements of ISO 9001:2008 to the revised requirements of ISO 9001:2015, please click here to begin comparing.

Our range of ISO 9001:2026 quality manuals and integrated manual templates cover the requirements of ISO 9001, ISO 14001 and ISO 45001, and offer an easy way to implement and document your organization's quality management system or integrated management system.

ISO 9001:2008: Design and development input 7.3.2 (superseded)

Define which inputs are required to carry out the design and development process. The customer requirement inputs should be determined according to the design and development activities. For example which employees are required or what information is required for every step of the development. Determine design and development inputs by determining:

  1. Functional and performance characteristics
  2. Statutory and regulatory requirements
  3. Relevant information from previous designs
  4. Requirements essential to the product
  5. The types of records that are required

An auditor might want to review evidence that the inputs (7.3.2) have been addressed based on the nature of the product being produced, that they have been reviewed for adequacy and that records are maintained of the activity.

An organization may include design personnel in the contract review stage; these records may suffice the review of design input requirements.

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Planning

ISO 9001:2026 ISO 14001:2026 ISO 45001:2018
4.1 Organizational Context 4.1 Organizational Context 4.1 Organizational Context
4.2 Relevant Interested Parties 4.2 Relevant Interested Parties 4.2 Workers & Interested Parties
4.3 Management System Scope 4.3 EMS Scope 4.3 OH&S Management System Scope
4.4 QMS Processes 4.4 Environmental Management System 4.4 OH&S Management System
 
ISO 9001:2026 ISO 14001:2026 ISO 45001:2018
5.1 Leadership & Commitment 5.1 Leadership & Commitment 5.1 Leadership & Commitment
5.2 Quality Policy 5.2 Environmental Policy 5.2 OH&S Policy
5.3 Roles, Responsibilities & Authorities 5.3 Roles, Responsibilities & Authorities 5.3 Roles, Responsibilities & Authorities
    5.4 Consultation & Participation
 
ISO 9001:2026 ISO 14001:2026 ISO 45001:2018
6.1 Risks & Opportunities (6.1.1–6.1.3) 6.1.1 Risks & Opportunities - General 6.1.1 Risks & Opportunities - General
6.2.1 Quality Objectives 6.1.2 Environmental Aspects 6.1.2 Hazard Identification & Assessment
6.2.2 Planning to Achieve Objectives 6.1.3 Compliance Obligations 6.1.3 Legal & Other Requirements
6.3 Planning of Changes 6.1.4 Risks & Opportunities 6.1.4 Planning Action
  6.1.5 Planning Action 6.2.1 OH&S Objectives
  6.2.1 Environmental Objectives 6.2.2 Planning to Achieve Objectives
  6.2.2 Planning to Achieve Objectives  
  6.3 Planning of Changes  
 

Doing

ISO 9001:2026 ISO 14001:2026 ISO 45001:2018
7.1 Resources 7.1 Resources 7.1 Resources
7.2 Competence 7.2 Competence 7.2 Competence
7.3 Awareness 7.3 Awareness 7.3 Awareness
7.4 Communication 7.4.1 Communication - General 7.4.1 Communication - General
7.5 Documented Information 7.4.2 Internal Communication 7.4.2 Internal Communication
  7.4.3 External Communication 7.4.3 External Communication
  7.5 Documented Information 7.5 Documented Information
 
ISO 9001:2026 ISO 14001:2026 ISO 45001:2018
8.1 Operational Planning & Control 8.1 Operational Planning & Control 8.1.1 General
8.2 Customer Requirements 8.2 Emergency Preparedness & Response 8.1.2 Eliminating Hazards
8.3 Design & Development   8.1.3 Management of Change
8.4 Purchasing   8.1.4 Procurement
8.5 Product & Service Provision   8.2 Emergency Preparedness
8.6 Release of Products & Services    
8.7 Nonconforming Outputs    
 

Checking

ISO 9001:2026 ISO 14001:2026 ISO 45001:2018
9.1 Monitoring & Measurement 9.1.1 Performance Evaluation 9.1.1 Performance Evaluation
9.2 Internal Audit 9.1.2 Evaluation of Compliance 9.1.2 Evaluation of Compliance
9.3 Management Review 9.2 Internal Audit 9.2 Internal Audit
  9.3 Management Review 9.3 Management Review
 

Acting

ISO 9001:2026 ISO 14001:2026 ISO 45001:2018
10.1 Continual Improvement 10.1 Continual Improvement 10.1 Improvement - General
10.2 Nonconformity & Corrective Action 10.2 Nonconformity & Corrective Action 10.2 Incident, Nonconformity & Corrective Action
    10.3 Continual Improvement