Management system guidance

8.3 Design and development of products and services

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8.3.1 Design and development - General

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This requirement mandates the introduction of a design and development process where this activity is required. You should seek and record evidence that, where applicable, your organization has implemented a design and development process to allow effective product or service provision, where the requirements for products and services are not defined by your customers or interested parties.

Many companies perform some enhancements or minor reconfiguration of mature designs, such organizations may have to introduce a comprehensive design system and related or processes. If your organization is ‘design responsible’ but outsources all of its design, all records from Section 8.3 must be maintained by your organization, as they are still responsible for design.

Determine your organization's arrangements for establishing, implementing and maintaining the design and development process that includes design and development planning, inputs, controls, outputs and changes. If you need a procedure and forms to help control your business's design and development process, click here.

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More information on PDCA

Planning

Context

ISO 9001:2015
ISO 14001:2015
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 Relevant Interested Parties
4.3 Management System Scope 4.3 Management System Scope 4.3 Management System Scope
4.4 QMS Processes 4.4 EMS Processes 4.4 OH&S Management System

Planning

ISO 9001:2015
ISO 14001:2015
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

Support

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
6.1 Address Risks & Opportunities 6.1.1 Address Risks & Opportunities 6.1.1 Address Risks & Opportunities
6.2.1 Quality Objectives 6.1.2 Environmental Aspects 6.1.2 Hazard Identifcation
6.2.2 Planning to Achieve Objectives 6.1.3 Compliance Obligations 6.1.3 Legal & Other Requirements
6.3 Planning for Change 6.1.4 Planning Action 6.1.4 Planning Action
  6.2.1 Environmental Objectives 6.2.1 OH&S Objectives
  6.2.2 Planning to Achieve Objectives 6.2.2 Planning to Achieve Objectives
 

Doing

Support

ISO 9001:2015
ISO 14001:2015
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 Communcation 7.4.1 Communcation - General 7.4.1 Communcation - General
7.5 Documented Information 7.4.2 Internal Communcation 7.4.2 Internal Communcation
  7.4.3 External Communcation 7.4.3 External Communcation
  7.5 Documented Information 7.5 Documented Information

Operations

ISO 9001:2015
ISO 14001:2015
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 8.1.2 Eliminating Hazards
8.3 Design & Development   8.1.3 Management of Change
8.4 Purchasing   8.1.4 Outsourcing
8.5 Product & Service Provision   8.2 Emergency Preparedness
8.6 Release of Products & Services    
8.7 Nonconforming Outputs    
 

Checking

Monitoring, measurement, analysis and evaluation

ISO 9001:2015
ISO 14001:2015
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

Improvement

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
10.1 Improvement - General 10.1 Improvement - General 10.1 Improvement - General
10.2 Nonconformity & Corrective Action 10.2 Nonconformity & Corrective Action 10.2 Incident, Nonconformity & Corrective Action
10.3 Continual Improvement 10.3 Continual Improvement 10.3 Continual Improvement
 

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