Management system guidance

8.3 Design and development of products and services

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8.3.5 Design and development outputs

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This requirement is comparable to the requirement from ISO 9001:2008 Clauses 7.3.3 – Design Development Outputs. You should seek and record evidence that the additional requirement to retain documented information concerning design outputs. You should also check the need for design outputs to reference monitoring and measuring requirements. If you need a procedure and forms to help control your business's design and development process, click here.

The design and development output is the result of design and development process. The output is a clear description of the product, containing detailed information for production. Ensure that your organization's design and development outputs reconcile with its design and development inputs by:

  1. Ensuring outputs meet input requirements e.g. checklists, design review records, authorization to proceed, customer acceptance, and product certification;
  2. Ensuring outputs are adequate for product and service provision e.g. standards, specifications, schemes, drawings, models, part lists, materials, methods, manufacturing instructions, technical packages, tooling, machine programs, preservation, handling, packaging, specialist training, user instructions, service manuals, repair schemes, and external provision;
  3. Reference to monitoring and measuring equipment e.g. inspection equipment, gages, instruments, environment;
  4. Acceptance criteria e.g. product/service specification, limits, tolerances, and quality acceptance standards;
  5. Product/service characteristics e.g. key characteristics, customer critical features, interface features, inspections, service intervals, and operating characteristics;
  6. Critical items such as identification, key characteristics, special handling, service intervals, component lifing, cyclic life, life management plans, source and method change, and traceability;
  7. Outputs are approved prior to release e.g. scope of authorization, authorized persons, levels of authorization, method of authorization and documented information is retained.

Outputs of the detailed design are the final technical documents used for purchasing, production, installation, inspection and testing, and servicing. Design output includes production specifications as well as descriptive materials which define and characterize the finished design and include drawings and documents used to procure components, fabricate, test, inspect, install, maintain, and service the product.

Design and development outputs are in the form of documented information that defines the product, including its characteristics that affect safety, fitness for use, performance, and reliability are provided for the manufacturing phase:

  1. Schematics, assembly drawings and wiring diagrams;
  2. Component and material specifications;
  3. Production and process specifications;
  4. Software design specifications;
  5. Bills of materials;
  6. User operation and maintenance instructions;
  7. Results of risk analysis and transfer of residual risk;
  8. Software source code and software machine code;
  9. Results of verification and validation activities;
  10. Quality assurance specifications and procedures;
  11. Installation and servicing procedures;
  12. Packaging and labelling specifications, including methods and processes;
  13. Details of new or revised procedures, work instructions, or processes;
  14. Applicable workmanship standards;
  15. Inspection and test criteria.

Specifications and procedures for product packaging and labelling are also part of the design and development output. Support documentation (e.g. calculations, risk analysis, test results, verification and validation reports, etc.) is also part of the design and development output.

The transfer of a design to production typically involves review and approval of specifications and procedures and, where applicable, the proving of the adequacy of the specification, methods and procedures through process validation including the testing of finished product under actual or simulated use conditions.

The design transfer phase ensures that the design is correctly translated into production specifications, such as assembly drawings, component procurement specifications, workmanship standards, manufacturing instructions, and inspection and test specifications. They may also be:

  1. Documentation (in electronic format as well as paper);
  2. Training materials (e.g. manufacturing processes, assembly, and test and inspection methods);
  3. Digital data files (e.g. computer-aided manufacturing (CAM) programming files);
  4. Manufacturing jigs and other aids (e.g. molds or templates).

The Engineering Manager should ensure that the design transfer process addresses the following basic elements by:

  1. Undertaking a qualitative assessment of the completeness and adequacy of the production specifications;
  2. Ensuring that all documents and articles that constitute the production specifications are reviewed and approved;
  3. Ensuring that only approved specifications are used for manufacture and production.

Prior to execution of a work transfer, analysis of any regulatory or contractual requirements are reviewed and flowed down through the supply chain to ensure compliance of any established requirements.

A Certifcation Auditor would expect to see objective evidence that the outputs have been verified against the design inputs. This can be accomplished by reviewing documents, plans, etc. interfacing with the customer or internal processes and by comparison with past proven designs. Outputs may also include product preservation methods, identification, packaging, service requirements, etc. as appropriate.

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More information on PDCA

Planning

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
 
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
 
ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
6.1.1 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

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
7.1.1 Resources - General
7.1 Resources 7.1 Resources
7.1.2 People 7.2 Competence 7.2 Competence
7.1.3 Infrastructure
7.3 Awareness 7.3 Awareness
7.1.4 Operational Environment 7.4.1 Communcation - General 7.4.1 Communcation - General
7.1.5 Monitoring & Measuring 7.4.2 Internal Communcation 7.4.2 Internal Communcation
7.1.6 Organizational Knowledge 7.4.3 External Communcation 7.4.3 External Communcation
7.2 Competence 7.5 Documented Information 7.5 Documented Information
7.3 Awareness    
7.4 Communcation    
7.5 Documented Information    

 

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
8.1 Operational Planning & Control
8.1 Operational Planning & Control 8.1.1 General
8.2.1 Customer Communication 8.2 Emergency Preparedness 8.1.2 Eliminating Hazards
8.2.2 Determining Requirements
  8.1.3 Management of Change
8.2.3 Reviewing Requirements   8.1.4 Outsourcing
8.2.4 Changes in Requirements
  8.2 Emergency Preparedness
8.3.1 Design Development - General    
8.3.2 Design Development - Planning
   
8.3.3 Design Development - Inputs    
8.3.4 Design Development - Controls    
8.3.5 Design Development - Outputs    
8.3.6 Design Development - Changes    
8.4.1 External Processes - General    
8.4.2 Purchasing Controls    
8.4.3 Purchasing Information    
8.5.1 Production & Service Provision    
8.5.2 Identification & Traceability    
8.5.3 3rd Party Property    
8.5.4 Preservation    
8.5.5 Post-delivery Activities    
8.5.6 Control of Changes    
8.6 Release of Products & Services    
8.7 Nonconforming Outputs    
 

Checking

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
9.1.1 Performance Evaluation 9.1.1 Performance Evaluation 9.1.1 Performance Evaluation
9.1.2 Customer Satisfaction 9.1.2 Evaluation of Compliance 9.1.2 Evaluation of Compliance
9.1.3 Analysis & Evaluation 9.2 Internal Audit 9.2 Internal Audit
9.2 Internal Audit 9.3 Management Review 9.3 Management Review
9.3 Management Review    
 

Acting

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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