Management system guidance
8.3 Design and development of products and services
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8.3.2 Design and development planning
This requirement expands upon ISO 9001:2008 Clause 7.3.1 – Design and Development Planning. It is likely that if your organization already complies with this clause, you will already be undertaking the activities required by ISO 9001:2015 Clause 8.3.1.
You should seek and record evidence that your organization has considered the explicitly referenced considerations relating to the design and development process set out above.
You should also ensure that your organization has retained documented information to confirm the identified design and development requirements were met and that design reviews were undertaken. You should have an overall plan for how you undertake your designs.
Your plan must specify the design and development stages, activities and tasks; responsibilities; timeline and resources; specific tests, validations and reviews; and outcomes. There are many tools available for planning ranging from a simple checklist to complex software. Control product design and development planning activities including:
- Scope of the design e.g. customer requirements (see 8.2.2) design rationale, design assumptions, objectives, complexity, size, detail, timescales, criticality, constraints, risks, producibility, accessibility, maintainability;
- Stages of the design process, distinct activities and review e.g. work breakdown structure, work packages (tasks, resources, responsibilities, content, inputs/outputs), concept design, preliminary design, detail design, design review gates preliminary design review, detail design review, critical design review);
- Verification and validation activities comprising checks, trials, tests, simulations, demonstrations required to ensure requirements are met;
- Assignment of responsibilities and authorities e.g. job profiles, CVs, accountability statements, delegation of authority, levels of approval, register of authority and approvals, authorized signatories;
- Internal and external resources such as knowledge acquisition, people, competency, investment, funding, facilities, equipment, innovation, technology, interested parties (customers, external providers, research establishments), information (principles, standards, rules, codes of practice);
- Organizational interfaces such as personnel and functions e.g. sales, project management, production, procurement, quality, finance, customers, end users;
- Levels of control required or implied by interested parties (customers, regulators, end users etc.) e.g. customer acceptance, safety checks, risk management, verification/validation activity, product certification;
- Required documented information e.g. design plan, design reviews, design outputs (specifications, schemes, drawings, models, data, reports), control plans, certificates.
Although the standard does not require a documented procedure, the design process needs to demonstrate how the process is controlled and planned. The organization, however, will need to provide some type of objective evidence as to what the planning activities include. This can be accomplished with the use of time-lines, Gantt charts or any other planning method such as Microsoft project manager.
In addition, auditors would likely want to see objective evidence of how the interfaces between other processes are managed, either through statements, or in associated procedures, process mapping, and matrix approach or in the time line planning.
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