There are six (6) implementable clauses within ISO 9001:2015 Quality Management System Standard.
Within this series of posts over the next six weeks we will discuss the requirements to all six clauses and the correct interpretation thereof.
8.0 Operation
8.3 Design and Development of Products & Services
8.3.1 General
This is a new requirement that 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 the customer or interested parties.
8.3.2 Design and Development Planning
This requirement expands upon the requirements from ISO 9001:2008 Clause 7.3.1 – Design and Development Planning. It is likely that if your organization already complies with ISO 9001:2008, you will already be undertaking the activities required by this clause.
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.
8.3.3 Design and Development Inputs
This requirement expands upon the requirements from ISO 9001:2008 Clause 7.3.2 – Design and Development Inputs 7.3.1. You should seek and record evidence that your organization has documented and retained information concerning the need for internal and external resources and the potential consequences of design or development failure.
8.3.4 Design and Development Controls
This requirement is comparable to the requirements from ISO 9001:2008 Clauses 7.3.3, 7.3.4, 7.3.5 and 7.3.6. You should seek and record evidence that your organization has applied the necessary controls to its design and development process in order to ensure that:
1. The results from undertaking the design and development process are clearly defined;
2. The design and development reviews take place in accordance with planned arrangements;
3. The design and development outputs meet the design and development inputs (verification);
4. The resulting products and services are fit for their intended use or specified application where this is known to the organization (validation).
8.3.5 Design and Development Outputs
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.
8.3.6 Design and Development Changes
This requirement is directly comparable to ISO 9001:2008 Clause 7.3.7 – Control of Design and Development Changes. It is important to control design changes throughout the design and development process and it should be clear how these changes are handled and what affects they have on the product. You should seek and record evidence that your organization has retained documented information concerning:
1. Design and development changes;
2. The results of reviews;
3. The authorization of changes;
4. Actions taken to prevent adverse impacts.
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