ISO 9001:2015 QMS Awareness – Operation – Design and Development of Products and Services

ISO 9001:2015 QMS Awareness – Operation – Design and Development of Products and Services

===========

Design and Development of Products and Services

 

Design and development of a product / service is an important activity that includes a number of processes to convert the needs and expectations for an object / entity / product / service into more detailed requirements. The words ‘design’ and ‘development’ and the term ‘design and development’ are sometimes used synonymously.

 

ISO 9000:2015 Para 3.4.8 defines the term ‘design and development’. The term ‘design and development’ is a set of processes. The set of processes transform requirements (needs and expectations) for an object into more detailed requirements for that object. Design and development can be stated as a crucial activity that involves a series of processes having the goal (objective) of transforming the needs and expectations for an object, entity, product or service into more detailed requirements. It encompasses the planning, creation, testing and validation of product, service or process.

 

General Requirements

 

The organization needs to establish, implement and maintain – Design and development process (appropriate to product / service requirements) consisting of its planning, inputs, controls, outputs and changes.

 

Planning Requirements

 

The organization needs to consider for the design and development process – (i) Nature, duration and complexity of the process, (ii) Required process stages, (iii) Applicable reviews, (iv) Required verification activities, (v) Required validation activities, (vi) Responsibilities and authorities involved, (vii) Resource (external and internal) needs, (viii) Needs to control interfaces between persons involved, (ix) Need to involve customer / user, (x) Subsequent product / service requirements, (xi) Level of control expected by customers / interested parties, and (xii) Retaining documented information needs.

 

The organization needs to determine – (i) Stages and controls for design and development process, and (ii) Documented information needed.

 

Inputs requirements

 

The organization needs to consider – (i) Functional and performance requirements, (ii) Information from previous similar design and development activities, (iii) Legal requirements, (iv) Standards to follow / implement, (v) Codes of practice to follow / implement, and (vi) Potential consequences of failure.

 

Legal requirements = Statutory requirements + Regulatory requirements

 

The organization needs to determine - Requirements essential for the product / service to be designed and developed

 

The organization needs to ensure – Design and development inputs to be adequate, complete, clear and not vague.

 

The organization needs to resolve – Conflicting inputs.

 

The organization needs to retain documented information (records) on design and development inputs.

 

Controls requirements

 

The organization needs to apply – Design and development controls

 

The organization needs to ensure – (i) Defining results to be achieved, (ii) Conducting reviews to evaluate the ability of design and development results to meet requirements, (iii) Conducting verification activities to verify that outputs meet the input requirements, (iv) Conducting validation activities to ensure that resulting product / service meeting requirement for specified application / intended use, (v) Taking any necessary actions on problems determined during design and development reviews, verification and validation activities.

 

The organization needs to retain – Documented information (records) of control activities.

 

Outputs requirements

 

The organization needs to ensure that– (i) Design and development outputs meet the input requirements, (ii) Design and development outputs are adequate for subsequent activities, (iii) Design and development outputs include / mention appropriate monitoring and measuring requirements, (iv) Design and development outputs include / mention acceptance criteria, (v) Design and development outputs specify product / service characteristics (essential for intended purpose, safe and proper provision).

 

The organization needs to retain – Documented information (records) on design and development outputs.

 

Changes requirements

 

The organization needs to identify, review and control – Design and development changes. Purpose – To ensure no adverse impact to conformity on product / service.

 

The organization needs to retain – Documented information (records) on – (i) Design and development changes, (ii) Results of reviews, (iii) Authorization of changes, and (iv) Action taken to prevent adverse impact to conformity on product / service.

 

Examples of design and development

 

(1)   A manufacturing organization may decide to develop a new product line to meet the changing market demands. Here the design and development process may involve conducting market research, conceptualizing product ideas etc. To develop a new product line the design and development requirements mentioned in ISO 9001:2015 QMS standard are useful.

 

(2)   A service organization may aim to introduce a new service to expand its portfolio. Here also the design and development requirements mentioned in ISO 9001:2015 QMS standard are helpful to introduce new service.

 

(3)   An organization may identify the need to improve its existing process, product or service for which the design and development requirements mentioned in ISO 9001:2015 QMS standard are useful.

 

Think of the following Questions

 

(1)   What is design and development?

 

(2)   Why an organization need design and development of a product or service?

 

(3)    What documented information you may need to maintain for design and development?

 

(4)   What documented information you may need to retain for design and development?

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.