ISO 9001:2015 Clause 8.3 Design and Development of Products and Services Explained
Introduction
Unlock the secrets of ISO 9001:2015 Clause 8.3 with our comprehensive guide on Design and Development. Learn how to establish a robust process for creating products and services that truly meet customer needs and comply with regulatory requirements. This blog demystifies the entire design phase, including planning, inputs, controls, verification, validation, and managing changes, with examples from various industries including services. Discover how effective design and development enhance product quality and customer satisfaction by clearly defining methods, procedures, and personnel roles. Implementing these best practices helps organizations minimize risks, reduce costly errors, and achieve regulatory compliance, all while driving continuous improvement.
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8.3.1 General
The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.
The Object of Design and Development
The organization should make clear what their products and services are.
Example:
- For a personal computer maker their product is the computer and this will be the object of the design and development.
- An organization which assembles a computer unit by the offer from the computer maker. The object of design and development for this organization would be the assembling method of the unit. Because what this organization is providing to the customer is an “appropriately assembled” unit.
When the organization determines the object of the design and development, it is important to consider what values their customers are acquiring through the products and services.
Activities for Design and Development
After determining the object of the design and development, next is to identify which activities in the organization correspond with the requirements of this clause.
If the organization is able to start the production or service provision only by the information given by their customer requirements, the activities for design and development may not exist in this organization.
However, there is a possibility that the organization is ignoring what they really have to do in the present situation. In this case, current state analysis will be needed.
Example:
- In a house construction, the customer requirements would be various: how many floors, number of toilets, living room measures, wall colour and material, etc.
- Could the organization build a house by only this information? When a qualified architect draws the detailed plan for the house by following building regulations, it would identify what materials are needed, how many days and workers are necessary, etc. Then it becomes possible to start building the house.
Therefore, it can be said that the activities of the Design and development are determination of methods to realize the requirements.
ISO 9001:2015 Clause Guide Panel
- Clause 1
- Clause 2
- Clause 3
- Clause 4 – Sub-clause 1
- Clause 4 – Sub-clause 2
- Clause 5 – Sub-clause 1
- Clause 5 – Sub-clause 2
- Clause 5 – Sub-clause 3
- Clause 6 – Sub-clause 1
- Clause 6 – Sub-clause 2
- Clause 7 – Sub-clause 1
- Clause 7 – Sub-clause 2
- Clause 7 – Sub-clause 3
- Clause 7 – Sub-clause 4
- Clause 8 – Sub-clause 1
- Clause 8 – Sub-clause 2
- Clause 8 – Sub-clause 3
- Clause 8 – Sub-clause 4
- Clause 8 – Sub-clause 5
- Clause 8 – Sub-clause 6
- Clause 8 – Sub-clause 7
- Clause 8 – Sub-clause 8
- Clause 8 – Sub-clause 9
- Clause 8 – Sub-clause 10
- Clause 8 – Sub-clause 11
- Clause 8 – Sub-clause 12
- Clause 9 – Sub-clause 1
- Clause 9 – Sub-clause 2
- Clause 9 – Sub-clause 3
- Clause 9 – Sub-clause 4
- Clause 10
Design and Development for Service Industry
The term “design” is unfamiliar for the service industry. However, most service industry organizations have design and development activities in their service provision operation.
Controlling these activities appropriately is very important for maintaining and improving the quality of service.
Example:
- In medical service, it is not possible to realize the requirement only by the requirement from the patient “cure my disease”.
- When medical services include operations, it has to make suitable consultation planning based on application of techniques and resources. This is design and development activity as required in this clause.
Other examples of design and development activities in service industry:
- Making guidance for instructors (Educational Institutions)
- Planning a customer service manual (Restaurants, Hotels, etc.)
- Establishing room making procedure (Hotels)
- Planning an inheritance according to customer assets, age, etc. (Trust Banks)
Characteristics of Design and Development in Service Industries
Most organizations of the service industry provide both products and services to the customer.
Examples:
- A restaurant provides a dish (product) and serving (service).
- An educational institution provides instruction (service) and teaching material (product).
This means most service organizations have design and development activities for both products and services.
Services performed at the interface between provider and customer like serving have to cope flexibly according to circumstances in many cases.
Therefore, serving does not always relate to customer satisfaction by strictly following the manual.
Example:
- In a fast-food restaurant, a customer ordered ten hamburgers. Should the clerk ask “For here or to go?” as stated in the manual? Or use wit and say “Will it be takeout?” and proceed to checkout. The second option likely provides better service.
To enhance service quality, considering many situations and identifying how to cope with actual situations is important at the design stage.
Design and Development Activities as Outputs
In some cases, the design and development activities output can be the product of the organization. In such cases, the organization must carry out these activities according to clause 8.3 and controlled conditions as per clause 8.5.
Summary of Design and Development
Design and development is the whole activity in the organization specifying product and service specifications, that is, specifying means to achieve requirements is the design and development activities.
In the service industry, defining processes, determining personnel roles and arrangements, etc., are design and development activities.
Some organizations do not design and develop products and services but apply, modify or adapt proven design, development, and processes to meet various customer requirements.
Examples Where Design and Development May Not Exist
- A tailor receiving a request to add fabric to a previous dress or suit.
- A small shop with specifications for a pneumatic clutch where a customer requests customization of the fit.
Cases with No Design and Development Activities
- Organizations providing traditional crafts where detailed requirements are already established.
- OEM (Original Equipment Manufacturer) suppliers who receive detailed design plans from clients.
Conclusion
Ultimately, ISO 9001:2015 Clause 8.3 shows that design and development isn’t just for engineers creating new gadgets. It’s a fundamental process for any organization, whether you’re building a house, serving a meal, or providing a medical service. By formally defining and controlling how you create your products and services, you ensure consistency, quality, and, most importantly, the ability to meet your customer’s needs every single time. It’s about turning a customer’s request into a clear, actionable plan that leads to a successful outcome.
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FAQ
What is the goal of Clause 8.3 in ISO 9001:2015?
It ensures organizations design and develop products or services that meet customer and regulatory requirements through a structured process.
Does Clause 8.3 apply to all businesses?
It applies to any business involved in design or development, whether in manufacturing or services, that affects product or service quality.
What documentation is required for Clause 8.3?
Organizations must document plans, inputs, controls, reviews, outputs, validations, and any design or development changes.
Can Clause 8.3 be excluded from a QMS?
It can be excluded only if no design or development is performed and customer satisfaction or product conformity won’t be affected.
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