ISO 9001 Clause: 8.3 Design and Development of Products and Services

Think of ISO 9001 Clause 8.3 as the blueprint for creating products or services that actually hit the mark and wow your customers. It’s all about having a solid plan for designing and developing new products or services, making sure you’re not just winging it but instead following a clear, well-thought-out process. From brainstorming ideas and turning them into prototypes to testing and tweaking, this clause makes sure you’re checking all the right boxes to create something legit.

What’s the Lowdown on Clause 8.3?

This clause is basically your game plan for innovation. It’s not just about coming up with new stuff; it’s about doing it in a way that’s organized, smart, and focused on quality. Whether you’re developing a brand-new app, a product line, or a service, Clause 8.3 ensures that every stage is planned out, risks are managed, and the customer’s needs are at the heart of everything you create.

Why It’s a Big Deal

With Clause 8.3, you’re not just hoping your product works – you’re proving it will. It’s about getting feedback, testing those features, and making sure everything matches up with what the customer wants. The goal? Delivering something that’s not only built to impress but also to last.

In short, Clause 8.3 is your go-to guide for making sure your design and development game is strong, consistent, and always on point with quality. It’s about turning ideas into reality with no surprises, no shortcuts, just solid results that your customers will love.

ISO 9000 Quality management systems — Fundamentals and vocabulary

3.4.8 design and development

set of processes (3.4.1) that transform requirements (3.6.4) for an object (3.6.1) into more detailed requirements for that object
Note 1 to entry: The requirements forming input to design and development are often the result of research and can be expressed in a broader, more general sense than the requirements forming the output (3.7.5) of design and development. The requirements are generally defined in terms of characteristics (3.10.1). In a project (3.4.2) there can be several design and development stages.
Note 2 to entry: In English the words “design” and “development” and the term “design and development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development. In French the words “conception” and “développement” and the term “conception et développement” are sometimes used synonymously and sometimes used to define different stages of the overall design and development.
Note 3 to entry: A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product (3.7.6) design and development, service (3.7.7) design and development or process design and development).

3.7.6 product

output (3.7.5) of an organization (3.2.1) that can be produced without any transaction taking place between the organization and the customer (3.2.4)
Note 1 to entry: Production of a product is achieved without any transaction necessarily taking place between provider (3.2.5) and customer, but can often involve this service (3.7.7) element upon its delivery to the customer.
Note 2 to entry: The dominant element of a product is that it is generally tangible.
Note 3 to entry: Hardware is tangible and its amount is a countable characteristic (3.10.1) (e.g. tyres). Processed materials are tangible and their amount is a continuous characteristic (e.g. fuel and soft drinks). Hardware and processed materials are often referred to as goods. Software consists of information (3.8.2) regardless of delivery medium (e.g. computer programme, mobile phone app, instruction manual, dictionary content, musical composition copyright, driver’s license).

3.7.7 service

output (3.7.5) of an organization (3.2.1) with at least one activity necessarily performed between the organization and the customer (3.2.4)
Note 1 to entry: The dominant elements of a service are generally intangible.
Note 2 to entry: Service often involves activities at the interface with the customer to establish customer requirements (3.6.4) as well as upon delivery of the service and can involve a continuing relationship such as banks, accountancies or public organizations, e.g. schools or hospitals.
Note 3 to entry: Provision of a service can involve, for example, the following: — an activity performed on a customer-supplied tangible product (3.7.6) (e.g. a car to be repaired); — an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); — the delivery of an intangible product (e.g. the delivery of information (3.8.2) in the context of knowledge transmission); — the creation of ambience for the customer (e.g. in hotels and restaurants);
Note 4 to entry: A service is generally experienced by the customer.

3.8.12 verification

confirmation, through the provision of objective evidence (3.8.3), that specified requirements (3.6.4) have been fulfilled
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection (3.11.7) or of other forms of determination (3.11.1) such as performing alternative calculations or reviewing documents (3.8.5).
Note 2 to entry: The activities carried out for verification are sometimes called a qualification process (3.4.1).
Note 3 to entry: The word “verified” is used to designate the corresponding status.

3.8.13 validation

confirmation, through the provision of objective evidence (3.8.3), that the requirements (3.6.4) for a specific intended use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test (3.11.8) or other form of determination (3.11.1) such as performing alternative calculations or reviewing documents (3.8.5).
Note 2 to entry: The word “validated” is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.

ISO 9001 Clause 8.3.1 is all about laying the groundwork for designing and developing products or services in a way that’s organized, efficient, and laser-focused on quality. It sets the vibe by emphasizing the need for a solid plan before you jump into the creative process. This means defining the stages of your design and development, outlining who’s responsible for what, and figuring out how to handle risks and changes along the way. Think of it as creating the blueprint for your project – getting everyone on the same page, making sure you have the resources you need, and setting clear goals for each step. It’s all about making sure that the design and development process isn’t just about creating something new, but creating it with purpose, precision, and customer satisfaction in mind.

ISO 9001 Clause 8.3.2 is all about making sure you’ve got a solid plan before you even start designing or developing your product or service. Think of it like prepping for a major project: you map out every detail, get your resources lined up, and make sure your whole team knows their roles. Clause 8.3.1 is your guide to setting up a strategy that covers every step of the design and development process, so you know exactly what needs to happen next.

This means thinking through timelines, assigning tasks, choosing the right tools, and figuring out how to measure success. It’s all about having a clear path from start to finish, making sure you’re ready to create something that’s not just good, but game-changing. With this kind of planning, you’re set to turn those ideas into reality without any hiccups along the way.

ISO 9001 Clause 8.3.3 dives into making sure you’ve got all the right info before you kick off any design or development project. It’s like collecting all the ingredients you need to make that perfect dish – you’ve got to have everything in place so you don’t miss out on any important details. This clause covers inputs that help shape your design and make sure you’re hitting the mark on quality, performance, and customer expectations. Let’s break it down by each point and throw in some real-life examples to make it even clearer.

a. Functional and Performance Requirements

These are the nuts and bolts of what your product or service needs to do and how well it should perform. For example:

• New smartphone – the functional requirement might include touchscreen capability and battery life of at least 20 hours.
• A customer service software –  performance requirements could be response times under 3 seconds and uptime of 99.9%.
• A car’s braking system – the function must ensure a complete stop within a specific distance under all weather conditions.

b. Applicable Legal and Regulatory Requirements

Make sure you’re not just building something awesome, but that it’s also legal and complies with industry standards. For example:

• Food products must comply with health and safety standards like FDA regulations.
• An electronic device needs to follow electromagnetic compatibility (EMC) standards to avoid interference with other devices.
• Medical devices have to meet ISO 13485 standards to ensure they’re safe and effective for use.

c. Standards or Codes of Practice the Organization has Committed to Implement

This means sticking to the rules or guidelines your company has promised to follow to keep quality up to par. For example:

• Following ISO 14001 for environmental management to reduce waste in manufacturing.
• Committing to Six Sigma principles to minimize defects in production processes.
• Using Agile methodology for software development to ensure flexibility and faster delivery.

d. Potential Consequences of Failure Due to the Nature of Products and Services

Consider what could go wrong and how bad it could be if your product or service doesn’t perform as expected. For example:

• A malfunction in a car’s airbag system could lead to serious injury or death.
• Failure of data encryption in a cybersecurity product could result in data breaches.
• In a medical ventilator, failure to function properly could put patients’ lives at risk.

e. Knowledge and Experience from Previous Similar Projects

Use lessons learned from past projects to make sure you’re not making the same mistakes twice. For example:

• A tech company uses feedback from a previous smartphone model to improve battery efficiency in the next release.
• A construction firm learns from past challenges with materials to choose a more durable solution for future projects.
• A software team builds on the user feedback of a prior app version to improve user interface design.

f. Information Derived from Product or Service Analysis

Analyze what makes your product or service unique and how it stacks up against the competition. For example:

• Analyzing a competitor’s mobile app for its user-friendly features and building similar improvements into your app.
• Assessing the performance of a competitor’s vehicle engine to develop a more fuel-efficient model.
• Reviewing data on your product’s failure rates to identify design improvements.

g. Interface Requirements Between Components or Between the Product and Other Systems

Consider how your product interacts with other systems or parts to ensure smooth integration. For example:

• Example 1: Making sure a software update is compatible with all devices it’s intended to run on.
• Example 2: Designing a car’s infotainment system to sync seamlessly with smartphones via Bluetooth.
• Example 3: Ensuring that a medical device’s sensors can communicate accurately with hospital monitoring systems.

h. Environmental Conditions and Constraints

Take into account the environmental factors that might impact the product’s performance. For example:

• Designing electronics that can operate in extreme temperatures, from freezing to very hot conditions.
• Creating a waterproof fitness tracker to handle both underwater use and heavy sweating.
• Building packaging that’s both eco-friendly and durable enough to withstand shipping wear and tear.

i. Requirements for Verification and Validation Activities

Set up criteria to check that your product works as intended and meets all necessary standards. For example:

• Conducting tests to ensure that a smartphone’s screen can withstand drops from a certain height.
• Verifying that a software update does not introduce bugs by running it through automated tests.
• Validating that a medical device provides accurate readings under all specified conditions.

j. Statutory and Regulatory Requirements for Disposal or Recycling

Ensure that the product’s end-of-life process complies with environmental and safety regulations. For example:

• Electronic devices should meet e-waste disposal guidelines to prevent environmental harm.
• Batteries need to follow strict recycling protocols to prevent leakage of toxic chemicals.
• Packaging materials should be recyclable or biodegradable to minimize environmental impact.

Putting It All Together 

Clause 8.3.3 is like your checklist to make sure you’ve covered all the angles before you start designing or developing your product or service. It’s about knowing what’s required, considering every risk, and pulling from past experiences to build something better and smarter. With these inputs dialed in, you’re setting yourself up for a smooth ride through the rest of the design and development process!

ISO 9001 Clause 8.3.4 is all about putting the brakes on chaos during the design and development phase by setting up solid controls to keep things in check. It’s like quality-proofing your creative process to make sure every idea that gets the green light is backed by logic, testing, and solid data. This clause focuses on putting quality controls in place at every stage of the design journey to spot any glitches or flaws before they turn into major problems.

You’ll need to verify that the design meets the original requirements, validate that it performs in real-life conditions, and review each stage to catch issues early. Whether you’re designing a slick new app or a cutting-edge product, it’s all about making sure everything works exactly how it’s supposed to—no surprises, just results that hit the mark every time. This clause helps you keep the process tight, organized, and ready to deliver products that are on point and exactly what your customers expect.

a. Reviews of Design and Development

These reviews are checkpoints where you stop and assess the progress to make sure everything is going as planned and is still aligned with the requirements. For example:

• In software development, teams conduct sprint reviews to evaluate progress and ensure the project is on track.
• During the development of a new car model, design reviews are held to check that the engineering meets safety and performance standards.
• In product design, holding regular design review meetings to get feedback from stakeholders and make adjustments as needed.

b. Verification Activities

Verification is all about making sure the design output matches the design input—basically checking that you’re building it right. For example:

• Testing the prototype of a smartphone to ensure its battery life meets the specifications outlined during the design phase.
• Conducting quality checks on a new piece of machinery to confirm that its components fit together as designed.
• Reviewing the software code to verify that it functions according to the initial user requirements and doesn’t contain critical errors.

c. Validation Activities

Validation ensures that the final product works as expected in real-world conditions, basically confirming that you’ve built the right thing. For example:

• Testing a new fitness app with actual users to ensure it tracks steps and workouts accurately.
• Running a field test for a new agricultural drone to confirm that it can handle the environmental conditions and performs as expected.
• Conducting a pilot run of a new product in the factory to validate that the production process consistently meets quality standards.

d. Actions Taken on Design and Development Issues

This step involves taking corrective actions if any issues or problems are identified during the design process. For example:

• If a bug is found during software testing, developers immediately update the code to fix the issue.
• Adjusting the materials used in a product design if testing shows that the current material is not durable enough.
• Modifying the design of a consumer electronics device if a review identifies overheating issues during prolonged use.

e. Documented Information of Design and Development Controls

Documenting all activities and decisions made during the design and development controls to ensure transparency and traceability. For example:

• Keeping records of all design review meetings, including decisions made, action items, and assigned responsibilities.
• Maintaining detailed test reports that outline the verification and validation activities performed on the product.
• Storing all versions of design drawings and specifications to track changes and updates throughout the development process.

f. Approval of Changes to Design and Development

Before any changes are made to the design, they need to be formally reviewed, documented, and approved to ensure they don’t negatively affect the end product. For example:

• A change request is submitted for approval before altering the software code to add a new feature.
• If a new material is proposed for a product design, it must go through a review and approval process to confirm it meets quality standards.
• Approving updates to the design of an electronic device to improve its performance based on customer feedback and then documenting those changes.

Why These Controls Matter 

Implementing these controls is like setting up guardrails for your design process. They keep everything moving in the right direction, make sure each stage of the design and development is solid, and help you catch issues before they spiral out of control. By following these steps, you’re not just designing cool stuff—you’re designing it in a way that’s smart, organized, and built to meet customer needs from the jump.

Clause 8.3.4 is all about making sure you’ve got the checks and balances in place to create a product or service that’s both high-quality and reliable. It’s the key to transforming your ideas into a real-world success story that not only meets but exceeds customer expectations.

ISO 9001 Clause 8.3.5 is all about making sure that the outputs from the design and development process are exactly what you need to create a product or service that hits the mark. It’s like having a well-drawn blueprint before you start building anything. These outputs are the detailed plans, specifications, and guidelines that your team needs to follow to ensure everything is on point. Let’s break down each requirement with real-world examples to bring it to life.

a. Meeting Input Requirements

The design and development outputs must meet the requirements that were originally specified in the design inputs. This means that the final design should align perfectly with what was initially expected or planned. For example:

• When designing a new car engine, the outputs should ensure that fuel efficiency requirements specified in the inputs are fully met.
• A software application’s design output should meet the user interface requirements defined during the planning phase.
• For a medical device, the output must guarantee it matches safety and functionality criteria laid out in the initial requirements.

b. Adequate for the Production and Service Provision

Outputs should be detailed enough to ensure that the production and service teams can create or deliver the product with no guesswork involved. For example:

• A clothing manufacturer provides detailed sewing patterns and fabric specifications to guide the production team.
• An electronics company supplies assembly instructions and technical drawings to ensure the production of circuit boards goes smoothly.
• For a logistics service, outputs include standard operating procedures (SOPs) for package handling and delivery timelines.

c. Including or Referring to Product and Service Specifications

The outputs must include all the necessary product or service specifications, or at least reference where they can be found. For example:

• A mobile phone design includes detailed technical specifications like processor speed, screen resolution, and battery capacity.
• A software development project lists code libraries, system requirements, and data flow diagrams to guide the engineering team.
• An automobile manufacturer’s design output specifies tire size, fuel type, and safety features required for each vehicle model.

d. Requirements for Safe and Proper Use of Products and Services

Design outputs should ensure that all necessary information for the safe and proper use of the product or service is provided to the customer or end-user. For example:

• A pharmaceutical company includes detailed instructions on dosage, storage, and potential side effects with its medication.
• A home appliance manufacturer provides user manuals that include safety warnings and maintenance tips.
• A software company’s output includes an FAQ and troubleshooting guide to help users navigate the app safely and effectively.

e. Acceptance Criteria

Clearly defined criteria to determine if the design outputs meet the original design and development objectives. For example:

• For a drone manufacturer, acceptance criteria might include tests to ensure that flight stability and GPS accuracy are within specified limits.
• A food production company’s design output includes taste and quality tests to confirm that the product meets flavor profiles and safety standards.
• A tech startup developing a new smartwatch sets criteria for battery life and water resistance that must be met before launch.

f. Results of Reviews, Verification, and Validation

Documented evidence that shows the design has been reviewed, verified, and validated to ensure it meets all necessary standards and requirements. For example:

• For a new fitness app, results of user testing are documented to confirm that all functionalities work as intended.
• An aerospace company records data from wind tunnel tests to verify that an aircraft’s design meets aerodynamic performance standards.
• A healthcare product developer documents validation tests to confirm that a medical device is safe for patient use under all expected conditions.

Why Design and Development Outputs Matter 

Design and development outputs are like the ultimate recipe for your product or service. They provide clear instructions, specs, and guidelines to ensure that the end result not only matches but exceeds the initial requirements. These outputs keep everyone in sync, reduce errors in production, and make sure that whatever you create is safe, reliable, and ready to wow your customers.

Clause 8.3.5 ensures that your final design is not just a sketch or an idea but a fully-formed plan that tells your production team exactly what to do and how to do it. It’s all about turning your vision into reality with precision and confidence.

ISO 9001 Clause 8.3.6 is all about managing changes like a boss when it comes to the design and development process. Let’s face it – designs rarely stay the same from start to finish. This clause makes sure that any tweaks, adjustments, or overhauls you make during design are done in a controlled way. It’s about reviewing, documenting, and approving those changes so they don’t mess up your project or leave you with a product that doesn’t match up to customer expectations.

When changes come up, you need to look at how they’ll impact other parts of the product, how they affect timelines, and if they’ll meet the original requirements. Then, you’ve got to make sure everyone on the team is in the loop and that these changes are backed up with the right data and approvals. In simple terms, Clause 8.3.6 keeps you agile and ready to adapt while making sure every change is a step forward, not a step back