How to Implement ISO 9001 Clause 8.3: Design and Development of Products and Services

If your organisation designs its own products or services - whether that’s manufacturing a new widget, developing bespoke software, or tailoring a training course - Clause 8.3 of ISO 9001 applies to you.

This article will show you exactly how to build a compliant design and development process, even if you’ve never done it before.

We’ll explain what the standard expects, how to meet each requirement, and give you a real-life example at the end to tie it all together.

What Is ISO 9001 Clause 8.3 All About?

Clause 8.3 requires you to control your design process from start to finish. That includes:

• Planning your design work

• Identifying customer and technical requirements

• Reviewing your design as it progresses

• Testing (verifying and validating) that it works

• Documenting what you did

• Managing any changes made along the way

Even service providers can fall under this clause - if you tailor services to specific customer needs, that counts as “design”.

Step-by-Step Implementation Guide

Step 1: Decide Whether Clause 8.3 Applies to You

Start by asking:

• Do we design or develop our own products or services?

• Do we modify customer specifications or create bespoke solutions?

• Do we define features or functions before delivery?

If the answer is yes, then Clause 8.3 applies, and you must implement a formal process.

Step 2: Create a Design and Development Procedure

Write a document that defines how design and development is planned, carried out, reviewed, tested, and controlled in your business. This can be a standalone procedure or part of a wider operational manual.

Your procedure should cover:

• Roles and responsibilities

• Planning stages (inputs, outputs, reviews)

• Verification and validation activities

• How you manage changes

• Required records

Tip: Keep it proportionate to the complexity of your design work. Don’t overcomplicate it.

Step 3: Plan the Design (Clause 8.3.2)

Each design project should have a clear plan.

You must consider:

• What are the stages (e.g. concept, prototype, final design)?

• What reviews or approval gates are needed?

• Who is responsible at each stage?

• What resources do you need (people, software, equipment)?

• Who will be involved (internally and externally)?

• How will customer feedback or approvals be gathered?

• What documents or evidence will be produced?

Step 4: Gather Your Design Inputs (Clause 8.3.3)

Inputs are the starting requirements for the design. These must be:

• Complete - nothing missing

• Clear - no contradictions

• Documented - written down and retained

You should gather and document:

• Customer needs (e.g. performance targets, functions, features)

• Legal requirements (e.g. safety regulations, standards)

• Lessons learned from similar designs

• Risks associated with design failure

Example:

If you’re designing a lifting device, inputs could include the weight limit, the type of material being lifted, and the relevant health and safety standards (e.g. LOLER).

Step 5: Apply Design Controls (Clause 8.3.4)

Controls ensure your design is fit for purpose. This involves:

• Design Reviews - are we on track? (Can be internal meetings or customer sign-offs)

• Verification - does the output match the input? (e.g. checking the drawing meets the brief)

• Validation - does it work in real life? (e.g. build it and test it under real conditions)

Each of these steps must be recorded.

These don’t have to be formal documents - emails, checklists, test logs, or signed-off drawings may all be suitable.

Step 6: Define Design Outputs (Clause 8.3.5)

Outputs are the final results of your design stage.

They must:

• Match the design inputs

• Be suitable for production or delivery

• Include clear acceptance criteria

• Describe key characteristics (e.g. material, dimensions, performance)

Example:

Your outputs could include CAD files, manufacturing instructions, inspection checklists, or test specifications.

Make sure outputs are controlled and versioned - so people don’t use the wrong one.

Step 7: Control Design Changes (Clause 8.3.6)

Any changes during or after the design process must be:

• Reviewed

• Approved

• Documented

• Assessed for potential impact

You’ll need a design change log or similar system to track what changed, why, when, and who authorised it.

Example:

If you update a software design after customer feedback, record what was changed, test it again, and reissue the updated documentation.

Templates and Records You’ll Likely Need

• Design & development procedure

• Design project plans

• Design input checklists

• Design review forms

• Verification and validation logs

• Final design output packages

• Change control logs

Real-World Scenario

The Situation

"Widget Company" designs and builds workbenches tailored to each customer. A client recently asked for an Electrostatic Discharge (ESD) safe version that could handle 500kg and integrate with their tool calibration station.

Implementation of Clause 8.3

• Design Planning: The team used a 5 stage gated process with clear roles, timelines, and checklists.

• Inputs: Gathered from the customer spec, ESD standards, and similar past projects.

• Reviews: Conducted an initial internal design review, followed by a customer sign-off.

• Verification: Checked drawings against input checklist.

• Validation: Built a prototype and tested with a 500kg load and anti-static matting.

• Outputs: Included 3D models, Bill of Materials (BoM), safety notes, and user instructions.

• Changes: Midway through, the client requested an extra monitor arm. The organisation logged the change, re-tested, and updated the design package.

Audit Outcome

When audited, the organisation was able to show clear evidence of compliance with Clause 8.3 - the auditor praised their structured yet simple approach.

Summary: What Clause 8.3 Really Asks For

You need to:

• Plan your design process

• Identify and control requirements

• Review and test your designs

• Capture the final results in usable form

• Manage changes professionally

With a basic procedure, a few templates, and a disciplined approach, you can meet the clause and make design a strength in your QMS.

Need Help Getting This Right?

Book a call with one of our fully qualified ISO 9001 Management System Consultants to see how we can help you implement a fully compliant, user friendly documentation system.

We work exclusively with organisations aiming for certification by UKAS accredited Certification Bodies.

All our consultants are Lead Auditor qualified by the Chartered Quality Institute (CQI) and registered with the International Register of Certificated Auditors (IRCA).

Email: Danny@onesystemmgt.com

Website: www.onesystemmgt.com