ISO 9001 Design Explained
5 Steps contributing to the ISO 9001 design process.
Design & Development Planning
The very first step pertains to design & development planning (Clause 8.3). The planning should consist of the following:
- The nature, design, and duration of the design/development activities.
- The number of stages during design/development activities such as conceptual, detailed design, discipline oriented, or progress stages.
- The nature of controls during design/development activities such as reviews, verification, and validation.
- Roles, responsibilities, and authorities during design/development process.
- Internal and external resources required.
- Interfaces required.
- Role of customers.
- Role of users.
- Requirements for final products/services.
- Level of control by customers and stakeholders.
- Nature of documented information to be retained.
Design/Development Inputs:
The nature of inputs for any specific design/development project could include the following:
1. Functional requirements:
- Business requirements describe the high-level business needs, such as carving a market share, reducing customer churn, or improving the customers’ lifetime value.
- User requirements cover the different goals your users can achieve using the product and are commonly documented in the form of user stories, use cases, and scenarios.
- Product requirements describe how the system needs to operate to meet the business and user requirements. They include functional requirements and non-functional requirements.
2. Performance requirements:
In addition, the inputs could include statutory & regulatory requirements, information from similar previous designs, applicable codes of practice, and potential consequences for failure. The inputs are retained as documented information.
Functional and performance requirements for a pump (as an example)
Functional requirements – A pump must have:
- The ability to effectively transfer liquids from one location to another.
- A reliable on/off switch for control of operation.
- An ability to handle a variety of liquid types, including water, chemicals, and oils.
- A minimum flow rate of X litres per minute.
- A maximum pressure rating of X psi.
- A durable construction to withstand regular use and potential harsh conditions.
Performance Requirements – A pump must:
- Be capable of operating continuously for at least X hours without overheating or malfunctioning.
- Have a low noise level during operation, not exceeding X decibels.
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Design/Development Controls:
The controls could include reviews, verification, and validation.
The ‘reviews’ could include evaluation of outputs against inputs for a given stage of the design/development i.e., conceptual, detailed design, specific discipline such as architecture, mechanical, electrical, structural, instrumentation, and chemical. The design stages could include conceptual, detailed design, and individual engineering discipline progress levels. The review could also be conducted on a single-engineering discipline drawings such as mechanical, electrical, etc.
The ‘verification’ refers to evaluation of overall outputs against inputs for a design/development project. This can be achieved through consolidated design reviews, alternate hand calculations to evaluate software-driven calculations, squad (multi-discipline) checks. The verification could include multi-discipline checks in terms of their outputs including their interfaces and alternate calculations for the original calculations (hand calculations VS computer/software calculations).
The ‘validation’ refers to the product being able to perform as design i.e., fit for the purpose. The validation can be achieved in several ways such as customer approval, performance test or approval by a relevant statutory and regulatory requirement.
Design/Development Outputs:
The requirements for design/development outputs could include:
- Must meet input requirements.
- Must be adequate to enable the normal functioning of the product/service.
- Must include checks and balances with the acceptance criteria.
- Must cover operating and maintenance instructions for the product/service designed.
Design/development outputs must be documented.
Design/development outputs could include design/development discipline drawings, layout drawings, process & instrumentation drawings, mechanical flow diagrams, electrical schematics, software driven calculations, engineering specifications, operating manuals, and maintenance manuals.
Design/Development Changes:
Design/development changes are managed so that there are no adverse impacts on the conformity to requirements. Ideally, the design/development change process should include the following:
- Identification of the changes.
- Risk assessment for the impact of the changes on the relevant process.
- Change development.
- Change execution.
- Documented information to be maintained and retained.
QMS Resources
Courses
- ISO 9001:2015 Requirements – Instructor Led Online Training Course – A competency-based 2-day training program that focuses on the ability of an organization to consistently provide products and services that meet or exceed customer and applicable statutory/regulatory requirements; and improve customer satisfaction and business performance.
- ISO 9001:2015 Management System Auditing – Instructor Led Online Training Course – A competency-based 3-day course that focuses on auditing management systems using ISO 19011:2018 Standard Guidelines to evaluate the level of conformance of organizational processes against the requirements of the ISO 9001:2015 Standard.
- ISO 9001:2015 Leading Management System Audits – Instructor Led Online Training Course – A competency-based 4-day course that focuses on the role of an auditor in leading teams for an audit of a management system using ISO 19011:2018 Standard Guidelines to evaluate the level of conformance of organizational QMS processes against the requirements of the ISO 9001:2015 Standard.
Blogs
- What is ISO 9001? – Learn about ISO 9001 standard, its purpose, benefits, how to implement it, get certified and more.
- Core elements – Learn about the 10 clauses of a Quality Management System in detail.
- ISO 9001:2015 standard – Learn about ISO 9001 principles, how the structure has changed, risk based thinking and more.
- What is Quality Management Systems? – An easy guide to a Quality Management System – definition of QMS, its benefits, purpose, past of quality and more.
