ISO 9001:2015 Clause 8.3.2
What is ISO 9001:2015 Clause 8.3.2?
In ISO 9001:2015, Clause 8.3.2 is related to the design and development of products and services. This clause is titled “Design and Development of Products and Services.” It outlines the requirements for organizations when they are involved in the creation and realization of products and services, including the planning, design, and development processes.
What are the Specific Objectives of Clause 8.3.2?
Planning for Product and Service Design and Development:
This involves defining the stages and activities for designing and developing products or services.
Inputs to Design and Development:
Identifying and understanding the requirements and expectations that need to be considered during the design and development process.
Control of Design and Development Outputs:
Ensuring that the outputs from the design and development process meet the input requirements. This includes verification and validation activities.
Changes to Design and Development:
Managing changes to the design and development process to ensure that the resulting products or services still meet the specified requirements.
Organizations implementing ISO 9001:2015 should carefully review and comply with the specific requirements outlined in Clause 8.3.2 to ensure that their design and development processes meet the standard’s criteria for quality management systems.
How does a company comply with Clause 8.3.2?
To comply with Clause 8.3.2 of ISO 9001:2015, which relates to the design and development of products and services, a company needs to establish and maintain a robust system that addresses the requirements outlined in this clause. Here is a general guideline on how a company can comply with Clause 8.3.2:
Establish a Design and Development Process:
- Define and document a systematic approach to design and develop products and services.
- Clearly outline the stages, activities, and responsibilities involved in the design and development process.
Plan for Design and Development:
- Develop a plan that addresses the scope, objectives, and resources needed for design and development activities.
- Consider factors such as risk management, regulatory requirements, and customer needs during the planning phase.
Inputs to Design and Development:
- Identify and document the input requirements for the design and development process.
- Consider inputs such as customer requirements, applicable statutory and regulatory requirements, and organizational needs.
Control of Design and Development Outputs:
- Establish controls to ensure that design and development outputs meet the identified input requirements.
- Implement verification and validation activities to confirm that the designed products or services fulfill the specified criteria.
Review and Approval of Design and Development Outputs:
- Define a process for reviewing and approving design and development outputs.
- Ensure that relevant stakeholders, including customers and regulatory bodies, are involved in the review and approval process as appropriate.
Changes to Design and Development:
- Implement a formal process for managing changes to the design and development process.
- Assess the impact of changes on product or service conformity and take appropriate actions to maintain compliance.
Record Keeping:
- Maintain comprehensive records of design and development activities, including inputs, outputs, reviews, and approvals.
- Ensure that records are easily retrievable for auditing purposes.
Competence and Training:
- Ensure that personnel involved in design and development activities are competent and adequately trained.
- Provide ongoing training to keep employees up-to-date with changes in technology, standards, and processes.
Monitoring and Measurement:
- Implement monitoring and measurement activities to evaluate the effectiveness of the design and development process.
- Use key performance indicators to assess the performance and identify areas for improvement.
Continuous Improvement:
- Establish mechanisms for continual improvement of the design and development process.
- Analyze performance data, customer feedback, and audit results to identify opportunities for improvement.
Organizations need to tailor these guidelines to their specific industry, products, and services. Regular internal audits and external assessments can help ensure that the company’s design and development processes comply with Clause 8.3.2 of ISO 9001:2015. Additionally, seeking certification from a recognized certification body can provide external validation of compliance.
Helpful Resources: ISO Audits – What Registrars Look For Part 1
In this episode of “The Quality Hub: Chatting with ISO Experts,” host Xavier Francis interviews AJ Puylara, National Sales and Marketing Manager at NQA, a global certification body. AJ shares his experience in the ISO industry and discusses the ISO certification process. He highlights the steps involved, including engaging with a third-party ISO consultant or registrar and conducting a gap assessment. Listen Now
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