ISO 9001:2015 Clause 8.3.6
What is ISO 9001:2015 Clause 8.3.6?
8.3.6 refers to the “Design and Development Changes.” This clause outlines the requirements for organizations when making changes to a product’s design and development activities after the initial release of the design and development outputs.
Key points outlined in Clause 8.3.6 include:
General Requirements:
- Organizations must establish, implement, and maintain a process for evaluating, authorizing, and implementing design and development changes.
- The organization should ensure that the integrity of the original design and development is maintained when changes are made.
Review of Changes:
Before making changes, a review should be conducted to evaluate the effects on the product, including any potential impact on its intended purpose, safety, performance, and conformity to requirements.
Authorization:
The organization needs to define the authority responsible for approving design and development changes.
Communication:
Relevant personnel should be informed about the changes and any necessary actions they need to take.
Records:
The organization must keep records of the results of the review, the authorization for changes, and any actions taken.
How does a company comply with Clause 8.3.6?
Compliance with Clause 8.3.6 of ISO 9001:2015, which addresses design and development changes, involves implementing a structured and documented process. Here’s a general guide on how a company can comply with this clause:
Establish a Process:
Develop a documented procedure that outlines the process for managing design and development changes. This procedure should define the steps to be taken when a change is proposed or required.
Change Review:
Conduct a thorough review of the proposed design and development changes. This review should assess the potential impact on the product, including its intended purpose, safety, performance, and conformity to requirements.
Risk Assessment:
Perform a risk assessment to identify and evaluate potential risks associated with the proposed changes. This includes considering the impact on product quality, customer satisfaction, and regulatory compliance.
Authorization:
Clearly define the authority responsible for approving design and development changes. This may involve obtaining approval from relevant stakeholders, such as project managers, engineers, quality assurance personnel, and others.
Communication:
Ensure effective communication regarding the approved changes. This includes notifying relevant personnel, departments, and stakeholders about the nature of the changes and any actions they need to take.
Documentation:
Maintain comprehensive records of the entire change management process. Document the results of the change review, authorization details, and any actions taken as a result of the changes.
Integrity of Design:
Emphasize maintaining the integrity of the original design and development. Ensure that changes do not compromise the product’s overall quality, safety, or compliance with requirements.
Training:
Provide training to personnel involved in the change management process. This includes those responsible for proposing, reviewing, authorizing, and implementing changes. Training helps ensure that everyone understands their roles and responsibilities.
Continuous Improvement:
Periodically review and evaluate the effectiveness of the change management process. Implement corrective actions as necessary to improve the process and prevent recurrences of issues.
Audit and Verification:
Include the change management process in internal audits to verify compliance with ISO 9001 requirements. This helps identify areas for improvement and ensures ongoing conformity.
Remember that the specific details of how a company implements Clause 8.3.6 may vary based on the organization’s size, complexity, and the nature of its products or services. It’s essential to tailor the process to fit the company’s unique circumstances while meeting the requirements of ISO 9001:2015.
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