ISO 9001:2015 Clause 8.6
What is ISO 9001:2015 Clause 8.6?
Clause 8.6 of ISO 9001:2015 relates to the release of products and services. It outlines the requirements for ensuring that products and services meet the organization’s specified requirements before they are released to customers or the next stage of production.
Key points outlined in Clause 8.6 include:
Release Process:
Establishing criteria for product and service release.
Review and Authorization:
Ensuring that all necessary reviews, inspections, and verifications are conducted before release.
Traceability:
Maintaining the ability to trace products and services to relevant stages of the process.
Customer Communication:
Ensuring that customers’ requirements are met and any issues are communicated before release.
Changes:
Managing changes that might occur during or after the release.
This clause emphasizes the importance of having a systematic process in place to verify that products and services meet quality standards and customer requirements before they are delivered.
How do you comply with Clause 8.6?
Compliance with Clause 8.6 of ISO 9001:2015 involves establishing and following a systematic process to ensure that products and services meet specified requirements before their release. Here’s a step-by-step compliance guide:
Establish Release Criteria:
Define clear criteria that products or services must meet before release. This includes quality standards, specifications, regulatory requirements, and customer expectations.
Develop a Release Process:
Create a documented process that outlines steps for product/service release. This process should include verification, validation, and any necessary testing procedures.
Verification and Validation:
Conduct thorough verification and validation to ensure products/services meet the established criteria. Verification confirms that requirements are met during each stage of production, while validation ensures that the final output meets the customer’s needs.
Review and Authorization:
Implement a review process involving relevant stakeholders or designated personnel. This involves checking all relevant documentation, test results, and compliance records before authorizing release.
Traceability:
Maintain traceability records that allow you to track products/services throughout their lifecycle. This helps in identifying any issues that may arise later and allows for swift action.
Customer Communication:
Ensure effective communication with customers regarding their requirements and any potential issues or changes that may affect the product/service. Obtain feedback to continuously improve processes.
Change Management:
Establish a process for managing changes that might occur after the release. This involves assessing the impact of changes on quality, re-validation if necessary, and updating relevant documentation.
Documentation and Records:
Maintain accurate and comprehensive documentation of the release process, including records of verifications, authorizations, test results, and any communicated information.
Continuous Improvement:
Regularly review and improve the release process based on feedback, audits, and performance metrics. Implement corrective actions to address any non-conformities or areas for improvement.
Training and Awareness:
Ensure that personnel involved in the release process are adequately trained and aware of their responsibilities, including compliance with release criteria and procedures.
By systematically following these steps and continually improving the release process, organizations can effectively comply with Clause 8.6 of ISO 9001:2015, ensuring that products and services consistently meet quality requirements and customer expectations.
What is the History of Clause 8.6?
Clause 8.6, about the release of products and services, is an important component of ISO 9001, the international standard for quality management systems (QMS). Its evolution can be traced through the revisions of the ISO 9001 standard over the years:
ISO 9001:1987:
The initial version of ISO 9001 did not have the same structure as the current version. However, the concept of ensuring product quality before release was present in various clauses related to quality control and inspection.
ISO 9001:1994:
This version introduced a more structured approach to quality management systems. While there was no specific clause dedicated to the release of products and services, the requirements related to quality control, inspection, and corrective actions contributed to ensuring product/service conformity before release.
ISO 9001:2000:
The 2000 revision aligned the standard with a process-based approach. While there was still no standalone clause for product/service release, the emphasis on process control and the need for monitoring and measurement indirectly addressed the aspect of ensuring conformity before release.
ISO 9001:2008:
This version continued the emphasis on process management and improvement. While there were no significant changes specifically addressing the release of products and services, the principles of quality management emphasized the need for ensuring conformity before delivery to customers.
ISO 9001:2015:
The current version introduced a more structured approach to addressing product and service conformity before release. Clause 8.6 specifically focuses on the requirements for the release process, emphasizing the need for clear criteria, verification, validation, review, and communication to ensure conformity.
Throughout its revisions, the ISO 9001 standard has evolved to place more explicit emphasis on ensuring that products and services meet specified requirements before they are released to customers or the next stage of production. Clause 8.6 in the 2015 version represents a more refined and focused inclusion of these requirements within the overall framework of a quality management system.
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