The release of products and services by the organization to the customer is a critical step in the quality management process, ensuring that only conforming and approved products and services reach the customer. Your organization must show evidence that a process (method, techniques, formats, etc.) is in place to monitor and measure the characteristics of product to verify that requirements are being met.This must be accomplished at appropriate stages of the design and development process. The auditor will verify that records are maintained to provide evidence of conformity and indicate the person(s) authorizing the release of products. The release of product or delivery of service must not be completed until the planned requirements have been met. The release of product may include, according to product planning and the verification stages; release to the next operation, release to an internal customer, or release to final customer, etc. Planned arrangements can include design verification and design validation, which can involve modelling, simulations, experiments, trials, prototypes, functional testing, performance testing; inspections comprising, in-process, first article and final inspection; thorough examination through destructive and non-destructive testing; customer acceptance testing, product certification/qualification, third party qualification from a regulator, recognized society, or independent testing body etc. For product release or service delivery, the planning requirements may be waived, but must be approved by relevant authority and by the customer as appropriate. Monitor and measure product characteristics to ensure they are able to demonstrate that Product characteristics are continually met and evidence of conformity with product requirements. Retain records to provide evidence that acceptance criteria have been met might include: e.g. certificate of conformity, release certificate, regulatory certificate. Ensure traceability to the person(s) authorizing the release such as name, authorized signatories, user identification, stamp impression etc., including their authority status (release signatory, certifying staff, scope of authorization etc.).
This process involves thorough verification and validation to guarantee that all customer requirements, specifications, and relevant standards have been met. Prior to release, the products and services undergo verification and validation processes. Verification involves checking that all defined requirements, including design specifications, have been met during the production or service provision. Validation ensures that the final output meets the intended use and customer expectations. Inspection and testing are essential steps in the release process. Products and services are examined for conformity and compliance with relevant standards. Any non-conformances or defects are identified and addressed before release. The release process involves thorough documentation and record-keeping. This includes records of inspections, testing results, verification, and validation activities. Proper documentation is crucial for traceability, audits, and customer verification. Only authorized personnel with the necessary competence should be allowed to approve the release of products and services. This ensures that the individuals responsible for release decisions have the expertise to assess compliance with requirements. The release process is carried out in a controlled environment to prevent any mix-ups or errors. Adequate measures are taken to avoid product or service mix-ups during handling and shipping. Once products and services are released, the customer is notified about the shipment, including any relevant details such as tracking information or delivery schedules. In case non-conforming products or services are identified during the release process, a proper procedure should be followed for handling and disposition, including identification, segregation, and resolution according to established protocols. The release process is subject to continuous improvement efforts. Feedback from customers, internal audits, and performance data analysis are used to identify areas of improvement and enhance the release process over time. The release of products and services is a crucial moment in the relationship between the organization and the customer. A well-defined and robust release process ensures that customers receive high-quality products and services that meet their expectations, contributing to customer satisfaction and loyalty. Moreover, it helps prevent costly recalls, customer complaints, and potential damage to the organization’s reputation.
Clause 8.6.1 Release of products and services
In addition to the requirement given in ISO 9001:2015 clause 8.6 Release of products and services, Clause 8.6 requires that the organization ensures that the planned arrangements to verify that the product and service requirements have been met encompass the control plan and are documented as specified in the control plan.The organization ensures that the planned arrangements for initial release of products and services encompass product or service approval.The organization shall ensure that product or service approval is accomplished after changes following initial release
The organization is responsible for ensuring that the planned arrangements to verify that product and service requirements have been met are fully documented as specified in the control plan. The control plan is a vital component of the quality management system, particularly in the automotive industry, and serves as a comprehensive document that outlines the specific steps and methods for verifying product and service conformity. The control plan provides a standardized approach for verifying product and service requirements, ensuring that the same methods and criteria are consistently applied across different production or service provision processes. The control plan is based on customer requirements and specifications, ensuring that all relevant requirements are addressed during the verification process. By specifying the planned arrangements for verification in the control plan, the organization can identify and mitigate potential risks associated with product or service non-conformances. The control plan serves as documented evidence of the organization’s commitment to meeting customer requirements and ensuring product and service quality. The control plan provides traceability, as it links specific requirements to the corresponding verification methods and responsible personnel. This accountability ensures that all necessary verification activities are carried out and recorded. The control plan is subject to continuous improvement efforts. Feedback from verification activities, customer feedback, and audits can be used to enhance the control plan and increase its effectiveness over time. The control plan facilitates training and competence development of employees involved in the verification process. It provides clear guidance on the required skills and knowledge for conducting the verification activities. By documenting the planned arrangements for verification, the organization can identify opportunities to optimize processes, reduce waste, and enhance efficiency in meeting product and service requirements.The control plan typically includes details such as the inspection and testing methods, acceptance criteria, frequency of verification activities, measurement tools, and responsible individuals or teams for each verification step. This comprehensive documentation ensures that all verification activities are well-defined, understood, and executed consistently to ensure product and service conformity. By adhering to the planned arrangements specified in the control plan, the organization can enhance its quality management practices, meet customer expectations, and maintain a competitive advantage in the market.
The organization ensures that the planned arrangements for the initial release of products and services encompass product or service approval. This approval process is a critical step in the quality management system, particularly in the automotive industry, to ensure that products and services meet all specified requirements and are ready for release to customers. Product or service approval verifies that the released products and services conform to all customer requirements, specifications, and relevant standards. This ensures that the organization delivers high-quality products and services that meet customer expectations. The approval process is designed to verify that the products and services are of acceptable quality and align with customer needs and preferences. Ensuring customer satisfaction is vital for building long-term relationships and fostering customer loyalty. The product or service approval process verifies that all applicable regulatory and statutory requirements have been met, ensuring that the organization operates within legal and industry standards. The approval process helps identify and manage potential risks associated with product or service non-conformances before releasing them to customers. Early detection of issues allows for prompt corrective actions. The product or service approval process generates documented evidence that the products and services have undergone a thorough verification process and have been approved for release. This documentation is essential for audits and customer verification. Feedback from the product or service approval process can be used to drive continuous improvement efforts. Lessons learned from the initial release can be incorporated into future improvements in the production or service provision processes. The product or service approval process ensures that products and services are not released until they have been thoroughly reviewed, inspected, and verified. This controlled release minimizes the risk of non-conforming products reaching customers. The product or service approval process helps identify training needs and ensures that personnel involved in the approval process are competent and equipped to make informed decisions.The product or service approval process typically involves a formal review and assessment of the products or services by designated personnel. It includes the verification of product or service characteristics, inspection results, compliance with requirements, and any customer-specific criteria. Once the products or services are approved, they can be released to customers with confidence, knowing that they meet all necessary quality standards and requirements.
The organization shall ensure that product or service approval is accomplished after changes following initial release. The product or service approval is an essential step that should be reaccomplished after implementing changes to the product or service following the initial release. This requirement ensures that any modifications or improvements made to the product or service are thoroughly reviewed, verified, and approved before being released to customers.
- Verification of Changes: After the initial release, any changes made to the product or service, such as design modifications, process changes, or material substitutions, should be carefully verified to ensure they meet customer requirements and do not negatively impact product quality.
- Risk Assessment: Changes to products or services can introduce new risks or affect existing risk profiles. Reaccomplishing the product or service approval process allows for a thorough risk assessment of the changes and the implementation of appropriate risk mitigation measures.
- Consistency and Standardization: Reaccomplishing product or service approval after changes ensures consistency and standardization in the review and verification process. This consistency helps maintain product quality and customer satisfaction.
- Customer Expectations: The product or service approval process verifies that the changes align with customer expectations and any specific requirements they may have.
- Regulatory Compliance: Changes to products or services may necessitate compliance with new regulations or standards. Reaccomplishing product or service approval ensures that these compliance requirements are met.
- Documented Evidence: The reaccomplished approval process generates documented evidence that the changes have been properly reviewed and approved, providing traceability and transparency.
- Continuous Improvement: The reaccomplished approval process contributes to continuous improvement efforts by identifying any issues or areas for enhancement resulting from the changes.
- Effective Change Management: Reaccomplishing product or service approval is a key element of effective change management. It ensures that changes are thoroughly assessed and implemented in a controlled manner.
The organization should have a structured and well-documented process for reaccomplishing product or service approval after changes. This process should involve relevant stakeholders, including engineering, quality, and any customer representatives if necessary. Any discrepancies or non-conformances identified during the approval process should be addressed and resolved before proceeding with the release of the updated product or service.By adhering to this requirement, the organization can maintain control over product quality, minimize the risk of product or service issues, and ensure customer satisfaction even after implementing changes following the initial release.
