ISO 9001:2015 requirement
The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met.
The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.
The organization shall retain documented information on the release of products and services. The documented information shall include:
a) evidence of conformity with the acceptance criteria;
b) traceability to the person(s) authorizing the release.
1) The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met.
The release of products and services to the customer is a critical stage of production. This is the time to check and ensure that your product or service is meeting the requirements of the customer and is created or delivered as per the acceptance criteria set by the client. Clause 8.6 Release of product and services of ISO 9001:2015 requires that an organization defines planned arrangements at suitable stages to verify that the product and service requirements have been met. The clause also requires that the evidence of conformity with acceptance criteria is retained by the organization. The quality of a product or service is an important criteria that influences customer satisfaction greatly. A product or service should be made as per the requirements defined by the customer and should meet the customer’s acceptance criteria. When a product does not meet the customer’s acceptance criteria and is released prior to verification by the organization, it can lead to customer dissatisfaction and in turn lead to the organization losing its credibility and finally losing its customer base including returning customers. A pre-determined set of verification steps at different stages of product or service can considerably reduce the chances of bad deliveries and that is what makes this clause an important clause where documented evidence of such verification activities should also be retained by the organization. Verifying that product and service requirements have been met is a critical aspect of quality management to ensure the delivery of high-quality products and services to customers. To fulfill this requirement, organizations should implement planned arrangements at appropriate stages of their processes. Here’s a breakdown of how organizations can implement these arrangements effectively:
- Define Verification Points: Identify the key stages in your processes where verification activities are necessary to ensure that product and service requirements are met. These verification points may vary depending on your industry and specific processes.
- Establish Criteria for Verification: Define clear criteria for verification at each identified stage. These criteria should be specific, measurable, and aligned with the product or service requirements and relevant quality standards.
- Select Verification Methods: Determine the most suitable verification methods for each stage. Verification methods can include inspections, testing, measurements, reviews, audits, or other relevant techniques.
- Develop Verification Plans: Create verification plans that outline the specific activities, responsibilities, and schedules for each verification point. These plans should also include the acceptance criteria that must be met.
- Allocate Resources: Ensure that you have the necessary resources, including personnel, equipment, tools, and materials, to carry out the planned verification activities effectively.
- Implement Verification Activities:Execute the verification activities at the designated stages of the process. This may involve conducting inspections, testing samples, reviewing documentation, or performing other relevant checks.
- Record Verification Results: Document the results of each verification activity, including whether the product or service met the specified requirements. Record any deviations, nonconformities, or issues identified during verification.
- Take Corrective Actions: If nonconformities or deviations are identified during verification, take appropriate corrective actions to address these issues promptly. Corrective actions may involve rework, adjustments, or process improvements.
- Validation of Processes: For critical processes or when introducing new products or services, conduct process validation to ensure that the process consistently produces results that meet requirements.
- Document Verification Activities: Maintain records of all verification activities, including the results, actions taken, and any changes made to the process as a result of the verification findings.
- Review and Continuous Improvement: Periodically review the effectiveness of your verification activities and make improvements as necessary. Continuously seek ways to enhance the verification process to prevent defects and nonconformities.
- Communication: Ensure effective communication within the organization regarding verification activities and their outcomes. Share important information with relevant stakeholders to support decision-making and improvement efforts.
By implementing planned arrangements for verification at appropriate stages of their processes, organizations can systematically ensure that product and service requirements are met, ultimately leading to improved quality, customer satisfaction, and compliance with quality management standards
2) The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable,by the customer.
This clause requires that an organization decide the verification activities, or simply put, inspection and testing methods that you will put in place to ensure that the product or service is what the customer needs. While determining the adequate level of inspection or testing, you need to look at your complete production process or service delivery process and decide on the stages or points at which verification activities should take place. Such activities may be planned in your quality plan or project programmes. The organization needs to identify, monitor and measure key characteristics of the product or service to verify their conformance to requirements and agreed acceptance criteria. All the planned verification activities should be carried out before the release is made to the customer. In case there is a need to release any intermediate/final product or service to the customer before all planned verifications to that stage have been completed, prior written approval should be obtained from relevant internal authority and/or customer. Planned arrangements for verification can include activities like simulations, trials, functional testing, system testing, performance or load testing, prototypes, inspection which may include in-process or final article inspection, user acceptance testing, product qualification/ certification, third party testing or qualification by a regulator, etc. While planning for these verification activities, an organization should also ensure that they determine the documentation necessary to demonstrate compliance with this clause. Another important aspect is to also determine who is responsible for these activities. In other words, who decides if all product or service characteristics are met. Also, identify what equipment is required for such activities as this equipment may also need to undergo calibrations. Let’s take an example of a software development firm. Verification activities may start at the very beginning of the software development with a detailed requirements review. This may be followed by design reviews and verification, code reviews, system and integration testing. At the end of the project, there may be user acceptance testing which will validate that the product meets the acceptance criteria set by the customer. At each stage of the software development, review and test records are maintained to show compliance. A final inspection may be performed before the final release to ensure that all the test results are passed using sample data. All these are planned arrangements that are substantiated with evidence of conformity at every point. Here’s a breakdown of the key elements involved in this process:
- Planned Arrangements: Develop clear and well-documented planned arrangements that specify the criteria, processes, and activities that must be completed before the release of products and services. These arrangements should align with the organization’s quality management system and relevant standards.
- Verification and Validation: Implement verification and validation processes to confirm that the products and services meet the specified requirements. This involves conducting inspections, tests, measurements, and other checks to ensure quality compliance.
- Review and Approval: Establish a review and approval process to evaluate whether the planned arrangements have been satisfactorily completed. Relevant personnel or authorities, often within the organization, should assess the results and make decisions regarding release.
- Relevant Authority Approval: If the planned arrangements have not been fully completed, and there is a need to release products or services for specific reasons, approval from a relevant authority within the organization is required. This authority should have the knowledge and authority to make informed decisions.
- Customer Approval (If Applicable): In some cases, especially when customer requirements are stringent or contractual agreements mandate it, seek approval from the customer before releasing products or services that deviate from the planned arrangements. This is particularly important for customized or critical projects.
- Concessions and Documentation: If there are deviations or nonconformities identified during the verification process, document these issues and any associated concessions, corrective actions, or preventive actions taken. Maintain comprehensive records for traceability and accountability.
- Communication: Ensure transparent and effective communication within the organization regarding the status of planned arrangements and the decision to release or not. Stakeholders should be informed of any deviations or approved concessions.
- Continuous Improvement: Periodically review the effectiveness of the release process and associated planned arrangements. Seek opportunities for improvement to prevent future issues and enhance quality control.
- Audit and Compliance: Include the release process in internal and external audits to ensure adherence to quality management standards and regulatory requirements. Audits can help identify areas for improvement.
By adhering to these principles and ensuring that the release of products and services is based on completed planned arrangements and approvals, organizations can minimize the risk of delivering non-conforming products or services to customers. This helps build trust, enhances customer satisfaction, and promotes compliance with quality standards such as ISO 9001.
3) The organization shall retain documented information on the release of products and services.
Maintaining records of the release of products and services is a critical aspect of quality management. These records provide evidence that the organization has followed its planned arrangements, verification processes, and approval procedures to ensure that the delivered products and services meet the specified requirements. Here’s what you should include in these records:
- Clearly specify the product or service that is being released. Include details such as product or service names, codes, or identifiers.
- Document the date and time when the release occurred. This timestamp is crucial for traceability and historical reference.
- Note whether the product or service met the planned arrangements and quality criteria as specified in the organization’s procedures.
- Include information about the results of verification and validation activities, such as inspections, tests, measurements, and reviews. This may involve records of test reports, inspection logs, or review findings.
- Identify the individuals or authorities responsible for reviewing and approving the release. Document their names, titles, and signatures.
- If there were any deviations or nonconformities identified during the verification process, document the reasons for releasing the product or service despite these issues. Include any concessions obtained or corrective actions taken.
- If customer approval was required as part of the release process, include records of customer approvals or any communication related to customer consent.
- Document any concessions granted, along with details of corrective actions taken to address nonconformities. This may involve records of corrective action plans, implementation dates, and verification of effectiveness.
- Ensure that the records are traceable to the specific product or service and that they are controlled to prevent unauthorized changes or tampering.
- Specify the retention period for these records in accordance with organizational policies, industry regulations, and applicable quality standards.
- Ensure that these records are easily accessible for internal and external audits and inspections.
- Maintain a well-organized system for record keeping, whether in physical or electronic form, to facilitate retrieval and reference when needed.
Maintaining records of product and service releases not only demonstrates compliance with quality management standards but also provides a historical record that can be invaluable for audits, customer inquiries, and continuous improvement efforts. Properly documented release records help ensure that products and services meet customer expectations and regulatory requirements.
4) The documented information shall include evidence of conformity with the acceptance criteria and traceability to the person(s) authorizing the release.
IT requires that documented evidence is available with respect to the acceptance criteria set. This clause requires that documentation is maintained to provide evidence of conformity which should also indicate the person(s) authorizing the release of the product. The extent of documentation may be based on the risk involved in the process and complexity of the product or service provided. It could just include a test report which shows the results of the product testing. If the equipment was used for testing or measurements, you may also need records to show equipment or test system used was within the calibration range. You may also need supporting evidence to show that the person who used the calibrated equipment was trained to use that equipment.Other records that provide evidence that acceptance criteria have been met may include release notes or certificates, certificate of conformity, regulatory certificate, etc. The final requirement of Clause 8.6 is the traceability of the person authorizing the release of the product or service. You will need to show that the personnel making the decision to release the product or service has the authority to do so. This could be due to his/her role or position in the organisation, appropriate competency and training or other reason deemed appropriate by the organisation. The information that may be included in verification records can be as simple as a signature on the test report or can include the name of the personnel authorizing the release of the product or service, authorized signatories, stamp impression, their authority status, etc.There may be conditions where a product is released without it meeting the requirements or specification provided by the customer/regulatory body. This also needs to be authorised by a relevant authority and reasons for doing so should also be documented. For example, there may be a case where the customer requests to ship a product early without certain inspection or testing being completed. A copy of such approvals should be maintained within the records of this product shipment. Here’s how to incorporate these elements into your release records:
- Evidence of Conformity with Acceptance Criteria: Ensure that the documented information clearly indicates how the product or service conforms to the acceptance criteria. This evidence can take various forms, including:
- Inspection reports showing that measurements and tests meet specified standards.
- Certificates of compliance or conformity.
- Records of reviews and verifications confirming that all requirements have been met.
- Test results, with values and comparisons against established limits.
- Any other relevant data or evidence demonstrating compliance.
- Traceability to the Person Authorizing the Release:
- Clearly state the name, title, and authority of the person who authorized the release. Include their signature or electronic approval to provide a clear link between the release decision and the responsible individual.
- Ensure that the documented information includes a date and timestamp for the authorization, allowing for traceability of the release decision to a specific point in time.
- Record Format: Create a structured record format that includes fields or sections for the evidence of conformity and the authorization details. This format should be standardized to facilitate consistency and ease of reference.
- Retention and Accessibility:
- Store these records in a manner that ensures their retention and easy retrieval during audits or inspections.
- Implement controls to protect the integrity and security of the records to prevent unauthorized alterations.
- Integration with Quality Management Systems (QMS):
- Integrate the release documentation into your organization’s QMS, making it a part of the overall quality control process.
- Ensure that personnel responsible for authorizing releases are aware of and follow established procedures for recording their approvals.
- Continuous Improvement:
- Periodically review the release records to identify opportunities for improvement in the release process and documentation.
- Consider feedback and lessons learned to enhance the traceability and evidence of conformity in release documentation.
Documented information that includes evidence of conformity with acceptance criteria and traceability to the authorizing authority not only helps demonstrate compliance with quality management standards but also enhances accountability and transparency in the product and service release process. It provides a clear record of the decision-making process and the basis for releasing products and services to customers or end-users.