ISO 9001:2015 Requirements
The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.
The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.
1) The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.
This clause requires that organizations implement three controls to ensure that the products are uniquely identifiable and traceable to inputs. Your organization must have a process in place for the identification and traceability of outputs, in terms of the monitoring and measurement requirements at all stages of production, to enable the demonstration of conformity to requirements, e.g. physical part marking, labeling, tags, bar codes, signage, visual indicators, part segregation, lay down areas, storage racks.There are several ways of identifying products to prevent them becoming mixed with other parts, components, or orders. The most obvious is using tags or stickers with a unique traceability identifier, such as a lot or batch number included on the product labels. The identification may be engraved in the product itself, or the product may simply be marked by a colour. Establish and implement a procedure to identify the product through the design, development, manufacture and delivery stages. The established a traceability system should track components from raw material through inspection, test, and final release operations, including rework:
- Establish the identity and status of products;
- Maintain the identity and status of products;
- Maintain records of serial or batch numbers.
An organization should make arrangements so that the process outputs are identified where this is necessary. This can simply be done by assigning project numbers wherever required. If you are refurbishing an aged care facility, the room numbers can be used to identify or trace all items attached to the room. For a bulk earthwork’s company, this can be work lot numbers that are marked on drawings/site maps or chain-age used to track construction for a construction company. In a software company, this can be assigning names to code repositories, components, infrastructure items, etc.
The requirement to use suitable means to identify outputs in order to ensure the conformity of products and services is a crucial aspect of quality management and product/service traceability. This means that the organization must establish clear and effective methods to mark, label, and identify its products and services throughout the production or service provision process. This helps in tracking and verifying that the final outputs meet the specified requirements and conform to quality standards. Here are some key actions and considerations:
- Identification and Labeling: Implement a system for labeling, tagging, or marking products and services at various stages of production or service delivery. This includes raw materials, work-in-progress, and finished products.
- Unique Identifiers: Assign unique identifiers, such as serial numbers, lot numbers, or batch numbers, to each product or service. These identifiers facilitate traceability and recall when needed.
- Documentation: Maintain accurate documentation that links product or service identifiers to specific requirements, specifications, and quality control criteria.
- Traceability Records: Create and maintain traceability records that capture information about the production or service provision process, including personnel involved, equipment used, dates and times, and any relevant measurements or tests.
- Quality Control Points: Define critical quality control points within the production or service provision process where identification and verification are essential to ensuring conformity.
- Inspection and Testing: Incorporate identification into inspection and testing procedures, ensuring that inspectors can easily associate products or services with their specifications.
- Non-Conformance Reporting: Establish procedures for reporting and handling non-conforming products or services. The identification system should enable quick identification and quarantine of non-conforming items.
- Packaging and Shipping: Implement identification and labeling on packaging to ensure that customers can readily identify the contents, including product details, batch/lot numbers, and expiry dates (if applicable).
- Customer Documentation: Provide customers with appropriate documentation and labeling that helps them identify and use the products or services correctly.
- Information Accessibility: Make sure that information related to identification and conformity is easily accessible to authorized personnel, including during audits and inspections.
- Training and Awareness: Train employees involved in production or service provision on the importance of proper identification and its role in ensuring conformity and quality.
- Audit and Verification: Periodically audit and verify the effectiveness of the identification system to ensure it meets its intended purpose and conforms to quality management system requirements.
- Change Control: Establish a change control process to manage any changes to product or service identification methods, ensuring that changes do not compromise conformity.
- Legal and Regulatory Requirements: Ensure that the identification system complies with any legal or regulatory requirements specific to your industry.
- Continuous Improvement: Use data collected through the identification system to drive continuous improvement efforts, identify trends, and prevent recurrence of non-conformities.
By implementing suitable means for identification and traceability, an organization can enhance its ability to consistently deliver products and services that conform to customer requirements and quality standards. This contributes to improved customer satisfaction and product/service reliability.
2) The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
Identifying the status of outputs with respect to monitoring and measurement requirements throughout production and service provision is essential to ensure that products and services meet specified quality standards and conform to customer requirements. This identification should also help an organization identify the status of process outputs regarding any monitoring and measurement requirements at all stages of production or service provision. For example, Inspection and test plans and checklists are prepared and completed throughout the works to show traceability of work and steps completed in accordance with standards, drawings and specifications.In a software company, using tools such as JIRA for tracking work and GitHub for traceability of code changes helps in monitoring the status of process outputs. This process helps organizations maintain control over their processes and take corrective actions when necessary. Here are the key steps to achieve this:
- Define Monitoring and Measurement Requirements: Clearly define monitoring and measurement requirements for each product or service, including critical parameters, tolerances, and acceptance criteria. Document these requirements in quality plans, work instructions, or product/service specifications.
- Incorporate Requirements into Work Instructions:Integrate monitoring and measurement requirements into work instructions and standard operating procedures (SOPs) for each relevant production or service provision process.
- Inspection and Testing:Implement inspection and testing procedures at various stages of production or service provision to assess whether outputs meet the defined requirements. Use appropriate tools, equipment, and techniques for inspections and tests.
- Identification and Labeling:Label or mark outputs to indicate their status with respect to monitoring and measurement requirements.Use visual indicators or labels to signify conformity or non-conformity.
- Record Keeping:Maintain records of all monitoring and measurement activities, including results, measurements, and the identification of each output.Ensure records are accurate, complete, and accessible for review and analysis.
- Conformity Verification: Regularly verify whether outputs conform to monitoring and measurement requirements. Compare measurements and test results to established acceptance criteria.
- Non-Conformance Handling: Establish a clear procedure for handling non-conforming outputs when they are identified. Segregate and control non-conforming items to prevent their unintended use or delivery.
- Reporting and Documentation: Report the status of outputs, including conformity and non-conformity, in documented records.Ensure that records provide clear traceability to the product or service involved and the monitoring and measurement requirements.
- Corrective and Preventive Actions:Initiate corrective actions when non-conformities are identified to address the root causes and prevent recurrence.Consider implementing preventive actions to proactively address potential issues.
- Communication: Communicate the status of outputs and any non-conformities to relevant personnel, including quality assurance teams and process owners. Promote transparency and information sharing within the organization.
- Continuous Improvement: Analyze data collected from monitoring and measurement activities to identify trends, potential process improvements, and opportunities for enhancing product or service quality.
- Audits and Reviews: Conduct internal audits and reviews to assess the effectiveness of the identification and monitoring of output status. Ensure compliance with established procedures and standards.
- Training and Awareness: Train employees involved in monitoring and measurement activities to understand the importance of identifying and reporting output status accurately.
- Regulatory Compliance: Ensure that the identification and monitoring of output status align with any industry-specific regulations or standards applicable to your organization.
By implementing these steps, an organization can effectively identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision. This proactive approach helps ensure product and service quality, customer satisfaction, and compliance with quality management standards.
3) The organization shall control the unique identification of the outputs when traceability is a requirement
Where traceability is a requirement, you should expect to see that your organization is controlling and recording the unique identity of the product throughout the production process to ensure that only products that have passed the required inspections and tests are utilised.n some cases, unique product identification is a contractual requirement from the customers or regulatory bodies. In such circumstances, the organization must maintain detailed records of the manufacturer of material, tools, equipment, inspection and test results for each product or product batches. This is particularly true in certain high-risk industries like aerospace or pharmaceutical, etc. This is due to the high safety and life-threatening risks of the products made by these companies.Organizations must establish controls to ensure the unique identification of outputs throughout the production and service provision process. Traceability is crucial for various reasons, including quality control, product recalls, and addressing customer concerns. Here’s how an organization can control the unique identification of outputs when traceability is necessary:
- Define Traceability Requirements: Clearly define traceability requirements based on customer specifications, industry standards, and regulatory mandates. Specify the information that needs to be traced, such as product or service identifiers, batch/lot numbers, serial numbers, or other unique identifiers.
- Unique Identifiers: Assign unique identifiers to each output or batch of outputs. These identifiers should be traceable to specific production or service provision activities.
- Record Keeping: Maintain accurate and detailed records that link unique identifiers to relevant information, including production dates, materials used, personnel involved, and quality control data.
- Labeling and Marking:Label or mark each output with its unique identifier. Use standardized and clear labeling methods to ensure that the information is easily accessible and legible.
- Documentation and Work Instructions: Document traceability procedures in your organization’s quality management system. Include traceability requirements in work instructions, standard operating procedures (SOPs), and quality plans for each relevant process.
- Verification and Validation: Implement verification and validation processes to ensure that unique identifiers are correctly assigned and recorded at each stage of production or service provision.
- Inspection and Testing: Integrate traceability checks into your inspection and testing processes to confirm that outputs meet traceability requirements.
- Change Control: Establish a change control process that addresses any changes to unique identifiers or traceability requirements. Ensure that changes are documented, communicated, and approved.
- Non-Conformance Handling: Develop procedures for handling non-conforming outputs, including those that do not meet traceability requirements. Segregate and control non-conforming items to prevent their unintended use or delivery.
- Reporting and Documentation: Maintain records that demonstrate traceability, including information on inputs, processes, and outputs. These records should provide a clear audit trail.
- Auditing and Verification: Conduct internal audits and verification to assess the effectiveness of your traceability system. Ensure that traceability requirements are consistently met.
- Communication: Ensure that relevant personnel are aware of traceability requirements and understand their roles in maintaining traceable records.
- Training: Provide training to employees involved in processes that require traceability to ensure they understand the importance of accurate identification and recording.
- Regulatory Compliance: Ensure that your traceability practices comply with any industry-specific regulations or standards that apply to your organization.
- Continuous Improvement: Continuously review and improve your traceability system by analyzing data, identifying areas for enhancement, and implementing corrective and preventive actions.
Controlling the unique identification of outputs when traceability is required is critical for ensuring that products or services can be tracked and verified throughout their life-cycle. This not only supports quality management but also aids in addressing issues, conducting recalls, and meeting customer and regulatory requirements.
4) The organization must retain shall retain the documented information necessary to enable traceability.
Retaining documented information necessary to enable traceability is a critical aspect of quality management, particularly when traceability requirements exist due to regulatory compliance, customer expectations, or internal quality control standards. Here’s how an organization can effectively retain the required documented information for traceability purposes:
- Define Traceability Requirements: Clearly define the traceability requirements for your products or services. Identify the specific information that needs to be documented and retained, such as unique identifiers, batch/lot numbers, serial numbers, and associated data.
- Document Control Procedure: Establish a documented procedure for the control and retention of relevant records and documents. This procedure should outline the steps for record creation, maintenance, access, and disposal.
- Record Types and Formats: Determine the types of records and formats required to support traceability. Common examples include production logs, inspection reports, test results, certificates of conformity, and shipping records.
- Data Entry and Recording: Ensure that data entry and recording processes are standardized, accurate, and consistent across relevant production or service provision activities. Train employees on the importance of complete and accurate record-keeping.
- Unique Identifiers: Assign unique identifiers, such as serial numbers or lot numbers, to each output or batch. Document these identifiers in your records.
- Labeling and Marking: Implement clear and standardized labeling and marking practices to associate unique identifiers with physical outputs. Labels should include key information for traceability.
- Retention Periods: Determine the appropriate retention periods for different types of records based on regulatory requirements, industry standards, and internal policies. Ensure that records are retained for at least the minimum required duration.
- Storage and Accessibility: Store retained records in a secure and organized manner to prevent damage, loss, or unauthorized access. Ensure that records are easily retrievable when needed for audits, inspections, or traceability purposes.
- Backup and Redundancy: Establish backup and redundancy measures for electronic records to safeguard against data loss due to technical failures or disasters.
- Auditing and Monitoring: Periodically audit and monitor the record retention process to verify compliance with procedures and to address any discrepancies or issues promptly.
- Record Destruction: Develop a process for the secure and documented destruction of records that have reached the end of their retention period. Ensure that records are destroyed in a manner that maintains confidentiality and prevents unauthorized access.
- Documentation of Retention: Document the retention of each record, including the unique identifier associated with the record, the date of retention, and the responsible personnel.
- Continuous Improvement: Continuously evaluate and improve the record retention process based on feedback, changes in regulations, or evolving industry best practices.
- Regulatory Compliance: Ensure that your record retention practices align with relevant regulatory requirements specific to your industry.
Here are the key documents and records required for Clause 8.5.2:
- Procedure for Identification and Traceability: Organizations should have a documented procedure that outlines the process for identifying and tracing products and services. This procedure should define how unique identifiers are assigned, how records are maintained, and how traceability is ensured.
- Work Instructions: Work instructions are essential documents that detail specific processes and steps for identifying and tracing products and services. They should provide guidance on labeling, marking, recording, and verification procedures.
- Product/Service Specifications: These documents specify the requirements and criteria that products and services must meet. They often include information about unique identifiers, batch/lot numbers, serial numbers, and other traceability-related requirements.
- Record Retention Policy: A policy outlining how long records related to identification and traceability will be retained, who is responsible for their retention, and how they will be stored and disposed of.
- Traceability Records: These records should include information that allows products or services to be traced back to their source, including unique identifiers (e.g., serial numbers, lot numbers), production or service provision dates, materials used, and personnel involved.
- Unique Identifier Records: Records that document the assignment of unique identifiers to products or services. This may include logs or databases of assigned numbers or codes.
- Inspection and Test Records: Records of inspections and tests conducted to verify that products or services meet specified requirements. These records should include results and, when applicable, identification of the inspected or tested items.
- Non-Conformance Records: Records of non-conformities identified during the identification and traceability processes, including actions taken to address and correct them.
- Change Control Records: Records of any changes to unique identifiers, labeling, marking, or traceability processes, along with the rationale for those changes.
- Retention Records: Records indicating the retention periods for various identification and traceability-related records, including when records can be destroyed.
- Audit and Review Records: Records of internal audits and management reviews related to the identification and traceability process, including findings and corrective actions.
- Customer Communication Records: Records of communications with customers related to identification and traceability, including requests for traceability information and responses provided.
- Training Records: Records of training provided to employees involved in the identification and traceability processes, demonstrating their competence in carrying out these activities.
- Supplier Records: Records related to supplier identification and traceability, particularly if suppliers play a role in providing unique identifiers or traceability information for materials or components.
Example for Procedure for Identification and Traceability
Objective: This procedure outlines the process for uniquely identifying products or services and ensuring their traceability throughout production and service provision, as required by ISO 9001:2015 Clause 8.5.2.
Scope: This procedure applies to all products and services provided by [Organization Name].
- The [Quality Manager/Designated Personnel] is responsible for overseeing and ensuring compliance with this procedure.
- All employees involved in product or service identification and traceability must adhere to this procedure.
1. Unique Identification:
- Assign a unique identifier to each product or service as appropriate. Common identifiers include serial numbers, batch/lot numbers, or project codes.
- Document these identifiers in the [Unique Identifier Log or Database].
- Maintain clear documentation specifying the unique identifier, product or service specifications, and any relevant customer requirements.
- Ensure that product or service specifications detail the specific traceability requirements.
3. Work Instructions:
- Develop and maintain work instructions that provide guidance on the application of unique identifiers and the traceability process for different product or service types.
- Ensure that work instructions are readily accessible to relevant personnel.
4. Labeling and Marking:
- Label or mark products or services with their assigned unique identifier according to the documented specifications.
- Use standardized labeling and marking methods to ensure clarity and legibility.
5. Record Keeping:
- Maintain accurate records that capture the unique identifier, production or service provision dates, materials used, and personnel involved.
- Ensure that records are easily retrievable and securely stored.
6. Inspection and Testing:
- Implement inspection and testing procedures that include verification of unique identifiers and traceability information.
- Record the results of inspections and tests, including the identification of items inspected or tested.
7. Non-Conformance Handling:
- Develop procedures for handling non-conforming items, including those that do not meet identification or traceability requirements.
- Segregate and control non-conforming items to prevent unintended use or delivery.
8. Change Control:
- Establish a change control process for any changes to unique identifiers, labeling, marking, or traceability procedures. Document the rationale for changes.
9. Record Retention:
- Adhere to the organization’s record retention policy for identification and traceability records. Retain records for at least [Specify Retention Period] or as required by regulatory standards.
10. Auditing and Verification: – Conduct periodic internal audits and verifications to assess compliance with this procedure and identify opportunities for improvement.
11. Continuous Improvement: – Analyze data collected through traceability records to identify trends, potential process improvements, and opportunities to enhance product or service quality.
12. Regulatory Compliance: – Ensure that the organization’s identification and traceability practices align with any industry-specific regulations or standards applicable to your products or services.
13. Training and Awareness: – Provide training to employees involved in identification and traceability processes to ensure they understand the importance of accurate identification and recording.
14. Reporting: – Report any critical issues, deviations, or non-conformities to management and initiate corrective actions as necessary.
15. Document Retention: – Retain this procedure and associated records as per the organization’s document control and record retention policy.
16. Review and Revision: – Periodically review and update this procedure to ensure its continued effectiveness and relevance.
17. Approval and Revision History: – Maintain records of procedure approvals and revisions.