ISO 9001:2015 Clause 8.5.2

What is ISO 9001:2015 Clause 8.5.2

Clause 8.5.2 of ISO 9001:2015 is titled “Identification and Traceability.” This clause focuses on the requirement for organizations to establish and maintain processes for identifying their products and services and providing traceability when necessary.

How do companies comply with clause 8.5.2?

Compliance with Clause 8.5.2 of ISO 9001:2015, which focuses on identification and traceability, involves implementing specific procedures and practices within a company’s quality management system (QMS). Here’s how a company can achieve compliance with this clause:

Establish Identification Procedures:

• Develop clear procedures for identifying products and services at various stages of production, delivery, and post-delivery activities. This may involve assigning unique identifiers, such as serial numbers, batch codes, or labels, to products or batches.
• Ensure that all relevant personnel are trained on these identification procedures and understand their importance in maintaining product integrity and traceability.

Implement Traceability Systems:

• Identify situations where traceability is required based on customer or regulatory requirements, product complexity, safety concerns, or other factors.
• Establish traceability systems to track the history, use, or location of products or batches throughout their lifecycle. This may involve using technology such as barcoding, RFID tags, or software systems to capture and store relevant data.
• Ensure that traceability systems are integrated into existing processes and workflows to facilitate seamless tracking and retrieval of information when needed.

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Maintain Accurate Records:

• Develop record-keeping procedures to document product and service identification, traceability information, and relevant documentation from suppliers.
• Maintain accurate and up-to-date records of product or batch identifiers, production dates, material specifications, supplier information, and any other relevant data.
• Ensure that records are stored securely and are easily accessible for verification, audits, or in the event of product recalls or quality issues.

Controlled Changes:

• Establish change control procedures to manage changes to product or service identification and traceability requirements.
• Assess the impact of proposed changes on product integrity, traceability, and compliance with customer or regulatory requirements.
• Obtain necessary approvals, update documentation and records, and communicate changes effectively to relevant stakeholders.

Training and Communication:

• Provide training and awareness programs to relevant personnel on the importance of product and service identification, traceability requirements, and related procedures.
• Foster a culture of accountability and compliance with identification and traceability practices through effective communication, regular reviews, and reinforcement of standards and expectations.

By implementing these measures, a company can effectively comply with Clause 8.5.2 of ISO 9001:2015 and demonstrate its commitment to maintaining product integrity, traceability, and adherence to quality management standards.

Other ISO 9001:2015 Clauses:

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