ISO 13485 Control of Production Overview
[ISO 13485 Cl 7.5.1]
This clause ensures that all manufacturing and service activities related to medical devices are carried out under controlled conditions so that the product consistently meets specifications and regulatory requirements. It focuses on planning, monitoring, and maintaining control over the production processes.
Key Requirements of Clause 7.5.1: To maintain controlled conditions, the organization must:
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Documented Procedures: Establish and maintain documented procedures for production and service provision.
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Work Instructions: Provide clear work instructions, SOPs, or manufacturing records where their absence could adversely affect product quality.
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Equipment and Environment Control: Use suitable equipment and maintain controlled environmental conditions (e.g., temperature, humidity, cleanliness).
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Monitoring and Measurement: Implement monitoring and measurement devices to verify that processes are within specified parameters.
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Release and Delivery Controls:
Ensure that products are not released until all required verification and validation activities are completed and documented. -
Post-Production Activities: Include service provision or installation as applicable, ensuring they are performed in controlled conditions.
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Qualification of Personnel: Ensure personnel performing production, installation, and servicing are trained and qualified for their respective tasks.
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Maintenance of Records: Maintain production and service records to provide traceability and demonstrate compliance.
Examples of Controlled Conditions are the Using validated processes (e.g., sterilization, welding, sealing), maintaining cleanroom conditions for critical manufacturing, calibration and maintenance of production machinery, verification of in-process controls and final product inspection and approved device master record (DMR) and device history record (DHR).
Common Nonconformities found are Missing or outdated work instructions on the production floor, Lack of environmental monitoring records, Production performed by unqualified personnel, Missing evidence of final inspection or batch release and Uncontrolled changes to production processes without proper review or revalidation.
A well-controlled production process is not only about equipment and environment, it’s about ensuring every person, document, material, and record in the process contributes to consistent and compliant product realization.
Frequently Asked Questions
What does “controlled conditions” mean in ISO 13485 Clause 7.5.1?
Controlled conditions mean that the entire production and service process is carried out using defined methods, trained personnel, calibrated equipment, and documented instructions to ensure product conformity. It includes environmental control, process validation, and proper record maintenance.
Why is documentation so important in production control?
Documentation (such as SOPs, work instructions, DMRs, and DHRs) ensures that production is consistent and traceable. It helps demonstrate that each medical device batch was produced according to approved specifications and regulatory requirements.
What are examples of controlled conditions in production?
Examples include:
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Verified and calibrated manufacturing equipment
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Controlled temperature or humidity environments
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Qualified operators performing production tasks
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Documented work instructions at each workstation
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In-process inspection and final verification steps
How does Clause 7.5.1 relate to process validation (Clause 7.5.6)?
Clause 7.5.1 ensures processes are controlled, while Clause 7.5.6 applies when the results of those processes cannot be fully verified through inspection or testing — requiring validation to confirm consistent performance.
What records should be maintained for production control?
Key records include:
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Batch or lot records
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Device History Records (DHR)
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Equipment maintenance and calibration logs
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Operator training records
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In-process and final inspection reports
Who is responsible for ensuring production is controlled?
Typically, the Production Manager or Quality Assurance (QA) team is responsible for ensuring that all production activities are carried out under controlled conditions and documented as per the Quality Management System.
How can an organization demonstrate compliance with Clause 7.5.1 during an audit?
By showing objective evidences covering the following
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Documented production procedures and work instructions
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Evidence of personnel training and qualification
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Calibrated and maintained equipment records
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Batch or DHR traceability documentation
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Environmental monitoring and process control records