ISO 9001 & ISO 13485

ISO 13485 for medical device quality control having several similar nature with ISO 9001.

Today, we are looking at the differences and similarities between these two criteria, and if life sciences firms and associated services require both certificates. ISO 13485 is a quality system for the medical device industry and its effectively covers ISO 9001 with some additional requirements.

Is that comparing ISO 9001 and ISO 13485 is a valuable exercise. By understanding the differences between these two standards, you have to learn where device manufacturers need to raise the bar on quality.

Similarities between ISO 9001 and ISO 13485

ISO 9001 & ISO 13485 both are basically about precisely the exact same things- helping in businesses to create always safe, higher quality solutions.

• Risk- reduction: These two criteria highlights the need for associations to integrate risk into production and design.

• Plan-Do-Check-Act: They utilize the Plan-Do-Check-Act procedure strategy regardless of how the two criteria don’t share exactly the same structure.

• Client focus: ISO 9001 and ISO 13485 are constructed around ensuring customer expectations are met.

• QMS needs: Organizations will need effective procedures and resources such as document control, Employee training, Audits and Corrective Action.

ISO 13485 builds on the requirement of ISO 9001 by addressing the responsibility of the manufacturer for “maintaining the quality management system.”

• Include regulatory document with system documentation.

• The QMS includes a file for identifying product related documents.

• A master record device must specifically define QMS requirement.

• Changes to QMS documentation must be reviewed and approved by the original approving functions.

• Manufacturer is required to analyse data standards based on product and its requirements.

Differences between ISO 9001 and ISO 13845:

In a lot of ways they are alike, but there are important ways that they’re different.

• Aims and results: ISO 9001 requirements are skewed heavily towards ensuring client focus and satisfaction. ISO 13485 puts emphasis on medical devices for safety.

• Continuous focus: ISO 9001 currently requires producer to reveal constant improvement and on the other side, ISO 13485 just needs demonstrating effective implementation and maintenance of the grade system.

• Documentation: For ISO 13485’s documentation demands are a lot more extensive than people at ISO 9001.

• Regulatory compliance: ISO 13485 is closely connected to regulatory demands, particularly towards criticism handling, regulatory alarms, and post market surveillance.

What are the additional requirements in ISO 13485-:

Quality Management System

• Effectiveness of the QMS.

• QMS documentation changes must be evaluated for their impact.

• Control and management of outsourced processes.

• Documented procedure for software validation.

• Organization should maintain each medical device file.

Management Responsibility

• Ensure effectiveness of the QMS by the management commitment.

• Promote awareness of regulatory requirements.

• Management review for revised regulatory requirements.

Resource Management

• Requirements for work environment, including cleanliness of clothing, temporary work conditions, and product control.

Product Realization

• Risk management procedures is associated with product realization planning.

• Advisory notices added to customer communication center.

• Development and Design procedures need to be documented

Measurement, Analysis and Improvement

• Documented procedure required for a feedback system.

• Additional requirements of inspection of product.

• Feedback included in analysis of data.

• Including update of documents in the taken actions.

• Including investigation records.

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