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ISO 13485:2003

ISO 13485 is the quality Management system standard for organizations engaged in medical device manufacturing.


ISO 13485 is based on ISO 9001 and supplemented with additional quality Management requirements relating to design, special processes, documentation, records, traceability, documentation records, and regulatory actions. Unlike ISO 9001, which requires organizations to demonstrate continual improvement, ISO 13485 requires only that an organization demonstrate that the quality system for medical device manufacturing is implemented and maintained.

Although being registered does not fulfill the requirements of the various industry regulators, such as those of the U.S. Food and Drug Administration (FDA), ISO 13485 is commonly used as the basis for regulatory requirements. As such, the ISO 13485 standard is an essential consideration not only for exporters but also for the local market, global suppliers, and subcontractors to prove that their medical device products are of the highest quality.

SCOPE

ISO 13485 international standard specifies requirements for a quality Management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of this international standard is to facilitate medical device regulatory requirements for quality Management systems. As a result, It includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory Requirements. Because of these exclusions, organizations whose quality Management a system conforms to this international standard cannot claim conformity to ISO 9001 unless their quality Management systems conform to all the requirements of ISO 9001.

APPLICATION

Companies, who design, manufacture, distribute, install and service medical devices for the European and World markets.
Companies who manufacture OEM products which are sold under other company names.
Companies who design and/or manufacture medical device components or raw materials for the medical device market
Companies selling, installing or servicing medical devices.
Consultants providing design services to the medical device market.
Companies providing services to the medical device market such as sterilization, cleaning, testing, etc

FEATURES OF ISO 13485

General Requirements

The organization shall establish, document, implement and maintain a quality Management system and maintain its effectiveness in accordance with the requirements of this International Standard.

The organization shall

Identify the processes needed for the quality Management system and their application throughout the organization
Determine the sequence and interaction of these processes,
Determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
Ensure the availability of resources and information necessary to support the operation and monitoring of these processes,

Monitor, measure and analyze these processes, and Implement actions necessary to achieve planned results and maintain the effectiveness of these processes.


These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality Management system (see 8.5.1).

Processes needed for the quality Management system referred to above should include processes for Management activities, provision of resources, product realization and measurement.

Documentation Requirements
The Medical device quality Management system documentation shall include

Documented statements of a quality policy & quality objectives
A quality manual
Documented procedures required by this International Standard,
Documents needed by the organization to ensure the effective planning, operation and control of its Processes.
Records required by this International Standard (see 4.2.4), and any other documentation specified by national or regional regulations.

Where this International Standard specifies that a requirement, procedure, activity or special arrangement be documented, it shall, in addition, be implemented and maintained.

For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality Management system requirements. These documents shall define the complete manufacturing process and, if applicable, installation and servicing.

The extent of the quality Management system documentation can differ from one organization to another due to
• The size of the organization and type of activities,
• The complexity of processes and their interactions, and
• The competence of personnel.

ISO 13485 IMPLEMENTATION BENEFITS

ISO 13485 implementation improves / leads to

POLICIES & OBJECTIVES set by 'top Management'
Conformance to Legal and Regulatory Requirements
Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements
Documents needed by the organization to ensure the effective planning, operation and control of its Processes.
Records required by this International Standard (see 4.2.4), and any other documentation specified by national or regional regulations.
Controlled consistency of manufactured products
Managed productivity and efficiency, controlling costs
Competitive advantage and increased marketing and sales opportunities.
Improved customer perception of the organization’s image, culture and performance.
Improved internal and external Communications greater understanding of the organization processes
Clear responsibilities and authorities agreed for all staff
Improved use of time and resources
Reduced wastage
greater consistency and traceability of products and services
Customer Confidence, Satisfaction and TRUST
Level of Assurance in Organisational QUALITY
Organisational PROFITABILITY
Ability to Differentiate Organisation for Competitive Advantage
Organisational Credibility & Reputation

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