ISO 13485:2003 Medical devices - Quality Management System

Request an ISO 13485:2003 Guideline document

ISO 13485 Key Clients :

ATPL Phoenix Orthosystem Roselabs


ISO 13485 is specification for the quality management system standard for organizations manufacturing medical device.

ISO 13485 is based on ISO 9001with additional requirements related to design, special processes, documentation, records, traceability, documentation records, and regulatory actions. ISO 13485 requires that the quality system for medical device manufacturing is implemented and maintained.

ISO 13485 is commonly used as the basis for regulatory requirements. ISO 13485 registration does not fulfill the requirements of the various industry regulators, such as those of the U.S. Food and Drug Administration (FDA),

Scope & Application

ISO 13485 specifies requirements for a QMS where an organization needs to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The aim of this standard is to facilitate regulatory requirements for medical device quality management systems. This includes 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.

ISO 13485 is applicable to:

  • 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 sterilisation, cleaning, testing, etc.

ISO 13485 Requirements

General Requirements

The organization shall

  1. Identify the processes of the organization & interaction of these processes,
  2. Determine operational controls to ensure processes are effective,
  3. Control any outsourced processes that affect product conformity
  4. Ensure the availability of adequate resources and information
  5. Monitor, measure and analyse processes, and
  6. Implement necessary actions to achieve planned objectives and targets

Documentation Requirements

ISO 13485 documentation shall include:

The quality management system documentation shall include

  1. Quality policy and quality objectives,
  2. Quality manual,
  3. Documented procedures & work instructions,
  4. Documents and records needed for effective implementation of processes,
  5. Quality requirements by the applicable regulatory authorities.

The extent of the ISO 13485 documentation can vary from one organization to another due to

  1. The size of the organization and type of activities,
  2. The complexity of processes and their interactions, and
  3. 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
  • 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's 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

Why Choose 4C Consulting ?

  • Team 4C has IRCA certified ISO 13485 auditors for Consulting Services
  • 800+ certifications in different industries
  • Hands on experience of Team 4C in implementing ISO 13485 will help to gain early benefits


We offer a customized training program on ISO 13485 for

ISO 13485 Know More

What are the key requirements of ISO 13485?

While encompassing the core elements of the ISO 9001 Quality Management System, ISO 13485 differs in a number of respects. The primary difference is its focus on regulatory compliance rather than customer satisfaction or continuous improvement as found in ISO 9001. Other key elements include:

  • A strong focus on risk management in the design and development process
  • Product traceability and recall
  • Process validation