ISO 13485:2016

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ISO 13485:2016

ISO 13485:2016 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system

Benefits of ISO 13485

By becoming an ISO 13485 certified professional, you will be able to:     

  • Increase the number of job opportunities
  • Create new business connections
  • Gain competitive advantage
  • Increase effectiveness and lower costs
  • Offer expertise on improving work processes
  • Offer safer and more efficient medical devices
  • Increase customer satisfaction

Mandatory documents and records required by ISO 13485:2016

  • Roles undertaken by the organization under applicable regulatory requirements (clause 4.1.1)
  • Procedure and records for the validation of the application of computer software (clause 4.1.6)
  • Quality Manual (clause 4.2.2)
  • Medical device file (clause 4.2.3)
  • Procedure for document control (clause 4.2.4)
  • Procedure for record control (clause 4.2.5)
  • Quality policy (clause 5.3)
  • Quality objectives (clause 5.4.1)
  • Responsibilities and authorities (clause 5.5.1)
  • Procedure and records for management review (clause 5.6.1)
  • Procedure for training (clause 6.2)
  • Requirements for infrastructure and maintenance activities (clause 6.3)
  • Requirements for work environment (clause 6.4.1)
  • Arrangements for control of contaminated or potentially contaminated product (clause 6.4.2)
  • Process for risk management in product realization (clause 7.1)
  • Outputs of product realization planning (clause 7.1)
  • Records of the results of the customer requirements review and actions arising from it (clause 7.2.2)
  • Arrangements for communication with customers (clause 7.2.3)
  • Procedure for design and development (clause 7.3.1)
  • Design and development planning (clause 7.3.2)
  • Design and development outputs (clause 7.3.4)
  • Records of design and development review (clause 7.3.5)
  • Design verification plans, results and conclusions (clause 7.3.6)
  • Design validation plans, results and conclusions (clause 7.3.6)
  • Procedure for transfer of design and development outputs to manufacturing (clause 7.3.8)
  • Procedure and records for control of design and development changes (clause 7.3.9)
  • Design and development file (clause 7.3.10)
  • Procedure for purchasing (clause 7.4.1)
  • Criteria and records for evaluation and selection of suppliers (clause 7.4.1)
  • Record of verification of purchased product (clause 7.4.3)
  • Record for each medical device or batch that provides traceability (clause 7.5.1)
  • Requirements for cleanliness of product (clause 7.5.2)
  • Requirements for medical device installation and acceptance criteria for verification of installation (clause 7.5.3)
  • Records for medical device installation and verification of installation (clause 7.5.3)
  • Procedure and records for servicing of the medical device (clause 7.5.4)
  • Records of sterilization process (clause 7.5.5)
  • Procedure and records of production and service provision process validation (clause 7.5.6)
  • Procedure and records for validation of process for sterilization and sterile barriers systems (clause 7.5.7)
  • Procedure for product identification (clause 7.5.8)
  • Procedure for traceability (clause 7.5.9.1)
  • Records of traceability and name and address of the shipping package consignee (clause 7.5.9.2)
  • Report on changes on customer property (clause 7.5.10)
  • Procedure for preserving the conformity of product (clause 7.5.11)
  • Procedure for monitoring and measuring (clause 7.6)
  • Record of calibration (clause 7.6)
  • Procedure and records for validation of the application of computer software used for monitoring and measuring (clause 7.6)
  • Procedure for customer feedback (clause 8.2.1)
  • Procedure and records for complaint handling (clause 8.2.2)
  • Records of reporting to regulatory authorities (clause 8.2.3)
  • Procedure for internal audit (clause 8.2.4)
  • Records of audits and their results (clause 8.2.4)
  • Identity of the person authorizing release of product (clause 8.2.6)
  • Procedure and record of control of nonconforming product (clause 8.3.1)
  • Records of rework (clause 8.3.4)
  • Procedure and records for data analysis (clause 8.4)
  • Procedure and records for corrective action (clause 8.5.2)
  • Procedure and records for preventive action (clause 8.5.3)

 

The importance of ISO 13485

ISO 13485 is the international standard for quality management systems within the medical device industry. Implementing this standard is not only required for market entry in the EU and other countries, but provides a solid foundation for quality throughout your product’s full life cycle.

FAQ

The purpose of the Standard is to specify requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities ( e.g. technical support).
An ISO medical device management system is defined as a formalized system that documents processes, procedures, and responsibilities covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labelling, etc. It is expressed as the organizational goals and aspirations, compliance with applicable regulations and standards, and the resources needed to implement and maintain them. Most medical devices will require some form of a QMS; the complexity of the MDMS will vary based on the classification of the device and the technical and manufacturing difficulties.
Organizations globally, both public and private spheres, and from every economic sector who are involved in the provision of medical device products and associated services need to demonstrate compliance with ISO 13485. This would include distributors and those trading in medical devices and this apply to any stage of the lifecycle.
Certificates are issued by CABs to organizations after they have gone through an ISO Certification Process This is based on a comprehensive 2-stage audit, that involves a review of documentation and an independent on-site audit. The CAB gathers and documents objective evidence of compliance with the requirements of ISO 13485. After the CAB has confirmed that all the requirements of the ISO 13485 Standard have been implemented and are being maintained, a Certificate is issued as is permission to use logos to publicise the fact.
Normally, an ISO 13485 certification is valid for up to 3 years. Also, annual surveillance audits are conducted to help organizations monitor their progress, as well as check if their current processes are up to date and if quality standards are still being followed.
1. Improve your company’s credibility and identity 2. Evidence-based decision making 3. Continual improvement 4. Increased employee involvement 5. Enhanced customer satisfaction 6. Better employee engagement
1. Quality policy and objectives 2. Quality manual 3. Computer software validation procedure 4. Quality procedures and records 5. Medical device file
1. Planning 2. First internal audit 3. Corrective actions 4. First management review 5. Initial ISO 13485 certification audit
To know the best price for ISO 13485 mail on realcertgroup@gmail.com or call on 9667269214.

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