Consulting & training & development & implementation & certification support
ISO 13485 Consulting and Implementation Service
ISO 13485 is based on the ISO 9001 format with additional requirements relating to design, special processes, environmental control, traceability, documentation records, and regulatory actions. The primary object of ISO 13485 quality management system is to standardize medical device regulatory requirements (Health Canada, FDA, etc) for quality management systems. As a result, it includes some particular requirements for medical devices but excludes some of the requirements of ISO 9001 that are not appropriate in a regulated environment.
The primary difference between ISO 13485 and ISO 9001 is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that the organization demonstrate that the quality system is implemented and maintained. Thus many organizations maintain dual registration against both standards.
Here's how we can help you:
- We will fully customize your ISO 13485 Certification process to meet your specific needs and make sure you are ready for ISO medical device certification audit.
- Our ISO consulting and project management teams work closely with you to implement your QMS on time and on budget.
- We can recommend qualified third-party testing and certification firms that specialize in your device category.
- MSI will perform on-site ISO 13485 training for your key employees as part of the implementation project.
- We guarantee you will pass your first ISO 13485 certification audit if you follow our plan.
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.
For most companies, ISO Certification in Medical devices allows the company to focus its resources and understand its roles, rights, and authorities. It helps management organize in a consistent way that is recognized on a global scale. The advantage with being ISO 13485 registered is that it is a prerequisite for many OEM in medial and biomedical industries.
As an ISO Consulting firm, our Quality Management System Consultants are here to support your organization. Please contact us for our free evaluation and competitive quote.
More Information on ISO 13485
Why ISO 13485 revised and what are the main Improvmnets?
ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.
Health CANADA and Qulity system iso 13485
Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.
The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1, 2003.
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