The ISO 13485- Medical devices- Quality management system- for regulatory purposes is an international standard developed by a recognized international standard body- International Organization for Standardization (ISO) first in 2003 with the latest version released in 2016. It is written to specify requirements for an organization to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Ethiobiomedical has developed and made available- Medical device Quality management system (ISO 13485) mandatory documents templates- for manufacturers and related companies to adapt and use them.
Medical device manufacturing is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.
Patient safety is at the very heart of ISO 13485, with its main purpose being to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices.
Who should comply with the ISO 13485 requirements?
- Medical device manufacturers
- Medical device suppliers
- Medical device service providers
- Medical device distributors
Is meeting the requirements of the ISO 13485 alone adequate for the regulatory QMS requirements?
YES, BUT NOT EVERYWHERE! because countries may have additional requirements besides the requirements listed in the standard. Therefore, integrating the national requirements for medical device quality management system and the requirements in this ISO standard is crucial for medical device industries. To do this, Ethiobiomedical maps required documentation (including quality manual, documented procedures and associated implementation records) in each clause of the standard and the national medical device QMS requirements of interest. Finally, the national or regional requirements specific to that jurisdiction or region that are not addressed in the standard are carefully incorporated into the company’s QMS.
Templates
All the QMS documentation templates prepared by Ethiobiomedical and intended to be customized and used by medical device industries include the following-
- Quality manual (containing generic quality policy and objectives);
- The required documented procedures in the form of Standard Operating Procedures (SOPs); and
- Forms (where the evidences of implementation are recorded).
Currently, these templates are prepared by mapping and integrating the requirements of ISO 13485, US FDA’s latest QMS requirements (QSR – 21 CFR 820) and EU MDR and IVDR (requirements specific to QMS, Article 10(9)). The templates also were prepared in way that they address the medical device Good Manufacturing Practice (GMP) requirements set out by the Ethiopian Food and Drug Authority’s guidelines for GMP. This helps companies establish and implement a quality management system that complies with these requirements that will ultimately let them market their devices in these countries and regions.
The ISO 13485 requirements are anchored on five clauses (clause 4 to 8) in which they are arranged from general to specific and lastly continuous improvement of an organization’s QMS. The latest version of this ISO 13485 standard- 2016 can be found from the ISO 13485 website page here. The corresponding clauses of the standard that require each QMS documentation to be prepared and implemented are mentioned in the first column of the table.
Table1: ISO 13485 Mandatory Documents Templates
| Clause | Required documentation |
| 4.1.1 | Roles undertaken by the organization under applicable regulatory requirements |
| 4.1.6 | Procedure and records for the validation of the application of computer software |
| 4.2.2 | Quality Manual |
| 4.2.3 | Medical device file |
| 4.2.4 | Procedure for document control |
| 4.2.5 | Procedure for record control |
| 5.3 | Quality policy |
| 5.4.1 | Quality objectives |
| 5.5.1 | Responsibilities and authorities |
| 5.6.1 | Procedure and records for management review |
| 6.2 | Procedure for training |
| 6.3 | Requirements for infrastructure and maintenance activities |
| 6.4.1 | Requirements for work environment |
| 6.4.2 | Arrangements for control of contaminated or potentially contaminated product |
| 7.1 | Process for risk management in product realization |
| 7.1 | Outputs of product realization planning |
| 7.2.2 | Records of the results of the customer requirements review and actions arising from it |
| 7.2.3 | Arrangements for communication with customers |
| 7.3.1 | Procedure for design and development |
| 7.3.2 | Design and development planning |
| 7.3.4 | Design and development outputs |
| 7.3.5 | Records of design and development review |
| 7.3.6 | Design validation plans, results, and conclusions |
| 7.3.8 | Procedure for transfer of design and development outputs to manufacturing |
| 7.3.9 | Procedure and records for control of design and development changes |
| 7.3.10 | Design and development file |
| 7.4.1 | Procedure for purchasing |
| 7.4.1 | Criteria and records for evaluation and selection of suppliers |
| 7.4.3 | Record of verification of purchased product |
| 7.5.1 | Record for each medical device or batch that provides traceability |
| 7.5.2 | Requirements for cleanliness of product |
| 7.5.3 | Requirements for medical device installation and acceptance criteria for verification of installation |
| 7.5.3 | Records for medical device installation and verification of installation |
| 7.5.4 | Procedure and records for servicing of the medical device |
| 7.5.5 | Records of sterilization process |
| 7.5.6 | Procedure and records of production and service provision process validation |
| 7.5.7 | Procedure and records for validation of process for sterilization and sterile barriers systems |
| 7.5.8 | Procedure for product identification |
| 7.5.9.1 | Procedure for traceability |
| 7.5.9.2 | Records of traceability and name and address of the shipping package consignee |
| 7.5.10 | Report on changes on customer property |
| 7.5.11 | Procedure for preserving the conformity of product |
| 7.6 | Procedure for monitoring and measuring |
| 7.6 | Record of calibration |
| 7.6 | Procedure and records for validation of the application of computer software used for monitoring and measuring |
| 8.2.1 | Procedure for customer feedback |
| 8.2.2 | Procedure and records for complaint handling |
| 8.2.3 | Records of reporting to regulatory authorities |
| 8.2.4 | Procedure for internal audit |
| 8.2.4 | Records of audits and their results |
| 8.2.6 | Identity of the person authorizing release of product |
| 8.3.1 | Procedure and record of control of nonconforming product |
| 8.3.4 | Records of rework |
| 8.4 | Procedure and records for data analysis |
| 8.5.2 | Procedure and records for corrective action |
| 8.5.3 | Procedure and records for preventive action |
Ethiobiomedical has developed and made available for purchase (with affordable prices) all the templates listed above. For each required ‘record’, templates of recording “forms” are developed. All these templates were prepared by experienced experts in the field (quality assurance experts in medical device industries) and medical device QMS auditors (from regulatory authorities).
Structure of the ISO 13485 documentation
The high-level document of the standard is the Quality manual that describes the full picture of the QMS starting from defining the company’s roles and responsibilities, establishing quality policy and objectives to referencing to all required documented procedures and work instructions. At the bottom of the structure, there are records (filled forms) that are used as evidence for implementation of the set procedures. The levels of the QMS documents can be put in pyramidal structure as seen in the following figure.
Why should manufactures consider using these templates
- Massively saves time
- Saves human and financial resources that would have been required to develop all these documents.
- Templates were developed carefully by highly qualified and experienced experts of the subject matter.
- Effective and seamless establishment and implementation of the QMS.
How to purchase the templates
Directly send message to admin@ethiobiomedical.com by listing the names of the templates you want to purchase. Then, the reply email will be sent back to your email with the quotation for the requested templates.
