The most deemed standard for medical devices is ISO 13485.
ISO 13485 Standard is flexible for both small and big organizations dealing with manufacturing, designing, and packaging of medical devices.
The accomplishment of ISO 13485 Certification clearly exhibits that the company works consistently to meet all the requirements of the customers and sustainably proffer quality.
All the medical devices like an instrument, apparatus, equipment, implant used to prevent, diagnose or treat a medical condition can certify themselves with ISO 13485 Standard.
Some major advantages of getting certified with ISO 13485 Standard-
Companies that hold ISO 13485 certification enjoy some benefits like:
Complies with the legal requirements and medical devices regulatory norms
Mitigates the chances of uncertainty
Risks based approach that helps in anticipating risks and eliminating them
Reduction in costs
Proffering quality products
Manufacturing the devices and equipment according to international standard
Opportunity to accessible enter international market
Competitive edge among in the market
Boost in productivity and profitability
ISO 13485 Standard and risk management
ISO 13485 Standard greatly focuses on following an approach based on risk anticipation and management.
A risk-based approach will help the certified company to focus on manufacturing or offering safety, quality, compliance and product efficacy.
ISO Certification can help to improve the organization’s performance to achieve notable goals and objectives.
ISO Certifying body in Morocco
SIS Certification proffers ISO Certification in Morocco.
Here is a brief explanation of some of ISO Standards-
ISO 9001 Certification :
ISO 9001 Certification is the global standard accommodating organizations with QMS (quality management system).
ISO 14001 Certification:
ISO 14001 Certification acknowledges the need to implement some measures for minimizing the impact on the environment.
ISO 14001 Certification directs the organizations to build up strategies and techniques, which will prompt a superior and efficient Environmental exhibition.
The standard works on three principles namely, integrity, confidentiality, and availability of information.