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ISO 13485 is that the International standard for Quality Management System For Medical Devices. ISO 13485 Certification in Ethiopia may be a Quality Management System for the medical device industry where a corporation must demonstrate its ability to manufacture, procure, store and sell medical devices and related services that consistently meet customer and relevant regulatory requirements.
Organizations can have multiple stages of lifecycle, incorporating design and development, production, storage and distribution, installation, or servicing of a medical device and other associated activities (e.g. technical support).
In simple words, ISO 13485 standard may be a combination of ISO 9001 requirements with a further set of medical device requirements. ISO 13485 is that the International standard for Quality Management Systems (QMS). It provides your company with a group of principles that ensure a standard sense approach to the management of your business activities to consistently achieve customer satisfaction while standardizing your processes and continually improving effectiveness of the business processes.
By getting ISO 13485 Certified there’s the potential for increased business in both current and new markets. additionally , there’s an overall improvement within the service/product quality being offered to the client. Having a certification in situ will provide a definite advantage over other competitors and helps your ability in client acquisitions.
Expert Certifier are a corporation known for offering professional consulting services altogether global locations. In Ethiopia we provide our services altogether major locations like Addis Ababa , Dire Dawa, Bahir Dar, Gondar etc.
ISO 13485 certification in Ethiopia may be a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. This differs from ISO 9001:2000 which focuses on customer satisfaction and continual improvement.
ISO 13485 standard provides how to scale back variation. Reducing variation can provide financial benefits for the corporate , like reduced scrap and general process efficiencies.
ISO 13485 in Ethiopia purchasing requirements cover purchasing from qualified suppliers, consistent with pre-established specifications, and assuring that purchased product meets those specifications.
ISO 13485:2016 standard is applicable to organizations no matter their size and their type. Requirements that are specified as applicable to medical devices shall even be applicable equally to associated services.
Therefore, the quality isn’t only applicable to medical device manufacturers but also to supporting firms like subcontractors, stockists, suppliers and European Authorized Representatives.
CHANGES BETWEEN ISO 13485:2003 & ISO 13485:2016
Now ISO 13485:2016 certification standard has taken many changes. Few important changes are as follows-
- Flexible – New standard ISO 13485:2016 is more flexible because it allows you to form exclusions in section 6, 7 & 8 if it are often justified while in old standard ISO 13485:2013 exclusion was permitted only in section 7. during this way new standard ISO 13485:2016 is more flexible.
- Regulations – In previous standard ISO 13485:2013 a QMS had to accepted carried demand of the quality & product, while in remake ISO 13485:2006 emphasis has been given on meeting regulatory requirements. Now QMS has got to be established encompassing applicable regulatory requirements.
- Risk Based Approach – In Previous version risk examination approach was related to ‘product realization’ only, while in remake ISO 13485:2016 risk based approach is applicable to all or any processes of QMS
- Enhanced Record Keeping – New standard ISO 13485:2016 expects you to keeps record of supplier monitoring, evaluation & re-evaluation. Now privacy has got to be maintained in maintaining confidential health information.
- Product Realization – New standard ISO 13485:2016 says to determine procedures for storage, handling of products, traceability, measurement & revalidation additionally to requirements of old standard ISO 13485 which required procedure for verification, validation, monitoring, inspection & testing.
- Training of Users – The new standard ISO 13485:2016 says to teach / train the user about product safety & regulatory norms.
BENEFITS OF ISO 13485 CERTIFICATION :
- Credibility – Increase access to greater market worldwide with the certification
- Process Approach – Increase efficiency, cut costs and monitor supply chain effectiveness
- Quality Compliance – Demonstrate that you simply produce safer and simpler medical devices
- Customer Satisfaction – Meet regulatory requirements and customer expectations
- Employee Engagement – Better people involvement to spot best solutions for improving processes
- Business Excellence – Shorter lead times and better services through quality and process improvement initiatives
- Provides management with an outlined & efficient management process
- Responsibility across the organization to realize the target
- One of the standards of a young to qualify for a few public sector work
- Positive atmosphere & builds trust in internal staff & customers
- Identifies areas to enhance & reduce iterations
- Metrics to scale back resources (Men, Money, Machine, Material & Method)
- Provides continuous assessment and improvement
- Marketing opportunities
- Improved customer retention and acquisition
- Globally recognized standard inviting for international opportunities
Requirements of ISO 13485 Certification in Ethiopia:
- General Requirements – This includes required documents like Quality Manual, documented procedures and records
- Management Responsibilities – Resource identification for MR and planning of QMS (Resource Management)
- Product Realization – Major concepts of designing and creation of the merchandise like Design Controls, Risk Management, Document Control and Records Management & Supplier Management are going to be addressed as a part of requirements
- Culture of Evaluation & Continual Improvement – These requirements include customer satisfaction, internal audits, handling non-conformities and corrective actions
- These concepts are supported Plan-Do-Check-Act cycle, which use the above-mentioned elements to implement, drive and maintain improvements within the processes.
Audit and Certification
Immediately as your processes are recognized, recorded and implemented, and therefore the effectiveness of your quality management system has been reviewed in internal audits and the results analysed during a management review, you’re ready for certification. We customize our getting to you, and that we coordinate with you supported your individual circumstances, corporate objectives and success factors. Then your organization will undergo the classic Expert Certifier certification process: we’ll assign auditors with excellent knowledge of the standards, also as a few years of experience within the respective business.
Our masters have more than 15 plus years of global experience, with hands-on experience in the field of ISO certification, assessment and training.
With Expert Certifier your Business and process excellence is guaranteed.
Reach us at: contact@ExpertCertifier .com