ISO 13485 certification in Afghanistan is an industry specific standard which has been published by international organization for standardization in order to increase the process efficiency on increasing the quality of the product being manufactured. This is a standard which has been derived from the quality management system. The difference between the quality management system and quality management system for medical devices that this standard focuses more on process in manufacturing area. This standard will be applicable for manufacturers, importers, distributors and supply chain. This standard has been frequently implemented across Medical and Pharmaceutical manufacturing industries and which is one of the critically sectors compared to other industrial sector. ISO 13485 Certification in Afghanistan specifies the requirement of Management commitment involvement in order to drive the seriousness within the company in order to adopt the management system without which the results are not guaranteed and its waste of time in implementing the standard requirement. To initially start with it is always advised to conduct a gap analysis based on standard requirement, company requirement, customer requirement and legal requirement which will make you understand the gaps between the four areas. Conducting the stringent and strong gap analysis will lead to identification of hidden loopholes within the system which will impact on the quality of product being manufactured. ISO 13485 Certification in Afghanistan specifies the requirement to have a gap analysis report based on the analysis conducted with which you can plan how to start the required documentation and evidence to fulfill the standard requirement.
ISO 13485 registration services in Kandahar specify the mandatory requirement on framing the quality policy on medical manufacturing process involving all the needs and Expectations of interested parties and standard requirement which has to be approved by the top management. Post approval the policy has to be circulated internally and externally. Department objective has to be framed based on the policy is framed which is one of the next mandatory area in order to achieve the effective results. During the audit it is necessary that you the demonstrate the evidence for the objectives but in order to need a standard requirement failing to which will result in cancellation of your certification. ISO 13485 registration in Afghanistan specifies their requirement appointment of leader which has replaced the term management representative in the previous version of the standard. Quality manual is no longer a mandatory requirement from a standard but all your process and work instructions at to be documented within the standard operating procedure. Based on the Standard operating procedures you should demonstrate the evidence required for the same. The term documents and record has been clubbed which is now known as document information to avoid the confusion which used to happen during the previous version of the standard.
The Consultants of ISO 13485 certification in Afghanistan should be the right person having the knowledge on the Standard requirement and was the experience on the previous implementing techniques should be helpful to help you as am working hand to adopt a management system helping you to save time and cost. Standard specifies to provide the required resource in order to implement the management system. Providing training to the resource on the Standard requirement would be very essential in order to setup the successful system in place. The standard specifies to conduct frequent internal audit and management review meeting which act as a tool in measuring the improvement. The Consultants of ISO 13485 Certification in Afghanistan should help you to provide the competency on how to conduct the audit and how to write the audit report. It should be made sure that the consultant provides the certification after completion of training which will act as an evidence for you to demonstrate during the external audit. Bengal conducting the internal audit the leader should plan on when to conduct the internal audit by fixing the audit calendar which act as an evidence to demonstrate the system. Post finalizing the audit calendar you should finalize on the audit schedule which is nothing but who is auditing on which department. Cross department audit is always suggested in order to achieve a successful results. On completion of the internal audit all the observations should be discussed in front of everyone as this is a practice done in order to achieve the improvement. All the observations should be noted down in the audit report on which the corrective action has to be taken place. ISO 13485 audit services in Afghanistan from a third party certification body which has an accredited accreditation body will add weight age to your management system and desertification. During the audit the leader should demonstrate the evidence to the auditor on the set up management system.
What are the advantages from the standard?
- ISO 13485 Certification in Afghanistan will help you to identify all the risk involved with in the process. Identify all the risk it will help you to mitigate them in order to safeguard the business in future.
- ISO 13485 consultants in Kabul will help the company to adopt the international standards from the best practices which are being implemented across all the successful companies.
- ISO 13485 Consulting Services in Kandahar increase the confidence in both customer and employees eliminating the problems of employee retention and increasing the profit margin by hitting business from the existing customers only.
- ISO 13485 Consulting in Afghanistan will act as an inbound marketing in attracting customers towards your product being manufactured which helps in reducing me marketing expenses and increasing the profit margin.
Now Let us know, what is the definition of the medical devices, it is one of the devices, instrument, apparatus, machine, implant or others similar article that are used for the diagnosis, prevention and treatment of the diseases or other medical conditions:
And there are different varieties of medical devices starting from Complex computer control Machines to hard tools which include:
- Simple devices like wound dressings, scalpels.
- Durable devices like wheelchair, dentist chair, hospitalized bed.
- Implantable devices like cardiac pacemakers, monitors, prosthetic joint, prosthetic limbs.
- Life supporting devices like ventilators for respiratory and lungs.
- Sophisticated, Software control devices such as MRI machines and CT scanners etc.
so for all of these devices it should have met with ISO 13485 certification in Afghanistan because of these requirements of the standard when it is applied to these devices it will be more qualitative and will be more effective when they are used.
How to get certified for ISO 13485 certification in Afghanistan?
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