ISO 13485 Certification Oman
ISO 13485 consists requirements that are important for any organization which operates at any tier within the medical device and pharmaceutical supply chain. it
What is ISO 13485?
ISO 13485 may be a specific certification standard for medical device industry. ISO 13485 certification oman fulfils your needs associated with production control, quality management, regulatory compliances & specific needs associated with production of a specific medical device. ISO 13485 is essentially a QMS for medical device industry that’s why it’s also referred to as ‘MD QMS’. ISO 13485 certificate ensures potential customers & stakeholders with the very fact that a tool has been manufactured following internationally recognised ISO 13485 standard. ISO 13485 audit by Expert Certifier ensures that an organisation meets all guideline of ISO 13485:2016 & this is often the rationale why Expert Certifier is an industry trusted ISO 13485 certification company. Our ISO 13485 certification process is result oriented & customer satisfaction. We are a foremost ISO 13485 certification body of India. All requirements of ISO 13485 are specific to organizations providing medical devices, no matter the sort or size of the organization
ISO 13485 is that the International standard for Quality Management Systems (QMS). It provides your company with a set of principles that informs a standard sense approach to the management of your business activities to consistently achieve customer satisfaction while the business processes standardizing your processes and continually improving the effectiveness
By getting ISO 13485 Certified your organization will be globally recognized with 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 site will provide a definite advantage over other competitors and helps your ability in client acquisitions.
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To Whom is ISO 13485 applicable in Oman?
ISO 13485 consists requirements that are important for any organization which operates at any tier within the medical device and pharmaceutical supply chain. it’s especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
ISO 13485 Certification Process in Oman
1. Apply for ISO 13485:2016 certificate by filling an application form for ISO 13485 form (Soft copy or hard copy).
2. form will be reviewed by our ISO 13485 Lead auditor / Technical expert & Once accepted a quotation for ISO 13485 certification are will be issued.
3. Once the ISO 13485 certification Charges is received, we’ll send you ISO 13485 audit plan (stage-1) & subsequently audit are going to be conducted.
4. After successfully Completing stage-1 audit closure of Non-Confirmatives (if any), Expert Certifier will send you stage -2 ISO 13485 audit plan. After a successfully Completing audit,the Lead auditor will recommend your organization for ISO 13485 certification.
5. supported auditor’s recommendation & audit findings Expert Certifier’s certification authority will Now ISO 13485:2016 certification standard has accompany many changes. Few important changes are as follows-
Changes Between ISO 13485:2003 & ISO 13485:2016
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 only in section 7.exclusion was permissible during this way new standard ISO 13485:2016 is more flexible.
Regulations – In old version, ISO 13485:2013 a QMS had to established supported requirements of the quality & product, while in the new version ISO 13485:2016 emphasis has been given on meeting regulatory requirements. Now QMS has got to be established encompassing applicable regulatory requirements.
Risk Based Approach – In old version, risk analysis approach was applicable only in ‘product realization’, while in the new ISO 13485:2016 risk-based approach is applicable to all or any processes of QMS
Enhanced Record Keeping – New version ISO 13485:2016 expects you to keeps a record of supplier monitoring, evaluation & re-evaluation. Now privacy has got to be maintained in maintaining confidential health information.
Product Realization – New version ISO 13485:2016 informs to decides additionally to requirements the procedures for storage, handling of products, traceability, measurement & revalidation. In old version ISO 13485 which required procedure for verification, validation, monitoring, inspection & testing
Training of Users – The new version of standard ISO 13485:2016 says to teach / train the user about product safety & regulatory norms.take a decision for granting of ISO 13485 certificate
Benefits of ISO 13485 certification in oman:
1. ISO 13485 ensures improvement in performance or products & processes of a medical device company.
2. ISO 13485 certificate is globally recognized & it includes regulatory & statutory norms of most of nations , your product gets market access.
3. ISO 13485 works as a representative of your medical device hence your sales will increase
4. ISO 13485 certification gives faith to your customers that device is safe to be used & it meets requirements of most of recognized technical standards associated with medical device
Why Expert Certifier?
We are here to supply a full-length auditing service to realize your ISO 13485 certification in Oman. Expert Certifier is a world widely recognized ISO certification body which provides ISO certification and Lead Auditor Training in various ISO standards. Our global presence helps to realize the clients the advantage of getting international expertise also because the real depth of local knowledge. we will assist you and your organization understand each phase of the assessment and certification process to form sure you’ve got in-depth knowledge in ISO 13485 process and regulations. We also are providing training courses which permit you to accumulate an honest knowledge of the complexities of complying with the quality , also because the rules and regulations the quality helps to discourse.
How to get ISO 13485 certification in Oman– Consultants in Oman?
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.Consultant ExpertCertifier Oman.
Reach us at: contact@ExpertCertifier .com