ISO 13485 certification in Baghdad

ISO 13485: Quality Management System for Medical Devices in Baghdad with PopularCert

Overview of ISO 13485 Certification

Offering ISO 13485 certification services in Baghdad, Iraq, PopularCert is a top ISO certification consulting company. ISO 13485:2016 is an international standard defining criteria for a quality management system (QMS) particular to the medical device sector. Organisations engaged in any phase of the life cycle of a medical device—design, development, manufacture, storage, distribution, installation, service, and associated activities—must be certified in this regard.

ISO 13485:2016 outlines the criteria for a QMS whereby a company must show that it can regularly supply medical devices and related services that satisfy customer and relevant legal criteria. It is relevant to companies of all kinds and sizes as well as suppliers and outside partners offering goods or QMS-related services.

Types Of ISO Certification In Baghdad

Get Free Consultation

    Essential elements of ISO 13485:2016


    Any company engaged in one or more medical device life cycle stages will find ISO 13485:2016 relevant. Suppliers or other parties that offer goods or QMS-related services to such companies can also be involved. Except as specifically indicated, the criteria of the standard are meant to be flexible and adaptable to companies of all kinds and sizes.

    Why Organisation should obtain ISO 13485 Certification?

    Medical device companies who want to guarantee their goods satisfy the highest quality and regulatory criteria must first be ISO 13485 certified. It shows the dedication of the company towards consumer happiness, safety, and excellence.

    Main Advantages of ISO 13485 Certificate : 

    ISO 13485:2016: Principles

    Three basic concepts drive ISO 13485:2016 to guarantee medical device quality and safety:
    Quality Management

    Guarantees a strong QMS for the company to keep and raise product quality. 

    Regulatory Compliance
    Ensures that the company follows pertinent medical device regulatory guidelines for Regulatory Compliance.
    Customer Satisfaction
    Emphasises on fulfilling consumer needs and raising customer happiness.

    Why We Need an Effective QMS for Medical Devices?

    Adopting a strong QMS grounded on ISO 13485:2016 has numerous important commercial advantages :

    Steps to Get ISO 13485 Certified in Baghdad

    PopularCert guides companies through each stage of the process and presents a complete method for attaining ISO 13485 certification.


    Step 1: Assessment
    Doing a first review to grasp the present policies and find deviations from ISO 13485 criteria.
    Step 2: Planning


    Creating a comprehensive implementation strategy catered to the demands of the company including goals, targets, and deadlines.
    Step 3: Documentation
    Producing and organising required documents to satisfy ISO 13485 criteria including records, processes, and quality guides.


    Step 4: Implementation
    Helping to support the everyday operations by including recorded procedures into them.


    Step 5: Training
    Training programmes to inform staff members on ISO 13485 criteria and their responsibilities in preserving the QMS should come in second.


    Step 6: Internal Audit
    Internal audits help to assess QMS performance and point up areas needing work.


    Step 7: Management Review
    Encouraging management reviews helps to evaluate the success of the QMS and implement required changes.


    Step 8 : Audit of certifications
    Getting ready for the outside certification audit carried out by a qualified certifying authority. We help you through the procedure to guarantee effective certification.


    PopularCert's Method, Cost, and Scheduling

    Our Method of Approach
    Popular Cert’s strategy is tailored to fit the particular requirements of every company. Our main focus is on providing useful ideas to improve your QMS and guarantee ISO 13485 compliance.
    The size and complexity of the company as well as the certification scope affect the cost of ISO 13485 certification. PopularCert offers a thorough cost breakdown at the first consultation and competitive rates.
    The degree of preparation of the company and the complexity of its procedures will determine the chronology for reaching ISO 13485 certification. Usually, the certification procedure takes three to twelve months. PopularCert guarantees timely completion of every phase and develops a reasonable schedule working with your company.

    Advantage of ISO 13485 Certification in Baghdad

    Why Choose PopularCert as your consultant?

    Perfect partner for ISO 13485 certification in Baghdad is PopularCert. Here is the reason companies pick us:


    Our experts are well knowledgeable about ISO 13485 guidelines and their implementation at several phases of the medical device life.

    Customized solutions

    We provide customised solutions to fit the particular requirements of every company, therefore guaranteeing a unique approach to ISO 13485 certification.

    End-to- end assistance

    From first evaluation to final certification, PopularCert addresses all facets of the certification process, therefore offering end-to- end assistance.

    Proven Success

    We have a history of successful certifications across numerous sectors, showcasing our ability to produce results and assist clients reach their ISO 13485 certification goals.


    For companies engaged in the medical device sector, ISO 13485 certification outlines the criteria for a quality management system (QMS). It guarantees that connected services and medical equipment regularly satisfy consumer needs as well as legal ones.
    The size and complexity of the company as well as current procedures will affect the time needed to get ISO 13485 certification. Between three to twelve months separate the first evaluation from the last certification audit on average.
    Several elements affect the cost of ISO 13485 certification: organisational size, certification scope, and certifying body of choice. PopularCert gives a thorough cost breakdown at the first consultation and cheap prices.
    Three fundamental ideas—quality management, regulatory compliance, and customer satisfaction—that ISO 13485:2016 emphasises help to guarantee the quality and safety of medical devices.
    Usually, ISO 13485 certifications have to be renewed every three years. Organisations must, nevertheless, go through yearly surveillance audits to guarantee ongoing compliance with the ISO 13485 criteria. PopularCert offers continuous assistance to enable companies keep their certification.
    Selecting PopularCert for ISO 13485 certification in Baghdad can help your company to become outstanding in market competitiveness, regulatory compliance, and quality control. Get in touch now to start your path to ISO 13485 certification.

    Get Certified Today!

    Get Certified with Confidence: Connect with PopularCert Today
    Please use the form to reach out for any inquiries, questions, or service requests.
    Our team is ready to promptly assist you.

    Get Free Consultation