ISO 13485

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WHAT IS ISO 13485?

ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485 contains requirements essential for organizations operating at any tier in the medical devices and pharmaceutical supply chain. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and as a result, it includes some particular requirements for manufacture, installation, and servicing such as added requirements on record-control, sterilization, and risk management. Organizations can register to ISO 13485 as a standalone or in conjunction with an ISO 9001 or other registration. An ISO 13485 certification from us demonstrates your organization's commitment to providing products and related services that consistently meet customer and regulatory requirements applicable to the medical industry.

Key Benefits  Implementing ISO 13485 Really Helps Your Company In The Following Way.

  • Provides a robust framework for assuring product consistency
  • Creates a competitive advantage
  • Engages top management involvement
  • Ensures a consistent and effective approach to business
  • Reduces risk factors via the use of risk management
  • ISO 13485 regulatory requirements for manufacturers of medical devices co an International scale.
  • A number of countries have Incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used In support of regulatory compliance.
  • It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.

The Certification Process

Online gap analysis allows us to see the current

  • quality benchmark within your organization,
  • the finances required
  • the time required for this project (System and Certification Fee)

Your Estimate will be shared with you in 24 hours.

Upon Estimate Approval the project starts:

  • A client executive is assigned to your project
  • Contact information is shared with you
  • The Payment details are provided to you

All Support is delivered Online.

The Client Executive will provide the Documentation Templates and explain to you how to amend it.
You will be required to perform the following tasks:

  1. Identify your core or business processes.
  2. Amend documentation that meets your business needs. (Policy statements, objectives, manuals, work instructions, job descriptions, forms.)
  3. Encourage employees to be aware of the new documented system
  4. Review, approve, and distribute the documents to those who need access to the information.

  • Ensure procedures are being performed as documented.
  • Ensure employees are trained properly for the tasks they are performing.
  • Create effective reporting systems.
  • Monitor the effectiveness of your processes through the use of measurable data, where possible.
  • Review and take action to improve in the areas required.
  • Plan internal auditing activities.
  • Submit your management system documentation for review to ensure it complies with the applicable standard.
  • Prepare for review by an external auditor to confirm that the system’s requirements are being satisfied and that the management system is implemented effectively.
  • Obtain ISO Certifcaiton
  • This periodic on-site review is usually conducted annually.
  • It ensures that the certified business continues to comply with Standard requirements, as confirmed during the Recertification Audit at the certification cycle's outset.
  • Most are conducted remotely.

Refer to learn more about Types of Audits

FAQ's

How long does it take to get ISO Certified?

Starting with your initial consultation with our ISO specialists and progressing through certification, the timeline can be as short as 15 days. However, the duration is contingent upon the size and complexity of your business. It's worth noting that we can often expedite the process and reduce costs by preparing the Documented Management System Manual on your behalf, which can also accelerate the certification for your business.

What is the duration of the certification?

Following ISO 17021 guidelines, accredited certification bodies must provide certified organizations with certificates covering a 3-year certification cycle. Extensions beyond this timeframe are possible with the completion of necessary external audits and adherence to the certification cycle. ISO Certification, for instance, commonly issues certificates throughout a ten-year contract period.

What is the cost associated with obtaining ISO certification?

At Company Certification, our dedication is to ensure that ISO certification remains cost-effective for all our clients. The expenses involved depend on various factors including your industry sector, annual turnover, number of employees, and other considerations. Feel free to utilize our complimentary calculator to receive an instant quote.

Is it possible for an individual to obtain ISO certification?

ISO certification is reserved for organizational entities, and not for individual professionals.

What does the term 'Internal Audit' mean?

An internal audit is a systematic and scheduled examination of the processes and procedures outlined in your management system. It serves as a vital component of ISO Standards compliance, ensuring that established processes are adhered to and validating the effectiveness of the implemented procedures.

What advantages does an Internal Audit offer?

The advantages of conducting an internal audit include:

  • Ensuring the achievement of goals and objectives.
  • Enhancing communication and understanding within the organization.
  • Offering individuals a platform to report concerns.
  • Serving as an effective training tool.
  • Verifying the maintenance of planned arrangements, such as product quality.
  • Providing valuable feedback to supervisors.
What is the process for establishing an internal audit timetable?

To formulate an internal audit schedule, you must determine the scope and timing of the audits. This information is documented in the internal audit schedule, a crucial document for consultants to review. For intricate processes, it may be necessary to conduct audits in distinct segments. Additionally, if particular areas have a history of recurring issues, more frequent and detailed checks may be required. When constructing the schedule, it's essential to consider past non-conformities.

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