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ISO 13485 - 2016
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What is ISO 13485 Certification

ISO 13485 deals with the medical organization’s optimal device standard to ensure that all medical devices meet proper regulatory compliance laws and customer requirements. The 13485 certification issued by ISO ensures credibility and makes the customers and professional workers safe in clinics and other medical environments.

ISO 13485:2016 has been based on the ISO 9001 process model perspective is a management systems standard specifically created for the manufacture of medical devices. Its main objective is to facilitate harmonized medical device’s regulatory needs. This standard allows organizations to lower safety and legal risks while creating more economical work environments. Once in 5 years, it is reviewed and revised, to make sure it aligns with industry needs.
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Benefits of ISO 13485 Certificate

Safety and quality are non-compromisable in the field of the medical device industry. That’s why the International Standard Organization created ISO 13485. The work required will depend on your products/services and non-applicable causes specific to your QMS.
Some of its key features are

 

  • It provides defining terms.
  • It does not replicate the ISO 9001:2015 changes.
  • It mandates more inputs for the analysis of data.
  • It strengthens controls of non-conforming products.
  • Clarifies and strengthens the validation requirements.
  • It requires more input to the risk management processes.
  • It includes newer sub-clauses and new additional clauses.
  • It helps in managing contamination and in preserving a product.
  • There is higher importance given to Complaints and their management.
  • There is a vast difference in the format and clauses, and how it gets documented.
  • It necessitates the need for a system based on risk management, which will manage the process.
  • There is a lot of significance in ensuring proper regulations and regulatory requirements in place, which get compiled throughout the deployment of QMS and its associated services.
  • There is an impact on the design and development aspect. Any minor improvement which raises concerns on traceability needs to be analyzed. There could also be a requirement to transfer design, design files, and more emphasis on design change and its considerations.
  • There is higher control given to providers who are external to the organization. It is especially true when they increase product risk when more records are needed when it needs increased action required on verification, and when the supplier of the equipment does not comply with the requirements.
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How to Register for ISO 13485 Certification

A certificate to the ISO 13485 norm can upgrade an organization’s believability by showing clients that its products and services meet conventions. On certain occasions, or in some enterprises, accreditation is required or legitimately ordered. The confirmation process incorporates executing the necessities of ISO 13485:2016 and afterward finishing a fruitful recorder’s review affirming the organization meets those prerequisites.

The ISO accreditation measures contain a couple of principle steps, like applying, the survey of reports, and the definite inspecting methodology. The steps or the phases that are a part of completing the ISO certification issuance process are

Applying

The application can be submitted either in hard copy via post or soft copy via email. It should contain all the basic information about the organization.

Applying

The application can be submitted either in hard copy via post or soft copy via email. It should contain all the basic information about the organization.
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Review of Documents

The inspector audits the reports based on the quality control practices and strategies implemented in the organization.

Review of Documents

The inspector audits the reports based on the quality control practices and strategies implemented in the organization.
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Pre-evaluation

At this phase, the auditor determines if there are any flaws in the existing quality control measures which is already in place in the organization.

Pre-evaluation

At this phase, the auditor determines if there are any flaws in the existing quality control measures which is already in place in the organization.
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Action Plan

Once the auditor completes the initial survey, the issues in the organization's existing quality control guidelines are audited.

Action Plan

Once the auditor completes the initial survey, the issues in the organization's existing quality control guidelines are audited.
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First Audit

Includes an exhaustive assessment by auditor on the existing and improved quality controls, covering the detections of non-conformances.

First Audit

Includes an exhaustive assessment by auditor on the existing and improved quality controls, covering the detections of non-conformances.
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Final Audit

By the last stage of review, the applicant would have handled most of the significant non-conformities.

Final Audit

By the last stage of review, the applicant would have handled most of the significant non-conformities.
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DOCUMENTATION

Documents Required For ISO 13485 Certification

Legal Documents

1. Incorporation Letter
2. GST Registration
3. MSME Registration

Profile

Company Profile with Scope of work of Organization

Invoice

1. Two Sell Invoices
2. Two Purchase Invoices

Other Documents

1. Letter Head
2. Visiting Card

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How We Help

At Parikalan, we have a team of experts who help companies register themselves to the ISO 13485:2016, and other ISO certifications, in India. We provide support in various stages in the process of registration and accreditations. With us, you will also have at your disposal the knowledge and expertise to gain the certification. We also help you design and execute measures to improve the quality of your product. We help you set up proper quality control and monitoring checks. We also help you grow your business with the help of this certification. Our team will make you understand the whole process of the certification. This way, you can run your business with customer satisfaction and assure your customers about the new, modern, and advanced devices available for them with you.

With the rapid rise in the importance and emphasis on safety protocols and safety of people, there has been a pressing need for an organization to have ISO 13485:2016 certification. It offers some measure of guarantee to the clients and to the patients of the clients. These are important factors which hospitals and clinics would look for when they are looking to purchase equipment. With medical sciences progressing at a very fast pace, if you are in the industry of manufacturing medical equipment, it is now more essential than ever to get this certification; you would not only be setting yourself on the same playing field as bigger competitors, you would also be ensuring your clients good quality and safety.

Our 13485:2016 Service Package

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Micro Business (1-10 Employees)

$ Price
  • ISO 9001 Certification: support for documentation and process implementation suitable for small businesses.
  • ISO 9001 Certification: External audit by an accredited certification body to assess compliance with ISO 9001:2015 standards.
  • Duration: 3 years
Get Certification
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Small Business (11-50 Employees)

$ Price
  • Assistance with documentation, process mapping, and implementation. Includes training sessions and guidance tailored to your organization's needs
  • ISO 9001 Certification: External audit by an accredited certification body to assess compliance with ISO 9001:2015 standards..
  • Duration: 3 years
Get Certification
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Medium Business (51-250 Employees)

$ Price
  • ISO 9001 Certification: Assistance in developing a quality management system aligned with ISO 9001:2015 requirements.
  • ISO 9001 Certification: External audit by an accredited certification body to evaluate compliance with ISO 9001:2015 standards.
  • Duration: 3 years
Get Certification
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FAQ's

ISO 13485 is meant to use by companies concern with the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as Certification Bodies (CBs), to help them with their auditing process.

It got published on 1st March 2016.
ISO 13485 is an Internationally known standard set for requirements issued by the International Organization for Standardization (ISO) to make a Quality Management System for those in the medical device industry.
The quality management system and its requirements are defined by this ISO. It helps the company to understand what is required and how they can produce medical devices and other equipment considering the safety of all its stakeholders.
ISO 13485 is the primary Quality Management System (QMS) standard for medical devices, even though several countries have their own set of regulations. It is not standard for products.

QMS must additionally be maintained and managed following applicable regulatory needs
Manage processes by IAW regulatory requirements.
There should be a written audit on the control of quality agreements.
There is also an additional need to have all the roles in the organization in a document.
Analyze the impact on Medical Devices and QMS before making any change to the QMS process.
It requires applying a “risk-based approach to the control of appropriate processes needed for the QMS.
Added requirements associated with validation of the appliance of computer software utilized in the QMS.
It considers the role of the people in the organization, and it determines their responsibility and accountability.
Execute control over outsourced processes, based on the risk involved and the ability of the external provider, to meet requirements.

Usually, it takes 4 to 6 months for organizations with fewer than 50 employees to get the certification.

A company must plan a framework from start to execution. It includes creating a method for documenting how thoughts are executed, concepts are checked, and products are created and developed. It also verifies and validates to satisfy the needs for ISO 13485 certification. For the design and development of the device, communication is important.Observing each part of the process involves all the requirements fulfilling the needs specific to the medical devices.

After the manufacturing of your product, it will be released for common use by the customers, you have a responsibility to make sure that customers get what they want.
Clause 8 is defined for the development of a procedure for effectually monitoring and measuring product success must include:

Cleanliness of product
Any mishandling complaints
Design and development (D&D) planning
Practicing internal assessment through auditing
Inspecting products that don’t meet the required design
The process should enhance continually by analyzing data created