WHAT IS ISO 13485? WHY SHOULD YOU IMPLEMENT IT?

What is a Medical Device? 

A medical device is a product i.e. instrument, machine, implant, or in vitro reagent that is intended for use in the diagnosis, prevention and treatment of diseases, rehabilitation of illness and disease, or other medical conditions.

What is ISO 13485?

ISO 13485 is an effective standard that helps businesses meet the comprehensive quality management requirements of medical devices. The standard provides a strategic framework and practical foundation to adhere to medical device directives, regulations, protocols and responsibilities. The standard essentially enables you to fulfil your commitment to the safety and quality of medical devices. 

ISO 13485 is an individual QMS (Quality Management System) standard derived from the internationally established and recognized ISO 9000 Quality Management Standard series. The standard is designed for the QMS of medical devices with the primary quality levels of the ISO 9000 series. Therefore, it is a complete system that guides businesses in medical device manufacturing and management to adhere to the standard safety and quality protocols in the medical industry. 

How Can ISO 13485 Help you?

ISO 13485 provides a fool proof quality check throughout the process for the excellent quality of medical devices. The standard ensures that the devices are functioning properly and serving as per their intended purposes with utmost safety. The standard will ensure 

• Consistent design
• Competent development 
• Streamlined production 
• Accurate installation 
• Safe delivery and distribution 

Who Should Implement ISO 13485 Standard?

ISO 13485 is primarily created for designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can implement the standard and gain a competitive advantage by enhancing the organization’s marketability and recognition. 

• The Standard is Applicable to
• Manufacturing of medical devices (MD) or in vitro diagnostic products (IVD)
• Manufacturing of reagents or substances for use in IVD or MD(for Pharma and diagnostic purpose
• Medical device Traders  

How can you Implement ISO 13485?

Similar to many ISO standards, the ISO 13485 also follows the PDCA framework. After considering the customer requirements and industry standards, you can identify quality objectives and then prepare the quality manual and policy. It will define the scope and give you a direction along with the framework for implementation. The standard ensures that the organization is capable of consistently achieving and maintaining the quality requirements and complies with the internationally recognized quality standards. 

What are the Requirements of ISO 13485? 

The ISO 13485 standard contains specific requirements for manufacture, installation and servicing of medical device, which strongly focuses on the compliance of EU Directives for MD or IVD such as

Documentation requirements

ISO 13485 quality management system – readymade documents is reducing your risk and saving you time and money. Suppliers that comply with your quality and ISO 13485 documents requirements reduce the need for more costly and regulatory inspections. Other helps to reduce your risk are providers who advise you of changes, support your warranty requirements, and take corrective and preventive measures when necessary.

ISO 13485 documentation kit by Global Manager Group consists of the following documents in editable .doc format.

• ISO 13485 Manual
• ISO 13485 Procedures
• Exhibits
• Sample Formats / Templates
• Quality SOP 
• Filled forms
• ISO 13485 Audit Checklist
• Medical Device File

What are the Benefits of ISO 13485 Implementation?

• The ISO 13485 emphasizes risk management, risk-based decision making and changes related to the increased regulatory requirements for organizations in the supply chain. 
• Increase access to more markets worldwide with certification
• Enhance credibility and recognition of your organization 
• Improve decision-making processes 
• Consistently improve your quality and performance 
• Outline how to review and improve processes across your organization
• Increase efficiency, cut costs and monitor supply chain performance
• Demonstrate that you produce safer and more effective medical devices
• Meet regulatory requirements and customer expectations.

Overview on ISO 13485 Manual

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements for medical devices and related services.

About ISO 13485 Manual

ISO 13485 Manual describes the company’s quality management system and defines the authorities and responsibilities of the scene of staff within the system. The manual also provides procedures or references for all activities including the QMS to describe the corporate compliance with the standard.

ISO 13485 Manual is used internally to guide employees of the company through the requirements of ISO standards that must be met and maintained to ensure customer satisfaction, continuous improvement, and create an empowered workforce

ISO 13485 Manual is used outdoors to introduce QMS to customers and other external organizations or individuals. The manual familiarizes them with the controls that have been implemented, and assures them that the integrity of the QMS is maintained and focuses on customer satisfaction and continuous improvement.

Purpose of ISO 13485 Manual

The purpose of ISO 13485 quality manual is to establish and clarify the terms and conditions governing the Quality Management System. These policies define the intentional provision of management to manage our operations and activities in accordance with the framework established by the ISO 9001 and ISO 13485.

ISO 13485 system is maintained and continually improved through the use of the quality policy, quality objectives, internal & external audit results, analysis of data, corrective and preventive action and periodic management reviews.

To design and implement the QMS within ISO 13485, we have to:

• Identify the processes needed for the QMS and their application throughout the organization,
• Determined the sequence and interaction of these processes,
• Criteria and methods needed to ensure that the operation and control of processes are effective determined,
• Ensure the continued availability of resources and information necessary for the operation and monitoring of processes,
• Systems established to monitor, measure and analyze these processes,
• Established processes to identify and implement the necessary actions to achieve results and maintain the effectiveness of these processes,
• Established control processes to identify and implement the actions necessary to achieve planned results of outsourced processes,
• Determined criteria and information necessary to ensure that regulations and required standards are met.

Process for ISO 13485 Certification Medical Devices

Like any ISO certification, medical device makers wish to get ISO 13485 certification initial ought to educate themselves on the requirements of regulators and customers, further as what a ISO 13485 quality management system can entail. Then a management system that conforms to the standard’s requirements must be enforced inside the organization.

The making the management system ought to be drafting a top quality manual; the standard manual outlines an organization’s goals, processes and procedures for compliance and quality management. A worker with the ability to develop and implement such a program will produce the management system internally; otherwise, an employed adviser with an experience within the ISO13485 market may be used. Once the standard manual has been written and a management system has been enforced, the organization must request a certification body it’s snug with.

When seeking a certification, the organization must make certain that the registrar is authorized by an accrediting body to incorporate ISO13485 standard certification in their scope. The organization seeking certification ought to rise to visualize credentials and references from a prospective registrar. For instance, in North America, certification bodies are authorized through a corporation like National certification Board. There are certification boards in each major country that review certification bodies to make sure they meet requirements.

It is also important to stay the target market in mind. For example, if a medical device manufacturer needs to sell in North America, it ought to request certification through a registrar authorized by a North American certification body to make sure they’re going to meet country-specific or client requirements.

If a consultant is required, the organization must make certain that the consultant has experience in ISO13485, and requesting referrals from an authorized registrar can also aid find the correct match. It’s important that the adviser understands the organization’s business, that the adviser has prohibited organizations of the same size before and has had expertise with similar product lines.

Also, a corporation ought to be cautious of consultants that endeavor to transform a management system that’s already performing arts well. Steve Upton, medical device business unit manager for NQA, states, “The adviser ought to are available in and align their information together with your necessities and also the client necessities, which can time period once time.”

The steps to applying ISO13485 certification are like those of 9001, with some kind of off-site document review followed by a pre-assessment. Once assessment, a corporation is subject to on-going external audit by its certification body. The period of the assessment is dependent on an organization’s scope-its size, range of personnel, and kind and quality of merchandise factory-made. Taking these components into thought, a corporation will expect an assessment to last anyplace from a few of days to quite a month.

The frequency of assessment audits are determined by an organization’s scope further as its performance, although they’re going to sometimes be conducted annually or semi- annually. However, organizations ought to expect an entire reappraisal 3 years once initial certification. An audit for assessment takes into consideration issues like the fulfillment of management responsibilities, the execution of internal audits and the way a corporation is performing arts in relevancy the state of the trade and client expectations.

What is the Aim of ISO 13485:2003 Standard?

ISO 13485 is quality system management standard designed specifically for medical device firms. The quality is obligatory for many category 2a, 2b and three medical devices and Europe and North American country. The ISO13485 standards supplements ISO 9001 and has several of identical needs. However, there area unit further needs for method management, style management, retention of records, responsibility, traceability, client satisfaction and a lot of.

Standard of ISO 13485:2003 specifies requirements for a top quality management system (QMS) wherever a company has to demonstrate its ability to supply medical devices and connected services that systematically meet client needs and restrictive needs applicable to medical devices and connected services.

The primary objective of ISO 13485:2003 is to facilitate in harmony medical device restrictive needs for quality management systems. As a result, it includes some explicit needs for medical devices and excludes a number of the needs the wants necessities of ISO 9001 that aren’t applicable as restrictive requirements. Due to these exclusions, organizations whose quality management systems adjust to the present International commonplace cannot claim adjusted to ISO 9001 unless their quality management systems conform to all or any the necessities of ISO 9001.