What is ISO 13485?

ISO 13485 is the world’s most recognized quality management standard used by millions of organizations all over the world to continuously improves performance. By becoming certified your organization by KRISHTECH under NABCB Accreditation is making a statement about your commitment to continually and consistently meet the expectations of your customers through the improved efficiency and effectiveness of your business processes

ISO 13485:2016 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 applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the previous version of ISO 9001, ISO 9000:2008 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance; therefore it is more prescriptive in nature and requires a more thoroughly documented QMS.

Importance of ISO 13485:2016 in your business?

ISO 13485 is important to designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can enhance an organization’s marketability as more and more manufacturers require certification in order to do business with a vendor.

Reason for use

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.

Other specific differences include:

• • the promotion and awareness of regulatory requirements as a management responsibility.

• • controls in the work environment to ensure product safety.

• • focus on risk management activities and design control activities during product development.

• • specific requirements for inspection and traceability for implantable devices.

• • specific requirements for documentation and validation of processes for sterile medical devices.

• • specific requirements for verification of the effectiveness of corrective and preventive actions.

• • specific requirements for cleanliness of products

How to get your ISO certificate ?

1. • Application to KRISHTECH- Application for registration is made by completely updating KRISHTECH  Application Form & submitting to KRISHTECH office. This provides information about your organization to KRISHTECH & so KRISHTECH can accurately define the scope of assessment. 

1. • Get a Quote – We’ll give you a clear indication of the costs of gaining and maintaining certification. 

1. • Assessment to ISO 13485 is undertaken by KRISHTECH – this consists of two mandatory visits that form the Initial Certification Audit (Stage 1 Audit + Stage 2 Audit). Please note that you must be able to demonstrate that your management system has been fully operational for a minimum of three months and has been subject to a management review and full cycle of internal audits. 

1. • Certification to ISO 13485 is issued by KRISHTECH and maintained through a program of annual surveillance audits and a three yearly recertification audit.

Benefits of implementing ISO 13485:2016 in your business?

Expanded market access – National regulatory authorities require or strongly prefer that manufacturers marketing medical products in their countries have a third-party audited and certified management system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others. 

Reduced cost of sales – Your certification establishes your company’s credibility and commitment to quality. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers’ trust and confidence. 

Improved performance – Based on a uniform and widely-accepted system of process control, your company’s certified management system helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners, and customers, and give you a real advantage in the marketplace.

ISO 13485 Certification Principles:

1. 1. Customer focus – aiming to improve for the betterment of the interested parties and customer, this will help one sustain customer, increase customer base, makes sure to communicate their needs and expectation by monitoring throughout the organization

1. 1. Leadership – to achieve quality objectives leaders need to establish unity of purpose which is by aligning its strategy, policies, procedure and resource this will lead to better coordination of the organization’s processes one needs to establish a culture of trust and integrity, provide people with the required resource, training, authority to act with accountability

1. 1. Engagement of people – for efficiency involve people of all levels, this can be done by communicating with the employees their needs in the organization, sharing knowledge, and experience, recognizing people’s contribution, learning, and improvement.

1. 1. Process approach – when activities are understood and then executed then the efficiency of the delivered output will increase, by understanding organizations’ capabilities and determining resource constraints prior to action.

1. 1. Improvement- improvement is important for an organization to maintain the current level of performance and to even keep on developing, this can be done by giving proper training and letting them understand that how does a work happens with that track, review and audit planning, implementation, recognize and acknowledgment, which will result into anticipation of internal and external risks and opportunity, improved process performance.

1. 1. Evidence-based decision making – learn from mistakes, it is simply that decisions should be driven from evaluation of data, this will help one take better efficient solutions adding more, intuitions should never be neglected.

1. 1. Relationship management – manage relations with relevant interested parties such as providers, one can achieve by keeping a well-managed supply chain that provides a stable flow of products and services, determining interested party’s relationship that needs to be managed,

PDCA Cycle

• • Plan – to think that what do we need to achieve in our organization

• • Do – to execute a planned action which will help us achieve the required objective

• • Check – monitor against the standards) (policies, objectives, requirements)

• • Action – finally implementing what has been rechecked.

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