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ISO 13485:2016 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. While it remains a stand-alone document, ISO 13485:2016 is based on ISO 9001:2008 with some additional clauses as well as the removal of some requirements. 

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 requirements and regulatory requirements applicable to medical devices and related services.  The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2016 are specific to organizations providing medical devices, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2016 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO 13485:2016 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2016,which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.

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With thorough understanding of this business industry, we are engrossed in providing ISO 9001 Certification Consultancy Service to our clients. Due to personnel dedication and knowledge helps us to meet the detailed needs of the clients within the given period of time. We have adroit employees, who offer these services in agreement with the defined guidelines.

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Leveraging on our affluent industry proficiency, we provide ISO 9001:2008 Certification Service. These services are accomplished employing the advanced techniques. In addition, our provided service is rendered in varied terms and forms that meet on customer’s demand. Moreover, we render this service at nominal costs.

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We are one of the leading service providers of ISO 13485:2016 Certification Services.

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The ISO 9001 standard is one of the best known international standards; it is implemented by countless companies and other organizations in over 150 countries. It is a customer focused standard. It is about effectively controlling key processes of an organization in order to continually improve and achieve customer's satisfaction. ISO 9001 addresses "quality management". This means what the organization does to fulfill:

- their customers' quality requirements, plus
- any applicable regulatory requirements,

While aiming to

- enhance customer satisfaction, and
- Achieve continual improvement of its performance.

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We offer our clients ISO 20000-1-2005 Service across country at competitive prices.

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What is HACCP / ISO 22000 (FSMS)? 

Hazard Analysis and Critical Control Point (HACCP) / ISO 22000 Food Safety Management System is a process control system designed to identify and prevent microbial and other hazards in food production and entire food chain. HACCP includes steps designed to prevent problems before they occur and to correct deviations through a systematic way as soon as they are detected. 
Such preventive control systems with documentation and verification are widely recognized by scientific authorities and international organizations as the most effective approach available for producing safe food. 
HACCP / ISO 22000 enables the producers, processors, distributors, exporters, etc, of food products to utilize technical resources efficiently and in a cost effective manner in assuring food safety. 
The ISO 22000:2005 standard outlines Food Safety Management System Requirements for any organization in the food chain, and is one of a family of standards focused at the development, implementation and improvement of a food safety management system.

Who should use ISO 22000:2005?

Since ISO 22000 is a generic food safety management standard it can be used by any organization directly or indirectly involved in the food chain including- Farms, Fisheries and Dairies, Processors of Meats, Fish and Feed, including Manufacturers of soups, snacks, bread, cereal, beverages, canned and frozen food, etc as well as food service providers such as restaurants, fast food chains, hospitals and hotels.

Supporting services should not be forgotten and providers of food transportation storage and distribution, catering services as well as product suppliers for equipment, additives, raw materials, cleaning and sanitizing products, packaging. In short if your products touch the food industry or the food we eat, part or all of the ISO 22000 requirements will apply.

The Benefits of implementing HACCP / ISO 22000 (FSMS)

- A preventative approach to food safety
- Can help identify process improvements & reduced customer complaints
- Reduces the need for, and the cost of end product testing
- Is complementary to quality management systems such as ISO 9000
- Provides evidence of due diligence & reduces the likelihood of product recall & adverse publicity
- Enhances customer satisfaction / reduces dissatisfaction
- Facilitates better understanding of food packaging safety issues throughout the organization
- Improves staff performance through the promotion of team spirit & improves staff morale and motivation through a cleaner working environment
- A clear, auditable, global standard providing a framework to bring together all parts of your Food Safety Management System (FSMS)
- Demonstrates commitment to customer satisfaction
- Tests compliance with statutory and regulatory requirements and your own systems through internal audits and management reviews
- Improves internal and external communications
- Improves your organizations image
- Links pre-requisite programs (PRP's & OPRP's), HACCP with the Plan-Do-Study-Act philosophies of ISO9001 to increase the effectiveness of your food management system
- Requires regular testing of data integrity / lot recall programs and process audits
- Aligns with other management systems (ISO 9001, ISO 14001)

 

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Backed by highly accomplished personnel in this arena, we are offering ISO 27001 Certification Services. A team of dexterous personnel works in close coordination with our patrons to impart these services as per their needs. Provided services are largely valued amid our patrons for their on-time execution.

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Backed by skillful experts, we are proficient in rendering ISO 14001 Certification Service. These services are enormously appreciated in the market due to their timely completion. Our professionals render our offered service employing the advanced techniques. Offered services are rendered in varied forms and terms that meet on customers demand.

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With the aid of well-informed team, we are occupied in rendering ISO 22000 Certification Service. These services are vastly well-liked among our patrons for their timely completion. Our offered service is accomplished employing the advanced techniques. In addition, these services are rendered at nominal costs.

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We offer our clients ISO 27000 Certification Service across country at competitive prices.

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With thorough understanding of this business industry, we are engrossed in providing ISO 45001:2018 Certification Service to our clients. Due to personal dedication and knowledge helps us to meet the detailed needs of the clients within the given period of time. We have adroit employees, who offer these services in agreement with the defined guidelines.

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As a notable name of this business sector, we are massively indulged in offering to our patrons’ ISO Certificate Training Services. Due to our devotion and specialization towards the quality, these services are enormously valued by our clients. Apart from this, these services are executed by nimble personnel as per the patrons’ demands.

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Due to our proficiency in this industry, our firm is occupied in rendering OHSAS 18001-2007 Service. These services are accomplished by industry capable professionals, who have the affluent understanding of this realm. Furthermore, we render this service at nominal prices.

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We offer our clients ISO 18001 Consultancy service across country at competitive prices.

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We are offering  EN ISO 14971:2012 Certification Service to our clients.

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The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements. The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. The program’s main mission is to jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.” 

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Ukas acceridiated certificate ISO 9001;2015,ISO 14001:2015,ISO 45000:2018

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As the international standard for Quality Management Systems in the medical device industry, ISO 13485 has already been tested and proven. Companies that have achieved certification can show proof to potential clients that they comply with best practices, and with regulatory requirements. And, along the way, your company will naturally enjoy better control over its processes, and continual improvement – driving continual ROI.

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Implementing an Environmental Management System is a systematic way to discover and control the effects your company has on the environment. Cost savings can be made through improved efficiency and productivity. These are achieved by detecting ways to minimize waste and dispose of it more effectively and by learning how to use energy more efficiently. It verifies compliance with current legislation and makes insurance cover more accessible.
How do you start to implement ISO 14001? What is involved? 
Firstly, you need to evaluate the effect your organization has on the environment. You then need to prioritize ways in which you might reduce them. Next, identify the boundaries of your management system and document your procedures for implementing the requirements of ISO 14001. You will need to ensure these procedures are implemented and then audited. If you have ISO 14000 systems in place, many of the requirements of ISO 14001 will already be covered, or can be easily incorporated into them. 

Once developed, internal audits are needed to ensure the system carries on working. The setting of targets for the environmental policy and continual measuring against it ensures the system is maintained.By understanding the demands of our patrons in the best possible way, we are increasingly engrossed in offering ISO 14001:2015 Consulting Services to our clients. Delivered in tune with the standards defined by the industry, these services are enormously in demand. Due to their cost-effectiveness, these provided services are hugely treasured.

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We offer our clients ISO 50001 Certification Service across country at competitive prices.

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