ISO 13485 certificate & ISO 13485 consultants for ISO certification. ISO 13485 certificate consultants and training in Iraq

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ISO 9001:2008

Quality Management System

A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered".

Implementing a Quality Management System will help the organization to improve the process to achieve the desired results consistently.

ISO 9001:2008
ISO 14001

Environmental Management System

The ISO 14001:2004 is a standard for environmental management systems that is applicable to any business, regardless of size, location or income. Environmental management means systematic approach to environmental implementation and certification of environmental management system brings advantage in many ways. The most recent version of "ISO 14001" was released in 2004 by the International Organization for Standardization "ISO" which has representation from committees all over the world.

ISO 14001

Occupational Health & Safety Management Sysytem

OHSAS 18000 is an international occupational health and safety management system specification. "OHSAS 18001" has been developed to be compatible with the ISO 9001 (Quality) & ISO 14001 (Environmental) management systems standards, in order to facilitate the integration of quality, environmental & "occupational health & safety management systems" by organizations.

ISO / TS 16949

Automotive Industry Standard Certification

Together with ISO 9001:2000, ISO/TS 16949:2002 specifies the quality system requirements for the design/development, production, installation and servicing of automotive related products.

"ISO/TS 16949:2002" was developed by The International Automotive Task Force (IATF), in conjunction with the "International Organization for Standardization" (ISO).

ISO / TS 16949
ISO 13485:2003

Medical Device Quality Management Standards

ISO 13485 is an "ISO standard", published in 2003, that represents the requirements for a comprehensive "management system for the design and manufacture of medical devices". While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. "ISO 13485" requires only that they demonstrate the quality system is implemented and maintained.

ISO 13485:2003
ISO 27001

Information Security Management Sysyte,

ISO 27000, An Information Security Management System "(ISMS)" provides a systematic approach to managing "sensitive information" in order to protect it.

ISO 27001 (ISMS) defines comprehensive requirements for an ISMS that deals with all the technical and Human aspects in information security in all its operational processes.

ISO 27001
ISO 27001

Information Security Management Sysyte,

ISO Consultants Iraq for ISO Certification Iraq. ISO 9001, ISO 14001, OHSAS 18001, ISO 17025, HACCP ISO 22000, ISO 27001, SA 8000, OHSAS 18001, ISO 13485, ISO 20000 Consulting, Implementation, training, documentation and certification in Iraq. ISO Consultants in Baghdad, Mosul, Erbil, Basrah, Suleimaniye, Kirkuk, al Najaf, Karbala, Nasriyah, Hillah, Rumadi, Diwaniya, Al-Kut, Amarah, Samarah, Baqubah, Fallujah, Tilafar, As-sumawah for ISO Certificate.

ISO 27001

Food Safety Management System

OHSAS 18000 is an international occupational health and safety management system specification. "OHSAS 18001" has been developed to be compatible with the ISO 9001 (Quality) & ISO 14001 (Environmental) management systems standards, in order to facilitate the integration of quality, environmental & "occupational health & safety management systems" by organizations.

iso certification

ISO 13485:2003
What is ISO 13485: 2003 Medical devices -- Quality management systems?

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:

Implementation of a Quality Management System with several enhancements
Risk Management approach to product development and product realization
Validation of processes
Compliance with statutory and regulatory requirements
Effective product traceability and recall systems

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

Benefits of ISO 13485 certification:-
Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
Improved stakeholder relationships - including staff, customers and suppliers

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Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
Improved risk management - through greater consistency and traceability of products and use of risk management techniques
Proven business credentials - through independent verification against recognized standards
Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector

How can Lakshy / Kurdistan Bridge Management Consultancy help to get ISO 13485 Certification?
Lakshy Management Consultant Pvt. Ltd. provides proven, proprietary implementation and training support to assure that your organization meets applicable ISO 13485 requirements promptly and effectively. A certified ISO 13485 Quality Management System will
Assure you meet all customer quality requirements
Improve your organization's competitiveness
Eliminate waste
Reduce risk
Control process variation

Lakshy Management Consultant Pvt. Ltd. ISO 13485 QMS Implementation Support is loaded with advantages for your organization. Basic Support provides a process- based, documented, implemented, audited Quality Management System (QMS), acknowledging all ISO 13485 quality requirements, ready for certification.

Full Support provides everything in Basic Support, plus we will train and mentor an Internal Quality Audit team for your organization. Lakshy Management Consultant Pvt. Ltd. will witness your certification audit, if you choose. Everything we provide meets one or more ISO 13485 requirements, including a quality manual unique to your organization, acknowledging all ISO 13485 requirements (no "gap assessment" required) documentation and implementation support for your value added quality management system development of a simple, effective document and record control system training of an Internal Quality Audit Team, if you choose a mentored, full system audit of the new quality management system (no registrar "preliminary assessment" required) corrective/preventive action support from the full system audit recommendation for an economical, effective registrar, if you choose our witness of your registration audit, if you choose We take the time necessary to custom fit all applicable ISO 13485 requirements to your organization. No "consultant" is as willing and able as Lakshy Management Consultant Pvt. Ltd. to take the time to build a QMS to both reduce your costs and "pass the audit," guaranteed.

ISO 13485 certificate Consultants for ISO 13485 certification QMS in Baghdad, Mosul, Irbil, Basrah, Suleymaniye, Kirkuk, al-Najaf, Karbala, Nasirah, Hillah, Rumadiya, Diwaniyah, al-Kut, Amarah, Samarra, Baqubah, Fallujah, Tilafar,as-Samawah. Consultants for ISO 13485 standards, ISO 13485 implementation, ISO 13485 training, ISO 13485 documentation and ISO 13485 certification in Iraq
Contact Lakshy / Kurdistan Bridge Consultants : Email :- | Phone :- 964 7400229000