ISO 9001 Quality Management
Demonstrate your organization’s commitment to quality and customer satisfaction

ISO 22000 Food Safety
The International Standard for businesses within the food chain, reflecting the core elements of 9001 and HACCP

ISO 27001 Information Security
Ensuring that companies have the controls to protect information assets, customer information and minimize cyber threats

ISO 14001 Environmental Management
Companies determine issues and practices to maintain high levels of Environmental Management performance

HACCP Control of Food Safety
Defining the requirements for effective control of food safety worldwide

ISO 45001 Occupational Health & Safety
Demonstrate your organization’s commitment to protect employees and visitors from workplace accidents and disease

ISO 13485 Medical Devices
The most recognized global assessment for the manufacture of medical devices and organizations that support it

ISO 22301 Business Continuity
Helps businesses prepare, respond to and recover from worst-case scenarios

ISO 50001 Energy Management
The International Standard to achieve energy efficiency in public and private sectors

ISO 28000 Supply Chain Security
Suitable for any organization, large or small, in any sector or part of the world where managing critical supply operations and keeping them secure is a prominent concern

MVO 8001 Corporate Responsibility
International Corporate Responsibility Standard for global responsible business that seamlessly integrates into existing 9001, 14001, 45001 and other management systems

ISO 20000 IT Service Management
Confirms that an organization is reliable, maintains a solid IT service infrastructure, excellent performance levels and processes are aligned with international best practice

MANUFACTURING
Manufactured goods tend to be built from different parts, assembled in stages and may be moved across borders before they reach the final consumer. Certification provides a foundation of trust between the manufacturer, supplier and the end user.

SERVICE INDUSTRY
The services sector is growing at a faster pace than manufacturing and make up the largest part of the world economy. The benefits of the ISO management systems are the same for small business as they are for multi-national companies.

FOOD & HOSPITALITY
Safe food production and distribution throughout the supply chain are serious concerns. Companies face increasing regulatory requirements as well as the need for traceability, transparency and customer safety.

SMALL BUSINESS
It is estimated that more than 90 % of the world’s businesses are small and medium-sized enterprises (SMEs). Many of these companies have been severely impacted by financial and health crises and the expansion of certification helps small businesses compete on an equal footing.

SHIPPING, TRANSPORT & LOGISTICS
As national and global trade expands, the potential for disruption of the supply chain increases. It is critically important to protect your goods and materials from the first point of shipping to the ultimate destination.

INFORMATION TECHNOLOGY
The risks to businesses of cyber threats are rising and it is critical that organizations control and protect their information and that of their customers. The concept of Managed IT services is increasingly important as businesses grow and enter new markets.

FINANCIAL & PROFESSIONAL
Organizations in the financial sector are moving toward more open customer networks, e-banking and mobile-banking services. They face stiffer legal and regulatory challenges and information security threats, such as phishing, malware or cyber-attacks.

GOVERNMENT AND PUBLIC SERVICES
Using standards is essential for international, national, state and local government organizations. QMS Global works with government and public services to improve their operations, provide social responsibility support and improve public a wide array of government programs.

ISO

MEDICAL DEVICES

The most recognized international standard specifically developed for the manufacture of medical devices.

ISO

MEDICAL DEVICES

The most recognized international standard specifically developed for the manufacture of medical devices.

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ISO 13485

Overview of ISO 13485

ISO 13485:2016 is the most recognized international standard specifically developed for the manufacture of medical devices. It applies to manufacturers and organizations that support them.

The standard aims to ensure devices consistently meet customer and applicable regulatory requirements.

ISO 13485 includes the need for a risk-based approach to the quality system, enhanced focus on regulatory requirements, the responsibilities of top management, increased controls over suppliers and outsourced activities, and emphasis on risk management throughout the product lifecycle.

QMS Global Services

Certification – We provide assessment and certification to ISO 13485

Gap Analysis – We offer gap analysis and preliminary assessments to prepare you for certification

Training – QMS Global provides remote and on-site introduction and internal audit training which will prepare you and your staff prior to and after the ISO 13485 certification process

ISO 13485 Benefits

Provides confidence that organizations throughout the supply chain can maintain compliance
Helps minimize manufacturing defects safety as a prime focus
Helps increase efficiency, reduce costs and monitor performance
Demonstrates that your company has the ability to produce safer medical devices
Allows easy adoption and integration to your existing ISO management systems and provides greater efficiency in maintaining and auditing your system

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