ISO Certification
ISO 9001 Key Benefits
- A flexible framework that allows a business to meet or exceed customer requirements
- Focuses on risk to meet areas of concern or potential problems
- Helps acquire new business retain existing customers
- Builds opportunities for global commerce with international recognition
- Provides the basis for consistent and fact-based decision making
- Allows easy adoption and integration to your existing ISO management systems and provides greater efficiency in maintaining and auditing your system
ISO 9001:2015 Quality Management Systems certification enables you to demonstrate your organization’s commitment to quality and customer satisfaction, as well as continuously improving your company’s operations. The standard represents the best practices in quality management and the standard is the preferred solution for more than a million organizations worldwide.
The standard follows Annex SL, the High-Level Structure used by all new and revised standard and is compatible with other management systems.
ISO 14001 Benefits
- Demonstrates commitment to improving environmental performance and managing risks
- Helps compliance with legal and regulatory requirements and increases a company’s credibility
- Can help to lower energy usage and increase recycling
- Maintains a focus on continual improvement leading to operating cost reductions
- Allows easy adoption and integration to your existing ISO management systems and provides greater efficiency in maintaining and auditing your system
ISO 14001:2015 The International Standard for Environmental Management Systems. It can be applied to all size manufacturing and service businesses requiring a company to define environmental objectives and targets along with the management system necessary to attain these targets.
The standard follows Annex SL, the High-Level Structure used by all new and revised standard and is compatible with other management systems
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
- Faster FDA approvals
ISO 13485:2016 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.
Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry
The FDA’s Adoption of ISO 13485: What Medical Device Manufacturers Should Know – click FDA and let HSMS assist you further for an approval
ISO 45001 Benefits
- Focuses on fewer accidents, leading to less absenteeism, lower employee turnover rate and better morale
- Addresses legal, ethical and industrial relations concerns regarding worker safety and employers’ responsibilities
- Reduces disruption to operations in terms of time and cost
- Increases top management involvement and greater participation of workers in the development of policy and systems
- Allows easy adoption and integration to your existing ISO management systems and provides greater efficiency in maintaining and auditing your system
ISO 45001:2018 is the most recognized International Standard for Occupational Health and Safety. This helps your company demonstrate commitment to protecting employees and visitors from workplace accidents and disease.
The International Labor Organization estimates that 2.3 million deaths are a result of work-related accidents or diseases every year; this corresponds to over 6000 deaths every single day. Worldwide, there are around 340 million occupational accidents and 160 million victims of work-related illnesses annually.
Businesses of all sizes use this framework to build or enhance solid occupational health and safety programs. In addition to their own health and safety concerns, organizations will consider what their community, government and stakeholders expect from them concerning the health and safety of the workplace.
The goal is to reduce unacceptable risks and ensure the safety and well-being of everyone involved in an organization’s activities.
The standard follows Annex SL, the High-Level Structure used by all new and revised standard and is compatible with other management systems
ISO 27001 Benefits
- Demonstrates the integrity of your data and systems and your commitment to information security
- Demonstrates to your customers and other stakeholders that you have verified controls and procedures in place to protect their data, manage legal requirements including GDPR, misuse and theft, personal data breaches, vandalism and viral attacks
- Meets corporate governance and business continuity requirements
- Creates business opportunities with security conscious customers and prospects
- Allows easy adoption and integration to your existing ISO management systems and provides greater efficiency in maintaining and auditing your system
ISO/IEC 27001:2013 The International Standard for Information Security Management Systems (ISMS). Implementing an ISMS and gaining ISO 27001 certification will ensure you have the processes and controls to protect your information assets, customer information and manage the threats posed to your organization from cyber-attacks.
ISO 27001 is suitable for any organization, large or small, in any sector or part of the world where managing sensitive company information and keeping it secure from outsiders is important. The standard is particularly suitable where the protection of information is critical, such as in the finance, health, public and IT sectors.
The standard follows Annex SL, the High-Level Structure used by all new and revised standards and is compatible with other management systems
When it comes to keeping information assets secure, organizations can rely on the ISO/IEC 27000 family
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We will assist you to build your organisations entire ISO, Health & Safety, Integrated Management Systems program for a cost. This program will assist you to maintain employee training and be in conformance.