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ISO 13485 Quality Management System for Medical Devices
ISO 13485 is a quality management system standard specifically for the medical devices industry, which encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements.
ISO 13485: 2016 has been harmonised against the three EU Medical Devices, so certification to this standard by an accredited certification body such as AQSCERT Product Service automatically
demonstrates compliance with specific clauses in these directives
Why certy your quality management system?
The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market. In the European Union, the fulfilment of EU Directives (e.g Active implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.
The current European medical device quality system standard is EN ISO 13485:2016. When manufacturers are active in the world market, the focus on global or international standards (e.g., ISO) is not only advantageous – it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485:2016.
Who is the standart for?
- Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union.
- Consultancies or agencies, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, as well as medical component manufacturers.
- Manufacturers of in vitro diagnostic medical devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.
Your benefits at a glance?
- Enhanced efficiency and marketability – Formal certification of your quality management system will help you to market your products and services and to improve the efficiency of your organisation.
• Expert partnership – Our experienced audit team has the goal of adding value to your business by identifying improvement opportunities in addition to risks from any non-conforming areas.
ISO 27001 Information Security Management System
Secure your knowledge and information with a systematic approach
Most organisations now rely on information systems to support all of their critical business processes. This dependency has led to an evolving risk from electronic security threats such as hacking, data loss, breach of confidentiality and even terrorism. These increasingly sophisticated attacks can come from individuals, private organisations or even clandestine foreign intelligence agencies. When these attacks result in loss of information, theft of confidential data or damage to critical systems and documents, organisations can suffer severe consequences including financial repercussions and reputational risk.
What is ISO/IEC 27001?
ISO/IEC 27001 is the leading international standard for information security management. It covers commercial, governmental and not-for-profit organisations, and specifies the requirements for establishing, implementing, monitoring and improving an information security management system (ISMS).
Why is ISO/IEC 27001 important?
Your organisation may not consider its information to be vulnerable or targeted for attack but in the borderless Internet-connected world, disruptions to business IT processes can cripple your operations and allow you
How can you prepare for ISO/IEC 27001?
Like many other management systems, ISO/IEC 27001 is based on the Plan-Do-Check-Act approach to quality improvement. You can prepare for the standard by undergoing training to learn more about it. AQSCERT offers a foundation course that provides an overview of the standard’s requirements. You will also learn what your organisation needs to do in order to ensure its continued compliance to the standard after initial certification.
Additional information security services
- Penetration testing– Our experts make use of specialised technology to find vulnerabilities in your website or internal network and assess the impact of possible attacks before they happen. We provide you with a prioritised and validated list of threats requiring your attention.
- PCI-DSS and PA-DSS– We provide support for security requirements, especially for the payment card industry, which has different requirements depending on the card company (MasterCard, VISA, AMEX)
Your benefits at a glance?
- Minimise risks– through a structured and globally recognised information security methodology that identifies and mitigates threats.
- Protect your confidential information – from the threat of hacking, data loss and breach of confidentiality, and ensure you can recover faster from such attacks.
- Establish business continuity plans
ISO 9001:2015
Businesses today seek to offer products and services that not only meet but also surpass customer expectations. At the same time, they are under pressure to cut costs to remain competitive. Organisations both large and small require a comprehensive approach to quality improvement that resolves these challenges of quality and cost efficiency.
What is ISO 9001?
The ISO 9001 Quality Management System is the world’s most popular quality improvement standard, with over one million certified organisations in 180 countries around the globe. It is the only standard in the 9000 family of standards published by the International Organization for Standardization (ISO) that can be used for the purpose of conformity assessment. ISO 9001 also serves as the basis for many other important sector-specific standards, including ISO 13485 medical devices), ISO/TS 16949 (automotive) and AS/EN 9100 (aerospace), as well as widely used management system standards such as OHSAS 18001 and ISO 14001.
Why is it important?
ISO 9001 certification demonstrates your organisation’s ability to consistently meet and exceed customer expectations. For this reason, many buyers require suppliers to be ISO 9001 certified to minimise their risk of purchasing a poor product or service. A business that achieves ISO 9001 certification will be able to attain significant improvements in organisational efficiency and product quality by minimising waste and errors, and increasing productivity.
Your benefits at a glance.
Save money and time – through quality management practices that increase your organisational efficiency, productivity and profitability.
Minimise risk – by consistently achieving a level of quality defined by the standard, thus ensuring your products and services are less likely to fall short of customer expectations.
Profit from an expert partnership – with AQSCERT, an internationally recognised and respected brand.
• Increase your competitiveness – with a quality management system certified by AQSCERT that attracts investors and lowers trade barriers to your business.
Gain market recognition – with the world’s most widely known quality management system, which can help establish your presence as a supplier when entering a new market
Agri-Food Certification
Types of certifications
• Quality Management Systems (ISO 9001)
• Management Systems ISO 22000 Food Safety
• Environmental Management Systems (ISO 14001)
• Validation EMAS
• Life cycle of the product (ISO 14040 – LCA)
• Management System for the Health and Safety in the workplace (OHSAS 18001)
• Management System for the Self-control and hygiene (HACCP)
• Voluntary Product Certification
• Product Certification regulated (PDO, PGI, TSG)
• Certification Chain (Controlled Chain and ISO 22005)
• BRC (FSGS), IFS, GLOBALGAP
• Labeling bovine meat and poultry (EC Regulation 1760/00 and Ministerial Decree of 29/07/2004)
• Corporate social responsibility (SA 8000, AA1000)
• E-commerce (QWeb)
• Globalgap
• Inspection Activities
AQSCERT offers all of these services with competence and professionalism, and attention to the emerging needs of the market, investing in innovation and resources in fulfilling a customer.
