ISO 13485:2016 Medical Devices - Quality Management Systems
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
GDPMDS - Good Distribution Practice for Medical Devices
The Good Distribution Practice for Medical Devices (GDPMDS) based on SS 620:2016 Standard is a mandatory audit for any organizations involved with importing, wholesale and distribution of medical devices prior to their license application. Certification against GDPMDS qualifies that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation or product specification.
In an effort to provide such assurance, organizations will require more than a few quality manuals. Organization needs to include appropriate procedures, suitably qualified personnel, correct processes / facilities / equipment as well as clear and timely documentation, to credibly demonstrate the consistency of quality assurance.
Organizations certified to ISO 13485 will not need to apply for GDPMDS and will find that they have partially fulfilled the GDPMDS requirements. You may want to visit the HSA website to find out more on the difference between GDPMDS and the other standards; and organizations will need to fill the gap before they can be considered compliant.
TL 9000 - Quality Management System for Telecommunication
Globalization of the telecommunications industry is driving the need to apply a common set of quality requirements throughout the supply chain. TL 9000 addresses this need and is synonymous with reduced costs, improved performance and enhanced customer/ supplier relationships.
Representatives from major stakeholders decided that only by defining specific quality needs and setting clear goals and objectives could the telecommunications industry promote a culture for continual improvement.
TL 9000 defines the telecommunications quality system requirements for the design, development, production, delivery, installation and maintenance of products and services. This also includes performance and cost-based measurements that measure reliability and quality performance.
TL 9000 is only relevant to those organizations currently engaged in work within the telecommunications industry and who want to implement a certified management system with international recognition.
ISO 14971 - Risk Management for Medical Devices
ISO 14971 is an international standard for risk management of medical devices. It is recognized by the US Food and Drug Administration (FDA), European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators as the "de facto" standard for risk management of medical devices. ISO 14971 is an integral part of a quality system and should be incorporated into the life cycle process of medical devices.
The following are some benefits from implementing ISO 14971:
Implement ideal methods of reducing risk for all stakeholders
Develop devices and therapies that are proven effective in the industry
Manage speed and cost to market
Optimize speed of iteration
Streamline the regulatory process that will enable entry to selected markets
If you have already implemented an ISO 13485 quality management system, we can assist with integrating ISO 14971 with your existing quality management system.
ISO 22000:2018 - Food Safety Management System
ISO 22000:2018 sets out the requirements for a food safety management system and can be certified to. It maps out what an organization needs to do to demonstrate its ability to control food safety hazards in order to ensure that food is safe. It can be used by any organization regardless of its size or position in the food chain in order to provide customer confidence in the product. This is becoming more & more important as customers demand safe food and food processors require that ingredients obtained from their suppliers to be safe.
Some of the major changes to the standard include changes to its structure as well as clarifying key concepts such as:
The new version of ISO 22000 follows the same structure as all the other ISO management system standards, the High Level Structure (HLS).
The standard now includes a different approach to understanding risk.
The standard clarifies the Plan-Do-Check-Act cycle, by having two separate cycles in the standard working together: one covering the management system and the other, covering the principles of HACCP.
A clear description is given of the differences between key terms such as: Critical Control Points, Operational Prerequisite Programmes and Prerequisite Programmes.
MDSAP - Medical Device Single Audit Program
Recognition of the need for a global program for medical devices has led to the development of the Medical Device Single Audit Programme (MDSAP). The Medical Device Single Audit Program (MDSAP) was developed by a group of medical device regulators to allow recognized third-party Auditing Organization to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2016 and that satisfies the requirements of multiple regulatory jurisdictions.
The purpose is to help ensure the safety and quality of medical devices, and raise standards around the globe.
The regulatory authorities that are currently participating in the MDSAP Program are: Australia (TGA), Brazil (ANVISA), Canada (Health Canada), US (FDA) and Japan (MHLW and PMDA).
Manufacturers should implement applicable requirements and may perform internal audits using the MDSAP audit documents (Audit Model and Companion document) available on the FDA Website.
FSSC 22000 - Food Safety System Certification
The FSSC 22000 Food Safety System Certification provides a framework for effectively managing your organization's food safety responsibilities. FSSC 22000 is fully recognized by the Global Food Safety Initiative (GFSI) and is based on existing ISO Standards. It demonstrates your company has a robust Food Safety Management System in place that meets the requirements of your customers and consumers.
FSSC 22000 is fully based on the international, independent standards: ISO 22000, ISO 22003 with sector specific technical specifications for Prerequisite Programs (PRPs) and additional scheme requirements.
The FSSC 22000 scopes define the requirements necessary to ensure a management system is in place to meet the demands of regulators, food business clients and consumers.
Organizations throughout the food supply chain can benefit from FSSC 22000 certification, regardless of their size or complexity.
The Attributes of Excellence describe key characteristics of high performing organisations and are embedded throughout the framework. These attributes are:
1. Leading with Vision and Integrity
2. Creating Value for Customers
3. Driving Innovation and Productivity
4. Developing Organisationa Capability
5. Valuing People and Partners
6. Managing with Agility
7. Sustaining Outstanding Results
8. Adopting an Integrated Perspective
9. Anticipating the Future
The Business Excellence (BE) Initiative helps organisations enhance their management systems and processes to deliver superior performance. The BE Framework, which is a globally benchmarked development tool, provides organisations with a roadmap to aling strategies and goals to their objectives. Organisations are required to undergo an assessment to validate their performance, understand their strengths and areas of improvements to achive better performance and growth.