Medical - Quality 13485

Medical - ISO 13485

What is ISO 13485?

ISO 13485 is the internationally recognised standard for quality management within the medical device sector. It is based on the ISO 9001 process model and its main objective is to enable a harmonised approach in the medical device industry. There are further requirements for the design, manufacture, servicing and installation of medical devices.

ISO 13485 is applicable to any business working in the medical device sector, helping to demonstrate that the business understands relevant regulatory requirements.

What are the benefits of ISO 13485?

The implementation of an ISO 13485 Management System will enable your company to realise a variety of benefits:

Customer Satisfaction – consistently deliver products and services that meet your customers’ requirements as well as meeting legal and safety requirements

Increase Efficiency – through the continuous improvement of processes resulting in reduced operating costs with less waste and fewer complaints

Legal Compliance – understand your legal requirements, the impact on your products, services and business and how to meet them

Improved Risk Management – with a better understanding of risk management techniques ensuring greater consistency and traceability of products

Improve Staff Motivation – staff will understand their roles and responsibilities enabling business improvement

Why a UKAS certified system?

A UKAS (United Kingdom Accreditation Service) certified quality management system shows a commitment to quality, customers and a desire to improve efficiency.

It shows that the quality system is effective, satisfying the requirements of an external, and more importantly, independent audit.

It will give your company a competitive advantage by enhancing the company image from customers and employees and giving you a marketing edge.

Medical Device Services

Regulatory Affairs inc. regulatory strategies

Technical Files/Dossiers

Technical Documentation

Clinical Evaluations

Worldwide Regulatory submissions inc. CE Marking, US FDA 510(k) Premarket Clearance and Health Canada Approvals

Risk Management

Project Management

IRCA Lead Auditor certified

Supplier Qualification and AuditingProcess validation

Internal Auditing

Management of Complaints, Corrective/Preventive Action



A CE mark is needed for many medical products in the European Economic Area (EEA), the letters ‘CE’ on a product show that the product complies with European legislation. CE marking was created at the beginning of 1992 to help free the restrictions of the European Marketplace.


A UKCA mark will be needed for medical products sold in the United Kingdom, the letters ‘UKCA’ on a product show that the product complies with UK Medical Device Regulations. UKCA marking will be introduced throughout the transition period. Compliance dates will vary depending on the product risk class


ISO 45001 is the internationally recognised standard for the management of health and safety within your business. By implementing a health and safety management system, your business demonstrates a clear desire to improve the health and safety in your company by setting measureable objectives.


CHAS stands for Contractors Health and Assessment Scheme, it is an accredited health and safety scheme for the construction industry. Some buyers require CHAS certification before they allow you to tender. This has been seen in public sectors such as schools, colleges etc.


With our guidance your organisation can become a member of Constructionline, Constructionline is the biggest register of contractors in the UK for the construction industry. Constructionline has a database of over 8,000 buyers that are a part of over 2,000 organisations, by becoming a registered member of Constructionline it will increase the brand reputation of your company and is an organised way of instilling verified competence to the buyer.


With our guidance your organisation can become a certified member of Safecontractor, once you have been certified as a member you will be added to the online database that the clients of  Safecontractor have access to. You can reduce the risk of accidents on your clients premise’s and ensure your health and safety competence in a cost effective way.


ISO 9001 is the internationally recognised standard for quality management within your business. It provides a systematic and common sense approach to ensure that the activities within your business are controlled, aiming to consistently achieve customer satisfaction by meeting their requirements and expectations.

QUALITY - Supplier Audit

A supplier audit is the process used to demonstrate your level of control over subcontracted processes. These may be carried out during supplier approval or ongoing surviellance of subcontracted processes. It helps to identify risks and opportunities within the subcontracted activities.

Environment -  ISO 14001

ISO 14001 is the internationally recognised standard for environmental management within your business. It focuses on the environmental aspects of your business and how you interact, influence    and control them. You will set objectives and targets for environmental performance and by implementing a programme improve your performance.


ISO 22000 is the internationally recognized standard for food safety management within your organisation. It helps to minimize food safety hazards within the food chain.


At SGR we can help you with your HACCP (Hazard Analysis and Critical Control Point), it is a system that introduces better food safety to your organisation’s activities when handling food products and how food is produced to make sure the food is safe to eat.