ISO 13485Medical Devices
It goes without saying that safety and quality are essential at every point of the life cycle of medical devices, all the way from design through to operation and disposal. Obtaining ISO 13485 accreditation will help your business meet the stringent standards and many regulatory requirements in this field by adopting clear quality management processes and best practices.
Key Benefits
of ISO 13485
- Internationally recognised, this is the most accepted global standard of its kind for medical devices.
- Encourages efficiencies and quicker cycle times that lead to process improvements and cost savings.
- Helps your business to reduce waste across all parts of the production process.
- Improves reliability leading to an increase in customer satisfaction and potential for repeat sales.
- Provides a competitive edge and marketing advantage based on quality assurance in a crowded marketplace.
ISO 27001
Information Security
Protecting your business information and customer data is critical for any size of organisation. That’s why ISO 27001 is rapidly becoming a prerequisite for doing business in today’s marketplace.
GDPR
GDPR Compliance Assessment
Demonstrate that your business is committed to protecting personal data and avoid the risk of bad publicity and hefty fines.
ISO 9001
Quality Management
By far the world’s most established international quality framework, ISO 9001 is the benchmark standard for businesses who want to demonstrate a commitment to providing quality products and services.
AS 9100
Quality Management for Aviation & Space
Developed especially for the aviation and space industries, AS 9100 certification goes beyond ISO 9001 with a particular focus on quality and reliability for this sector.
ISO 45001
Health & Safety
ISO 45001 helps you to protect your workforce by providing safe and healthy working conditions that prevent work-related injury and ill health.
ISO 14001
Environmental Management
Every business is expected to do its bit for the environment and ISO 14001 accreditation demonstrates that you are taking your responsibilities seriously and to an internationally recognised standard.
ISO 50001
Energy Management
Highlighting the latest best practice in energy management, ISO 50001 has been developed by experts from over 60 countries across the world.
Energy
Energy Audits for Commercial Properties
Our energy audits help you understand the energy efficiency and thermal properties of your buildings, pinpointing where improvements can be made and money saved.
ESOS
Energy Savings Opportunity Scheme
Compulsory for large businesses in the UK – and advisable for large businesses anywhere.
ISO 17025
Testing & Calibration Laboratories
Producing reliable results is essential for any organisation that performs testing, sampling or calibration and ISO 17025 accreditation is a way to demonstrate your competency in this field.
ISO 17020
Performing Inspections
Accreditation with ISO 17020 demonstrates that your business is able to carry out inspection work competently, impartially and to a consistent standard.
ISO 13485
Medical Devices
Safety and quality are essential at every point of the life cycle of medical devices, all the way from design through to operation and disposal.
How we work with you:
All ISO accreditations follow the same process:
Step 1:Gap Review
An ISO QA Consultant will visit your business to review and document your current processes and procedures, highlighting any areas that do not meet the requirements of the Standard.
Step 2:Implementation
Now it’s time to make sure any required process or procedural changes are made, as highlighted in the Gap Review. ISO QA will work with you every step of the way to make these changes.
Step 3:Certification
An Auditor visits your business to check that the documented processes are being followed and that the necessary changes have been made. Once they are satisfied, you will be awarded your certification.
Contact
Call 0330 043 5101
Head office
ISO QA Isle of Man Limited
Design House (18B)
Carrs Lane
Tromode
Isle of Man
IM4 4RG
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