ISO 13485 Consultant
What is ISO 13485?
ISO 13485:2016 is an internationally agreed standard that specifies and sets out the requirements for a quality management system (QMS) specific to the medical devices industry.
ISO 13485 is designed to be used by organisations involved in the design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities e.g. technical support.
ISO 13485 can be applied throughout the entire life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.
The requirements set out in ISO 13485 are generic and are intended to be applicable to all organisations, regardless of type, size or nature.
How do you achieve ISO 13485 Certification?
An ISO 13485 compliant QMS has a number of key elements or milestones. Romano Security Consulting recommend a structured and pragmatic approach to implementing ISO 13485 and the key elements below can inform this approach:
Scoping, planning and budgeting
Securing and maintaining senior management and board commitment
Conducting a gap analysis
Identify interested parties, legal, regulatory and contractual requirements
Designing a suitable risk management framework
Conducting a risk assessment and producing a risk treatment plan
Reviewing, identifying and implementing the controls to mitigate risks
Development of a Medical Device File
Developing internal competence, accountability and assigning responsibilities
Developing ISO 13485 QMS documentation, policies, procedures and records
Developing process documentation
Conducting regular QMS staff awareness training
Measuring, monitoring and reviewing the QMS
Internal auditing of the QMS
UKAS accredited ISO 13485 certification audit
How can Romano Security Consulting help you achieve ISO 13485 Certification?
Romano Security Consulting have the skills and experience to assist in the implementation and ongoing management of your ISO 13485 QMS, having successfully implemented and managed numerous QMS’s and ISMS’s over the last 10 years for organisations of all types, shapes and sizes, from small businesses all the way up to government departments and multinational corporations.
Romano Security Consulting provide various levels of consultancy support for organisations who are looking to implement an ISO 13485 QMS and gain ISO 13485 certification or who already have an ISO 13485 QMS embedded within the organisation and are looking for some support to maintain their ISO 13485 certification.
Romano Security Consulting provide the following ISO 13485 consultancy services:
What are the Benefits of implementing ISO 13485?
Demonstrate compliance with regulatory and legal requirements
Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
Manage risks effectively
Improve processes and efficiencies
Gain a competitive advantage
What ISO 13485 consultancy services do Romano Security Consulting provide?
ISO 13485 Certification Support
End to end, advice, guidance and consultancy support covering all of the required ISO 13485 elements from scoping all the way through to ISO 13485 certification for businesses of all types, sectors and sizes.
Specific ISO 13485 Milestone Consultancy Support
If you require consultancy support at various stages of your ISO 13485 implementation or certification project e.g. risk assessment, staff training, QMS documentation creation, internal audits, project management.
ISO 13485 for Startups and Small Businesses
If you are a startup or small business of up to 20 staff or need to implement ISO 13485 quickly, then we offer a superfast ISO 13485 implementation in just 16 weeks. We’ll manage your ISO 13485 certification project from start to finish from scoping all the way through to accredited certification.
ISO 13485 Gap Analysis
If you need to measure your current level of compliance against ISO 13485 then our ISO 13485 Gap Analysis is a great starting point. We’ll work with you through the ISO 13485 QMS sections to identify any gaps and provide you with a detailed report on where those gaps are and provide you with a detailed roadmap on how to close the gaps.
ISO 13485 Internal Audit
If you need assurance prior to your certification audit or you don’t have the resources, skills and experience in house to conduct ongoing ISO 13485 internal audits, we can provide an internal audit resource and detailed audit report to highlight any non compliance.
ISO 13485 Managed Service
If you are looking for a dedicated ISO 13485 resource to pro actively manage, monitor and maintain an already established and certified ISO 13485 QMS at regular intervals, then let us be that helping hand and keep your ISMS up to date and your risks managed.
