ISO 13485 Medical Device Quality Management System
To discuss how our team can help your company achieve ISO 13485 Certification, please
Tel : +852 23664622
What is ISO 13485 ?
ISO 13485:2016 is a management system for medical device.It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Medical Device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
a) Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury
investigation, replacement, modification or support of the anatomy or of a physiological process,
- supporting or sustaining life
- control of conception
- disinfection of medical devices
- providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body;
- and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means
Benefit of ISO 13485
- ISO13485: 2016 certification can help to expand global market access
- Assist companies to improve their processes
- Improve efficiency, cut costs and monitor supply chain performance
- Explain the production of safer and more effective medical devices
- Meet regulatory requirements and customer expectations
What is ISO 13485 for
- Comply with Contract requirement
- Enhance compliance of relevant regulation
- Give Customer more confidence
Looking for an ISO 9001 Consultant?
ISO 13485 Consultancy Service
We established 4 different milestones for monitoring purpose and described our activities in consultancy services from zero to certification.
Phase 1 System Review
- Understand the existing operation and documentation
- Identify key gap against ISO 13485 requirements
Phase 2 Documentation
- Establish management system framework
- Establish required procedures and forms
Phase 3 Implementation
- Implement and operate the quality management system
- Prepare various records required by the documentation
- Assist client during implementation via regular advisory visit
Phase 4 ISO 13485 Certification Audit
- Liaise with Certification Body for audit arrangement.
- Support the whole Certification Audit
- Provide suggestion for closing non conformity
Frequent Asked Question
UKAS means the United Kingdom Accreditation Service. UKAS is the UK’s National Accreditation Body, responsible for determining, in the public interest, the technical competence and integrity of organisations such as those offering testing, calibration and certification services.
ISO 13485 certification without UKAS accreditation may mean that your organisation have a risk to lose large contracts and business opportunities due to unrecognised ISO certification.
The Fees depend on company size, number of locations, business nature and operation complexity.
For Company (Staff < 20), it take 5 months on average.
For Company (Staff ~50), it take 6 months on average.
For Company (Staff ~100), it take 7-9 months on average.
You may take below steps :
1) ISO Gap Analysis.
2) Establishment of ISO 13485 Documentation.
3) Attend ISO 13485 Training.
4) Implementation of ISO 13485 System.
5) Arrange an Internal Audit
6) External ISO 13485 Audit by Certification Body.
There are two major Fees.
1) ISO 13485 Certification Fee charged by Accredited Certification Body such as SGS, Lloyd’s Register,BV, BSI, ACI, DW..
2) Consultant Fee charged by us.
The Fees depend on company size, number of locations, business nature and operation complexity
Yes. You can take a series of training courses, draft the documentation…. liaise with Certification Body if you have sufficient time and master the ISO 13485 requirements
No. Because of conflict of interest. Certification Body can provide ISO 13485 Standard generic training only but cannot tell you how to implement ISO 13485 System in your company.
Absolutely Yes. In general, ISO Consultant will draft documentation, guide your company to implement ISO 13485 system until passing in ISO 13485 Certification Audit.
In general, the company can put the ISO 13485 logo in the website, name card and letterhead after receipt of corresponding ISO 13485 Certificate.
highly recommended anyone seeking for ISO management consultancy service….
Professional support, Effective Training, Process smooth. Zero NC
…internal communication and company operation have been highly enhanced….
We are looking forward to your continuing support in maintaining the system…
….we will plan to get more certifications through your professional service….
…..they gave us full support and professional guidance …..
Clients I've Helped
Let the Numbers Speak
Over 20 Years in ISO Certification Consultancy industry and completion over 400+ Projects.
Over 10 years of experiences in the fields of Quality Management, Environmental Management, Safety Management, Business Continuity Management and Information Security Management.