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ISO 13485 Medical Devices Certification




ISO 13485 Certification assists Medical Device related Organisations in achieving their aims & improving their business by helping them to manage & improve (rather than fire-fight). For CE Mark of Medical Device/s, the business will require ISO 13485 Certification.

Contact us today to also benefit from ISO 13485 certification and accreditation with increased operational efficiency. The requirements are well tested and help improve operations, productivity and profitability.

Medical Devices CertificationClick the following links for more specific information:

What is ISO 13485 Certification?

Benefits of ISO 13485 Certification

Why you need it

How to gain ISO 13485 Certification

How much does it cost?

What is ISO 13485?

ISO 13485 is the Quality Management Standard for Medical Devices. It is required for the CE Mark of Medical Devices. Additionally it is not the only way of improving Quality. Over the last 100 years, there have been many different initiatives. Regrettably they have generally suffered from being:

  • Internally driven by a few key personnel, who have limited access to Best Practice, (which is an additional benefit of external Assessors)
  • Often oriented on Manufacturing. Over 85% of businesses are Service organisations in the Developed economies
  • Often oriented large volume activities, which justify major investment to achieve improvements. Most organisation employee less than 20 persons
  • Few agreed and documented methods covering all of the activities affecting Customer service
  • Emphasis on operational improvements, with little consideration of Customer views
  • Lack of external Assessment to provide a reality check and incentive for maintaining and improving

ISO 13485 addresses each of these limitations.

Organisations, to achieve ISO 13485 Certification, must be committed to a focused and systematic approach to business with fact based decision making. They should be able to demonstrate both internally and to the external Assessor:

  • Focus on Customers, with Customer requirements required to be fully understand and agreed.
  • Management commitment to quality
  • External independent UKAS accredited Assessment & on-going Surveillance visits at least yearly
  • Involvement of trained, qualified and competent employees
  • Processes approach and working systems are effective
  • Applicable laws and regulations are complied with
  • The necessary facilities and resources are provided
  • Mutually beneficial Supplier relationships
  • Problems are identified, investigated and corrected
  • Important aspect of the business are monitored, reviewed and improved

Additionally any ISO 13485 Quality system needs to be flexible, so assisting the business to succeed in today’s volatile and competitive environment. For instance your hosted Per4ma Business Model enables immediate online editing to ensure everyone is working from the latest Documents and Forms, whether they are working inside or externally to the Company.

Benefits of ISO 13485

  1. Competitive
    A. Requirement if needing to CE Mark Medical Device/s
    B. ISO 13485 gives an externally checked confidence that your business is using a documented system to fulfil Customer requirements as well as being committed to improve. It also provides assurance to Customers that they can depend on consistent Quality of Service.
  2. Operational
    ISO 13485 provides a systematic and integrated approach to business processes. It provides a clear structure of operating processes, with an emphasis on continual improvement of working systems as well as reducing errors, duplication, complaints and problems.

The evidence is that implementation costs are an investment with the return of cost advantages and other improvements gained by better methods, improved productivity, reduction of waste and better management control. Achieving successful Assessment and Certification also assists in retaining existing Customers and in gaining new Customers.

Why You Need it

For CE Marking of Medical Devices and to invest in your business

How to Gain ISO 13485 Certification

The quick answer is contact us, but there are common steps

  1. Review your operation compared to the Standard’s requirements & then document
  2. Implement, train & refine
  3. Check internally (Audit) & Management Review; Continue the refining
  4. External Check (UKAS accredited Assessor). When successful the Certification, then on-going yearly Surveillance visits

Three Format Options for your manual, documents, forms, process diagrams/ procedures and forms:

  1. Text – the traditional approach but limits the opportunity for Business Improvement
  2. Process Diagrams – assists with clearer understanding of processes and process interaction but often cumbersome to interlink electronically
  3. Integrated Per4ma Business Model – Opportunity for Business Improvement, with your latest processes, Manual, documents, forms, tasks, indicator graphs and blogs.

Contact us today for the first steps to ISO 13485 Certification

How Much Does it Cost?

Invest in your future by improving your Business. We have options to suit your situation including

  • Price Right -The Cost Effective Solution – if the Cost of achieving ISO is the critical factor. We personalise & document your Systems to comply with the relevant Standard & check compliance before UKAS accredited Assessment
  • Manage Right – The Time Effective Solution – We save you Time. If you do not have the internal resources for the Documenting, Project Management & Training, we assist.
  • Risk Right If you do not have the internal resources for the Documenting, Project Management, Admin & Training, we can assist as Deputy Quality Management Representative
  • Support Right – Support as & when you want it – whether Onsite assistance & Auditing / Convert documentation /Additional Standards (i.e. ISO 13485, API Monogram & Q1, AS 9120 etc.) / Improvements / Refresh your System.
  • Personalised Solution

Call us: (0)1635 595123
Email us: info@charter4.com
For a free discussion or quote or for further information about this certification standard.

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