ISO 13485

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Sylvain
Manager, Global HSE

ISO 13485 Quality Management System – Medical Devices

An effective solution to meet the comprehensive requirements of QMS is the ISO 13485 standard. Manufacturers that adopt ISO 13485 are provided with a pragmatic foundation for the regulations and responsibilities towards the addressing and also demonstrating their commitment to quality and safety of medical devices.

ISO 13485 certificates are renown and trusted in industries involved in medical devices and manufacturers, suppliers and authorities around the world.

ISO 13485 is an individual QMS standard that is derived from ISO 9000 standard series which is recognized and accepted internationally. It adapts the ISO 9000 model based on process into a regulated environment for manufacturing medical devices. ISO 13485 is a more prescriptive in nature and often does require a rather thorough documentation of the QMS system. While retaining the Plan, do, check concepts of ISO 9001, It is designed for regulatory compliance.

ISO 13485 was transcribed singularly to manufacturers of their designing of quality management systems that effectively establish and maintain their processes. It ensures the consistency design and development, production, delivery and installation of medical devices in a manner that is safe for their intended purpose

What are Significant Features of ISO 13485?

Specific
requirements
for inspection
and traceability
for implantable
devices
Specific
requirements
for
documentation
and
validation
of processes
for sterile
medical devices
Focus
on risk
management
activities
and design
control activities
during product
development
Specific requirements for documentation
and validation of processes for sterile
medical devices
Specific requirements for documentation
and validation of processes for sterile
medical devices
Specific requirements for documentation and validation of processes for sterile medical devices
Specific requirements for documentation and validation of processes for sterile medical devices

Benefits of ISO 13485

ISO 13485 – It’s Key Benefits

  • Certification increases access to worldwide markets
  • Process review and improvement outline across your organization
  • Monitor supply chain performance, increase efficiency and cut costs.
  • Demonstration of safer and effective medical device production.
  • Meeting customer expectation and Regulatory requirement.

Who can Use ISO 13485 Certification?

ISO 13485 Quality Management System –Medical Devices is designed by experts which can be used by any organisation, which handles process of Medical Devices manufacturing , Reselling , Exporting to European Business Market Namely ,irrespective of their size or geographical location.

How Vegas CG Can Help You?

You get much more than just a certificate with Vegas CG as your audit and certification partner, Vegas CG provides valuable tools to reduce documentation, and helps identify cost savings, and provides assistance in avoiding loss of production. Out Team of experts function as an part of your management team and help you promote a workplace safety culture and build strong Organisation.

Certification process

VCG shall initially review the client enquiry and send them a questionnaire for their completion. Based on the completed questionnaire from the client VCG will take a decision for certification, for which a quote will be sent to the client for 3 years of certification period.

Conformity Assessment Stages & Cycle

Before carrying out your assessment, we need to find out if you’re ready. We do this at our first visit. We’ll normally carry out the stage 1 visit on site.

CARRYING OUT STAGE 1 – VISIT

During the visit we will:

  • evaluate the location and specific conditions of your organisation.
    hold discussions with members of your organisation to find out how prepared you are for the second visit.
  • see how well you understand the requirements of the standard and what your progress is towards meeting them.
  • collect information on the scope of your management system, the processes and locations of your organisation and the related statutory, regulatory and compliance aspects. For example, these could include the environmental or legal aspects of your organisation’s operation and the risks associated with them.
  • agree the details of visit 2 and see how we allocate LRQA’s resources for it.
  • try to understand your management system and operations so we know what to focus on in the planning of the second visit.
    see if your organisation is planning and performing internal audits and a management review.
  • check that the level of implementation of the management system is high enough for us to carry out our stage 2 visit.

Reporting

We will document the results from this visit and communicate them to you before the assessment team leaves. We’ll tell you if we have any areas of concern that could be classed as a non-conformity during the stage 2 assessment. The time between the two visits will depend on how long we think it will take you to resolve any areas of concern from the first visit.

Now you’re ready for your initial assessment. This visit will take place at your site. Its purpose is to evaluate the implementation and effectiveness of your management system. We’ll gather evidence that the management system conforms to the standard and other certification requirements.

CARRYING OUT STAGE 2 – THE VISIT , INITIAL ASSESSMENT

During this visit, the assessment team will assess enough examples of your organisation’s activities for us to be able to make decisions on the implementation and effectiveness of the management system. We’ll interview staff, including top management and operational personnel, so that we’re sure the system is implemented and understood throughout the organisation.

The assessment team will analyse all the information and evidence we gathered during both visits to decide whether all of the certification requirements have been met and whether any non-conformists exist. The team might propose opportunities for improvement based on their experience.

We will examine your management system to address at least the following points:

  • information and evidence about conformity to all requirements of the standard
  • performance monitoring, measuring, reporting and reviewing against key performance objectives and targets
  • your management system and performance with regards to legal compliance
  • operational control
  • internal auditing and management review
  • management responsibility for your organisation’s policies
  • links between the requirements of the standard(s), policy, performance objectives and targets, any applicable legal requirements, responsibilities, personnel competence, operations, procedures, performance data and internal audit results.

Reporting

When the stage 2 visit has been completed, the assessment team will write up the findings in the report of the visit. This report will record the results of the assessment, any areas for improvement and any identified and agreed non-conformist. The report will normally be left with you prior to the team leaving your site.

To make sure your management system is still effective, and to follow up on the progress that has been made since our last visit. Visits occur at regular intervals.

The surveillance visits aim to confirm that the approved management system continues to:

  • be maintained
  • be in operation
  • deliver continual improvements.

Pre – visit contact

For clients who are..

a) New to the approach: The assessor will discuss the new approach and the best way to introduce it to your company and agree the arrangements for talking to senior management at the opening meeting.

b) Used to the approach: The assessor will confirm that the theme selected at the previous visit is still relevant and that the right people will be available. They will agree modifications to theme as necessary.

If the visit is the certificate renewal planning visit, the assessors will introduce the Review, Preview and Planning principles.

HOLDING THE CONVERSATION WITH SENIOR MANAGEMENT

The assessor will…

  • Introduce what LRQA will be doing differently on this visit and why.
  • Establish what issues are important to the client and their stakeholders and select the visit theme.
  • Identify where management systems can be used to drive performance improvement in respect of these issues.
  • Listen to your views on the issues around the theme selected for this visit and take account of them in your audit.
  • Discuss your future organisational objectives and identify opportunities for future visit themes.

THE VISIT PLAN

With the theme agreed for this visit (or for future visits) the assessor will identify which departments, processes controls and systems relate to the theme and are assess able:

The theme + the people, processes, controls and systems to be audited = The Visit Plan

Future plan flexibility – Plans for future visits should be flexible. If the circumstances change, such as with a major customer complaint or regulatory breach, LRQA should be able to modify the theme of the visit, or introduce a new one, to address issues of current concern to our client and / or their stakeholders.

PERFORMING THE VISIT

When performing the visit the assessor will:

  • Audit the theme through the areas as planned. The assessor may wish to follow trails which were not identified in the original plan if they are significant to the theme.
  • Use the assessment of the areas to confirm that the system controls are in place and are being effectively used.
  • Determine if you are using the management system to manage and / or improve the issues related to the identified theme.
  • Report any weaknesses in the system or its effectiveness and suggest potential improvements for you to consider.

REPORTING THE VISIT – THE VISIT REPORT

The visit report left with you after the visit will:

  • Contain a summary of the senior management discussions
  • Track a sample of long term improvement projects
  • Record the trails followed and evidence examined, along with the evaluation and conclusions
  • Record any findings
  • Record the overall conclusion on the effectiveness of the management system in relation to the theme and in meeting the requirements of the assessment standard
  • Identify themes and areas for the next visit.
  • Feedback to senior management

In the closing meeting the assessor will:

  • Give an overview of his findings and state his conclusions.
  • Highlight where the management system assists you in addressing the issues related to the theme where it is helping to drive improvement.
  • They will describe any system weaknesses related to the theme and explain how these weaknesses may impact adversely on your business.

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