SWISS APPROVAL HEALTH CARE & MEDICAL TECHNOLOGY ASSESSMENT

Audit and Conformity Assessment Services, for Products, Services and Processes

Aim to develop the Trust and Confidence between the stakeholders, suppliers and market, through Third Party Audits, assessing objectively, processes, products and services, assuring the credibility and safety of the operations, against any interested party, including Authorities.

Pharmaceutical Industry and Health Care providers, have of major interest, to assure the quality and safety of patients and Society, and eliminate risks, which could affect credibility or have a negative impact on the Society, for both industries.

Swiss Approval Health Care and Medical Technology Assessment firm, guaranties the maximum sensibility against the auditing principles and ethics, using Qualified Auditors with strong and long experience in production or service delivery processes, within the Pharma and Health Care industry.

Our 5 Steps Process for Auditing and Conformity Assessment

Critical Client Task

  • Market Impact: Register, Monitor, Understand and predict the market needs, in terms of Legislation, Norms, Standards, Market Requirements and Regulatory framework, in International, National or Regional level.
  • Customers: Analyse Customers needs, in terms of conformity assessment and certification. Identify the potential standardisation framework, for each specific Market.
  • Assessment Target: Mapping the Structure of product or service or even process, identifying the Regulatory and Authorisation framework in different markets.
  • Norms & Standards: Mapping the Standards and Norms to apply, in International, National and Regional level.

Services We Provide

  • Market Impact: Market assessment, intelligence collection, trend analysis and insights, related to Legislation, Norms, Standards, Market Requirements and Regulatory framework, in International, National or Regional level.
  • Customers: Stakeholder mapping reporting. List of Guidelines, Standards, Norms & Work instructions applied. Auditing and Conformity Assessments Reports.
  • Assessment Target: Rapid, targeted or systematic reviews of similar products or services. Identification and definition of assessment scopes and activities.
  • Norms & Standards: Identification of regulatory framework, development of customised Norms and Standards. We can also design the Syllabus of customised technical norms.

Critical Client Task

  • Resources: Identify the kind of resources and Auditors, according the declared scopes of Auditing activity, for possible assignment according the rules.
  • Bibliography: Identify the related to the audit scope, bibliography and Standardisation framework, proceeding on the selection of Norms or Standards.
  • Good Manufacturing Practice: Identify the documents and resources of Good Manufacturing Practices, for the products or services or processes to be audited.

Services We Provide

  • Resources: Provide the most experienced and qualified human resources, in order to guarantee the maximum added value, and respect the rules.
  • Bibliography: We can develop Standards, Norms and Work instructions, customised according the international bibliography, client needs, and scientific trends.
  • Good Manufacturing Practice: Review and Approval of procedures and processes or Good Manufacturing Practices.

Critical Client Task

  • Risk Analysis: Analyse critical tasks and processes, according Customer business and technology requirements.
  • Objectives Synthesis: A full synthesis of risk analysis results, according Customer activities under examination.

Services We Provide

  • Risk Analysis: Risk Analysis Assessment Report, based on the audit check list elements, and the evaluation of findings.
  • Objectives Synthesis: Conclusions and recommendations included in the Risk Assessment Report.

Critical Client Task

  • Build Validation Evidence: Build evidence to Validate the Risk Analysis Report
  • Communicate Validation Results: Build tools to communicate the Validated results.

Services We Provide

  • Build Validation Evidence: Validation calculations and Reporting of results.
  • Communicate Validation Results: Communication materials related to Validation Report.

Critical Client Task

  • Perform the Audit: Audit Preparation, Planing and Execution.
  • Audit Close Meeting: Inform the Customer of the actions and measures to undertake in order to guarantee the Conformity Assessment according the Standard or Norms audited.

Services We Provide

  • Perform the Audit: Audit Report. Certificate issue if possible.
  • Audit Close Meeting: Suggestions and Reporting.
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