Policies

Company Policy

In order to establish, maintain and enhance public confidence and trust to clients, customers of the organizations whose management systems are certified, governmental authorities, non-governmental organizations, consumers and other members of the public, the top management of Swiss Certification Services SA is fully committed to the following core values:

  • Impartiality
  • Confidentiality
  • Competency
  • Implementation and application of applicable standards and guidance documents
  • Customer Satisfaction

This commitment is transposed in Swiss Certification Services SA’s daily operation through the application of:

  • Application of impartiality, as described in the Impartiality Policy, to provide equal treatment to all clients:
    • Commercial, financial or other pressures to compromise impartiality are not allowed
    • Management system consultancy are not offered nor provided
    • Internal audits services are not offered nor provided
    • Certification of another certification body for its quality management system is not offered nor provided
    • Outsourcing audits to a management system consultancy organization is not allowed
    • Management system consultancy organization services are notmarketed nor offered
    • Statement implying that certification would be simpler, easier, faster or less expensive if a specified consultancy organization is used are not allowed
    • Inappropriate links or statements by any consultancy organization will be corrected.
    • Employees, external and contractors are free of self-interest, self-review, familiarity and intimidation
  • Application of confidentiality, as described in the Confidentiality Policy, to safeguard privacy of all clients:
    • All information, except information made publicly accessible by the client, are considered as confidential
    • All information considered as confidentialwill not be disclosed
    • All information obtained or created during certification activities except if required by law
    • Implementation and maintenance an infrastructure in compliance with the state of the art of safety
  • Management of human resources to ensure certification activities are conducted by competent personal:
    • Selection of employees and external based on academic background, work experience and knowledge
    • Provide initial and continuous training, in order to set, maintain and develop competences
    • Authorization of auditing staffs based on theory and practical training
    • Monitor auditing staff to ensure sufficient hours of auditing / review to maintain authorization
    • Periodic evaluation based on performances
  • Implementation and application of applicable standards and guidance documents:
    • To ensure safety of patients, users, and third parties.
    • To ensure certification activities are based on objective evidences
  • Ensure customer satisfaction by:
    • Reviewing client’s requirements in order to ensure the ability to meet the requested requirements
    • Manage any conflict of interest
    • Professional handling of complaint and appeals without any prejudice to the complainant / appellant
    • Establish and maintain a management system in compliance with the requirements of ISO/IEC 17021-1

Confidentiality Policy

The respect of confidentiality is one of the core value of Swiss Certification Services SA, therefore the top management is fully committed to safeguard any confidential information gathered during certification activities.

 

As a general rule, all information, except information made publicly accessible by the client, disregarding the source are considered as confidential and will not be disclosed.

 

Any employee, including any committee members, contractors, personnel of external bodies or individuals acting on behalf of Swiss Certification Services SA, will keep confidential all information obtained or created during the performance of the certification activities except if required by law.

 

All information obtained by SwissCertification Services SAregarding its clients in the framework of its certification activities are considered as confidential and must not be shared with a third party, unless:

 

  • The information is already publicly accessible
  • The information falls within the scope of public Information, as defined in ISO/IEC 17021
  • The client or the individual concerned has provided a written consent
  • It is required by law or authorized by contractual arrangements

 

In order to ensure proper safeguard of confidentiality, Swiss Certification Services SAis implementing and maintaining an infrastructure in compliance with the state of the art of safety.

Impartaility Policy

The principle of impartiality is one of the core value of Swiss Certification Services SA, therefore the top management is fully committed to provide impartial assessment of each client in order to establish, maintain and enhance public confidence and trust to the following parties:

  • Clients
  • Customers of the organizations whose management systems are certified
  • Governmental authorities
  • Non-governmental organizations
  • Consumers and other members of the public

 

Swiss Certification Services SA’s top management is not allowing any commercial, financial or other pressures to compromise impartiality and will not offer or provide management system consultancy or offer or provide internal audits nor certify another certification body for its quality management system.

 

In addition, Swiss Certification Services SA will not outsource audits to a management system consultancy organization and will not market or offer services as linked with the activities of an organization that provides management system consultancy.

 

Statement implying that certification would be simpler, easier, faster or less expensive if a specified consultancy organization is used are prohibited and action to correct inappropriate links or statements by any consultancy organization stating or implying this will be taken.

 

In order to ensure impartiality of certification activities, Swiss Certification Services SA ensures that any member of the company are free of:

  • Self-interest (e.g. Financial, Reputation, … )
  • Self-review (e.g. Own work, Former client as a consultant, …)
  • Familiarity (e.g. Relationship, Trust not based on objective evidence, …)
  • Intimidation (e.g. Pressure from clients or other parties, …)

 

All employees, external and contractor linked to Swiss Certification Services SA performing auditing or certification activities are not entitled to perform any QMS consultancy or internal audit for any client parts of the company portfolio.

 

All employees, external and contractor linked to Swiss Certification Services SA performing auditing or certification activities must disclose if they performed any QMS consultancy, internal audit for clients parts of the company portfolio, involved in design, manufacture, construction, marketing, installation, servicing or supply of the medical device or an authorized representative of the client organizationin the past 2 years and are required to reveal any situation known to them that can present them or company with a conflict of interests.

 

In summary, certification decisions are based exclusively on objective evidence of conformity / nonconformity, which are substantiated by documents.