Procedure for Advisory and Impartiality Committee

Procedure for Advisory and Impartiality Committee

Purpose

PRNS Global Certifications Pvt Ltd (PRNS) is committed to provide services in an impartial, transparent, and independent way which adds value to the client and meets the benchmarks set by the accreditation bodies. This ensures the integrity of PRNS’s decisions and provides confidence to our clients, auditors, staff and other stakeholders.

Scope

• This procedure contains requirements for the competence, consistency and impartiality of services provided by PRNS.
• Conformity assessment activities like Application Review, Selection of Audit team, Audit Schedule, Conduct of Audit, Decision making, Audit cycle, Certification agreements & Decisions, Post certification services, Appeals & Complaint grievance handling, Record-keeping are covered under the policy.

Procedure for Impartiality

• PRNS Management team will be completely inducted with the policy of impartiality and ensure to carry out the certification activities without any compromise under financial, commercial, and other trade pressure which would cause a conflict of interest.
• PRNS doesn’t offer management system consultancy or other form of consultancy, to companies or organisations.
• PRNS does not offer or provide any management system consultancy services including internal audit services for its certified clients.
• PRNS identifies and analyses all relationship (formal or personal) with other organisations or individual which may result in a conflict of interest arising from its certification activities.
• Individual employed or contractors by PRNS are required to provide self -declaration documents on their current and past relationship with all related companies.
• PRNS does not provide certification services to any organization where a relationship with PRNS poses a threat to impartiality.
• PRNS can decide to change the team to perform the audit if the following interests pertain.

1. 1. A vested interest in the client (self-interest threats)
   2. Past employment / contractual services with the client within the past two years (self-review threats)
   3. Member/team is too personally close to or familiar with employees, officers, or directors of the client company (familiarity threats)
   4. If the client’s management tries to intimidate or threaten the member/team (intimidation threats)

• Within PRNS, risk assessment is conducted annually and where required in relation to specific activities or contracts on impartiality and potential conflict of interest relating to certification business. This is reviewed by the impartiality committee of the PRNS, which is an independent committee made up of members representing stakeholders
• Certification manager (CM) identifies the risks whereas Quality Manager (QM) plans for formulating, assessing and evaluating the identified risks. The risk management process of PRNS is:
  • An integral part of management
  • Embedded in the culture and practices Tailored to the business processes of the organization.
• Operation Director communicate and consult with external and internal stakeholders during all stages of the risk management process including the interested parties. Operation Director will determine aspects that can impact the business plan for the year.
• Aspects that can cause Harm are:

• • Business development
  • Field operation
  • Back-end operation
  • Information security
  • Partiality
  • Work environment.
  • Staff and Facility
  • Documents and Records maintenance
• The aspects will have associated risks which may include.
  • The objectives of the audit
  • The sampling used in the audit process.
  • Real and perceived impartiality
  • The client organization being audited and its operative environment.
  • Impact of the audit on the client and its activities
  • Legal, regulatory and liability issues
  • Health and safety of the audit teams
  • Perception of interested parties.
  • Misleading statements by the certified client
  • Use of marks

• Operation Director will establish the External and Internal Context. Evaluating the PRNS's external context includes, but is not limited to:

• • the social and cultural, political, legal, regulatory, financial, technological, economic, natural, and competitive environment, whether international, national, regional, or local.
  • key drivers and trends having an impact on the objectives of the organization; and
  • relationships with, and perceptions and values of, external stakeholders.
• Evaluating the PRNS's internal context may include, but is not limited to:
  • governance, organizational structure, roles, and accountabilities.
  • policies, objectives, and the strategies that are in place to achieve them.
  • capabilities understood in terms of resources and knowledge (e.g. capital, time, people, processes, systems and technologies);
  • information systems, information flows and decision-making processes (both formal and informal);
  • relationships with, and perceptions and values of, internal stakeholders;
  • the organization's culture;
  • standards, guidelines, and models adopted by the organization; and
• the form and extent of contractual relationships.
  • PRNS will not provide any training on addressing any non-conformities issued against management systems certification standards
  • any training that provides improvements in management systems of the company which can favour certification leading to consultancy activities.

NOTE- Any generic pieces of training that share information available on the public forum don’t categorize as consultancy services.

Impartiality Committee

The Impartiality Committee will ensure all the PRNS activities are safeguarded with proper procedures. The core objectives will be

1. To assist in forming new policies related to the impartiality of PRNS activities.
2. To review & verify resources and finances.
3. To review any financial or personal relations doesn’t pressurize the employees to compromise the impartiality of the ethics of the PRNS.
4. To have a control on any tendency of PRNS to involve in the commercialization of the activities of the certification process.
5. To advise on matters related to certification activities and gain confidence with the perceived perception of the public and stakeholders.
6. To review the decision-making processes of the PRNS

The impartiality committee is formed with members from PRNS’s stakeholders based on nominations from representative stakeholders. It consists of a total of 6 members and a minimum of three members to be present in any meeting from the below mentioned.

a) Certified Client
b) Customer of the certified client
c) Regulator
d) Auditor/s
f) Consultants Representative
g) Medical device industry Association Representative

The committee will meet annually to review impartiality aspects of PRNS certification functions (all threats to impartiality). The records of the review are kept in the form of meeting minutes in the risk analysis record. PRNS will update the requirements of impartiality as per ISO 17021-1:2015 standard.

Impartiality Committee members are appointed for a period of three years and if needed, this can be extended for another period of three years with the approval of the certification manager.

Doc. No.: PRNS-P-003
Rev No.:01
Effective Dt: 10-05-2025