ISO/IEC 17011 places significant emphasis on the impartiality, competence, and consistency of the accreditation body's operations, and this is particularly critical in its decision-making process for granting, maintaining, extending, reducing, suspending, or withdrawing accreditation.

Here's a breakdown of the key elements of the decision-making process as set out in ISO/IEC 17011:

1. Impartiality is Paramount (Clause 4.4):

• Independence of Decision-Makers: This is the cornerstone. The standard explicitly requires that the decision on accreditation shall be taken by person(s) who have not been involved in the assessment of the Conformity Assessment Body (CAB) and who are not subject to undue influence from the assessment team or other internal/external pressures. This separation ensures objectivity.

• Risk Management for Impartiality: The accreditation body must have a documented process to identify, analyze, evaluate, treat, and monitor risks to its impartiality. This includes risks arising from its activities, relationships, or the relationships of its personnel. Measures must be in place to eliminate or minimize these risks.

• No Consultancy: The accreditation body shall not offer or provide any conformity assessment services or consultancy to CABs. This is to avoid any perception of conflict of interest or that accreditation would be easier or faster by using their services.

2. Competence of Decision-Makers (Clause 6.2):

• Defined Competence Criteria: The accreditation body must define the competence criteria for all personnel involved in the accreditation process, including decision-makers. This includes knowledge, skills, and experience relevant to the scope of accreditation being decided.

• Authorization: Decision-makers must be formally authorized by the accreditation body's top management, based on their demonstrated competence.

3. Decision-Making Process (Clause 7.7):

• Review of Assessment Information: Before making a decision, the decision-maker(s) must thoroughly review all relevant information from the assessment process. This typically includes:

  • The application for accreditation.

  • The assessment report(s) (initial, surveillance, re-assessment).

  • Records of nonconformities identified and the proposed corrective actions by the CAB.

  • Evidence of the effective implementation of corrective actions and their closure.

  • Records of surveillance activities.

  • Any complaints or appeals related to the CAB.

  • Witnessing reports (where the AB has witnessed the CAB's activities).

  • Any other relevant information that might impact the CAB's continued conformity or competence.

• Sufficiency of Information: The decision-maker(s) must be satisfied that there is sufficient information to make an informed decision and that the assessment activities were conducted competently, consistently, and fairly.

• Consistency: The accreditation body must ensure that decisions are made consistently across all accreditations and that the application of accreditation criteria is uniform.

• Clear Rationale: The decision should be based on clear, objective evidence, and the rationale for the decision should be documented.

4. Types of Decisions:

The decision-making process applies to various stages of accreditation:

• Initial Grant of Accreditation: The first decision to grant accreditation.

• Extension to Scope: Decision to add new activities or locations to an existing accreditation.

• Renewal of Accreditation: Decision to re-accredit a CAB after a full re-assessment at the end of an accreditation cycle.

• Suspension, Reduction, or Withdrawal of Accreditation: Decisions taken when a CAB no longer meets the accreditation requirements or fails to address nonconformities.

• Lifting of Suspensions: Decision to reinstate accreditation after a suspension has been addressed.

5. Documentation of Decisions (Clause 7.14 & 9.4):

• All accreditation decisions, along with the supporting documentation and rationale, must be systematically recorded and retained. This provides an auditable trail and evidence of the decision-making process.

In essence, the decision-making process under ISO/IEC 17011 is designed to be:

• Objective: Free from bias and undue influence.

• Evidence-based: Relies on factual information gathered during the assessment.

• Competent: Made by qualified and authorized individuals.

• Consistent: Applied uniformly across all CABs.

• Transparent (internally): Documented and auditable within the accreditation body.

This rigorous approach ensures the credibility and reliability of the accreditation system, fostering confidence in the competence of accredited conformity assessment bodies.