American Association for Laboratory Accreditation

Explanations for the ISO/IEC 17025 Requirements

This section presents A2LA's official explanations of the ISO/IEC 17025 requirements. It is expected that laboratories will implement the requirements of the standard in accordance with the explanations listed here. Otherwise, areas of non-conformance will be identified by the assessor during the on-site assessment. To have the latest updates delivered to you directly, please subscribe to the RSS feed below:.

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4.1.5 b

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Do the clauses 4.1.5 (b) and (d) require our laboratory to have a Code of Ethics in place?

ISO/IEC 17025 does not explicitly require that a laboratory have a Code of Conduct or Code of Ethics in place as part of its management system. That said, however, each accredited organization is strongly encouraged to have such measures in place to aid in fully complying with these sections of the Standard and to aid in substantiating the ethical grounds upon which an organization operates if their actions are ever called into question.

A helpful tool to assist any organization in developing and maintaining a Code of Conduct or Code of Ethics is an ethics self-assessment. Such a self-assessment can help an organization identify those areas where they are on strong ethical ground as well as areas that they may wish to examine further as an opportunity to enhance or further define their ethical and leadership practices. Some points to consider in an ethics self-assessment might include:

• Do you strive to be a role model for ethical behavior?

• Are your statements and actions consistent with professional ethical standards?

• Are your statements and actions honest even when circumstances would allow you to confuse the issues?

• Do you advocate ethical decision making by your organization’s Board, management team and staff?

• Do you use an ethical approach to conflict resolution?

• Do you initiate and encourage discussion on the ethical aspects of your organization’s management issues?

• Do you use your authority solely to fulfill your responsibilities and not for self-interest or to further the interests of family, friends or associates?

• When an ethical conflict confronts you or your organization, are you successful in finding an effective resolution and ensuring it is followed?

• Do you demonstrate your organization’s vision, mission and value statements in your actions?

• Do you have a routine system in place for members of your organization to make full disclosure and reveal potential conflicts of interest?

• Do you maintain confidences entrusted to you?

• Do you demonstrate through personal action and organizational policies zero tolerance for any form of staff harassment?

• Do you expect and hold staff accountable for adherence to your organization’s ethical standards (for example, through periodic performance reviews)?

• Do you hold all staff and business partners accountable for compliance with professional standards, including ethical behavior?

• Are you mindful of the importance of avoiding even the appearance of wrongdoing, conflict of interest or interference with free competition?

• Do your organization’s structure and processes ensure the integrity of its activities?

• Does your organization present itself accurately and honestly to the public?

• Do you understand and abide by local, state and federal laws and regulations applicable to you?

(Information drawn from The Joint Commission on Accreditation of Healthcare Organizations, The American College of Healthcare Executives and the Higher Learning Commission.)