ISO 17025 General requirements | Yazenkom

Summary

This video provides an insightful overview of ISO 17025 requirements, specifically focusing on general requirements regarding impartiality and confidentiality. It outlines the importance of lab impartiality, emphasizing risk identification and mitigation strategies, and the need for written policies and documented procedures. Additionally, the video explains how labs must manage confidential information, ensuring customer approval and legal compliance. Practical steps for maintaining confidentiality include training, agreements, and restricted access to sensitive data. The video concludes by preparing viewers for the next part of the series on structure requirements.

Takeaways

• 😀 ISO 17025 outlines general requirements for laboratory activities, focusing on impartiality and confidentiality.
• 😀 Impartiality means laboratory activities must be free from bias and conflicts of interest, ensuring neutrality in all operations.
• 😀 Lab management must commit to impartiality, actively working to ensure unbiased results and decisions.
• 😀 The lab is responsible for ensuring impartiality in all its activities, from testing to reporting.
• 😀 Labs must identify and manage risks to impartiality, taking steps to minimize any identified risks.
• 😀 Demonstrating impartiality in laboratory operations requires a written policy, documented procedures, and a code of conduct for all personnel.
• 😀 Confidentiality in labs means protecting all information gathered during operations, and gaining customer consent before sharing data with third parties.
• 😀 Labs must inform customers when their information will be released, especially when required by law.
• 😀 Confidential information from a third party must remain confidential between the lab and the customer, with third-party identities kept anonymous unless agreed otherwise.
• 😀 A written confidentiality policy, confidentiality agreements with employees, restricted access to confidential documents, and training on data handling are essential for maintaining confidentiality.
• 😀 The video concludes with a promise to cover the structure requirements in the next part of the series.

Q & A

What does impartiality mean in the context of ISO 17025?

Impartiality refers to conducting lab activities without bias or conflict of interest, ensuring that all processes are fair and free from external influences.

What is the role of lab management in ensuring impartiality?

Lab management must be committed to impartiality and should actively ensure that lab activities are conducted in a neutral, unbiased manner.

How should a lab demonstrate impartiality according to the ISO 17025 standard?

A lab can demonstrate impartiality by having a written impartiality policy, documented procedures for handling impartiality risks, a code of conduct for all personnel, and referring to ISO 14065 guidance for further details.

What are some key risks to impartiality that a lab might need to identify?

Risks to impartiality can include conflicts of interest, undue influence from external parties, and any bias that could affect the objectivity of lab results or decision-making.

What is the purpose of a written policy on impartiality?

A written policy on impartiality outlines the lab's commitment to fair and unbiased practices and provides clear guidance on how impartiality will be maintained.

What is required in terms of confidentiality under ISO 17025?

The lab is responsible for managing all information obtained during its activities, including obtaining customer approval before releasing information, informing customers when confidential information is released by law, and ensuring third-party information remains confidential.

What steps should a lab take to manage confidentiality effectively?

A lab should establish a written confidentiality policy, have confidentiality agreements with employees, restrict access to confidential documents, and provide training on handling data and records.

How can a lab ensure customer information stays confidential when dealing with third parties?

The lab must ensure that information shared with third parties remains confidential between the lab and the customer, and the third party’s identity should remain unknown unless agreed otherwise.

What does the term 'shall' signify in ISO 17025, particularly regarding impartiality and confidentiality?

'Shall' indicates mandatory requirements in ISO 17025, meaning labs are required to comply with these standards, such as maintaining impartiality and confidentiality.

Why is it important for a lab to provide training on confidentiality procedures?

Training ensures that all personnel understand the importance of confidentiality and are equipped with the necessary knowledge to handle sensitive information appropriately, reducing the risk of breaches.