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Procedures listed in equipment's manual

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Guest user Created:   Jun 05, 2020 Last commented:   Jun 05, 2020

Procedures listed in equipment's manual

1. 6.4.3 The laboratory shall have a procedure for handling, transport, storage, and use and planned maintenance of equipment, these procedures could they be the ones that listed in the equipment's manual? Or a procedure must be created according to the manual and the laboratory's policy? 2. If the laboratory has a code of ethics and conducts, to which every employee signed his agreement to respect, does that prove the company's impartiality and confidentiality?
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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Jun 05, 2020

1. 6.4.3 The laboratory shall have a procedure for handling, transport, storage, and use and planned maintenance of equipment, these procedures could they be the ones that listed in the equipment's manual? Or a procedure must be created according to the manual and the laboratory's policy?

The mandatory requirement for ISO 17025:2017 is that your laboratory has a procedure and necessary records. I assume you are referring to you own equipment manual, which covers all your equipment. Yes, you could use you own equipment manual as your documented procedure and refer to the relevant sections of Suppliers manuals; as long as the references and information is up to date and controlled.

Regarding your reference to “the laboratory's policy”, there is no need for a policy on management of your equipment. Your ISO 17025 management system must include an overall quality policy and specific objectives. How you meet the requirements for equipment management must be risk and opportunity based, to support your quality policy and to achieve your objectives.

2. If the laboratory has a code of ethics and conducts, to which every employee signed his agreement to respect, does that prove the company's impartiality and confidentiality?"

If the established code of ethics and conduct addresses the requirements to safeguard impartiality and confidentiality, this is evidence of management’s commitment to these topics. The purpose of a signed acknowledgment by an employee is to show that, firstly it has been communicated to them (again a requirement of management), they have received it and that they acknowledge the content of the code. Even if they declared by signing that they will abide by the code; this is not evidence of actual compliance with the policies. There is no objective evidence through acknowledging the code that impartiality and confidentiality is in fact upheld.

Ensuring Impartiality and confidentiality is an activity that is ongoing. It is achieved through a process approach by knowing your process inputs and outputs and the factors that could affect your objective of safeguarding impartiality and confidentiality for every laboratory activity. Risk assessments should be performed upfront to identify and address any initial risks to impartiality and confidentiality. Then use surveillance activities such as audits, employee meetings/feedback and customer feedback on an ongoing basis to monitor compliance. Take appropriate action to mitigate any new or changed risks.

For more information, have a look at the ISO 17025 Expert Advice Community answersAssuring impartiality and confidentiality - https://community.advisera.com/topic/assuring-impartiality-and-confidentiality/Compliance with the ISO/IEC 17025:2017 requirement for Impartiality - https://community.advisera.com/topic/compliance-with-the-isoiec-170252017-requirement-for-impartiality/Procedure for impartiality - https://community.advisera.com/topic/procedure-for-impartiality/

Have a look to see how the following toolkit documents can assist you:Quality Policy, Quality Manual and procedure Addressing Risks and Opportunities.  Previews are available at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

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Jun 05, 2020

Jun 05, 2020