Note: International, regional or national standards (m ethods) that contain sufficient and concise information on how to perform laborato ry activities need not be rewritten if t hese standards are written in a way that can be used by t he operating personnel in the L ab.

December 2017 DOI: 10.13140RG.2.2.21075.53283 Conference: Training on Migration to ISO 17025:2017 Project: ISOIEC 17025 laboratory accreditation Authors: Sani Ibrahim Sanichem Resoures Download file PDF Read file Download file PDF Read file Download citation Copy link Link copied Read file Download citation Copy link Link copied Abstract This Guide to ISO 17025:2017 describes implementation of the requirements for the revamped standard for laboratories, Discover the worlds research 19 million members 135 million publications 700k research projects Join for free Public Full-text 1 Content uploaded by Sani Ibrahim Author content All content in this area was uploaded by Sani Ibrahim on May 02, 2020 Content may be subject to copyright.

ISOIEC 17000-Conformity assessment Vocabulary and General principles 3.

Other terms that convey the meaning of impartiality include Independence Freedom from conflicts of interes t Freedom from bias Lack of prejudice Neutrality, fairness, open-mindedness Even-handedness, detachment, balance.

How to demonstrat e impartiality in laboratory operation Have written policy of impartiality Have documented pr ocedure (or SOP) on identifying risk to impartiality and handling impartiality.

Have a writte n Code of Conduct for all levels of personnel including manag ement.

See ISO 14065 guidance on impartiality ( pa.euclimasitesclimafiles etsmonitoringdocsgoodpractice iso14065impartialityand managementen.pdf) 4.0 General Req uirement 4.2 Confidentiality 4.2.1 Lab is responsible for the management of all information acquired during its activities.

Customers approval must be obtained prior to release of information to third party.

Customer shall be informed when confidential information are to be released by law.

Information about customer from third party sources shall be confidential between customer and lab.

The third party shall remain unknown to customer unless agreed.

Lab personnel and any other related individual shall keep confidential all information obtained during lab activities they are involved in.

How to manage confidentiality in laboratory operation Have written policy of confidentiality in laboratory operation.

Have confiden tiality agreement with all employees Restrict access to CONFIDENTIAL docu ments Training on Confidentiality procedur e and handling of data and recor ds.

No specific requirement for Risk Management Syst em such as ISO 31000: Risk Management - Principles and Guide lines.

17025 Requirements Manual And SOPsQPs

Document its procedures have all procedures documented, similar to having the Quality Manual and SOPsQPs.

Even though LM, QM and TM positions are NOT specified, Their job functions are Appoint them.

Laboratory Management replaces T op management 5 Structural R equirement 5.7 Laboratory management shall ensure that: a) communication takes place regarding the effectiveness o f management system and the importance of meeting customers and other requirements; b) the integrity of the management system is maintained when changes to the management system are planned and implemented.

Competence - The ability to do something successfully or efficiently Oxford.

BM Kecekapan) Competency Framework including monitoring of competency -.mindtools.compagesarticlenewISS91.htm.

Then Lab shall examine the effect of the defect a nd shall initiate nonconforming work procedure.

Equipment list and inventory Equipment logbook and maintenance record.

Shall include; a) Requirements are adequately defined, documented and understood, b) Lab has the capability and resources to meet the requirements, c) When external providers are used, Lab advised customer of specific activities to be performed by external provider and gains customers approval.

SOP on Review of requests, tenders and contracts.

Process R equirements 7.1 Review o f Requests, Tenders and Contracts 7.1.2 Lab shall inform customer when the method requested by customer is considered inappropriate or out of date.

When customer requests a statement of conformity to a specification or standard, the specification or standard and the decision rule shall clearly be defined.

The decision rule selected shall be communicated to and agreed with customer unless it is clearly defined.

Any differences between the request and the co ntract shall be resolved before Lab activities commence.

Deviation requested by customer shall not impact integrity of Lab or validity of results.

The customer shall be informed of any deviation from c ontract.

Decision Rule a rule that describes how measurement uncertainty will be accounted for when stating conformity with a specified requirement.

Records of all related discussions with customer shall also be retained.

17025 Requirements Verification Of Methods

Process R equirements 7.2 Selection, v erification and validations of methods 7.2.1 Selection and verification of methods 7.2.1.1 The laboratory shall use appropriate methods a nd procedures for all laboratory activities and, for evaluation of the measurement uncertainty as well as statistical techniques for analysis of data.

All methods, procedures and supporting documentation shall be k ept up to date and shall be made readily available to personnel.

The laboratory shall ensure that it uses the latest valid version of a method unless it is not appropriate or possible to do so.

Iso 17025 Requirements Pdf