ISO/IEC 17025:1999
Description of 4.0 Management Requirements

Description
This portion of the standard requires that laboratories be held responsible, from a legal standpoint, to test and calibrate according to ISO/IEC 17025 specifications. There can be no conflict of interest, commercial interest, or compromising of confidential information. The organization needs to identify the chain of command and the responsible employees for each stage of testing and calibration. Additionally, there needs to be an appointed quality manager for the ISO/IEC 17025 functions. The organization needs to operate under an appropriate and complete quality management system. Documents must be controlled and approved by authorized individuals. If there are any changes to documents, the person who did the review in the first place should approve them. The organization is required to utilize adequate, doable, documented and appropriate procedures for request, tender and contract reviews. The lab may subcontract its tests and calibrations to a competent outside lab. The organization must maintain accurate records of all services and supplies that are purchased. Additionally, labs must cooperate with clients who wish to monitor lab performance and provide clients with a procedure for making complaints. Utilizing a practical procedure, the lab should address nonconformance with immediate corrective actions, evaluations of nonconformance significance, and, where needed, recalls. Corrective actions should include cause analysis, appropriate action, monitoring, and, where needed, additional audits. When required, preventive actions should be performed. Legible quality/technical records must be held in a secure place and be backed up as appropriate. Internal audits and management reviews should be performed on a regular basis.

Subclauses
4.1 Organization
4.2 Quality System
4.3 Document Control
4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the client
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Corrective action
4.11 Preventive action
4.12 Control of records
4.13 Internal audits
4.14 Management reviews

EwQMS® Modules
Below are the Enterprise-wide Quality Management System® modules which address this clause of the standard:

Audit Pro - Internal and external audit function with a focus on process improvement. 4.13
BOSS - Managing customer expectations, customer satisfaction, continual improvement, and data analysis. 4.14
Document Pro - Document management. 4.3, 4.12
HR Pro - Human performance management functions, competency, training management and satisfaction 
surveys. 4.7, 4.8
Project Planner - Project management. 4.0

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