ISO 17025 Quality Manual Template
Tuesday, January 31, 2006
4.1 Organization / 4.1.5 (c) Customer Confidentiality
Confidential information and proprietary rights of the customer must be protected. This includes electronic storage and transmission of results.
Monday, January 30, 2006
4.1 Organization / 4.1.5 (b) Undue Pressure
Lab employees should sign a conflict of interest statement to ensure that management and personnel are free from undue pressures and influences including:
- internal or external
- commercial
- financial
- anything that may adversely affect the quality of their work
The lab can also meet this requirement by having a specific policy on the matter, or a code of ethics, employment contracts, and arrangements to relieve internal pressures from excessive workloads.
- internal or external
- commercial
- financial
- anything that may adversely affect the quality of their work
The lab can also meet this requirement by having a specific policy on the matter, or a code of ethics, employment contracts, and arrangements to relieve internal pressures from excessive workloads.
Friday, January 27, 2006
4.1 Organization / 4.1.5 (a) Management and Technical Personnel
A commitment by the lab the lab to have managerial and technical personnel in place who have the authority and resources needed to carry out their duties, including implementation, monitoring, and improvement of the management system.
Personnel must identify the occurence of departures from the management system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimize such departures.
Personnel must identify the occurence of departures from the management system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimize such departures.
Thursday, January 26, 2006
4.1 Organization / 4.1.4 Potential Conflicts of Interest
When the lab is part of an organization that does other things besides testing or calibration, key personnel in that organization that influence the lab must have their responsibilities defined in order to identify potential conflicts or interest.
Wednesday, January 25, 2006
4.1 Organization / 4.1.3 Scope of Management System
ISO 17025 is a generic standard covering all types of testing and calibration laboratories. Hence, the laboratory must describe what the management system actually covers.
Permanent facility?
Satellite locations?
Temporary or mobile facilities?
This description will allow the accreditation body to identify and assess what will actually be accredited.
Permanent facility?
Satellite locations?
Temporary or mobile facilities?
This description will allow the accreditation body to identify and assess what will actually be accredited.
Tuesday, January 24, 2006
4.1 Organization / 4.1.2 Lab requirements
4.1.2 Lab requirements
To follow ISO 17025 and satisfy customer needs, regulatory authorities, or accrediting bodies.
Interpretation...it is what it is!
To follow ISO 17025 and satisfy customer needs, regulatory authorities, or accrediting bodies.
Interpretation...it is what it is!
Monday, January 23, 2006
4.1 Organization / 4.1.1 Legal identification
4.1 Organization
4.1.1 Legal identification
ISO 17025 requires that the lab be held legally responsible.
This has been interpreted and accepted by accreditation bodies as "Legal Identification" or "identifiable under law".
Essentially, the laboratory or organization needs to be able to state their business name and place of business so that the accreditation body can ensure control over the status of accreditation. In the end the accreditation covers a distinct organization and is limited to that entity. If "corporate" boundaries are not clear and distinguishable, the labortory is not legally identifiable.
4.1.1 Legal identification
ISO 17025 requires that the lab be held legally responsible.
This has been interpreted and accepted by accreditation bodies as "Legal Identification" or "identifiable under law".
Essentially, the laboratory or organization needs to be able to state their business name and place of business so that the accreditation body can ensure control over the status of accreditation. In the end the accreditation covers a distinct organization and is limited to that entity. If "corporate" boundaries are not clear and distinguishable, the labortory is not legally identifiable.
Friday, January 20, 2006
Section 4 - Management Requirements
Section 4 of ISO 17025 outlines all of the management requirements of the standard. Essentially it is ISO 9001 for testing or calibration laboratories. There are 15 sub-sections under management requirements. These are:
4.1 Organization
4.2 Management 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 customer
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Improvement
4.11 Corrective action
4.12 Preventive action
4.13 Control of records
4.14 Internal audits
4.15 Management reviews
iso 17025
Thursday, January 19, 2006
ISO 17025
ISO 17025 is the recognized international standard to which testing and calibration laboratories become accredited. In an effort to speed up the process of developing a quality management system, a laboratory should consider utilizing a template. The ISO 17025 Quality Manual Template can be located at www.e-shoq.com
