ISO 17025 Quality Manual Template
Friday, March 24, 2006
4.3 Document Control / 4.3.3 Document Changes
4.3.3.2
Altered or new text must be identified in management system documents.
Interpretation:
One of the most common ways of identifying revised text in at document is to place a bar in the left hand margin of the hard copy text.
When you are displaying PDF documents through Adobe Acrobat, it is good practice to change the colour of the changed text so that it stands out to the user.
iso 17025
Altered or new text must be identified in management system documents.
Interpretation:
One of the most common ways of identifying revised text in at document is to place a bar in the left hand margin of the hard copy text.
When you are displaying PDF documents through Adobe Acrobat, it is good practice to change the colour of the changed text so that it stands out to the user.
iso 17025
Thursday, March 23, 2006
4.3 Document Control / 4.3.3 Document Changes
When documents are revised they require the same review and approval process that they were originally issued through.Those doing the review and approval will be knowledgable and have access to the pertinent background information.
iso 17025
iso 17025
Wednesday, March 22, 2006
4.3 Document Control / 4.3.2 Document Approval and Issue
4.3.2.3
Management system documents must be uniquely identified. This will include:
- date of issue
- revision identification
- page numbering
- total number of pages (or a mark to signify the end of the document)
- issuing authority
iso 17025
Management system documents must be uniquely identified. This will include:
- date of issue
- revision identification
- page numbering
- total number of pages (or a mark to signify the end of the document)
- issuing authority
iso 17025
Tuesday, March 21, 2006
4.3 Document Control / 4.3.2 Document Approval and Issue
4.3.2.2
The document control procedure must ensure:
- documents are authorized and available in the appropriate locations
- documents are periodically reviewed and/or revised to ensure they still meet the needs of the lab
- obsolete documents are promptly removed
- obsolete documents are suitably marked when retained for either legal or knowledge preservation
iso 17025
The document control procedure must ensure:
- documents are authorized and available in the appropriate locations
- documents are periodically reviewed and/or revised to ensure they still meet the needs of the lab
- obsolete documents are promptly removed
- obsolete documents are suitably marked when retained for either legal or knowledge preservation
iso 17025
Monday, March 20, 2006
4.3 Document Control / 4.3.2 Document Approval and Issue
4.3.2.1
Management system documents must be reviewed and approved for use by authorized personnel prior to use.
The lab must have a Master List or a document control procedure that identifies the current revision status and distribution of documents.
The purpose for this is to ensure that invalid and/or obsolete documents are not used in the laboratory.
iso 17025
Management system documents must be reviewed and approved for use by authorized personnel prior to use.
The lab must have a Master List or a document control procedure that identifies the current revision status and distribution of documents.
The purpose for this is to ensure that invalid and/or obsolete documents are not used in the laboratory.
iso 17025
Friday, March 17, 2006
4.3 Document Control / 4.3.1 General Requirements
All documents in the management system (internally generated or external sources) must be controlled through standard procedures. These documents include:
- regulations
- standards
- normative documents
- test and/or calibration methods
- drawings
- software
- specifications
- instructions
- manuals
Interpretation:
Document - policy statements, procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc. They could be hard copy, electronic, digital, analog, photographs or written.
iso 17025
- regulations
- standards
- normative documents
- test and/or calibration methods
- drawings
- software
- specifications
- instructions
- manuals
Interpretation:
Document - policy statements, procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc. They could be hard copy, electronic, digital, analog, photographs or written.
iso 17025
Wednesday, March 15, 2006
4.3 Document Control
Document control within the ISO 17025 standard will cover the following
- General requirements
- Document approval and issue
- Document changes
iso 17025
- General requirements
- Document approval and issue
- Document changes
iso 17025
Tuesday, March 14, 2006
4.2 Management System / 4.2.7 Maintenance
It is the responsibility of top management to maintain the changes to the management system.
iso 17025
iso 17025
Monday, March 13, 2006
4.2 Management System / 4.2.6 Technical Management and Quality Manager
The responsibilities of technical management and the Quality Manager are defined in the Quality Manual.
iso 17025
iso 17025
Friday, March 10, 2006
4.2 Management System / 4.2.5 Structure of Management Structure
The quality manual must outline the structure of the management system.
Interpretation:
For example,
Tier 1 - Quality Manual
Tier 2 - Technical procedures and support procedures (often called standard operating procedures...sops)
Tier 3 - Record keeping documents
iso 17025
iso 17025 quality manual
Interpretation:
For example,
Tier 1 - Quality Manual
Tier 2 - Technical procedures and support procedures (often called standard operating procedures...sops)
Tier 3 - Record keeping documents
iso 17025
iso 17025 quality manual
Wednesday, March 08, 2006
4.2 Management System / 4.2.4 Communication of Requirements
The following requirements are communicated by top management to the laboratory:
- importance of meeting customer requirements
- statutory requirements
- regulatory requirements
iso 17025
- importance of meeting customer requirements
- statutory requirements
- regulatory requirements
iso 17025
Tuesday, March 07, 2006
4.2 Management System / 4.2.3
There must be proof that top management are committed to the development and implementation of the management system and to continually improve its effectiveness.
Interpretation: if you write all your policies and procedures you have the proof. If you follow Section 4.10 and 4.15 of the standard then you have continually improved the management system. This clause is slightly redundant.
iso 17025
Interpretation: if you write all your policies and procedures you have the proof. If you follow Section 4.10 and 4.15 of the standard then you have continually improved the management system. This clause is slightly redundant.
iso 17025
Monday, March 06, 2006
4.2 Management System / 4.2.2 Quality Policy Statement (continued)
The quality policy statement must include:
- lab management's commitment to good professional practice and quality of its testing/calibration service
- a statement from management about the lab's standard of service
- the purpose of the management system
- a requirement for all personnel to be familiar with the management system policies and procedures related to their job
- and a statement of management's commitment to comply with ISO 17025 and continually improve the effectiveness of the management system.
A copy of the ISO 17025 standard can be obtained from:
http://www.17025-standard.com/
iso 17025
- lab management's commitment to good professional practice and quality of its testing/calibration service
- a statement from management about the lab's standard of service
- the purpose of the management system
- a requirement for all personnel to be familiar with the management system policies and procedures related to their job
- and a statement of management's commitment to comply with ISO 17025 and continually improve the effectiveness of the management system.
A copy of the ISO 17025 standard can be obtained from:
http://www.17025-standard.com/
iso 17025
Thursday, March 02, 2006
4.2 Management System / 4.2.2 Quality Policy Statement
The lab's management system policies (including a quality policy statement) are defined in a Quality Manual.
A sample of a Laboratory Quality Manual can be viewed at:
http://www.e-shoq.com/wst_page9.html
See www.e-shoq.com for more details.
iso 17025
A sample of a Laboratory Quality Manual can be viewed at:
http://www.e-shoq.com/wst_page9.html
See www.e-shoq.com for more details.
iso 17025
Wednesday, March 01, 2006
4.2 Management System / 4.2.1 Management System Documentation
1. Establish
2. Implement
3. Maintain
The lab must establish, implement, and maintain a management system for their testing and calibration activities.
This includes:
- policies
- systems
- programmes
- procedures
- instructions
The system must be communicated, understood, and implemented.
See the following for more info:
http://www.aoac.org/pubs/iso17025.htm
iso 17025
2. Implement
3. Maintain
The lab must establish, implement, and maintain a management system for their testing and calibration activities.
This includes:
- policies
- systems
- programmes
- procedures
- instructions
The system must be communicated, understood, and implemented.
See the following for more info:
http://www.aoac.org/pubs/iso17025.htm
iso 17025
