Iso 17025 Certification Requirements
ISO/IEC 17025 standards is a generic document and it does not specify "how" to do
, but only states "what" to do. As per the standard, the ISO 17025 Management System should be documented and be demonstrable in the manner consistent with the requirements of ISO 17025 laboratory management system standard requirements. The total demonstration in the ISO 17025 Management System consists of four tiers of documents.
1. ISO 17025 Manual
2. ISO 17025 Procedures
3. Work Instruction/Operating Procedure Manual
4. Forms, Records
The amount of documentation should support ISO 17025 laboratory management system without creating a paper bureaucracy. The details for documenting above four tiers of documents are described in this paper. IN the below paragraphs details of all 4 tiers of documentation is given.
ISO 17025 Manual:-
ISO 17025 Manual states the ISO 17025 policy and describes the ISO 17025 System of an organization. It may relate to an organizations total activities or to a selected part of it, e.g. specified requirements depending upon the nature of products or services, processes, contractual requirements, governing regulations etc. It is expected to provide an adequate description of the Management intention to fulfill system requirement while serving as a permanent reference for implementation and maintenance of the system. It should include how ISO 17025 system is implemented in the organization at macro level.
ISO 17025 manual should normally contain, or refer to: -
1. The title, scope and the introduction,
2. The table of contents of the manual,
3. The introductory pages about the organization concerned and the manual itself,
4. The ISO 17025 policy of the organisation,
5. The organisation,
6. Macro level how Elements of the ISO 17025 standards Management system is implemented,
7. A definitions section, if appropriate,
8. Guide to the ISO 17025 manual, if appropriate.
9. List of procedures as a reference
ISO 17025 Procedures:-
It is a manual comprising of a number of ISO 17025 procedures, each procedure being independent in it. Procedure manual should be made department wise / element wise. It is also called a "Middle Management Book". Generally these ISO 17025 procedures are prepared by the functional head/co-coordinator in consultation with HOD. ISO 17025 procedures are also called operational procedure, as they are a snapshot of the actual activities taking place in a company at a particular point of time. They are considered to be the core of the system documentation for ISO 17025 achievement and assurance and confidential documents. They are intended for internal use and should be protected from misuse. These procedures are meant to instruct in broad terms, how the policies and objectives expressed in the ISO 17025 manual are to be addressed and achieved. They describe how the tasks and functions of the various departments should be performed to meet the requirements of the ISO: 17025 standards at micro level. In general it describes 6 major questions for the activity. For detail list of procedures refer our web site and download our ISO 17025 documentation demo.
ISO 17025 Work Instructions
The standard requires work instructions to be available, where the absence of such instruction would adversely affect ISO 17025. In the practical sense, work instruction may be written, drawings, photographs, computer menu options, machine care / operation, work production documentation etc. Work instructions deals with shop-floor level of activities. Their purpose is to clearly direct the operator as to what has to be done, and what standard of workmanship is required to control significant aspects. The instructions must therefore clearly identify:
What has to be done?
The correct sequence of activities.
Any special ISO 17025 conditions, e.g. temperature, humidity cleanliness etc.
Reference to standards / codes of practice which must be complied with
In case of special processes, work instructions are a mandatory element and for this, detailed instructions are needed. These work instructions should be written in the local language, so that they are easily understood by the operators. For the laboratory or Q.C. activity and calibration of instruments the operating procedure is documented describing how particular activity shall be done.
ISO 17025 Forms and Records:
Forms, records etc. are supporting documents used by the company to record information for different procedures followed. They link the activities written in the procedure to the records kept in the department. This documentation serves to demonstrate that the ISO 17025 System is operating efficiently to produce the product in accordance with specified requirements of the ISO 17025 System. They should be legible, easily retrievable and available when asked for by the auditor. On all the forms establish proper document control on them. As a part of documentation company can also prepare the audit checklist and verify ISO 17025 system with the help of audit checklist.
It is a commitment for the ISO 17025 and a demonstration of the commitment through documentation. This documentation is Herculean task. The company has to prepare ISO 17025 Manual, Procedures and Work instructions and supporting records also to satisfy requirements of standard. During documentation it is to be kept in view that the ISO 17025 manual, ISO 17025 procedure and records should be linked with each other. The reference to record in procedure manual and to procedure in ISO 17025 manual should be made to make the system more visible and transparent. The user has to take care in writing the procedures, so that they are understandable, actionable and mandatory.
by: jamesmiller
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