25 February 2012

Requirements of ISO 17025 Documentation

ISO 17025 is a generic document and it does not specify "how" to do, but only states "what" to do. Accordance with the standard, the ISO 17025 management system should be documented and demonstrable manner consistent with the requirements of ISO 17025 laboratory management system standard. The demonstration in the total management system ISO 17025 consists of four levels of documents.

1. ISO 17025 Manual

2. ISO 17025 Procedures

3. The work instruction / manual operation procedure

4. Forms, records

The amount of documentation should support ISO 17025 laboratory management system, without creating a bureaucratic paper. The details for the documentation above four levels of documents are described in this document. IN below the details of all paragraphs 4 levels of documentation is given.
ISO 17025 Manual: -

ISO 17025 Manual provides ISO 17025 describes the policies and ISO 17025 system of an organization. It may be the total activity of an organization or a selected portion of it, for example, requirements depending on the nature of the products or services, processes, contractual requirements, the regulations governing etc. It is intended to provide an adequate description of the intention of management to meet the requirement of the system while serving as a permanent reference for implementation and system maintenance. It should include how the ISO 17025 system is implemented in the organization at the macro level.

ISO 17025 should normally contain or refer to: -

1.The title, scope and implementation,
Table 2.The contents of this manual,
3.The introductory pages on the organization concerned and the manual itself,
4.The ISO 17025 organizational policy,
5.The organization,
6.Macro level, how the elements of ISO 17025 management system standards is implemented,
7.A definitions section, where appropriate,
8.Guide to ISO 17025 manual, if applicable.
9.List procedures as a reference

ISO 17025 - Procedures:

This is a manual that includes a number of ISO 17025 procedures, each procedure is independent of it. Procedures manual should be done department wise / item wise. It is also called a "Management Book East". Generally, these procedures ISO 17025 are prepared by the functional head / coordinator in consultation with HOD. ISO 17025 procedures are also known as operational procedures, because they are a snapshot of the actual activities that take place in a society at a given moment of time. They are considered the core of the system documentation for ISO 17025 and implementing insurance and confidential documents. They are intended for internal use and must be protected against misuse. These procedures are intended to instruct in general terms, how the policies and objectives expressed in ISO 17025 Manual need to be addressed and achieved. They describe how the tasks and functions of different departments should be performed to meet the requirements of ISO: 17025standard at the micro level. In general, it describes six key issues for the activity. For a detailed list of procedures to check our website and download our ISO certification
17,025 demo documentation.

Work instructions ISO 17025

The standard requires work instructions to be available, where the absence of this instruction would be detrimental to ISO 17025. In the practical sense, work instructions can be written, drawings, photographs, computer menu items, machine care / operation, the work of production documentation, work instructions etc. deals with the shop floor of activities. Their goal is clearly to direct the operator as to what should be done, and what is the manufacturing standard is needed to control the important aspects. The instructions must clearly identify:

"What needs to be done?

"The correct sequence of activities.

"The ISO 17025 special conditions, eg temperature, humidity, cleanliness etc.

"The reference to standards and codes of practice that must be met

In the case of special processes, work instructions are a mandatory part and for that, detailed instructions are necessary. These work instructions should be written in the local language, so they are easily understood by operators. For laboratory or QC activity and calibration of instruments operating procedure is documented describing how the particular activity should be done.

ISO 17025: Forms and Records

Forms, documents, etc. are documents used by the company to record information for various procedures. They link the activities in the procedure of written records maintained in the department. This documentation serves to demonstrate that the ISO 17025 system works effectively to produce the product in accordance with specified requirements of the ISO 17025 system. They must be legible, readily retrievable and available when requested by the auditor. On all forms of control over them establish appropriate document. As a part of society can also prepare the documentation checklist and check the ISO 17025 system with the help of checklist.

This is a commitment to ISO 17025 and a demonstration of commitment through documentation. This documentation is a Herculean task. The company must prepare ISO 17025 manuals, procedures and work instructions and supporting materials also meet the requirements of the standard. In the literature, it must be kept in mind that ISO 17025 Manual, ISO 17025 and procedure records should be linked to each other. Link to record in the manual procedure and the procedure in ISO 17025 manual must be done to make the system more visible and transparent. The user must take care to release procedures, so they are understandable, applicable and binding.