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Documentation system PowerPoint PPT Presentation


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Documentation system. Q-Policy statement. Q-manual. Procedures (SOPS). Instructions and forms . Document control -1 (ISO 17025: 2005,4.3). Laboratory shall establish and maintain procedures to control all documents of the management system

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Documentation system

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Documentation system l.jpg

Documentation system

Q-Policy statement

Q-manual

Procedures (SOPS)

Instructions and forms


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Document control -1(ISO 17025: 2005,4.3)

  • Laboratory shall establish and maintain procedures to control all documents of the management system

  • Internal documents; specifications, instructions manuals etc.

  • External documents; normative documents regulations, standards etc.)

  • Documents = Electronic or paper copies


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Document control - 2 (ISO 17025: 2005,4.3)

  • All documents reviewed and approved by authorised personel

  • Master list identifying current revision status and distribution

  • Documents should be available at all locations where operations are performed

  • Periodically reviewed

  • Invalid or obsolete documents are promptly removed and suitably marked if retained for knowledge preservation purpose

  • Unique identified: date and /or revision, page numbering including total pages and issuing authorithies


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Document control - 3(ISO 17025: 2005 4.3)

Document changes

  • Changes reviewed and approved by same function of original review

  • Where practical altered/new text is identified

  • If amendment by hand is allowed define procedures and authorities for amendments

  • Procedure describing changes in electronic documents


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Quality policy statement(ISO 17025: 2005, 4.2)

  • Written according to current version of ISO 17025

  • Independent or included in Manual

  • Including the management’s commitment to meet requirements and to continually improve the QMS

  • Communicated and understood by staff

  • Reviewed for continous suitability


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Quality manual (ISO 17025: 2005 4.2)

  • QMS policies related to quality (including a quality policy statement) shall be defined in a quality manual

  • Quality manual includes or make reference to the procedures. Outline of structure of documentation is given.

  • Roles and responsibilities of technical management and quality manager shall be defined


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Quality manual contents -1

  • Title

  • Table of contents

  • Proof of review

  • Revision number, issue date

  • Tracking of changes

  • Information related to organization (name,adress, activities history,size etc)

  • Mention the standard on which QMS is based

  • Scope of QMS


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Quality manual contents - 2

  • Quality Policy or reference

  • Responsibilities (organizational chart, description of functions

  • Description of the QMS ( processes and their interactions)

  • Structure of QMS documentation

  • Written procedures or references to them

  • References

  • Annexes


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SOP’S and Workinstructions

  • Harmonized format

  • Uniquely identified

  • Proof of review

  • Tracking of changes

  • Defined structure: Name organization, title, purpose, scope,responsabilities/authorities, description activity (including resources needed)

  • Related documents and forms

  • Archiving


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External documentation

  • Pharmacopoeias

  • Legislation

  • Standards

  • Guidelines

  • Reference material certificates

  • User Manuals equipment

  • Software

  • External calibration reports


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Forms

  • Adequate to record data to prove compliance with the QMS requirements

  • Title, unique identification, revision index, issue date

  • Procedures / instructions should mention the forms to be used related to the described activity or be annexed to them


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External documentation

  • Documents of external origin, which are part of the QMS or can have a large influence on the system should be controlled

  • Review: updates of external docs are followed by documentated evaluation of the impact on internal QMS documents, if necessary internal QMS docs are updated

  • Also check by update of internal docs if referred external docs are still valid


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Plans

  • Plans apply to a specific situation

  • Examples :sampling, testing, validation, auditing training etc

  • Define the purpose of the plan

  • Unique identification

  • Proof of approval

  • For plans specific forms can be used


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Registration of records -1( ISO 17025:2005,4.13)

  • Procedure required for identification, maintenance, storage

  • Legible and easy retrievable

  • Fully traceability of test circumstances (give information to identify factors affecting the uncertainity and to enable the test under the same conditions, including identity of personel acting in the tests.


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Registration of records- 2(ISO 17025:2005,4.13)

  • Retention time established

  • Archived in suitable environment

  • Held secure and in confidence

  • Electronic records: back-up and protection against unauthorized access or amendments

  • Mistakes crossed out (original entry still visble) and signed and dated(ISO 17025:2005, 5.4.7)

  • Calculations and data transfer (appropriate checks)


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Review of documents and approval

Review:

  • By competent personel to check clarity, accuracy, adequacy of content and structure

  • By users to verify information, practical useApproval:

  • By management responsible for application of the procedure

  • Controlled copies should show proof of approval

  • Proof of approval should be kept


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Distribution of QMS-documents-1

The system’s documentaion shall be communicated to, understood by, available to and implemented by the appropriated personnel

Controlled distribution

Paper:

  • Distributed where needed

  • Obsolete original archived and copies retrieved

    Electronic:

  • Only QA-manager has write –access

  • Retrieval of obsolete file and access to new file


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Distribution of QMS-documents-2

Non-controlled copies:

  • Clearly identified as non-controlled copy

  • Inform the receiver that no information of updates will be given


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Archiving of records (ISO 17025:2005, 4.13)

  • For the chosen period follow national and specific regulations according to the tests carried out

  • Normally minimal 5 years

  • Related documents have to be also available (SOP’s)


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Experience of participants

  • Choice of author

  • Review of documents: period and procedure

  • Changes in documents

  • Content: How detailed is a description of a procedure

  • Procedure to inform workers about new changed documents

  • Choice to refer or repeat information


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