Q-Policy statement

Q-manual

Instructions and forms

Procedures (SOPS)

Documentation systemDocumentation system

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

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

Internal documents; specifications, Internal documents; specifications, instructions manuals etc.instructions manuals etc.

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

Documents = Electronic or paper copiesDocuments = Electronic or paper copies

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

All documents reviewed and approved by authorised All documents reviewed and approved by authorised personelpersonel

Master list identifying current revision status and Master list identifying current revision status and distributiondistribution

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

Periodically reviewedPeriodically reviewed Invalid or obsolete documents are promptly removed and Invalid or obsolete documents are promptly removed and

suitably marked if retained for knowledge preservation suitably marked if retained for knowledge preservation purposepurpose

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

Document control - 3Document control - 3(ISO 17025: 2005 4.3)(ISO 17025: 2005 4.3)

Document changesDocument changes Changes reviewed and approved by same function of Changes reviewed and approved by same function of

original revieworiginal review

Where practical altered/new text is identifiedWhere practical altered/new text is identified

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

Procedure describing changes in electronic documentsProcedure describing changes in electronic documents

Quality policy statementQuality policy statement(ISO 17025: 2005, 4.2)(ISO 17025: 2005, 4.2)

Written according to current version of ISO Written according to current version of ISO 1702517025

Independent or included in ManualIndependent or included in Manual Including the management’s commitment Including the management’s commitment

to meet requirements and to continually to meet requirements and to continually improve the QMSimprove the QMS

Communicated and understood by staffCommunicated and understood by staff Reviewed for continous suitabilityReviewed for continous suitability

Quality manual Quality manual (ISO 17025: 2005 4.2)(ISO 17025: 2005 4.2)

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

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

Roles and responsibilities of technical Roles and responsibilities of technical management and quality manager shall be management and quality manager shall be defineddefined

Quality manual contents -1Quality manual contents -1

TitleTitle Table of contentsTable of contents Proof of reviewProof of review Revision number, issue dateRevision number, issue date Tracking of changesTracking of changes Information related to organization (name,adress, Information related to organization (name,adress,

activities history,size etc)activities history,size etc) Mention the standard on which QMS is basedMention the standard on which QMS is based Scope of QMSScope of QMS

Quality manual contents - 2Quality manual contents - 2

Quality Policy or referenceQuality Policy or reference Responsibilities (organizational chart, Responsibilities (organizational chart,

description of functionsdescription of functions Description of the QMS ( processes and their Description of the QMS ( processes and their

interactions)interactions) Structure of QMS documentation Structure of QMS documentation Written procedures or references to themWritten procedures or references to them ReferencesReferences AnnexesAnnexes

SOP’S and WorkinstructionsSOP’S and Workinstructions

Harmonized formatHarmonized format Uniquely identifiedUniquely identified Proof of reviewProof of review Tracking of changesTracking of changes Defined structure: Name organization, title, Defined structure: Name organization, title,

purpose, scope,responsabilities/authorities, purpose, scope,responsabilities/authorities, description activity (including resources needed)description activity (including resources needed)

Related documents and formsRelated documents and forms ArchivingArchiving

External documentationExternal documentation

PharmacopoeiasPharmacopoeias LegislationLegislation StandardsStandards GuidelinesGuidelines Reference material certificatesReference material certificates User Manuals equipmentUser Manuals equipment SoftwareSoftware External calibration reportsExternal calibration reports

Forms Forms

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

Title, unique identification, revision index, Title, unique identification, revision index, issue date issue date

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

External documentationExternal documentation

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

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

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

PlansPlans

Plans apply to a specific situationPlans apply to a specific situation Examples :sampling, testing, validation, Examples :sampling, testing, validation,

auditing training etcauditing training etc Define the purpose of the planDefine the purpose of the plan Unique identification Unique identification Proof of approval Proof of approval For plans specific forms can be used For plans specific forms can be used

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

Procedure required for identification, Procedure required for identification, maintenance, storagemaintenance, storage

Legible and easy retrievableLegible and easy retrievable

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

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

Retention time establishedRetention time established ArchivedArchived in suitable environment in suitable environment Held secure and in confidenceHeld secure and in confidence Electronic records: back-up and protection Electronic records: back-up and protection

against unauthorized access or amendmentsagainst unauthorized access or amendments Mistakes crossed out (original entry still visble) Mistakes crossed out (original entry still visble)

and signed and datedand signed and dated (ISO 17025:2005, 5.4.7)(ISO 17025:2005, 5.4.7)

Calculations and data transfer (appropriate Calculations and data transfer (appropriate checks)checks)

Review of documents and approvalReview of documents and approval

Review:Review: By competent personel to check clarity, accuracy, adequacy of By competent personel to check clarity, accuracy, adequacy of

content and structurecontent and structure

By users to verify information, practical useBy users to verify information, practical use

Approval:Approval:

By management responsible for application of the procedureBy management responsible for application of the procedure

Controlled copies should show proof of approvalControlled copies should show proof of approval

Proof of approval should be keptProof of approval should be kept

Distribution of QMS-documents-1Distribution of QMS-documents-1

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

Controlled distributionControlled distributionPaper:Paper: Distributed where neededDistributed where needed Obsolete original archived and copies retrievedObsolete original archived and copies retrieved

Electronic:Electronic: Only QA-manager has write –accessOnly QA-manager has write –access Retrieval of obsolete file and access to new fileRetrieval of obsolete file and access to new file

Distribution of QMS-documents-2Distribution of QMS-documents-2

Non-controlled copies:Non-controlled copies: Clearly identified as non-controlled copyClearly identified as non-controlled copy Inform the receiver that no information of Inform the receiver that no information of

updates will be givenupdates will be given

Archiving of records Archiving of records (ISO 17025:2005, 4.13)(ISO 17025:2005, 4.13)

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

Normally minimal 5 years Normally minimal 5 years Related documents have to be also Related documents have to be also

available (SOP’s)available (SOP’s)

Experience of participants Experience of participants

Choice of authorChoice of author Review of documents: period and Review of documents: period and

procedureprocedure Changes in documentsChanges in documents Content: How detailed is a description of a Content: How detailed is a description of a

procedureprocedure Procedure to inform workers about new Procedure to inform workers about new

changed documents changed documents Choice to refer or repeat informationChoice to refer or repeat information