NAME OF LABORATORY

PROCEDURES MANUAL

PROCEDURES MANUAL No P 402 P 403 P 404 P 405 P 461 P 462 P 463 P 408 P 409 P 410 P 411 P 413 P 414 P 415 P 501 P 531 P 532 P 504 P 508 Procedure Quality system documentation Document control Contract review Referral laboratories Supplier review Purchasing Verification of purchased products Customer complaints and feedback Identification and control of non-conformities Corrective actions Preventive actions Control of quality and technical records Internal audits Management review Training Preventive maintenance Calibration Sample preparation and identification Reporting of the results Version 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Issue date 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02 03/06/02

P 402 Quality system documentation

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NAME OF LABORATORY

PROCEDURES MANUAL

1. Purpose and scope The purpose of this procedure is to establish and maintain a quality system which complies with the requirements of the ISO 15189 standard and to write quality system documentation in accordance with ISO 15189. This procedure applies to the integral quality management system of our laboratory. 2. Procedure-Sections
40201 40202 40203 Quality manual Structure of documentation Procedures

3. Documents 3.1. System documents 3.2. Specific documents 3.3. External documents 4. Method 40201 Quality manual version 1 03/06/2003

The Quality Manager has the responsibility and the authority to establish and maintain a quality management system which ensures that our tests meet specified requirements. The Quality Manager has been instructed by the Management to draft a quality manual which complies with the international standard ISO/DIS 15189: 2003. The quality manual consists of: - an overview of the quality management system and the quality policy - procedures with concrete arrangements and methods - process plans - instructions

Written by

Checked by

Approved by

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NAME OF LABORATORY

PROCEDURES MANUAL

40202 Structure of the documentation version 1 03/06/2003 The numbering of the quality manual and the procedures refers to the different sections of the standard ISO 15189. For the quality manual, the reference consists of the number of the corresponding ISO 15189 requirement. The reference of the procedures consists of the character "P" followed by three digits: the digits refer to the corresponding ISO 15189 requirements. Every procedure is divided into several "procedure-sections". These procedure-sections have a reference of five digits: the first three refer to the corresponding ISO 15189 requirement and the last two indicate the rotation number. The instructions have the code "IN" followed by a rotation number. The system documents are indicated by the character "D". For documents which are directly related to procedures, the character "D" is followed by five digits: the first three refer to the corresponding ISO 15189 requirement and the last two indicate the rotation number. Specific documents have the code "DS" followed by a rotation number. External documents have the code "DEX" followed by a rotation number.

40203 Procedures

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The procedures are consistent qua contents with the requirements of the ISO 15189 standard and the quality policy of our laboratory. The procedures always contain: - the name of the procedure - the current version and the revision date - the objective and scope - the procedure-sections with reference and title, current version and revision date - the associated documents with reference, title, current version and revision date - the method

Written by

Checked by

Approved by

The procedures are supplemented by instructions, when the absence of such instructions would harm the quality of the tests provided by our laboratory.

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Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 403 Control of documents 18/06/11 version 1 03/06/2003 4 / 63 . 5. checked and approved the document. a footnote mentions who wrote. When necessary. special points for attention are mentioned at the bottom of the instructions. a method which reproduces the tasks to fulfill and a final condition.NAME OF LABORATORY PROCEDURES MANUAL The instructions contain an initial condition. For both procedures and work-instructions.

1. Procedure-Sections 40301 40302 40303 40304 40305 40306 40307 40308 40309 Control of changes in the manual Request for revision of a document Release of documents Information on documents and forms Request and control of int.2. their review. This procedure deals with the development and change of quality documents. 2. distribution and administration manuals Control of the PC' s Control of passwords Software changes 3. This procedure also describes the method of protecting and saving computer files. Documents 3. documents Control.NAME OF LABORATORY PROCEDURES MANUAL 1. System-documents D 40301 Overview of the procedures D 40302 Overview of the processes D 40303 Overview of the instructions D 40304 Overview of the responsibilities D 40305 Overview of the documents D 40306 Document change request D 40307 Distribution of the manuals D 40308 Contents of the dossiers D 40309 Distribution of the dossiers 3. their approval. Purpose and scope The objective of this procedure is to establish and maintain a method of controlling documents and data throughout our laboratory. Method 40301 Control of changes version 1 03/06/2003 18/06/11 5 / 63 . External documents Written by Checked by Approved by 4. Specific documents 3. This procedure applies to all quality documents and to other data required by ISO 15189 (including external documents). their announcement and their distribution.3. en ext.

the new or revised procedure. 18/06/11 6 / 63 . 40302 Request for revision of a document version 1 03/06/2003 Any individual within the organization may request to add. with one date and one version for all documentation. the initiator of the request will be informed.Procedures and instructions are paraphed in the footnote. instruction or document is approved and paraphed by the Managing Director. procedure. When necessary. When the document change request is definitively refused. the Quality Manager can decide to re-issue the whole manual.External documents are approved via their respective lists. This method is repeated till the quality meeting accepts the request or definitively refuses it. 40303 Release of documents version 1 03/06/2003 If acceptable. where necessary. When necessary. process plan. the individual submits. the Quality Manager will write a new request. . revise or delete a quality document (policy. The requests and the associated remarks are discussed during the quality meeting. He ensures that the version and date are updated. . The parties involved inform the Quality Manager of their remarks on this request. the request along with appropriate attachments to the Quality Manager. The Quality Manager enters the definitive change into the access-database. in writing. and that the changed documents are distributed to the parties involved.ISO 15189-system-documents are approved via the procedure which contains them. . Written by Checked by Approved by For procedures and instructions approval always follows after the discussion of the document change request during the quality meeting.NAME OF LABORATORY PROCEDURES MANUAL The Quality Manager distributes each document change request to the parties involved. whereas documents can be approved at once by the Managing Director. In this case. work instruction or form).

version 1 03/06/2003 Written by Checked by Approved by 40306 Control and distribution of the manuals General: The Quality Manager is responsible for: 18/06/11 version 1 03/06/2003 7 / 63 . instructions of documents: When a staff member wants to have a specimen of a procedure. safety-data. Quality dossier: every owner of a quality dossier updates the appropriate documents and replaces new revisions. The Quality Manager distributes the external documents and ensures that the latest versions of the documents are put into circulation. The Quality Manager observes the use of the new or changed documents and communicates potential problems during the quality meeting. Control of internal documents: Manual: the owner of a complete manual updates the appropriate documents and replaces new revisions in his controlled copy. the analysis of products. Invalid.documents Request for (internal) procedures. external documents are destroyed. instruction or document which hasn't been part of his quality dossier. 40305 Request and control of intern. This announcement shall be mentioned on the report of the quality meeting. The Quality Manager decides whether the staff member can get what he asked. Software-packages also are considered as external documents. technical data which are part of the quality management system.NAME OF LABORATORY PROCEDURES MANUAL 40304 Information on documents and forms version 1 03/06/2003 The Quality Manager informs the parties involved of the changes in procedures. external price lists. instructions or documents and of the introduction of new procedures. Control of external documents: External documents which affect quality are among others the regulatory and legal requirements. he can ask one to the Quality Manager. and extern. instructions or documents. The external documents are marked with a date and are listed on the list of external documents.

Written by Checked by Approved by He reports his findings to the Managing Director during the quality meetings. .the control of the originals of all manuals and documents. Composition and maintenance of reference lists: The current version of the procedures. Control of completed quality records: The preservation of quality records is described in procedure P 413. he proposes measures to improve the system and he inspects their implementation. In some exceptional cases (for example for legal reasons) the Quality Manager is allowed to keep invalid specimens. This is not the case for blank forms.NAME OF LABORATORY PROCEDURES MANUAL . Well functioning of the system: The Quality Manager regularly verifies if all rules concerning the control of documents are followed.the maintenance of the document control system Control of the original manuals and documents: The original documents (with the original signatures of the involved managers and printed on white paper) are kept by the Quality Manager. which can be copied by their users.the composition and maintenance of reference lists .the control of completed forms . Distribution of the manuals: 18/06/11 8 / 63 . The index of the quality dossiers indicates which quality records must be kept by the dossier owner. The copies are on colored paper. instructions or documents are destroyed by the Quality Manager or by their owner. including the computerfiles and the back-ups. Only the Quality Manager has the authority to make copies of these documents (or manuals). The revised procedures. instructions and other documents and the modified indexes are distributed by the Quality Manager Control of obsolete quality documents: In general obsolete or invalid procedures.the control of obsolete documents . These specimens are identified by the word "obsolete". the instructions and the documents is mentioned on the index of the manual involved or on the index of the quality dossier. When he finds violations. where possible.

This password is known only by the user himself and by the Quality Manager. version 1 03/06/2003 Written by Checked by Approved by 40309 Control of passwords version 1 03/06/2003 The Quality Manager has the disposal of a list with passwords. the Quality Manager decides whether the applicant can get what he asked. Virus protection: A virus scan is executed while bringing in an unknown diskette. 18/06/11 9 / 63 . and moreover to all managers which are mentioned on the quality manual distribution list. If a password changes. The passwords are changed once a year. instructions and documents are distributed in a controlled manner via the quality dossiers of the collaborators. when necessary. the adjustment of the tables of contents of the quality dossiers. 40307 Control of the PC's Admittance protection: Every PC is protected by a password for every user. When a collaborator asks for a specimen of a procedure. Procedures. an instruction or a document which is not part of his quality dossier. The Quality Manager is responsible for this and ensures that all uncontrolled documents are provided with the word "uncontrolled". the Quality Manager sees to it that a daily back-up is taken of the changed files. The uncontrolled documents only are valid at the moment of their issue.NAME OF LABORATORY PROCEDURES MANUAL Integral manuals are minimally distributed to the Managing Director and the Quality Manager. Data protection: To ensure that as few data as possible is accidentally lost. he will revise the list. The Quality Manager is responsible for the determination and. Manuals or documents can also be given in an uncontrolled manner to a person who asks them.

P 462.NAME OF LABORATORY PROCEDURES MANUAL The Quality Manager regularly checks whether the passwords are changed sufficiently often. Purpose and scope version 1 03/06/2003 18/06/11 10 / 63 . 40310 Software changes version 1 03/06/2003 Every request for changing software is discussed by the Quality Manager during the quality meeting or during a special meeting in attendance of all users of the software involved. 5. Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 404 Review of contracts 1.writing or adjusting the necessary instructions . The Quality Manager evaluates the changes and reports his findings during the quality meeting. The Quality Manager ensures that no software change is implemented without: .training the users . The Quality Manager purchases new software as per the purchasing procedure. The proposed changes and their potential impact are discussed.making a broad test-run An action plan is set up.

The contracts have to be reviewed. which also includes the result (order.2.1. no answer). Documents 3. the client will be contacted to find a solution for every requirement which can not be met unambiguously by our laboratory. Requirements not specified by the client. When an enquiry to tender is unclear or incomplete or when the tender can 't be carried out fully in accordance with the client requirements. External documents 4. System documents D 40401 Tests that are offered by our lab D 40402 Specifications of our tests 3. no order.Requirements differing from those in the tender have to be resolved before accepting a contract. but which are necessary for the defined.NAME OF LABORATORY PROCEDURES MANUAL The purpose of this procedure is to define the method for the review of contracts. is retained. . Specific documents 3. implied or intended use of the ordered test.The tenders have to be reviewed. . Method 40401 Invitations to tender version 1 03/06/2003 All enquiries to tender are handled by the Departmental Manager. 2. . are also identified (including regulatory and statutory requirements). . . Written by Checked by Approved by All client arrangements and the pertinent discussions with the client relating to the client's requirements are noted down on the tender. 18/06/11 11 / 63 . A copy of the tender made.3. Then the Departmental Manager paraphs and releases the tender.The requirements have to be adequately defined and documented before accepting a contract. Procedure-Sections 40401 40402 40403 Invitations to tender Orders Order changes 3.The capability to meet the contractual requirements has to be assessed before accepting a contract. The Departmental manager can decide to renounce the tender and then he informs the client.

18/06/11 12 / 63 . the made arrangements will be fastened down and confirmed. When the order change request is not accepted. The Departmental Manager decides when the order can be carried out. 40403 Order changes A. The Departmental Manager assesses the consequences of the request: the consequences for the price and the necessary time for the execution of the order. Records are maintained of pertinent discussions with the client relating to the results of the work during the period of execution of the contract. When the order is unclear. He also examines if the technical capacity of our laboratory is sufficient. The client requests an order change: version 1 03/06/2003 On receipt of an order change request. Written by Checked by Approved by B. The agreement is made over in writing to the client and at the same time the invoice with the payment conditions is transmitted. the Departmental Manager will contact the client to find a solution for the indistinctness. Our laboratory requests an order change: The Departmental Manager is responsible for the execution of the order within the premised time. the Departmental Manager writes an order change request. the Departmental Manager will inform the client.NAME OF LABORATORY PROCEDURES MANUAL 40402 Orders version 1 03/06/2003 The Departmental Manager receives an order from a client. the Departmental Manager makes a note. When necessary. When the request is accepted. When this is not possible because of exceptional circumstances. He makes a note of the person to be contacted. he re-negotiates the order. Then the change is forwarded to the functions concerned in the laboratory. Then the Departmental Manager decides if the order change request can be accepted.

The change is forwarded to the functions concerned in our laboratory. he modifies the proposal. Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 405 Examination by referral laboratories version 1 03/06/2003 1. He negotiates if the request is acceptable for the client and when necessary. 5. Objective and field of application 18/06/11 13 / 63 . The made agreements are fastened down and confirmed.NAME OF LABORATORY PROCEDURES MANUAL The Departmental Manager contacts the client and communicates the request.

Method 40501 Arrangement with referral laboratories version 1 03/06/2003 The laboratory director is responsible for selecting and monitoring the quality of referral laboratories and consultants and ensures that the referral laboratory or referral consultant is competent to perform the requested examinations. cytology and related disciplines. documented and understood . . Procedure-sections 40501 Arrangements with referral laboratories 40502 Registration 40503 Reports 3.the referral laboratory is able to meet the requirements and that there are no conflicts of interest.1. Records of such reviews are maintained (mention the documents involved).selection of examination procedures is appropriate for the intended use. The laboratory director periodically reviews the arrangements with referral laboratories to ensure that: .2.NAME OF LABORATORY PROCEDURES MANUAL This procedure defines the method of evaluating and selecting referral laboratories as well as consultants who are to provide second opinions for hispatology.respective responsibilities for the interpretation of examination results are clearly defined. are adequately defined. Documents 3. System documents D 40501 Referral laboratories 3. External documents 4. including the pre-examination and post-examination procedures.3. and . 2. 18/06/11 14 / 63 . The field of application covers all referred tests and examinations. Written by Checked by Approved by 40502 Registration version 1 03/06/2003 Our laboratory maintains a register of all referral laboratories that it uses (D 40501). Specific documents 3.requirements.

The referring laboratory director may elect to provide additional interpretative remarks to those. If the referring laboratory prepares the report. without alterations that could affect clinical interpretation. However. if any. it does not require that the referring laboratory report includes every word and have the exact format of the referral laboratory report. 40503 Reports version 1 03/06/2003 The name and address of the laboratory responsible for the examination result is provided to the user of laboratory services. it includes all essential elements of the results reported by the referral laboratory. Purpose and scope version 1 03/06/2003 18/06/11 15 / 63 . unless national/local laws or regulations require it. The referring laboratory and not the referral laboratory is responsible for ensuring that referral laboratory examination results and findings are provided to the person making the request. A duplicate of the laboratory report is retained in both the patient record and in the permanent file of the laboratory. of the referral laboratory.NAME OF LABORATORY PROCEDURES MANUAL A register is kept of all samples that have been referred to another laboratory (mention which document). Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 461 Supplier evaluation 1. The author of such added remarks are clearly identified. 5. in the context of the patient and the local medical environment.

1. Specific documents 3. Documents 3. The criteria for the selection are the price. The concerned manager evaluates the received tenders against the requirements and. when applicable.NAME OF LABORATORY PROCEDURES MANUAL The purpose of this procedure is to establish and maintain a method of ensuring that purchased products conform to specified requirements and of evaluating and selecting suppliers.the date .a precise description of the products . The concerned manager decides whether the new supplier can be accepted. quality and delivery time.the name of the supplier .signature of the concerned manager Our laboratory always asks a written tender to the supplier. This procedure applies to all products and services that affect quality. System documents D 40601 Supplier problems since one year D 40602 Supplier review D 40603 Approved suppliers D 40604 Suppliers on probation 3.the number of products . The inquiry to tender or the product specification includes the quality requirements.3. External documents 4. 2. The inquiry to tender contains at least: . 18/06/11 16 / 63 . Written by Checked by Approved by This evaluation is noted down on the tender itself. Procedure-Activities 46101 46102 Selection of new suppliers Review of suppliers 3. including quality requirements. he evaluates them by means of a comparison between the different tenders. Method 46101 Selection of new suppliers version 1 03/06/2003 The Departmental Manager selects a supplier on the basis of his ability to meet contractual requirements.2.

commercial attitude 18/06/11 17 / 63 . ascertained after the delivery. Follow-up of the corrective actions takes place during the quality meetings or earlier when necessary. Suppliers on probation are mentioned separately. Supplier review All supplier problems (noted down on a corrective action request) are grouped by the different suppliers. They are noted down on the corrective action request. transportation damage. version 1 03/06/2003 Written by Checked by Approved by This review is based on five criteria: . When it is necessary to contact the supplier to take immediate measures. In this case the order documents must clearly indicate that it concerns an order on probation. insufficient documentation. but also late deliveries. Resolution of the non-conformity The concerned manager negotiates with the supplier about immediate and corrective measures.quality on receipt . bad packing. C. Once a year a review of all suppliers affecting quality.NAME OF LABORATORY PROCEDURES MANUAL When necessary the concerned manager can decide to make an order on probation. electricity. is noted down on a corrective action request. Registration of every non-conformity Every supplier non-conformity. the Departmental Manager will be informed. wrong deliveries. The concerned manager notes down the selected supplier on the list of approved suppliers..furnished documents . on behalf of both the supplier and our laboratory. A supplier non-conformity can concern the quality of the delivered product or service.. B.. 46102 Review of suppliers A. and current office material are not mentioned. The concerned product is also mentioned. is made by the Quality Manager.quality during use . Suppliers of ordinary products like water.

On the basis of the yearly evaluation or earlier on the basis of ascertained supplier nonconformities. The Quality Manager modifies the list of approved suppliers.delivery behavior This review is written on the document "supplier review".NAME OF LABORATORY PROCEDURES MANUAL . asking to take measures. a decision is made on the measures with respect to the concerned supplier (for example sending of a notice. removing from the list of approved suppliers...). 5. Purpose and scope 18/06/11 version 1 03/06/2003 18 / 63 .. Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 462 Purchasing 1.

External documents 4. 2.2.NAME OF LABORATORY PROCEDURES MANUAL This procedure defines which criteria the purchase documents have to meet to prevent wrong deliveries. but when the inquiry to tender was expressed verbally. Procedure-Sections 46201 46202 46203 46204 46205 Inquiry to tender Order Investment planning Budget and release of investments Purchase of investment goods 3.3. The inquiry to tender includes at least: .application of the supplier evaluation procedure (list of approved suppliers).name of the supplier .1.former experience with the supplier . Documents 3. delivery time . System documents D 40607 Overview of the purchased product D 40608 Specification of a purchased product 3.price.precise description of the products . a note is made of the inquiry.signature of the responsible manager. The procedure applies to all products and services affecting quality and also to all boardingouts. The concerned manager notes down the evaluation on the tender itself.number . Specific documents 3. Written by Checked by Approved by 46202 Order version 1 03/06/2003 18/06/11 19 / 63 . Method 46201 Inquiry to tender version 1 03/06/2003 The inquiry to tender can be verbal or written.date . The tenders are compared and evaluated against: .

reference applicable standards and other relevant technical data and state quality and compliance requirements. the investment budget is assessed and approved by the Managing Director.identification of the order-form . 18/06/11 20 / 63 .precise description of the products . All order forms are prepared by Purchasing.signature of the concerned manager. a new order-form is completed with a clear indication that it concerns an order change.destination of the products . The request for investment consists of a reasoned report (with an estimation of the costs). 46204 Budget and release of investments The investments are subdivided into the following categories: . Annually in November.expansion investments Written by Checked by version 1 03/06/2003 Approved by For each category the pay-back-period is determined. They include precise identification of the products/services. The forms clearly describe ordered products/services. An order-form is used.NAME OF LABORATORY PROCEDURES MANUAL Orders can only be placed with suppliers that are on the Approved Supplier List and that haven't obtained a score lower than 7 during the yearly supplier review or earlier on the basis of a non-conformity. 46203 Investment planning version 1 03/06/2003 The Departmental manager determines once a year the investment needs in his department.person who places the order . The determined needs are annually forwarded to the Managing Director in October. When an order needs to be changed.replacement investments . This form minimally contains: .safety investments .person who will receive the order .name of the supplier . The new order form mentions the date or identification of the original order form.date .quality investments .number of products .

This evaluation is noted down and is forwarded to the Managing Director. Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 463 Verification of purchased product 18/06/11 version 1 03/06/2003 21 / 63 .NAME OF LABORATORY PROCEDURES MANUAL Then the specific investments are discussed during the quality meetings. the quality meeting decides to purchase and to invest. 5. On the basis of the tenders forwarded by the Departmental Manager. The Managing Director releases the purchase by signing the order-form. 46205 Purchase of investment goods version 1 03/06/2003 The Departmental Manager is responsible for the inquiry to tender of investment goods. The tender is evaluated by the Department Manager.

46302 Supplier verification at subcontractor's premises version 1 03/06/2003 To obtain an adequate level of assurance the Quality Manager will determine whether it is necessary to carry out surveillance and/or product acceptance at subcontractor's premises and to specify the appropriate quality assurance requirements. External documents 4. Method 46301 Customer verification of subcontracted product version 1 03/06/2003 When specified in the contract.1.3. System documents 3. Specific documents 3.NAME OF LABORATORY PROCEDURES MANUAL 1. Customer verification doesn't free our laboratory from the responsibility to deliver the highest quality. nor does it exclude later customer disapproval. Revision history 18/06/11 22 / 63 . Procedure-Activities 46301 46302 Customer verification of subcontracted product Supplier verification at subcontractor's premises 3. Written by Checked by Approved by 5. Documents 3. the Quality Manager is responsible for allowing the customer or his representative to visit suppliers or verify goods. 2. Purpose and scope This procedure defines the way in which our laboratory will verify purchased products. The procedure applies to all purchased products and services affecting quality.2. Agreements on the verification and the requirements are mentioned on the order-form.

NAME OF LABORATORY PROCEDURES MANUAL REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 408 Client feedback and complaints version 1 03/06/2003 18/06/11 23 / 63 .

2. the conversation with the client.3. All client enquiries are recorded.1.identification of the client (may not be applicable for feedback) . Classification of the client feedback and complaints 18/06/11 24 / 63 . are forwarded to the customer service department. Method 40801 Client feedback A. Receiving and logging client feedback All after-sale client communication. Specific documents 3. or immediately following.category classification The feedback recorded by the customer service department. Verbal communication by phone is documented in a memo which is written during. whether written or verbal.reference number . Documents 3. version 1 03/06/2003 Written by Checked by Approved by B. The records for client feedback include: .reference to the concerned order (may not be applicable for feedback) . External documents 4.NAME OF LABORATORY PROCEDURES MANUAL 1. Procedure-Activities 40801 40802 40803 Client feedback Registration of client complaints Handling of client complaints 3. patients or other parties. This procedure concerns all complaints and other feedback received from clinicians.brief description of the feedback . Purpose and scope The objective of this procedure is to establish and maintain a method of receiving and processing client feedback and complaints. 2. System documents D 40803 Client complaints since one year D 40804 Client feedback 3.

The purpose is to allow for better tracking of trends and evaluating improvements in specific domains.NAME OF LABORATORY PROCEDURES MANUAL Client feedback is assigned to an appropriate category.availability (responsibility: sales department) .distribution and delivery (responsibility: test department) .product information (responsibility: sales department) .samples damaged in delivery .nonconforming test results . The records for client complaints include: . Possible causes are: . price (responsibility: sales department) When necessary.wrong test results shipped Written by Checked by Approved by . Receiving and logging client complaints version 1 03/06/2003 Client complaints are recorded via a corrective action request filled in by the person who receives the complaint.packaging (responsibility: test department) .general enquiries (responsibility: sales department) . The complaint is entered into the access-database by the Quality Manager.late delivery to client .labeling problem . Classification of the client feedback and complaints Client complaints are classified according to their cause.cause of the complaint .problems with communication and responsiveness 18/06/11 25 / 63 . 40802 Client complaint registration A.brief description of the complaint .immediate action + executor The involved departmental manager is informed of the complaint.contracts.date . Responsible functions for each type of feedback have been defined. client inquiries are re-directed to these responsible functions.identification of the client . B.test performance (responsibility: test department) . Following catergories are used: .accuracy of the test results (responsibility: test department) .order handling and order changes (responsibility: sales department) .after-sale support and service (responsibility: service department) .

records of internal investigations may be merged with records of the corresponding corrective or preventive actions. This decision is recorded on the corrective action request.). referral laboratories or other external organizations contributed to the complaint. In general. the Quality Manager contacts these organizations and provides them with all relevant information. Every client complaint is recorded.complaints regarding business practices. records of complaint investigation are maintained by the department that conducts the investigation. which are maintained by Quality Assurance. and so forth. records of investigations that concerns testt performance or other test characteristics are maintained by Testing. Depending on the nature of the nonconformity. when applicable. reports and other documents related to a complaint. When the investigation of client complaints determines that remote operations. etc. Then the quality meeting can decide to take a corrective action. Written by Checked by Approved by 5. repair. Revision history 18/06/11 26 / 63 . records of investigations that involve referral laboratories or subcontractors are maintained by Purchasing. 40803 Client complaint handling version 1 03/06/2003 Customer Service and the function responsible for the complaint decide how to respond to the client and. For example. The client is informed of this decision. subcontractors. etc. publicity. When a client returns nonconforming tests results. Control of Nonconformities. these records are organized into a file and are identified with the complaint number. The records are maintained by the Customer Service. what needs to be done to correct the problem for the client (exchange. the test results are evaluated and inspected. The Quality Manager reviews every client complaint to determine whether it should be discussed during the quality meeting. refund. and are handled and processed in accordance with procedure P 409. When there are copies of written communication. the Quality Manager may follow up with requests for corrective and preventive actions.NAME OF LABORATORY PROCEDURES MANUAL .

NAME OF LABORATORY PROCEDURES MANUAL REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 409 Identification and control of non-conformities version 1 03/06/2003 18/06/11 27 / 63 .

customer complaints The procedure applies to every failure which is the consequence of disregarding made arrangements. a customer complaint or a supplier problem fill in a corrective action request (CAR) as per procedure P 410. The initiator of the corrective action request immediately contacts the Quality Manager.the identification of the non-conformity: is it a customer complaint.internal non-conformities . a supplier problem or an internal problem .1. Procedure-Sections 40901 40902 40903 40904 Registration of non-conformities Blocking of non-conforming tests Treatment of non-conformities Eliminating the root cause 3. This registration includes: .3.the executed immediate action When possible. The Quality Manager records the non-conformity on a corrective action request form and forwards the corrective action request to the involved manager.2.the description of the ascertained non-conformity . The procedure deals with: . the cause of the problem is indicated. corrective actions. System documents 41001 Corrective action request (CAR) 3.NAME OF LABORATORY PROCEDURES MANUAL 1. External documents 4. 2. Specific documents 3.supplier non-conformities . Purpose and scope The purpose of this procedure is to describe the method of handling non-conformities. Written by Checked by Approved by 40902 Blocking of non-conforming tests 18/06/11 version 1 03/06/2003 28 / 63 . Method 40901 Registration of non-conformities version 1 03/06/2003 Collaborators ascertaining an internal problem. Documents 3.

NAME OF LABORATORY PROCEDURES MANUAL When a collaborator ascertains a non-conformity. This decision is recorded on the corrective action request. 40904 Eliminating the root cause version 1 03/06/2003 If it is determined that nonconforming examinations could recur or that there is doubt about the laboratory's compliance with its own policies or procedures as given in the quality manual. If the quality of a test is affected by these non-conformities. He decides which measures have to be taken. the report is withheld (as necessary) and the Departmental Manager is informed. installations and reports are marked by the Departmental Manager. the impact on previous tests is assessed by the Departmental Manager. installations and reports are not processed or used until the Departmental Manager releases them. The Departmental Manager authorizes the resumption of the examinations. Written by Checked by Approved by 5. the examination is halted. Non-conforming samples. Revision history 18/06/11 29 / 63 . the requesting clinician will be informed (where appropriate). the procedure P 410. The results of nonconforming examinations already released are recalled or appropriately identified (if necessary). In case of a collaborator exercising a method in a wrong way. 40903 Treatment of non-conformities version 1 03/06/2003 The involved manager considers the medical significance of the non-conformities and decides if these examinations have to be done over again. Nonconforming samples. corrective actions will be implemented to identify. document and eliminate the root cause.

NAME OF LABORATORY PROCEDURES MANUAL REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 410 Corrective Actions 18/06/11 version 1 03/06/2003 30 / 63 .

NAME OF LABORATORY PROCEDURES MANUAL 1. When a collaborator notices a non-conformance. Purpose and scope This procedure defines the system for corrective actions in our laboratory. he completes the first section of a nonconformance report (CAR) with as much detail as possible. the results of internal and external audits and customer satisfaction surveys are taken into account. Especially customer complaints. quality objectives.1. Corrective actions are actions taken to correct the occurence of noncompliance and conditions adverse to quality. System documents 41001 Corrective action request (CAR) 41002 Action plan 3. analysis of data. Procedure-Sections 41001 41002 41003 41004 Continual improvement Immediate action Corrective action Control of corrective actions 3. the procedures. the resources. internal non-conformities. corrective and preventive actions and management reviews. the processes. 41002 Immediate action version 1 03/06/2003 When collaborators experience a problem or non-conformity.3. the tests are suspended and an immediate action is taken by the Departmental Manager to solve the problem. supplier problems. audit results. This procedure applies to the organization. Documents 3. Specific documents 3. the immediate action and the implementation responsibility. 18/06/11 31 / 63 . External documents 4. The CAR contains the nonconformance identification. Method 41001 Continual improvement version 1 03/06/2003 The management system is continuously improved through the use of the quality policy. Written by Checked by Approved by The concerned Departmental Manager monitors the implementation of the immediate action. 2. the personnel and the management of our laboratory.2.

the complete process is done over again. This corrective action is recorded on the corrective action request. Corrective actions are reviewed for long-term effects and process improvements via the management reviews.NAME OF LABORATORY PROCEDURES MANUAL Thereupon the CAR is submitted to the Quality Manager for review and entered into the CAR LOG and assigned a number by the Quality Manager. On the basis of that examination a corrective action is taken. 41004 Control of actions and projects version 1 03/06/2003 During the quality meetings the status of the actions is followed-up with the help of the action plans. 41003 Corrective action version 1 03/06/2003 By means of a periodic analysis of the registered data in the CAR LOG the Departmental Manager determines the frequency and the gravity of the various problems. Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 411 Preventive actions 18/06/11 version 1 03/06/2003 32 / 63 . When the measure was not effective. When necessary. He decides if a corrective action is necessary and therefore he examines with the involved collaborator the root cause of the non-conformity. extra measures are taken for planned actions which have not been finished in time or which cause unexpected troubles. The execution dates are noted down. 5. instructions or other elements of the quality management system. This measure can lead to changes in procedures. The Departmental Manager approves the implemented corrective action if it is found to be effective upon review.

External documents 4. quality results. System documents 41002 Action plans 41101 Project data 3. customer satisfaction inquiries. Written by Checked by Approved by The project document contains: 18/06/11 33 / 63 .NAME OF LABORATORY PROCEDURES MANUAL 1. Documents 3. the processes. Preventive actions are intended to prevent problems from occurring in the first place. the collaborators and the management of our laboratory. This procedure applies to the organization. 2. Purpose and scope This procedure defines the system of preventive actions and continual improvements in our laboratory. Method 41101 Continual improvement version 1 03/06/2003 The management system is continuously improved through the use of the quality policy. the results of internal and external audits and customer satisfaction surveys are taken into account.3. Procedure-Sections 41101 41102 41103 Continual improvement Preventive action Control of actions and projects 3. customer complaints and processes and activities which influence quality. The projectmanager fills in a project document and forwards it to the Quality Manager. audit results. internal non-conformities. supplier problems. the procedures. 41103 Preventive actions version 1 03/06/2003 The Quality Manager tries to discover potential causes of non-conformities and possible improvements with the help of audit results.1. Structuring via projects: The preventive measures are structured via projects with a responsible projectmanager. corrective and preventive actions and management reviews. quality objectives. the resources. analysis of data. Especially customer complaints. Specific documents 3.2.

implementation of the selected solution .purpose and wished results . The execution dates are recorded.responsible project manager . 41104 Control of actions and projects version 1 03/06/2003 During the quality meetings the status of the actions is followed-up with the help of the action plans.examination of the effectiveness.NAME OF LABORATORY PROCEDURES MANUAL . . Preventive actions are reviewed for long-term effects and process improvements via the management reviews.inquiry of alternative solutions .measuring method and units: how will it be possible to check if the project was successfull ? Each project is approved by the Managing Director. When necessary.planned date of effectiveness . Action plan: The project manager monitors the project action plan. This action plan includes the different actions necessary for the project implementation.selection of a solution . The project manager submits the relevant project data to the Managing Director.project team .analysis of the problem and/or current situation . extra measures are taken for planned actions which have not been finished in time or which cause unexpected troubles. The executed projects are reviewed for effectiveness during the quality meetings. Revision history 18/06/11 34 / 63 . Written by Checked by Approved by 5.name and number of the project .

NAME OF LABORATORY PROCEDURES MANUAL REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 413 Control of quality and technical records version 1 03/06/2003 18/06/11 35 / 63 .

the internal audit reports and the associated corrective and preventive actions . including the periodic management review of the quality system .records of every non-conformity. filed.calibration records 18/06/11 36 / 63 . Method 41301 Determination of quality and technical records version 1 03/06/2003 Following activities and documents demonstrate the effective operation of the quality system: .records of client complaints . Specific documents 3.evaluations and audits of suppliers ( particularly for boarding-out ) . Procedure-Activities 41301 41302 41303 41304 41305 41306 Determination of quality and technical records Classification of current quality and technical records Control of quality and technical records Archive Confidentiality of records Removal of documents out the records-office 3. External documents 4. collected.the records concerning contract reviews: orders.reports of quality meetings. disposed.the control. 2.NAME OF LABORATORY PROCEDURES MANUAL 1. Documents 3.3. announcement and distribution of quality records . retained.maintenance records .. composition. System documents D 40305 System documents D 40306 Specific documents D 40307 External documents 3.1. maintained. purchase documents and other relevant purchase data .records of corrective and preventive actions .2. indexed. change. This includes how quality and technical records are identified. quotations. accessed.. .list of approved suppliers. Purpose and scope The purpose of this procedure is to establish the requirements for the generation of quality system procedures governing quality and technical records. This procedure applies to designated quality and technical records as required in D 40305 (minimum set of records) of this document and to other quality and technical records identified in implementing documents. and stored within the quality system. including damaged client property ..training records Written by Checked by Approved by .

where possible.numbering the data .the preservation in good condition .. record-office and archive period of each record are determined by the Quality Manager.keeping the dossier up-to-date .) of the data.rightly sorting the data . The Departmental Manager is responsible for the use of suitable and fit documents in his department. Each record contains the name of the collaborator.the presence of the dossier on the agreed location . The other quality and technical records are gathered in specificly named dossiers. 41303 Control of quality records version 1 03/06/2003 The responsibility for the correctness and the completeness of the quality and technical records is indicated in the procedures and the work instructions. Written by Checked by Approved by He ensures that all records used in his department are well readable. copy.the removal of the out-dated data (at least once a year) . 18/06/11 37 / 63 .design records All quality and technical records belonging to the quality management system.. The current records are brought over to the record-office once a year. The quality and technical records are appropriately identified by a descriptive title and a rotation number. He decides who is allowed to look into the records. This particularly applies for dossiers with external documents.NAME OF LABORATORY PROCEDURES MANUAL .. are listed on different tables of contents.the preservation of the documents during the agreed period . The dossier owner is responsible for: .the prevention of damage The dossier owner keeps a check on the distribution (look into. The dossier owner. The registration takes place during the execution of the activities. Every dossier has got an owner. the revision date and the identification of the piece of work. The dossier owner is responsible for bringing the dossier and/or documents to the recordoffice. 41302 Classification of current records version 1 03/06/2003 The table of contents of every quality dossier mentions the quality and technical records which are to be kept. Therefore he regularly checks the documents in use. Every dossier has an index with the different records belonging to the dossier.

their depository and their preservation period are mentioned on archive documents. their dossier owner. The records. The Quality Manager is responsible for taking appropriate measures to prevent damage or loss of the records. clearly identified and paraphed by the collaborator. This removal takes place at least once a year. The Quality Manager takes every contractually agreed preservation period for the records into account (when applicable). 41305 Confidentiality of quality records version 1 03/06/2003 All documents with confidential information are kept by the Quality Manager. The Quality Manager ensures that all out-dated records are removed from the record-office.NAME OF LABORATORY PROCEDURES MANUAL When corrections are necessary. Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 414 Internal quality audits version 1 03/06/2003 18/06/11 38 / 63 . 5. 41304 Archive version 1 03/06/2003 The Quality Manager keeps all completed quality and technical records in the archive. they are mentioned next to the marginal line. Therefore he regularly checks the record-office.

or to find fault with individuals' performance.3. Procedure-Sections 41401 41402 41403 41404 41405 41406 Audit planning Audit preparation Auditing Writing of the audit report Follow-up actions Quality records concerning audits 3.2. process plans and work instructions. 2. which will generally be performed against the requirements of ISO 15189.not the individuals. System documents D 41401 Internal auditors D 41402 Audit planning D 41403 Audit questionnaire D 41404 Audit report 3. Method 41401 Audit planning 18/06/11 version 1 03/06/2003 39 / 63 .the quality system documentation adequately defines the needs of the business . the laboratory's quality manual. External documents Written by Checked by Approved by 4. Internal audits are the most effective way of continually assessing the effectiveness of the Quality System.the training of employees is adequate to allow them to do their tasks The purpose of internal audits is not to search for the guilty. The system is being audited . Purpose and scope The purpose of internal auditing is to ensure that the Quality Management is being operated correctly and effectively. Documents 3.the documented procedures and instructions are practical. understood and implemented . This procedure defines the way in which our laboratory will perform internal auditing of the quality management system.1. It applies to all internal quality audits.NAME OF LABORATORY PROCEDURES MANUAL 1. and must approach this important task with the seriousness it deserves. Auditors may be laboratory employees or external consultants. The auditors must be suitably qualified. procedures. by performing planned and documented checks. designed to ensure that: . Specific documents 3.

or that areas previously unexamined can be looked at more closely) . version 1 03/06/2003 41403 Auditing During the audit.by contacting the auditee and confirming the date/time for the audit . and for preparing the internal audit schedule.requests from Management . The schedule should define for each audit: .actual problems . for allocation and training of internal auditors. Audit planning consists of preparing the internal audit schedule. which is a controlled document.by reading through previous audit reports covering the same area (in order that previous problem areas can be examined in more detail. The schedule should leave room (time) for unscheduled audits in response to: .the date (at the planning stage the month for the audit will be sufficient: as the time approaches the auditor will set a firm date with the auditee). work instructions) .by familiarising himself with the requirements of ISO 15189 and the local standards (quality manual.anticipated problem areas . 41402 Audit preparation The auditor will prepare for each audit as follows: .the auditee .the auditor . process plans. procedures. authorised by the Managing Director.not respond to rumour and hearsay . the auditor will: version 1 03/06/2003 Written by Checked by Approved by . The schedule should cover all aspects of the Quality Management System at least once a year.make use of standard auditing techniques to collect objective information concerning the subject being audited .NAME OF LABORATORY PROCEDURES MANUAL The quality manager is responsible for ensuring that the internal audit programme takes place.by preparing an audit checklist or similar aide-memoir. although particular activities may be audited more frequently depending on their importance.avoid confrontational situations and arguments 18/06/11 40 / 63 .unforeseen changes in circumstances.

records only factual evidence (not hearsay) .makes notes to aid the writing of the audit report . and who is responsible for carrying them out . procedures. * major: fails to satisfy the requirements of ISO 15189 * minor: satisfies the requirements of ISO 15189 but fails to satisfy the laboratory's own internal standards.is signed off by all parties as being a true and accurate representation of the facts. 41404 Writing the audit report version 1 03/06/2003 As soon as practical after the audit. the auditor will prepare an audit report which .collect documentary evidence of conformity or nonconformity .record the good points as well as the bad . If an auditee persistently fails to carry out the assigned follow-up actions. manual. the auditor will sign off the audit report as complete. who will take steps to ensure that the follow-up action take place. auditees. etc. The actions are structured in action plans.keep the auditee informed as to the progress of the audit and any findings. . As the follow-up actions are completed the auditor will record them by up-issuing the original audit report. observers * location of the audit * date of the audit . the auditor must inform the managing director. 41405 Following-up version 1 03/06/2003 The auditor is responsible for checking that follow-up actions take place.NAME OF LABORATORY PROCEDURES MANUAL . manual.classifies the findings of the audit as follows: * acceptable: satisfies the requirements of ISO 15189 and the laboratory's own standards. * observation: an area of weakness that could be improved. etc.clearly identifies the areas where corrective actions are required. Once all follow-up actions have been completed.makes constructive suggestions where possible . Written by Checked by Approved by 41406 Quality records concerning audits version 1 03/06/2003 18/06/11 41 / 63 .contains * the names of the auditor. procedures.note where current procedures could be improved .

5. is functioning and effective .providing valuable summary for use in Management Reviews of the Quality System.allowing analysis of types of problems and identifying the most common problems so that preventive actions can be taken .demonstrating that the audit system exists. Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 415 Management review version 1 03/06/2003 18/06/11 42 / 63 .analysing response and correction times .allowing the auditor to prepare for audits by reviewing the past reports for that area or function .NAME OF LABORATORY PROCEDURES MANUAL Completed audit records are stored as quality records and have the following important functions: .

1. External documents 4. Method 41501 General version 1 03/06/2003 The management review process is intended to provide a forum for discussion and improvement of the quality management system and to provide management with a vehicle for making any changes to the quality management system necessary to achieve the organization's goals.3.2. Procedure-Sections 41501 General 41502 Method for management review 41503 Registration of management review 3. Purpose and scope The purpose of this procedure is to document the process and primary agenda of issues to be included in the management review meetings for evaluating the status of the organization's quality management system. Documents 3. 2. Specific documents 3. The quality management system in use will be regularly reviewed by the laboratory's management to ensure: .NAME OF LABORATORY PROCEDURES MANUAL 1.that it continues to be effective and suitable.that the results of internal audits are reviewed to ensure that the defined quality system is being implemented and followed. Written by Checked by Approved by 41402 Method for management review version 1 03/06/2003 18/06/11 43 / 63 . System-documents 41501 Minutes of the quality meetings 41502 Meeting reports 3. This procedure applies to all management review meetings conducted by the organization.that the quality system is updated as necessary . fulfilling the changing and future needs of the laboratory and its clients .

Special attention is devoted to the evolution of the client complaints and the non-conformities.supplier problems . Potential agenda: . Every ISO 15189-requirement is reviewed for its present situation. the realized progress and possible improvements. to the working of the corrective and preventive action system.internal and external audits .client complaints . The purpose is to ensure the suitability and the effectiveness of the system in the light of the ISO 15189 requirements.investment needs .internal non-conformities .quality indicators for monitoring the laboratory's contribution to patient care .supplier evaluation .monitoring of turnaround times At least once a year a broad evaluation of the quality system is made.management reviews .NAME OF LABORATORY PROCEDURES MANUAL The management review of the quality management system takes place during the monthly quality meetings.action plans .status of preventive and corrective actions .analysis of client complaints . Written by Checked by Approved by The quality objectives for the present year are discussed.analysis of supplier problems .training efforts .non-conforming product . 18/06/11 44 / 63 . Decisions are made how the effectiveness of the quality system and the processes can be improved and how client requirements can be met better.client feedback .any changes in the volume and type of work undertaken .approval of the previous report . the quality policy and the objectives of our laboratory. in attendance of all Departmental Managers and the Director of the laboratory. to the working of the audit process and of the training process.quality system documents .analysis ot internal non-conformities .quality objectives of the last year . The Quality Manager has the disposal of a planning of quality meetings showing the agenda.

Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 Written by Checked by Approved by P 501 Training and awareness 18/06/11 version 1 03/06/2003 45 / 63 .action items arising from the meeting He also summerizes the overall performance.list of attendees . The Quality Manager records the following: . Follow-up action items are structured via action plans. A copy of the meeting minutes will also be retained on file. A copy of the meeting minutes will be distributed to the attendees and any individuals assigned action items.review period . 5.NAME OF LABORATORY PROCEDURES MANUAL 41402 Registration of management review version 1 03/06/2003 Minutes of the management reviews are written.calendar year .date performed . The Quality Manager is responsible for this.

or verify work affecting the quality of our tests. Our laboratory ensures that personnel have the training needed to perform their jobs safely and effectively and to produce quality tests. Written by Checked by Approved by 50102 Training of new personnel version 1 03/06/2003 The new collaborator fills in a personal card with personal information. System documents D 50101 Personnel card D 50102 Function description D 50103 Overview trainings 3.2. This job offer is subsequently advertised in the newspapers. Method 50101 Recruitment of new personnel version 1 03/06/2003 The Departmental Managers. determining training responsibilities and providing training to personnel performing work that affects quality. 2. The Managing Director is responsible for the formal determination of vacancies. Purpose and scope This procedure establishes a method for identifying training requirements. perform. Procedure-Sections 50101 50102 50103 50104 50105 Recruitment of new personnel Training of new personnel Planning and registration of training Determination of training needs Motivation and quality awareness of collaborators 3. External documents 4. All unsuccessful candidates receive a message.3. The candidate who conforms best to the job profile of the vacancy. is accepted. This procedure applies to all collaborators who manage. Documents 3. Specific documents 3.NAME OF LABORATORY PROCEDURES MANUAL 1. 18/06/11 46 / 63 . A job offer stating the minimal schooling and experience for candidates is written by the Managing Director. The selection of the candidates takes place with the help of their curriculum vitae and a personal conversation. the Quality Manager and/or the Managing Director determine the need for new personnel.1.

B. problem analysis. communicates whether the concerned collaborator has passed. schooling about statistical techniques. Planning of the trainings: The Departmental Manager is responsible for the translation of the training needs into a concrete training plan. After a training. and experience before entrance into office. The new employee is also made aware of the potential consequences resulting from mistakes made and/or improper performance of assigned activities and duties. the institute delivering the training. Written by Checked by Approved by version 1 03/06/2003 Details of the training and its effectiveness are discussed and reviewed in order to make the final overall evaluation. actions are taken to correct the problem.. Effectiveness of the training is evaluated on the basis of the feedback from the employee who received the training and/or on the basis of the performance of the employee prior and after the training. If the training was not effective. and may take place by means of job rotation.. This evaluation concludes if the training was appropriate for the intended purpose. The training planning is presented to the Managing Director. The Quality Manager promotes the awareness of client requirements and communicates the importance of meeting these requirements (along with regulatory and statutory requirements). 18/06/11 47 / 63 . collective or individual. Every new collaborator must know that the execution of the tests and the use of the equipment have to be carried out in accordance with relevant work instructions and procedures. Registration of the trainings: For every collaborator a personal card is kept stating the schooling. training. courses about the quality management system and the evaluation of its effectiveness. He hands him the quality policy and the quality objectives..NAME OF LABORATORY PROCEDURES MANUAL The Quality Manager explains to the new collaborator the working of the laboratory and gives him a conducted tour. The Quality Manager sees to it that the quality policy is understood and accepted by the new collaborator. who assesses and approves it. The training may be internal or external. 50103 Training planning and registration A.

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Finally the training is recorded on the personal card of the collaborator. 50104 Determination of the training needs version 1 03/06/2003

The need for training can arise in an environment of changing regulatory requirements, technologies, processes, personnel, and mission. In addition the collaborator himself can ask for training. Besides, the Departmental Manager ascertains once a year the need for training: with the help of the function descriptions indicating the necessary knowledge and skills and with the help of tables indicating which skills the different collaborators are master of . Then the Departmental Manager and the concerned collaborator discuss and evaluate the situation.

50105 Motivation of the personnel Communication:

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The Departmental Manager is responsible for the motivation of the personnel in his department. Every collaborator gets maximal information on the laboratory objectives, the organization, the action plans and the concrete actions taken to realize the objectives. Each collaborator is implicated as much as possible in corrective and preventive measures, problem analysis, work organization, improvement projects,... The starting point for this is the monthly quality meeting. Objectives: The Quality Manager and the collaborators agree upon specific and measurable objectives which are a concrete translation of the objectives of our laboratory, including the quality objectives. The Quality Manager translates the different aspects of the quality system to the collaborators into a concrete, comprehensible language. He ensures that the message is understood and accepted.
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P 531 Preventive maintenance 1. Purpose and scope

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The purpose of this procedure is to describe the method of structured (preventive) maintenance of the equipment. Moreover, the procedure ascertains the maintenance responsibilities. The scope of this procedure is all test equipment. 2. Procedure-Activities
53101 53102 53103 53104 53105 Control of the maintenance system Curative maintenance request Maintenance history Externally executed maintenance Control of spare parts

3. Documents 3.1. System documents D 50301 Maintenance card D 50302 Maintenance calendar D 50303 Maintenance contracts D 50304 Maintenance history D 50305 Different tasks 3.2. Specific documents 3.3. External documents 4. Method 53101 Control of the maintenance system version 1 03/06/2003

The Maintenance Manager is responsible for the control of the maintenance system. His task includes: - development of an effective maintenance system - planning, execution and registration of the maintenance activities - advice on the purchase of machines and installations - analysis of the maintenance results - verification of the effectiveness of the executed maintenance and of the maintenance process - reporting of the conclusions during the quality system management review.

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The maintenance frequency (the period between two turn-outs) is indicated on the maintenance card.NAME OF LABORATORY PROCEDURES MANUAL All installations.maintenance type: preventive or curative . are identified by a combination of letters and digits. Maintenance instructions: The Maintenance Manager decides for which installations an instruction is necessary in order to assure the correct execution of the maintenance activities. serial number. All installations show this identification and all documents relating to them also mention it.name of the installation .. Written by Checked by Approved by 55103 Maintenance history 18/06/11 version 1 03/06/2003 51 / 63 .date of acquisition . which require maintenance. including: .supplier . The effect of the defect on previous tests is examined..most important spare parts and minimal stock Preventive maintenance planning: Preventive maintenance also includes the supervision of the installations and machines. which contains all relevant information.. he notifies the Departmental Manager or the Maintenance Manager .the installation characteristics (capacity. 53102 Curative maintenance request version 1 03/06/2003 When the operator of an installation or machine ascertains that maintenance is necessary. prominent labelling or marking.identification of the installation .manufacturer . Maintenance cards: Each installation has a "maintenance card".) . The defective equipment is removed from service by segration.

NAME OF LABORATORY PROCEDURES MANUAL For each machine or installation the executed maintenance is recorded (from a frequency greater than monthly). including safety instructions. The maintenance date and the executor are also registered. The executed work is released by recording it. Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 18/06/11 52 / 63 . All maintenance contracts are recorded. 5. The Maintenance Manager is responsible for the release of externally executed maintenance activities. 53104 Externally executed maintenance version 1 03/06/2003 The Maintenance Manager is responsible for giving instructions to the external maintenance firm. He pays attention to the fixed minimal stock. This is also the case for externally executed maintenance. 53105 Control of spare parts version 1 03/06/2003 The Maintenance Manager manages the spare parts warehouse.

Specific documents 3. 18/06/11 53 / 63 .release of measuring equipment after repair or calibration. The procedure applies to all measuring devices used in the laboratory. the procedure ensures that the measuring equipment has the necessary accuracy. This includes: .development and implementation of a calibration system . the procedure defines the way in which the measuring and monitoring equipment is identified. . 2.NAME OF LABORATORY Written by Checked by PROCEDURES MANUAL Approved by P 532 Calibration 1.2. Finally. calibrated and preserved in good condition.advice to the concerned collaborators on the purchase of measuring devices . In addition. when the equipment went outside the direct control of the laboratory. External documents 4.planning.evaluation of the calibration results .3. Documents 3. execution and registration of the calibrations . Purpose and scope version 1 03/06/2003 The purpose of this procedure is to describe the responsibilities and the method for the control of measuring and monitoring equipment. Method 53201 Responsibility version 1 03/06/2003 The Calibration Manager is responsible for the managing of the calibration system. Procedure-Sections 53201 53202 53203 53204 Responsibility Registration system General procedure Defects and inexactitudes 3.1.check the function and calibration status of the equipment. Systemdocuments D 50306 Calibration card D 50307 List of measuring devices D 50308 Calibration planning D 50309 Calibration contracts D 50310 Calibration history 3.

For internal calibrations he follows calibration instructions.supplier . General . The Calibration Manager makes a note of the effective calibration date. The Calibration Manager makes an calibration card for every device with the following data: 1. 53203 General procedure version 1 03/06/2003 When the calibration planning indicates that a calibration is necessary.measuring range . 18/06/11 54 / 63 .internal/external calibration . "Purchasing" and he always asks a calibration certificate to guarantee the reducibility. Then the Calibration Manager executes the calibration internally or externally. He determines for every measuring device the calibration frequency on the basis of following aspects: the manufacturer's indications. the directions for use. The Calibration Manager determines the calibration planning bearing in mind the calibration frequency.accuracy 2.year of acquisition . For every measuring device the Calibration Manager retains a calibration survey with all performed.name and identification of the device . the Calibration Manager takes back the concerned measuring device. Calibration data .calibration frequency .manufacturer . The calibration planning mentions the identification code of the measuring device and the planned month for the calibration.NAME OF LABORATORY PROCEDURES MANUAL Written by Checked by Approved by 53202 Registration system version 1 03/06/2003 The Calibration Manager makes an inventory of all measuring devices in our laboratory on the "list of measuring devices". internal and external calibrations.place . the environmental conditions and the required accuracy. for external calibrations he follows the procedure P 462.calibration steps.

53204 Defects and inexactitudes version 1 03/06/2003 Every measuring device.g. bear a label with the words: "no calibration necessary". P 410. Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 18/06/11 55 / 63 . in computer software) are correctly updated by the Calibration Manager. Measuring devices which don't have to be calibrated. 5. is immediately marked with a red label and blocked. is provided with a label by the Calibration Manager which indicates till when the calibration is valid. The Calibration Manager fills in a corrective action request (CAR) and decides to repair with re-calibration or to do away with the concerned device. or that has another non-conformity. The Calibration Manager also contacts the concerned Departmental Manager to check the measurings executed with the non-conforming device. that is damaged or outside the tolerance limits. A decision is made if the measurings have to be executed again. These actions are written on the corrective action request as per the corrective actions procedure. Written by Checked by Approved by Where calibrations give rise to a set of correction factors. copies (e..NAME OF LABORATORY PROCEDURES MANUAL Every measuring device subject to calibration.

regional or local requirements.. 2.. Objectif and field of application This procedure defines the method for the identification of the samples received. Documents 3.1..NAME OF LABORATORY PROCEDURES MANUAL Written by Checked by Approved by P 504 Sample preparation and identification version 1 03/06/2003 1.. (Describe how this is done and who is responsible. (indicate the temperature interval) en with the designated preservatives to ensure the integrity of samples (indicate which preservatives).within a temperature interval. The field of application covers all samples received by the laboratory..2.3.. namely: . External documents 4. (Describe how the laboratory arranges the sample transportation and who is responsible for this.) The samples are stored under conditions ensuring stability of sample properties..within a time frame appropriate to the nature of the requested examinations and the laboratory discipline concerned . in compliance with national.. Systemdocuments 3.) 18/06/11 56 / 63 . Method 50401 Transportation and storage of the samples version 1 03/06/2001 The laboratory monitors the transportation of samples to the laboratory such that they are transported . the general public and the receiving laboratory. Procedure-section 50401 50402 50403 50404 Transportation and storage Receipt of the samples Request form Sample identification 3. and . Specific documents 3.in a manner that ensures safety for the carrier.

and.date and time of receipt of samples by the laboratory When an examination is urgent.date and time of primary sample collection . The date and time of receipt of samples. if applicable. the request form is marked with the word "URGENT".NAME OF LABORATORY PROCEDURES MANUAL Written by Checked by Approved by 50402 Receipt of the samples version 1 03/06/2003 All primary samples received are recorded in an accession book. as well as pertinent clinical data.name or other unique identifier of physician or other person legally authorized to request examinations or use medical information together with the destination for the report.type of primary sample and the anatomic site of origin. 50403 Test request form version 1 03/06/2003 The request form contain information sufficient to identify the patient and the authorized requester. worksheet.. The request form is a paper which is filled out. computer or other system. for interpretation purposes .. 18/06/11 57 / 63 .unique identification of the patient . are recorded. as well as the identity of the receiving officer. the final report will indicate the nature of the problem. .. The request form allows space for the inclusion of at least the following: . 50404 Sample identification version 1 03/06/2003 Primary samples are traceable by request form to an identified individual.clinical information relevant to the patient which includes gender and date of birth as a minimum.. On receipt.) If compromised samples are accepted. where appropriate.examinations requested .. (Describe the system used + refer to the document concerned). The requesting clinician's address is provided as part of the request form information when it is different from that of the receiving laboratory . (Describe the acceptance criteria for the primary samples. the primary samples are verified if they meet following acceptance criteria: . that caution is required when interpreting the results..

NAME OF LABORATORY PROCEDURES MANUAL The primary samples are identified via the following code: ... are identified. (Describe how the primary samples are identified + describe in partical how samples which have to be processed urgently.... Where there is uncertainty in the identification of the primary sample or instability of the analytes in the primary sample (cerebrospinal fluid. the signature of that person taking responsibility for the primary sample identification is recorded on.g. the person responsible is identified on the report if the examination is carried out. or traceable to. Samples to be set aside for future examination (e. 5. etc.) Written by Checked by Approved by Primary samples lacking proper identification are not accepted or processed by the laboratory...... Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 18/06/11 58 / 63 . the request form. or for providing proper information or all these. If this requirement is not met for any reason....) and the primary sample is irreplaceable or critical. viral antibodies. biopsy. metabolites relevant to the clinical syndrome) are also identifiable.. In such an instance.. the laboratory may choose initially to process the sample but not release the results until the requesting physician or person responsible for the primary sample collection takes responsibility for identifying and accepting the sample.

The format of the report and the manner in which it is to be commnunicated from the laboratory has been determined in discussion with the users of laboratory services. the measument procedure.the identification of the laboratory that issued the report. Specific documents 3. 2.NAME OF LABORATORY PROCEDURES MANUAL Written by Checked by Approved by P 508 Reporting of results version 1 03/06/2003 1.unique identification and location of the patient. 18/06/11 59 / 63 . The field of application covers all test reports which are drown up by the laboratory including those which contain results of tests that have been referred to other laboratories. Method 50801 Drawing up of the test report version 1 03/06/2003 Laboratory management is responsble for formatting reports.1.2. . and destination of the report. unambiguous identification of the examination including. Procedure-sections 50801 50802 50803 50804 50805 Drawing up the test report Release and distribution Changes Turnaround times Alarming test results 3. External documents 4. Documents 3. The report is noted down on paper and includes at least: . Objective and field of application This procedure defines the method of drawing up and transmitting test reports to clinicians and to the patient. Systemdocuments P 50801 Alarming intervals P 50802 Actions in response to alarming test results 3. where appropriate. where possible.3. .clear.

International Society of Haematology (ISH) .International Union of Pure and Applied Chemistry (IUPAC) .signature or authorization of the person checking or releasing the report.if relevant. .interpretation of results.International Union of Immunological Societies (IUIS) .European Committee for standardisation (CEN) .date and time of primary sample collection.International Union of Microbiological Societies (IUMS) .date and time of release of report. version 1 03/06/2003 18/06/11 60 / 63 . the report identifies examinations undertaken as part of a development programme and for which no specific claims on measurement performance are made. where applicable.source and system (or primary sample type). which. The test report is transmitted to the clinician who requested the test and may be transmitted to the patient concerned. Written by Checked by Approved by .International Union of Biochemistry and Molecular Biology (IUBMB) .SNOMED International (College of American Pathologists) . . use of developmental procedure).World Health Organisation (WHO) 50802 Release and distribution of test reports The laboratory director is responsible for releasing test reports. a written reports always follows.name or other unique identifier of the requester and the requester's address. .biological reference intervals. The description of examinations performed and their results follow the vocabulary and syntax recommended by one or more of the following organizations: (Remove the organization which are not applicable. . original and corrected results.results of the examination reported in SI units or units traceable to SI units (see ISO Guide 31). where applicable.other comments (e. When results are transmitted verbally.NAME OF LABORATORY PROCEDURES MANUAL .International Society of Thrombosis and Haemostasis (ISTH) .) .International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) . The report indicates if the quality of the primary samples received was unsuitable for examination of could have compromised the result.identification of the person authorizing the release of the report. . where appropriate. information on detection limit and uncertainty of measurement are provided on request. is readily accessible when needed.g. where applicable. where possible. quality or adequacy of primary sample which may have compromised the result. . .International Council for Standardization in Haematology (ICSH) . . when available and relevant to patient care. . and. results/interpretations form referral laboratories. if not on the report. and time of receipt by the laboratory.

the clinician is immediately notified. This applies to all examinations. Turnaround times as well as any feedback from clinicians in relation to it are monitored. 50806 Alarming test results version 1 03/06/2003 When examination results for critical properties fall within established "alert" or "critical" intervals. 50804 Turnaround times version 1 03/06/2003 Laboratory management istablishes turnaround times for each of its examinations. date. 18/06/11 61 / 63 . Copies of the reports are kept in the laboratory and can be easily retrieved. A turnaround time reflects clinical needs. The laboratory has determined the critical properties and thier "alert/critical" intervals in agreement with the clinicians using the laboratory (see D 50801). the record must show the time. person notified and examination results. responsible laboratory staff member. This includes results received on samples sent to referral laboratories for examination. Records of actions taken in response to results in the critical intervals are maintained. When an examination is delayed. recorded and reviewed by the laboratory director. Original electronic records are retained and alterations added to the record through appropriate editing procedures so that reports clearly indicate the alteration. including nominal and ordinal properties. When necessary. the final report is always forwarded to the requester.NAME OF LABORATORY PROCEDURES MANUAL For results transmitted as an interim report. date and name of the person responsible for the change. corrective actions are taken to address any problems so identified (see P 410). Written by Checked by Approved by 50803 Changes of the reports version 1 03/06/2003 When altered. the requesting clinician is notified if the delay could compromise patient care. These include time. Original entries remain legible when alterations are made.

Revision history REVISION HISTORY Rev 0 Initial Release Description of Change Author Effective Date 10/11/03 18/06/11 62 / 63 .NAME OF LABORATORY PROCEDURES MANUAL Written by Checked by Approved by 5.

NAME OF LABORATORY PROCEDURES MANUAL Written by Checked by Approved by 18/06/11 63 / 63 .

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