Name of Laboratory Procedures Manual

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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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
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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
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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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The instructions contain an initial condition, a method which reproduces the tasks to fulfill and a final condition. When necessary, special points for attention are mentioned at the bottom of the instructions. For both procedures and work-instructions, a footnote mentions who wrote, checked and approved the document.
5. Revision history
REVISION HISTORY Rev 0 Initial Release Description of Change Author

Effective Date
10/11/03
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P 403 Control of documents 18/06/11
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1. Purpose and scope The objective of this procedure is to establish and maintain a method of controlling documents and data throughout our laboratory. This procedure deals with the development and change of quality documents, their review, their approval, their announcement and their distribution. This procedure also describes the method of protecting and saving computer files. This procedure applies to all quality documents and to other data required by ISO 15189 (including external documents). 2. 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. en ext. documents Control, distribution and administration manuals Control of the PC' s Control of passwords Software changes
3. Documents 3.1. 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 3.2. Specific documents 3.3. External documents
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4. Method 40301 Control of changes version 1 03/06/2003
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The Quality Manager distributes each document change request to the parties involved. The parties involved inform the Quality Manager of their remarks on this request. The requests and the associated remarks are discussed during the quality meeting. When necessary, the Quality Manager will write a new request. This method is repeated till the quality meeting accepts the request or definitively refuses it. When the document change request is definitively refused, the initiator of the request will be informed. The Quality Manager enters the definitive change into the access-database. He ensures that the version and date are updated, where necessary, and that the changed documents are distributed to the parties involved. When necessary, the Quality Manager can decide to re-issue the whole manual, with one date and one version for all documentation.
40302 Request for revision of a document
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Any individual within the organization may request to add, revise or delete a quality document (policy, procedure, process plan, work instruction or form). In this case, the individual submits, in writing, the request along with appropriate attachments to the Quality Manager.
40303 Release of documents
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If acceptable, the new or revised procedure, instruction or document is approved and paraphed by the Managing Director. - Procedures and instructions are paraphed in the footnote. - ISO 15189-system-documents are approved via the procedure which contains them. - External documents are approved via their respective lists.
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For procedures and instructions approval always follows after the discussion of the document change request during the quality meeting, whereas documents can be approved at once by the Managing Director.
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40304 Information on documents and forms
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The Quality Manager informs the parties involved of the changes in procedures, instructions or documents and of the introduction of new procedures, instructions or documents. This announcement shall be mentioned on the report of the quality meeting. The Quality Manager observes the use of the new or changed documents and communicates potential problems during the quality meeting. 40305 Request and control of intern. and extern.documents Request for (internal) procedures, instructions of documents: When a staff member wants to have a specimen of a procedure, instruction or document which hasn't been part of his quality dossier, he can ask one to the Quality Manager. The Quality Manager decides whether the staff member can get what he asked. Control of internal documents: Manual: the owner of a complete manual updates the appropriate documents and replaces new revisions in his controlled copy. Quality dossier: every owner of a quality dossier updates the appropriate documents and replaces new revisions. Control of external documents: External documents which affect quality are among others the regulatory and legal requirements, the analysis of products, external price lists, safety-data, technical data which are part of the quality management system. Software-packages also are considered as external documents. The external documents are marked with a date and are listed on the list of external documents. The Quality Manager distributes the external documents and ensures that the latest versions of the documents are put into circulation. Invalid, external documents are destroyed. version 1 03/06/2003
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40306 Control and distribution of the manuals General: The Quality Manager is responsible for: 18/06/11
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- the control of the originals of all manuals and documents, including the computerfiles and the back-ups. - the composition and maintenance of reference lists - the control of obsolete documents - the control of completed forms - 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. Only the Quality Manager has the authority to make copies of these documents (or manuals). The copies are on colored paper, where possible. This is not the case for blank forms, which can be copied by their users. Composition and maintenance of reference lists: The current version of the procedures, the instructions and the documents is mentioned on the index of the manual involved or on the index of the quality dossier. 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, instructions or documents are destroyed by the Quality Manager or by their owner. In some exceptional cases (for example for legal reasons) the Quality Manager is allowed to keep invalid specimens. These specimens are identified by the word "obsolete". Control of completed quality records: The preservation of quality records is described in procedure P 413. The index of the quality dossiers indicates which quality records must be kept by the dossier owner. Well functioning of the system: The Quality Manager regularly verifies if all rules concerning the control of documents are followed.
He reports his findings to the Managing Director during the quality meetings. When he finds violations, he proposes measures to improve the system and he inspects their implementation. Distribution of the manuals: 18/06/11 8 / 63
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Integral manuals are minimally distributed to the Managing Director and the Quality Manager, and moreover to all managers which are mentioned on the quality manual distribution list. Procedures, instructions and documents are distributed in a controlled manner via the quality dossiers of the collaborators. The Quality Manager is responsible for the determination and, when necessary, the adjustment of the tables of contents of the quality dossiers. When a collaborator asks for a specimen of a procedure, an instruction or a document which is not part of his quality dossier, the Quality Manager decides whether the applicant can get what he asked. Manuals or documents can also be given in an uncontrolled manner to a person who asks them. The Quality Manager is responsible for this and ensures that all uncontrolled documents are provided with the word "uncontrolled". The uncontrolled documents only are valid at the moment of their issue. 40307 Control of the PC's Admittance protection: Every PC is protected by a password for every user. This password is known only by the user himself and by the Quality Manager. The passwords are changed once a year. Data protection: To ensure that as few data as possible is accidentally lost, the Quality Manager sees to it that a daily back-up is taken of the changed files. Virus protection: A virus scan is executed while bringing in an unknown diskette. version 1 03/06/2003
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40309 Control of passwords
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The Quality Manager has the disposal of a list with passwords. If a password changes, he will revise the list.
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The Quality Manager regularly checks whether the passwords are changed sufficiently often. 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. The proposed changes and their potential impact are discussed. The Quality Manager purchases new software as per the purchasing procedure, P 462. The Quality Manager ensures that no software change is implemented without: - training the users - writing or adjusting the necessary instructions - making a broad test-run An action plan is set up. The Quality Manager evaluates the changes and reports his findings during the quality meeting. 5. Revision history

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P 404 Review of contracts 1. Purpose and scope
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The purpose of this procedure is to define the method for the review of contracts. - The tenders have to be reviewed. - The contracts have to be reviewed. - The requirements have to be adequately defined and documented before accepting a contract. - Requirements differing from those in the tender have to be resolved before accepting a contract. - The capability to meet the contractual requirements has to be assessed before accepting a contract. 2. Procedure-Sections
40401 40402 40403 Invitations to tender Orders Order changes
3. Documents 3.1. System documents D 40401 Tests that are offered by our lab D 40402 Specifications of our tests 3.2. Specific documents 3.3. External documents 4. Method 40401 Invitations to tender version 1 03/06/2003
All enquiries to tender are handled by the Departmental Manager. 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, 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, but which are necessary for the defined, implied or intended use of the ordered test, are also identified (including regulatory and statutory requirements). The Departmental manager can decide to renounce the tender and then he informs the client.
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All client arrangements and the pertinent discussions with the client relating to the client's requirements are noted down on the tender. Then the Departmental Manager paraphs and releases the tender. A copy of the tender made, which also includes the result (order, no order, no answer), is retained. 18/06/11 11 / 63
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40402 Orders
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The Departmental Manager receives an order from a client. He makes a note of the person to be contacted. When the order is unclear, the Departmental Manager will contact the client to find a solution for the indistinctness. The Departmental Manager decides when the order can be carried out. The agreement is made over in writing to the client and at the same time the invoice with the payment conditions is transmitted. Records are maintained of pertinent discussions with the client relating to the results of the work during the period of execution of the contract.
40403 Order changes A. The client requests an order change:
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On receipt of an order change request, the Departmental Manager makes a note. The Departmental Manager assesses the consequences of the request: the consequences for the price and the necessary time for the execution of the order. He also examines if the technical capacity of our laboratory is sufficient. When necessary, he re-negotiates the order. Then the Departmental Manager decides if the order change request can be accepted. When the request is accepted, the made arrangements will be fastened down and confirmed. Then the change is forwarded to the functions concerned in the laboratory. When the order change request is not accepted, the Departmental Manager will inform the client.
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B. Our laboratory requests an order change: The Departmental Manager is responsible for the execution of the order within the premised time. When this is not possible because of exceptional circumstances, the Departmental Manager writes an order change request.
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The Departmental Manager contacts the client and communicates the request. He negotiates if the request is acceptable for the client and when necessary, he modifies the proposal. The made agreements are fastened down and confirmed. The change is forwarded to the functions concerned in our laboratory. 5. Revision history

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P 405
Examination by referral laboratories
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1. Objective and field of application
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This procedure defines the method of evaluating and selecting referral laboratories as well as consultants who are to provide second opinions for hispatology, cytology and related disciplines. The field of application covers all referred tests and examinations. 2. Procedure-sections 40501 Arrangements with referral laboratories 40502 Registration 40503 Reports 3. Documents 3.1. System documents D 40501 Referral laboratories 3.2. Specific documents 3.3. External documents 4. 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. The laboratory director periodically reviews the arrangements with referral laboratories to ensure that: - requirements, including the pre-examination and post-examination procedures, are adequately defined, documented and understood - the referral laboratory is able to meet the requirements and that there are no conflicts of interest. - selection of examination procedures is appropriate for the intended use, and - respective responsibilities for the interpretation of examination results are clearly defined. Records of such reviews are maintained (mention the documents involved).
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40502 Registration
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Our laboratory maintains a register of all referral laboratories that it uses (D 40501).
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A register is kept of all samples that have been referred to another laboratory (mention which document). 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. A duplicate of the laboratory report is retained in both the patient record and in the permanent file of the laboratory. 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. If the referring laboratory prepares the report, it includes all essential elements of the results reported by the referral laboratory, without alterations that could affect clinical interpretation. However, it does not require that the referring laboratory report includes every word and have the exact format of the referral laboratory report, unless national/local laws or regulations require it. The referring laboratory director may elect to provide additional interpretative remarks to those, if any, of the referral laboratory, in the context of the patient and the local medical environment. The author of such added remarks are clearly identified. 5. Revision history

Effective Date
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P 461 Supplier evaluation 1. Purpose and scope
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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. This procedure applies to all products and services that affect quality. 2. Procedure-Activities
46101 46102 Selection of new suppliers Review of suppliers
3. Documents 3.1. System documents D 40601 Supplier problems since one year D 40602 Supplier review D 40603 Approved suppliers D 40604 Suppliers on probation 3.2. Specific documents 3.3. External documents 4. 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, including quality requirements. The inquiry to tender or the product specification includes the quality requirements. The inquiry to tender contains at least: - the name of the supplier - the date - a precise description of the products - the number of products - signature of the concerned manager Our laboratory always asks a written tender to the supplier. The concerned manager evaluates the received tenders against the requirements and, when applicable, he evaluates them by means of a comparison between the different tenders.
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This evaluation is noted down on the tender itself. The concerned manager decides whether the new supplier can be accepted. The criteria for the selection are the price, quality and delivery time.
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When necessary the concerned manager can decide to make an order on probation. In this case the order documents must clearly indicate that it concerns an order on probation. The concerned manager notes down the selected supplier on the list of approved suppliers. The concerned product is also mentioned. Suppliers on probation are mentioned separately. Suppliers of ordinary products like water, electricity, and current office material are not mentioned. 46102 Review of suppliers A. Registration of every non-conformity Every supplier non-conformity, ascertained after the delivery, is noted down on a corrective action request. A supplier non-conformity can concern the quality of the delivered product or service, but also late deliveries, wrong deliveries, insufficient documentation, bad packing, transportation damage,... When it is necessary to contact the supplier to take immediate measures, the Departmental Manager will be informed. B. Resolution of the non-conformity The concerned manager negotiates with the supplier about immediate and corrective measures, on behalf of both the supplier and our laboratory. They are noted down on the corrective action request. Follow-up of the corrective actions takes place during the quality meetings or earlier when necessary. C. Supplier review All supplier problems (noted down on a corrective action request) are grouped by the different suppliers. Once a year a review of all suppliers affecting quality, is made by the Quality Manager. version 1 03/06/2003
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This review is based on five criteria: - furnished documents - quality on receipt - quality during use - commercial attitude 18/06/11 17 / 63
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- delivery behavior This review is written on the document "supplier review". On the basis of the yearly evaluation or earlier on the basis of ascertained supplier nonconformities, a decision is made on the measures with respect to the concerned supplier (for example sending of a notice, asking to take measures, removing from the list of approved suppliers,...). The Quality Manager modifies the list of approved suppliers. 5. Revision history

Effective Date
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P 462 Purchasing 1. Purpose and scope 18/06/11
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This procedure defines which criteria the purchase documents have to meet to prevent wrong deliveries. The procedure applies to all products and services affecting quality and also to all boardingouts. 2. Procedure-Sections
46201 46202 46203 46204 46205 Inquiry to tender Order Investment planning Budget and release of investments Purchase of investment goods
3. Documents 3.1. System documents D 40607 Overview of the purchased product D 40608 Specification of a purchased product 3.2. Specific documents 3.3. External documents 4. Method 46201 Inquiry to tender version 1 03/06/2003
The inquiry to tender can be verbal or written, but when the inquiry to tender was expressed verbally, a note is made of the inquiry. The inquiry to tender includes at least: - name of the supplier - date - number - precise description of the products - signature of the responsible manager. The tenders are compared and evaluated against: - price, delivery time - former experience with the supplier - application of the supplier evaluation procedure (list of approved suppliers). The concerned manager notes down the evaluation on the tender itself.
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46202 Order
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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. An order-form is used. This form minimally contains: - name of the supplier - date - identification of the order-form - number of products - precise description of the products - person who places the order - person who will receive the order - destination of the products - signature of the concerned manager. All order forms are prepared by Purchasing. The forms clearly describe ordered products/services. They include precise identification of the products/services, reference applicable standards and other relevant technical data and state quality and compliance requirements. When an order needs to be changed, a new order-form is completed with a clear indication that it concerns an order change. The new order form mentions the date or identification of the original order form.
46203 Investment planning
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The Departmental manager determines once a year the investment needs in his department. The determined needs are annually forwarded to the Managing Director in October. 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: - quality investments - safety investments - replacement investments - expansion investments
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For each category the pay-back-period is determined. Annually in November, the investment budget is assessed and approved by the Managing Director.
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Then the specific investments are discussed during the quality meetings. On the basis of the tenders forwarded by the Departmental Manager, the quality meeting decides to purchase and to invest. 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. This evaluation is noted down and is forwarded to the Managing Director. 5. Revision history

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P 463 Verification of purchased product 18/06/11
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1. 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. Procedure-Activities
46301 46302 Customer verification of subcontracted product Supplier verification at subcontractor's premises
3. Documents 3.1. System documents 3.2. Specific documents 3.3. External documents 4. Method 46301 Customer verification of subcontracted product version 1 03/06/2003
When specified in the contract, the Quality Manager is responsible for allowing the customer or his representative to visit suppliers or verify goods. Customer verification doesn't free our laboratory from the responsibility to deliver the highest quality, nor does it exclude later customer disapproval. 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. Agreements on the verification and the requirements are mentioned on the order-form.
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5. Revision history
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P 408 Client feedback and complaints
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1. Purpose and scope The objective of this procedure is to establish and maintain a method of receiving and processing client feedback and complaints. This procedure concerns all complaints and other feedback received from clinicians, patients or other parties. 2. Procedure-Activities
40801 40802 40803 Client feedback Registration of client complaints Handling of client complaints
3. Documents 3.1. System documents D 40803 Client complaints since one year D 40804 Client feedback 3.2. Specific documents 3.3. External documents 4. Method 40801 Client feedback A. Receiving and logging client feedback All after-sale client communication, whether written or verbal, are forwarded to the customer service department. Verbal communication by phone is documented in a memo which is written during, or immediately following, the conversation with the client. All client enquiries are recorded. The records for client feedback include: - reference number - identification of the client (may not be applicable for feedback) - reference to the concerned order (may not be applicable for feedback) - brief description of the feedback - category classification The feedback recorded by the customer service department. version 1 03/06/2003
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B. Classification of the client feedback and complaints
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Client feedback is assigned to an appropriate category. Responsible functions for each type of feedback have been defined. Following catergories are used: - general enquiries (responsibility: sales department) - test performance (responsibility: test department) - accuracy of the test results (responsibility: test department) - packaging (responsibility: test department) - distribution and delivery (responsibility: test department) - product information (responsibility: sales department) - availability (responsibility: sales department) - order handling and order changes (responsibility: sales department) - after-sale support and service (responsibility: service department) - contracts, price (responsibility: sales department) When necessary, client inquiries are re-directed to these responsible functions.
40802 Client complaint registration A. Receiving and logging client complaints
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Client complaints are recorded via a corrective action request filled in by the person who receives the complaint. The records for client complaints include: - identification of the client - date - brief description of the complaint - cause of the complaint - immediate action + executor The involved departmental manager is informed of the complaint. The complaint is entered into the access-database by the Quality Manager. B. Classification of the client feedback and complaints Client complaints are classified according to their cause. The purpose is to allow for better tracking of trends and evaluating improvements in specific domains. Possible causes are: - labeling problem - nonconforming test results - samples damaged in delivery - wrong test results shipped
- late delivery to client - problems with communication and responsiveness
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- complaints regarding business practices, publicity, etc. 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, when applicable, what needs to be done to correct the problem for the client (exchange, repair, refund, etc.). The client is informed of this decision. The Quality Manager reviews every client complaint to determine whether it should be discussed during the quality meeting. Then the quality meeting can decide to take a corrective action. This decision is recorded on the corrective action request. When a client returns nonconforming tests results, the test results are evaluated and inspected, and are handled and processed in accordance with procedure P 409, Control of Nonconformities. Depending on the nature of the nonconformity, the Quality Manager may follow up with requests for corrective and preventive actions. When the investigation of client complaints determines that remote operations, subcontractors, referral laboratories or other external organizations contributed to the complaint, the Quality Manager contacts these organizations and provides them with all relevant information. Every client complaint is recorded. The records are maintained by the Customer Service. When there are copies of written communication, reports and other documents related to a complaint, these records are organized into a file and are identified with the complaint number. In general, records of complaint investigation are maintained by the department that conducts the investigation. For example, records of internal investigations may be merged with records of the corresponding corrective or preventive actions, which are maintained by Quality Assurance, records of investigations that concerns testt performance or other test characteristics are maintained by Testing, records of investigations that involve referral laboratories or subcontractors are maintained by Purchasing, and so forth.
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5. Revision history
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P 409 Identification and control of non-conformities
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1. Purpose and scope The purpose of this procedure is to describe the method of handling non-conformities. The procedure deals with: - supplier non-conformities - internal non-conformities - customer complaints The procedure applies to every failure which is the consequence of disregarding made arrangements. 2. Procedure-Sections
40901 40902 40903 40904 Registration of non-conformities Blocking of non-conforming tests Treatment of non-conformities Eliminating the root cause
3. Documents 3.1. System documents 41001 Corrective action request (CAR) 3.2. Specific documents 3.3. External documents 4. Method 40901 Registration of non-conformities version 1 03/06/2003
Collaborators ascertaining an internal problem, a customer complaint or a supplier problem fill in a corrective action request (CAR) as per procedure P 410, corrective actions. This registration includes: - the identification of the non-conformity: is it a customer complaint, a supplier problem or an internal problem - the description of the ascertained non-conformity - the executed immediate action When possible, the cause of the problem is indicated. The initiator of the corrective action request immediately contacts the Quality Manager. The Quality Manager records the non-conformity on a corrective action request form and forwards the corrective action request to the involved manager.
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40902 Blocking of non-conforming tests 18/06/11
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When a collaborator ascertains a non-conformity, the examination is halted, the report is withheld (as necessary) and the Departmental Manager is informed. Non-conforming samples, installations and reports are marked by the Departmental Manager. Nonconforming samples, installations and reports are not processed or used until the Departmental Manager releases them.
40903 Treatment of non-conformities
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The involved manager considers the medical significance of the non-conformities and decides if these examinations have to be done over again. This decision is recorded on the corrective action request. If the quality of a test is affected by these non-conformities, the requesting clinician will be informed (where appropriate). In case of a collaborator exercising a method in a wrong way, the impact on previous tests is assessed by the Departmental Manager. He decides which measures have to be taken. The results of nonconforming examinations already released are recalled or appropriately identified (if necessary). The Departmental Manager authorizes the resumption of the examinations.
40904 Eliminating the root cause
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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, the procedure P 410, corrective actions will be implemented to identify, document and eliminate the root cause.
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P 410 Corrective Actions 18/06/11
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1. Purpose and scope This procedure defines the system for corrective actions in our laboratory. Corrective actions are actions taken to correct the occurence of noncompliance and conditions adverse to quality. This procedure applies to the organization, the processes, the procedures, the resources, the personnel and the management of our laboratory. Especially customer complaints, supplier problems, internal non-conformities, the results of internal and external audits and customer satisfaction surveys are taken into account. 2. Procedure-Sections
41001 41002 41003 41004 Continual improvement Immediate action Corrective action Control of corrective actions
3. Documents 3.1. System documents 41001 Corrective action request (CAR) 41002 Action plan 3.2. Specific documents 3.3. External documents 4. Method 41001 Continual improvement version 1 03/06/2003
The management system is continuously improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews. 41002 Immediate action version 1 03/06/2003
When collaborators experience a problem or non-conformity, the tests are suspended and an immediate action is taken by the Departmental Manager to solve the problem. When a collaborator notices a non-conformance, he completes the first section of a nonconformance report (CAR) with as much detail as possible. The CAR contains the nonconformance identification, the immediate action and the implementation responsibility.
The concerned Departmental Manager monitors the implementation of the immediate action.
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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. 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. He decides if a corrective action is necessary and therefore he examines with the involved collaborator the root cause of the non-conformity. On the basis of that examination a corrective action is taken. This corrective action is recorded on the corrective action request. This measure can lead to changes in procedures, instructions or other elements of the quality management system. The Departmental Manager approves the implemented corrective action if it is found to be effective upon review. When the measure was not effective, the complete process is done over again. 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. The execution dates are noted down. When necessary, extra measures are taken for planned actions which have not been finished in time or which cause unexpected troubles. Corrective actions are reviewed for long-term effects and process improvements via the management reviews. 5. Revision history

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P 411 Preventive actions 18/06/11
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1. Purpose and scope This procedure defines the system of preventive actions and continual improvements in our laboratory. Preventive actions are intended to prevent problems from occurring in the first place. This procedure applies to the organization, the processes, the procedures, the resources, the collaborators and the management of our laboratory. Especially customer complaints, supplier problems, internal non-conformities, the results of internal and external audits and customer satisfaction surveys are taken into account. 2. Procedure-Sections
41101 41102 41103 Continual improvement Preventive action Control of actions and projects
3. Documents 3.1. System documents 41002 Action plans 41101 Project data 3.2. Specific documents 3.3. External documents 4. Method 41101 Continual improvement version 1 03/06/2003
The management system is continuously improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews.
41103 Preventive actions
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The Quality Manager tries to discover potential causes of non-conformities and possible improvements with the help of audit results, quality results, customer satisfaction inquiries, customer complaints and processes and activities which influence quality. Structuring via projects: The preventive measures are structured via projects with a responsible projectmanager. The projectmanager fills in a project document and forwards it to the Quality Manager.
The project document contains:
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- name and number of the project - responsible project manager - purpose and wished results - planned date of effectiveness - project team - measuring method and units: how will it be possible to check if the project was successfull ? Each project is approved by the Managing Director. Action plan: The project manager monitors the project action plan. This action plan includes the different actions necessary for the project implementation. - analysis of the problem and/or current situation - inquiry of alternative solutions - selection of a solution - implementation of the selected solution - examination of the effectiveness. The project manager submits the relevant project data to the Managing Director.
41104 Control of actions and projects
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During the quality meetings the status of the actions is followed-up with the help of the action plans. The execution dates are recorded. When necessary, 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. Preventive actions are reviewed for long-term effects and process improvements via the management reviews.
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P 413 Control of quality and technical records
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1. 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 includes how quality and technical records are identified, collected, indexed, accessed, filed, retained, maintained, disposed, and stored within the quality system. 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. 2. 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. Documents 3.1. System documents D 40305 System documents D 40306 Specific documents D 40307 External documents 3.2. Specific documents 3.3. External documents 4. 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: - the control, composition, change, announcement and distribution of quality records - the records concerning contract reviews: orders, quotations,... - the internal audit reports and the associated corrective and preventive actions - evaluations and audits of suppliers ( particularly for boarding-out ) - list of approved suppliers, purchase documents and other relevant purchase data - records of client complaints - records of every non-conformity, including damaged client property - reports of quality meetings, including the periodic management review of the quality system - records of corrective and preventive actions - training records
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- maintenance records - calibration records
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- design records All quality and technical records belonging to the quality management system, are listed on different tables of contents. The quality and technical records are appropriately identified by a descriptive title and a rotation number.
41302 Classification of current records
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The table of contents of every quality dossier mentions the quality and technical records which are to be kept. The other quality and technical records are gathered in specificly named dossiers. Every dossier has an index with the different records belonging to the dossier. This particularly applies for dossiers with external documents. Every dossier has got an owner. The dossier owner is responsible for: - keeping the dossier up-to-date - rightly sorting the data - numbering the data - the preservation in good condition - the presence of the dossier on the agreed location - the preservation of the documents during the agreed period - the removal of the out-dated data (at least once a year) - the prevention of damage The dossier owner keeps a check on the distribution (look into, copy,...) of the data. He decides who is allowed to look into the records. The dossier owner is responsible for bringing the dossier and/or documents to the recordoffice. The current records are brought over to the record-office once a year. The dossier owner, record-office and archive period of each record are determined by the Quality Manager. 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. The Departmental Manager is responsible for the use of suitable and fit documents in his department. Therefore he regularly checks the documents in use.
He ensures that all records used in his department are well readable. The registration takes place during the execution of the activities, where possible. Each record contains the name of the collaborator, the revision date and the identification of the piece of work.
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When corrections are necessary, they are mentioned next to the marginal line, clearly identified and paraphed by the collaborator. 41304 Archive version 1 03/06/2003
The Quality Manager keeps all completed quality and technical records in the archive. The records, their dossier owner, their depository and their preservation period are mentioned on archive documents. The Quality Manager takes every contractually agreed preservation period for the records into account (when applicable). The Quality Manager ensures that all out-dated records are removed from the record-office. This removal takes place at least once a year. The Quality Manager is responsible for taking appropriate measures to prevent damage or loss of the records. Therefore he regularly checks the record-office.
41305 Confidentiality of quality records
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All documents with confidential information are kept by the Quality Manager. 5. Revision history

Effective Date
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P 414 Internal quality audits
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1. Purpose and scope The purpose of internal auditing is to ensure that the Quality Management is being operated correctly and effectively, by performing planned and documented checks, designed to ensure that: - the quality system documentation adequately defines the needs of the business - the documented procedures and instructions are practical, understood and implemented - 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, or to find fault with individuals' performance. The system is being audited - not the individuals. The auditors must be suitably qualified, and must approach this important task with the seriousness it deserves. Auditors may be laboratory employees or external consultants. Internal audits are the most effective way of continually assessing the effectiveness of the Quality System. This procedure defines the way in which our laboratory will perform internal auditing of the quality management system. It applies to all internal quality audits, which will generally be performed against the requirements of ISO 15189, the laboratory's quality manual, procedures, process plans and work instructions. 2. 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. Documents 3.1. System documents D 41401 Internal auditors D 41402 Audit planning D 41403 Audit questionnaire D 41404 Audit report 3.2. Specific documents 3.3. External documents
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4. Method 41401 Audit planning 18/06/11 version 1 03/06/2003 39 / 63
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The quality manager is responsible for ensuring that the internal audit programme takes place, for allocation and training of internal auditors, and for preparing the internal audit schedule. Audit planning consists of preparing the internal audit schedule, which is a controlled document, authorised by the Managing Director. The schedule should cover all aspects of the Quality Management System at least once a year, although particular activities may be audited more frequently depending on their importance. The schedule should leave room (time) for unscheduled audits in response to: - anticipated problem areas - actual problems - requests from Management - unforeseen changes in circumstances. The schedule should define for each audit: - the auditor - the auditee - 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). 41402 Audit preparation The auditor will prepare for each audit as follows: - by reading through previous audit reports covering the same area (in order that previous problem areas can be examined in more detail, or that areas previously unexamined can be looked at more closely) - by familiarising himself with the requirements of ISO 15189 and the local standards (quality manual, procedures, process plans, work instructions) - by contacting the auditee and confirming the date/time for the audit - by preparing an audit checklist or similar aide-memoir. version 1 03/06/2003
41403 Auditing During the audit, the auditor will:
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- make use of standard auditing techniques to collect objective information concerning the subject being audited - not respond to rumour and hearsay - avoid confrontational situations and arguments
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- makes notes to aid the writing of the audit report - collect documentary evidence of conformity or nonconformity - note where current procedures could be improved - keep the auditee informed as to the progress of the audit and any findings. 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 - classifies the findings of the audit as follows: * acceptable: satisfies the requirements of ISO 15189 and the laboratory's own standards, procedures, manual, etc. * 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, procedures, manual, etc. * observation: an area of weakness that could be improved. - record the good points as well as the bad - makes constructive suggestions where possible - records only factual evidence (not hearsay) - clearly identifies the areas where corrective actions are required, and who is responsible for carrying them out - contains * the names of the auditor, auditees, observers * location of the audit * date of the audit - is signed off by all parties as being a true and accurate representation of the facts. 41405 Following-up version 1 03/06/2003
The auditor is responsible for checking that follow-up actions take place. The actions are structured in action plans. If an auditee persistently fails to carry out the assigned follow-up actions, the auditor must inform the managing director, who will take steps to ensure that the follow-up action take place. As the follow-up actions are completed the auditor will record them by up-issuing the original audit report. Once all follow-up actions have been completed, the auditor will sign off the audit report as complete.
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41406 Quality records concerning audits
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Completed audit records are stored as quality records and have the following important functions: - demonstrating that the audit system exists, is functioning and effective - allowing analysis of types of problems and identifying the most common problems so that preventive actions can be taken - analysing response and correction times - allowing the auditor to prepare for audits by reviewing the past reports for that area or function - providing valuable summary for use in Management Reviews of the Quality System. 5. Revision history

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P 415 Management review
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1. 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. The quality management system in use will be regularly reviewed by the laboratory's management to ensure: - that it continues to be effective and suitable, fulfilling the changing and future needs of the laboratory and its clients - that the quality system is updated as necessary - that the results of internal audits are reviewed to ensure that the defined quality system is being implemented and followed. This procedure applies to all management review meetings conducted by the organization. 2. Procedure-Sections
41501 General 41502 Method for management review 41503 Registration of management review
3. Documents 3.1. System-documents 41501 Minutes of the quality meetings 41502 Meeting reports 3.2. Specific documents 3.3. 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.
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41402 Method for management review
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The management review of the quality management system takes place during the monthly quality meetings, in attendance of all Departmental Managers and the Director of the laboratory. The Quality Manager has the disposal of a planning of quality meetings showing the agenda. Potential agenda: - approval of the previous report - action plans - quality system documents - client complaints - client feedback - internal non-conformities - supplier problems - non-conforming product - internal and external audits - analysis of client complaints - analysis ot internal non-conformities - analysis of supplier problems - supplier evaluation - training efforts - investment needs - management reviews - quality objectives of the last year - quality indicators for monitoring the laboratory's contribution to patient care - status of preventive and corrective actions - any changes in the volume and type of work undertaken - monitoring of turnaround times At least once a year a broad evaluation of the quality system is made. The purpose is to ensure the suitability and the effectiveness of the system in the light of the ISO 15189 requirements, the quality policy and the objectives of our laboratory. Every ISO 15189-requirement is reviewed for its present situation, the realized progress and possible improvements. Special attention is devoted to the evolution of the client complaints and the non-conformities, to the working of the corrective and preventive action system, to the working of the audit process and of the training process. Decisions are made how the effectiveness of the quality system and the processes can be improved and how client requirements can be met better.
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The quality objectives for the present year are discussed.
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41402 Registration of management review
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Minutes of the management reviews are written. The Quality Manager is responsible for this. The Quality Manager records the following: - calendar year - date performed - review period - list of attendees - action items arising from the meeting He also summerizes the overall performance. A copy of the meeting minutes will be distributed to the attendees and any individuals assigned action items. A copy of the meeting minutes will also be retained on file. Follow-up action items are structured via action plans. 5. Revision history

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P 501 Training and awareness 18/06/11
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1. Purpose and scope This procedure establishes a method for identifying training requirements, determining training responsibilities and providing training to personnel performing work that affects quality. Our laboratory ensures that personnel have the training needed to perform their jobs safely and effectively and to produce quality tests. This procedure applies to all collaborators who manage, perform, or verify work affecting the quality of our tests. 2. 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. Documents 3.1. System documents D 50101 Personnel card D 50102 Function description D 50103 Overview trainings 3.2. Specific documents 3.3. External documents 4. Method 50101 Recruitment of new personnel version 1 03/06/2003
The Departmental Managers, the Quality Manager and/or the Managing Director determine the need for new personnel. The Managing Director is responsible for the formal determination of vacancies. A job offer stating the minimal schooling and experience for candidates is written by the Managing Director. This job offer is subsequently advertised in the newspapers. The selection of the candidates takes place with the help of their curriculum vitae and a personal conversation. The candidate who conforms best to the job profile of the vacancy, is accepted. All unsuccessful candidates receive a message.
50102 Training of new personnel
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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. He hands him the quality policy and the quality objectives. 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. The Quality Manager promotes the awareness of client requirements and communicates the importance of meeting these requirements (along with regulatory and statutory requirements). The new employee is also made aware of the potential consequences resulting from mistakes made and/or improper performance of assigned activities and duties. 50103 Training planning and registration A. Planning of the trainings: The Departmental Manager is responsible for the translation of the training needs into a concrete training plan. The training may be internal or external, collective or individual, and may take place by means of job rotation, courses about the quality management system and the evaluation of its effectiveness, schooling about statistical techniques, problem analysis,... The training planning is presented to the Managing Director, who assesses and approves it. B. Registration of the trainings: For every collaborator a personal card is kept stating the schooling, training, and experience before entrance into office. After a training, the institute delivering the training, communicates whether the concerned collaborator has passed. 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.
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Details of the training and its effectiveness are discussed and reviewed in order to make the final overall evaluation. This evaluation concludes if the training was appropriate for the intended purpose. If the training was not effective, actions are taken to correct the problem. 18/06/11 47 / 63
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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.
5. Revision history
REVISION HISTORY
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Rev 0 Initial Release
Description of Change
Author
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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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Identification of the installations:
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All installations, which require maintenance, are identified by a combination of letters and digits. All installations show this identification and all documents relating to them also mention it. Maintenance cards: Each installation has a "maintenance card", which contains all relevant information, including: - name of the installation - identification of the installation - maintenance type: preventive or curative - the installation characteristics (capacity, serial number,...) - manufacturer - supplier - date of acquisition - most important spare parts and minimal stock Preventive maintenance planning: Preventive maintenance also includes the supervision of the installations and machines. The maintenance frequency (the period between two turn-outs) is indicated on the maintenance card. Maintenance instructions: The Maintenance Manager decides for which installations an instruction is necessary in order to assure the correct execution of the maintenance activities.
53102 Curative maintenance request
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When the operator of an installation or machine ascertains that maintenance is necessary, he notifies the Departmental Manager or the Maintenance Manager . The defective equipment is removed from service by segration, prominent labelling or marking. The effect of the defect on previous tests is examined.
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55103 Maintenance history 18/06/11
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For each machine or installation the executed maintenance is recorded (from a frequency greater than monthly). The maintenance date and the executor are also registered. This is also the case for externally executed maintenance. The executed work is released by recording it. 53104 Externally executed maintenance version 1 03/06/2003
The Maintenance Manager is responsible for giving instructions to the external maintenance firm, including safety instructions. All maintenance contracts are recorded. The Maintenance Manager is responsible for the release of externally executed maintenance activities. 53105 Control of spare parts version 1 03/06/2003
The Maintenance Manager manages the spare parts warehouse. He pays attention to the fixed minimal stock. 5. Revision history

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P 532 Calibration 1. Purpose and scope
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The purpose of this procedure is to describe the responsibilities and the method for the control of measuring and monitoring equipment. In addition, the procedure ensures that the measuring equipment has the necessary accuracy. Finally, the procedure defines the way in which the measuring and monitoring equipment is identified, calibrated and preserved in good condition. The procedure applies to all measuring devices used in the laboratory. 2. Procedure-Sections
53201 53202 53203 53204 Responsibility Registration system General procedure Defects and inexactitudes
3. Documents 3.1. Systemdocuments D 50306 Calibration card D 50307 List of measuring devices D 50308 Calibration planning D 50309 Calibration contracts D 50310 Calibration history 3.2. Specific documents 3.3. External documents 4. Method 53201 Responsibility version 1 03/06/2003
The Calibration Manager is responsible for the managing of the calibration system. This includes: - development and implementation of a calibration system - planning, execution and registration of the calibrations - advice to the concerned collaborators on the purchase of measuring devices - evaluation of the calibration results - release of measuring equipment after repair or calibration. - check the function and calibration status of the equipment, when the equipment went outside the direct control of the laboratory.
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53202 Registration system
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The Calibration Manager makes an inventory of all measuring devices in our laboratory on the "list of measuring devices". The Calibration Manager makes an calibration card for every device with the following data: 1. General - name and identification of the device - manufacturer - supplier - place - year of acquisition - measuring range - accuracy 2. Calibration data - internal/external calibration - calibration frequency - calibration steps. The Calibration Manager determines the calibration planning bearing in mind the calibration frequency. He determines for every measuring device the calibration frequency on the basis of following aspects: the manufacturer's indications, the directions for use, the environmental conditions and the required accuracy. The calibration planning mentions the identification code of the measuring device and the planned month for the calibration. The Calibration Manager makes a note of the effective calibration date. For every measuring device the Calibration Manager retains a calibration survey with all performed, internal and external calibrations.
53203 General procedure
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When the calibration planning indicates that a calibration is necessary, the Calibration Manager takes back the concerned measuring device. Then the Calibration Manager executes the calibration internally or externally. For internal calibrations he follows calibration instructions; for external calibrations he follows the procedure P 462, "Purchasing" and he always asks a calibration certificate to guarantee the reducibility.
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Every measuring device subject to calibration, is provided with a label by the Calibration Manager which indicates till when the calibration is valid. Measuring devices which don't have to be calibrated, bear a label with the words: "no calibration necessary".
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Where calibrations give rise to a set of correction factors, copies (e.g., in computer software) are correctly updated by the Calibration Manager.
53204 Defects and inexactitudes
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Every measuring device, that is damaged or outside the tolerance limits, or that has another non-conformity, is immediately marked with a red label and blocked. 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. The Calibration Manager also contacts the concerned Departmental Manager to check the measurings executed with the non-conforming device. 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, P 410. 5. Revision history

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P 504
Sample preparation and identification
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1. Objectif and field of application This procedure defines the method for the identification of the samples received. The field of application covers all samples received by the laboratory. 2. Procedure-section 50401 50402 50403 50404 Transportation and storage Receipt of the samples Request form Sample identification
3. Documents 3.1. Systemdocuments 3.2. Specific documents 3.3. External documents 4. 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 - within a time frame appropriate to the nature of the requested examinations and the laboratory discipline concerned - within a temperature interval, namely: ......... (indicate the temperature interval) en with the designated preservatives to ensure the integrity of samples (indicate which preservatives), and - in a manner that ensures safety for the carrier, the general public and the receiving laboratory, in compliance with national, regional or local requirements. (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. (Describe how this is done and who is responsible.) 18/06/11 56 / 63
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50402 Receipt of the samples
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All primary samples received are recorded in an accession book, worksheet, computer or other system. (Describe the system used + refer to the document concerned). The date and time of receipt of samples, as well as the identity of the receiving officer, are recorded. On receipt, the primary samples are verified if they meet following acceptance criteria: ....... (Describe the acceptance criteria for the primary samples.) If compromised samples are accepted, the final report will indicate the nature of the problem, and, if applicable, that caution is required when interpreting the results. 50403 Test request form version 1 03/06/2003
The request form contain information sufficient to identify the patient and the authorized requester, as well as pertinent clinical data. The request form is a paper which is filled out. The request form allows space for the inclusion of at least the following: - unique identification of the patient - 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. The requesting clinician's address is provided as part of the request form information when it is different from that of the receiving laboratory - type of primary sample and the anatomic site of origin, where appropriate; - examinations requested - clinical information relevant to the patient which includes gender and date of birth as a minimum, for interpretation purposes - date and time of primary sample collection - date and time of receipt of samples by the laboratory When an examination is urgent, the request form is marked with the word "URGENT". 50404 Sample identification version 1 03/06/2003
Primary samples are traceable by request form to an identified individual.
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The primary samples are identified via the following code: ............... (Describe how the primary samples are identified + describe in partical how samples which have to be processed urgently, are identified..)
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Primary samples lacking proper identification are not accepted or processed by the laboratory. Where there is uncertainty in the identification of the primary sample or instability of the analytes in the primary sample (cerebrospinal fluid, biopsy, etc.) and the primary sample is irreplaceable or critical, 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, or for providing proper information or all these. In such an instance, the signature of that person taking responsibility for the primary sample identification is recorded on, or traceable to, the request form. If this requirement is not met for any reason, the person responsible is identified on the report if the examination is carried out. Samples to be set aside for future examination (e.g. viral antibodies, metabolites relevant to the clinical syndrome) are also identifiable. 5. Revision history

Effective Date
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P 508
Reporting of results
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1. Objective and field of application This procedure defines the method of drawing up and transmitting test reports to clinicians and to the patient. 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. 2. Procedure-sections 50801 50802 50803 50804 50805 Drawing up the test report Release and distribution Changes Turnaround times Alarming test results
3. Documents 3.1. Systemdocuments P 50801 Alarming intervals P 50802 Actions in response to alarming test results 3.2. Specific documents 3.3. External documents 4. Method 50801 Drawing up of the test report version 1 03/06/2003
Laboratory management is responsble for formatting reports. 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 report is noted down on paper and includes at least: - clear, unambiguous identification of the examination including, where appropriate, the measument procedure; - the identification of the laboratory that issued the report; - unique identification and location of the patient, where possible, and destination of the report; 18/06/11 59 / 63
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- name or other unique identifier of the requester and the requester's address; - date and time of primary sample collection, when available and relevant to patient care, and time of receipt by the laboratory; - date and time of release of report, which, if not on the report, is readily accessible when needed; - source and system (or primary sample type);
- results of the examination reported in SI units or units traceable to SI units (see ISO Guide 31), where applicable; - biological reference intervals, where applicable; - interpretation of results, where appropriate; - other comments (e.g. quality or adequacy of primary sample which may have compromised the result, results/interpretations form referral laboratories, use of developmental procedure); the report identifies examinations undertaken as part of a development programme and for which no specific claims on measurement performance are made, and, where applicable, information on detection limit and uncertainty of measurement are provided on request; - identification of the person authorizing the release of the report; - if relevant, original and corrected results; - signature or authorization of the person checking or releasing the report, where possible. The report indicates if the quality of the primary samples received was unsuitable for examination of could have compromised the result. 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.) - International Council for Standardization in Haematology (ICSH) - International Society of Haematology (ISH) - International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) - International Union of Pure and Applied Chemistry (IUPAC) - International Society of Thrombosis and Haemostasis (ISTH) - European Committee for standardisation (CEN) - International Union of Biochemistry and Molecular Biology (IUBMB) - International Union of Microbiological Societies (IUMS) - International Union of Immunological Societies (IUIS) - SNOMED International (College of American Pathologists) - World Health Organisation (WHO) 50802 Release and distribution of test reports The laboratory director is responsible for releasing test reports. The test report is transmitted to the clinician who requested the test and may be transmitted to the patient concerned. When results are transmitted verbally, a written reports always follows. version 1 03/06/2003
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For results transmitted as an interim report, the final report is always forwarded to the requester. Copies of the reports are kept in the laboratory and can be easily retrieved.
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50803 Changes of the reports
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When altered, the record must show the time, date and name of the person responsible for the change. Original entries remain legible when alterations are made. Original electronic records are retained and alterations added to the record through appropriate editing procedures so that reports clearly indicate the alteration. 50804 Turnaround times version 1 03/06/2003
Laboratory management istablishes turnaround times for each of its examinations. A turnaround time reflects clinical needs. When an examination is delayed, the requesting clinician is notified if the delay could compromise patient care. Turnaround times as well as any feedback from clinicians in relation to it are monitored, recorded and reviewed by the laboratory director. When necessary, corrective actions are taken to address any problems so identified (see P 410). 50806 Alarming test results version 1 03/06/2003
When examination results for critical properties fall within established "alert" or "critical" intervals, the clinician is immediately notified. This includes results received on samples sent to referral laboratories for examination. The laboratory has determined the critical properties and thier "alert/critical" intervals in agreement with the clinicians using the laboratory (see D 50801). This applies to all examinations, including nominal and ordinal properties. Records of actions taken in response to results in the critical intervals are maintained. These include time, date, responsible laboratory staff member, person notified and examination results.
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5. Revision history

Effective Date
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P 402 Quality system documentation

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 403 Control of documents 18/06/11

4. Method 40301 Control of changes version 1 03/06/2003

40302 Request for revision of a document

40303 Release of documents

40304 Information on documents and forms

40309 Control of passwords

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 404 Review of contracts 1. Purpose and scope

40403 Order changes A. The client requests an order change:

REVISION HISTORY Rev 0 Initial Release Description of Change Author

Examination by referral laboratories

1. Objective and field of application

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 461 Supplier evaluation 1. Purpose and scope

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 462 Purchasing 1. Purpose and scope 18/06/11

46203 Investment planning

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 463 Verification of purchased product 18/06/11

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 408 Client feedback and complaints

B. Classification of the client feedback and complaints

40802 Client complaint registration A. Receiving and logging client complaints

- late delivery to client - problems with communication and responsiveness

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 409 Identification and control of non-conformities

40902 Blocking of non-conforming tests 18/06/11

40903 Treatment of non-conformities

40904 Eliminating the root cause

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 410 Corrective Actions 18/06/11

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 411 Preventive actions 18/06/11

41103 Preventive actions

The project document contains:

41104 Control of actions and projects

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 413 Control of quality and technical records

- maintenance records - calibration records

41302 Classification of current records

41305 Confidentiality of quality records

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 414 Internal quality audits

4. Method 41401 Audit planning 18/06/11 version 1 03/06/2003 39 / 63

41403 Auditing During the audit, the auditor will:

41406 Quality records concerning audits

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 415 Management review

41402 Method for management review

The quality objectives for the present year are discussed.

41402 Registration of management review

REVISION HISTORY Rev 0 Initial Release Description of Change Author

P 501 Training and awareness 18/06/11

50102 Training of new personnel

50105 Motivation of the personnel Communication:

Rev 0 Initial Release

P 531 Preventive maintenance 1. Purpose and scope

Identification of the installations:

53102 Curative maintenance request