4.1 Organization
4.1.1 The Laboratory, or the organization in which it is located, shall be an entity capable of assuming legal responsibility.
4.1.2 The role of the Laboratory is to perform testing and calibration in a manner that meets the requirements of this Standard and is responsive to the needs of the Client, the Statutory Authority, or the organization providing accreditation.
4.1.3 The Laboratory's management system shall cover the work performed by the Laboratory within its fixed facilities, at sites away from its fixed facilities, or in associated temporary or mobile facilities.
4.1.4 If the organization in which the Laboratory is located also engages in activities other than testing and/or calibration, in order to identify potential conflicts of interest, the roles of key personnel in the organization who are involved in, or have an influence on, testing and/or calibration should be defined.
Note 1: If the Laboratory is part of a larger organization, the organization should be such that its conflict-of-interest scent, such as production, trade marketing, or finance, does not adversely affect the Laboratory's ability to meet the requirements of this Standard.
Note 2: If the Laboratory wishes to be accredited as a third party Laboratory, it should be able to demonstrate its impartiality. The Laboratory and its staff shall be able to resist any undue commercial, financial, or other pressures that might influence its technical judgment. A third-party testing or calibration laboratory should not engage in any activity that compromises its independence of judgment and the integrity of its testing or calibration.
4.1.5 The Laboratory shall:
a) Have management and technical staff. They have the authority and resources needed to perform their duties, to recognize deviations from the quality system or testing and/or calibration procedures, and to take steps to prevent or minimize such deviations (see 5.2);
b) have measures in place to assure that its management and staff are free from any undue commercial, financial, and other pressures and influences, internal or external, that adversely affect the quality of its work;
c) have measures in place to assure that its management and staff are free from any undue commercial, financial, and other pressures and influences, internal or external, that adversely affect the quality of its work;
c) have policies and procedures to protect the confidential information and proprietary rights of clients, including procedures to protect the electronic storage and transmission of results;
d) have policies and procedures to avoid involvement in any activity that might diminish the credibility of its competence, impartiality, judgment, or integrity of its operations;
e) determine the Laboratory's organizational and management structure, its position within the parent organization
e) Define the organization and management structure of the Laboratory, its position within the parent organization, and the relationship between quality management, technical operations, and support services;
f) Define the responsibilities, authority, and interrelationships of all managerial, operational, and verifying personnel having an impact on the quality of the tests and/or calibrations;
g) Provide adequate supervision of the testing and calibration personnel, including employees in training, by persons knowledgeable in the methodology, procedures, objectives, and evaluation of results of the tests and/or calibrations;
g) Provide adequate supervision of the testing and calibration personnel, including employees in training supervision;
h) technical management with overall responsibility for technical operations and the resources required to ensure the quality of the Laboratory's operations;
i) designation of a person as the Quality Supervisor (however called) who, regardless of other existing responsibilities, shall be given the responsibility and authority to ensure that the Quality System is implemented and followed at all times. The Quality Supervisor shall have direct access to the highest level of management that determines Laboratory policies and resources;
j) Designate the agents of key management personnel (see Note).
Note: Individuals may have multiple functions and it may be impractical to designate an agent for each duty.
4.2 Quality System
4.2.1 The Laboratory shall establish, implement, and maintain a quality system appropriate to the scope of its activities. It shall document its policies, systems, plans, procedures, and instructions to the extent necessary to ensure the quality of the Laboratory's testing and/or calibration results. The system documentation shall be communicated to, understood, accessed, and implemented by appropriate personnel.
4.2.2 The policies and objectives of the Laboratory quality system shall be set forth in the Quality Manual (however called). The overall objectives shall be documented in a statement of quality policy; the statement of quality policy shall be issued under the authority of the chief executive officer and shall include, at a minimum, the following;
a) the Laboratory management's commitment to good professional conduct and to the quality of testing and calibration services provided to the client;
b) the management's statement of the standard of Laboratory services;
c) the objectives of the quality system;< /p>
d) the objectives of the quality system; <
d) the requirement that all Laboratory personnel involved in testing and calibration activities be familiar with the quality documents that pertain to them and implement these policies and procedures in their work;
e) the Laboratory management's commitment to compliance with this Standard.
Note: A concise statement of quality policy is desirable and may include the requirement that testing and/or calibration should always be performed in accordance with prescribed methods and the needs of the client. When the testing and/or calibration laboratory is part of a larger organization, some elements of the quality policy may be included in other documents.
4.2.3 The quality manual shall include or indicate supporting procedures, including technical procedures, and outline the structure of the documents used in the quality system.
4.2.4 The roles and responsibilities of technical management and the quality manager shall be defined in the quality manual, including responsibility for ensuring compliance with this standard.
4.3 General
The Laboratory shall establish and maintain procedures for the control of all documents (internally developed or externally sourced) that comprise its quality system, such as regulations, standards, other normative documents, testing and/or calibration methods, and drawings, software, specifications, instructions, and manuals.
Note 1: "Documents" in this document may be statements of policy, procedures, specifications, calibration forms, charts, diagrams, textbooks, postings, memos, software, drawings, plans, etc. These documents may be carried on a variety of carriers. These documents may be carried on a variety of carriers, evolutionary hard copy or electronic media, and may be in digital, analog, photographic, or written form.
Note 2: The control of test and calibration data is specified in 5.4.7; the control of records is specified in 4.12.
4.3.2 Approval and Release of Documents
4.3.2.1 All documents issued to Laboratory personnel as part of the Quality System shall be reviewed and approved for use by authorized personnel prior to release. A control list or equivalent document control procedure that identifies the current revision status and distribution of documents in the quality system shall be established and easily accessible to prevent the use of invalid and/or obsolete documents.
4.3.2.2 Procedures shall be used to ensure that:
a) Authorized versions of appropriate documents are available in all workplaces important to the effective operation of the Laboratory;
b) Documents are reviewed periodically and revised as necessary to ensure continued relevance and to meet the requirements of the use;
c) Invalid or obsolete documents are removed in a timely manner from all use and distribution.
c) Remove invalid or obsolete documents from all use and distribution in a timely manner, or otherwise ensure that misuse is prevented;
d) Appropriately mark retained and obsolete documents for legal or intellectual preservation purposes.
4.3.2.3 Quality System documents developed by the Laboratory shall be uniquely identified. This identification shall include the date of publication and/or revision identification, page number, total number of pages or marking indicating the end of the document, and the issuing organization.
4.3.3 Document Changes
4.3.3.1 Unless specifically designated otherwise, changes to documents shall be reviewed and approved by the person responsible for the original review. The designated person shall be provided with relevant background information on which to base the review and approval
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4.3.3.2 Changed or new content shall be identified in the document or appropriate attachments, if feasible.
4.3.3.3 If the Laboratory's document control system permits handwritten changes to a document before it is reprinted, the procedure and authority for making the changes should be defined. Revisions should be clearly labeled, initialed, and dated. Revised documents should be released as soon as possible.
4.3.3.4 Procedures shall be established to describe how to change and control documents stored on a computer system.
4.4 Review of Requirements, Bids, and Contracts
4.4.1 The Laboratory shall establish and maintain procedures for reviewing customer requirements, bids, and contracts. These policies and procedures for evaluation for the purpose of contracting for testing and/or calibration shall ensure that:
a) the requirements, including the methods to be used, are appropriately specified, documented, and easily understood (see 5.4.2);
b) the Laboratory has the capability and resources to meet the requirements;
c) the selection of appropriate testing and/or calibration methods (see 5.4.1) is made that meets the client's requirements;
c) the selection of appropriate tests and/or calibration methods (see 5.4.1) is made to meet the client's requirements. ) calibration methods (see 5.4.2 );
Any discrepancies between the Client's requirements or between the Bid and the Contract shall be resolved prior to the commencement of work. Each contract shall be accepted by both the Laboratory and the Client.
Note 1: Evaluation of requirements, bids and contracts shall be conducted in a feasible and efficient manner, taking into account the impact on scheduling, etc. The review of requirements, bids and contracts from internal customers can be carried out in a simplified manner.
Note 2: The evaluation of the Laboratory's competence shall confirm that the Laboratory has the necessary physical, human and information resources and that the Laboratory personnel have the necessary skills and expertise for the testing and/or calibration performed. The review may also include the results of previously participated inter-laboratory comparisons or proficiency tests and/or the results of experimental testing or calibration programs performed on samples or articles of known value used for the determination of measurement uncertainties, limits of detection, confidence limits, etc.
Note 3 : A contract can be any written or verbal agreement to provide testing and/or calibration services for guest rooms.
4.4.2 Records of reviews, including any significant changes, shall be maintained. Records of discussions with the Client regarding the Client's requirements or the results of work performed during the performance of the Contract shall be maintained.
Note: Reviews of routine and other simple tasks are to be dated and identified (e.g., by signature initials) as written by the Laboratory personnel responsible for the contract work. For repetitive routine tasks, reviews are required only at the initial investigation stage if the client's requirements remain unchanged, or at the time of contract approval for ongoing routine work under a general agreement with the client. For new, complex or advanced testing and/or calibration tasks, more comprehensive records need to be kept.
4.4.3 The review should include all work subcontracted out by the Laboratory.
4.4.4 Any deviation from the contract shall be notified to the client.
4.4.5 If modifications to the contract are required after work has begun, the same contract review process shall be repeated and all affected personnel shall be notified of all modifications.
4.5 Subcontracting of Testing and Calibration
4.5.1 When the Laboratory needs to subcontract work for unanticipated reasons (e.g., workload, need for additional expertise, or lack of competence at the present time) or for continuing reasons (e.g., through long-term subcontracting, agency, or special agreements), the work shall be subcontracted to a qualified subcontractor, such as one that is capable of performing the work in compliance with the requirements of this Standard.
4.5.2 The Laboratory shall notify the Client in writing of the subcontracting arrangements and, where appropriate, obtain the Client's permission, preferably in writing.
4.5.3 The Laboratory shall be responsible to the Client for the work of its subcontractors, other than those appointed by the Client or statutory governing body.
4.5.4 The Laboratory shall maintain registration information for all subcontractors used in testing and/or calibration and maintain records of evidence that their work complies with this Standard.
4.6 Procurement of Services and Supplies
4.6.1 The Laboratory shall have policies and procedures for the selection and purchase of services and supply commodities that have an impact on the quality of testing and/or calibration. There shall also be procedures for the purchase, acceptance, and storage of reagents and consumable materials related to testing and calibration.
4.6.2 The Laboratory shall ensure that supplies, reagents, and consumable materials purchased that affect the quality of testing and/or calibration are put into service only after they have been checked or verified to be in conformance with the standard specifications or requirements set forth in the relevant testing and/or calibration method. The services and supplies used shall comply with the specified requirements. Records of compliance checking activities undertaken shall be maintained.
4.6.3 Procurement documents for items affecting the quality of the Laboratory's output shall contain information describing the services and supplies purchased. The technical content of these procurement documents is reviewed and approved prior to issuance.
Note: This description may include type, category, grade, precise identification, specifications, drawings, inspection instructions, other technical information including approval of test results, quality requirements, and the quality system standards under which they are performed.
4.6.4 The Laboratory shall evaluate suppliers of critical consumables, supplies, and services that affect the quality of testing and calibration and maintain records of these evaluations and a list of approved suppliers.
4.7 Serving the Client
The Laboratory shall work with the client or his/her representative to clarify the client's requirements and allow the client to come to the Laboratory to monitor operations related to his/her work while ensuring the confidentiality of other clients.
Note 1: Such cooperation may include:
a) allowing the client or his/her representative reasonable access to the relevant areas of the Laboratory to observe directly the tests and/or calibrations performed on his/her behalf;
b) the preparation, packaging, and shipment of test and/or calibration items required by the client for validation purposes.
Note 2 : The Client places great importance on maintaining good communication with the Laboratory on technical aspects and obtaining advice and guidance, as well as opinions and interpretations based on results. It is desirable for the Laboratory to maintain contact with the client throughout the process, especially for large volumes of business. The Laboratory should inform the client of any delays and major deviations in the testing and/or calibration process.
Note 3: The Laboratory is encouraged to collect additional feedback from its customers (e.g., through customer surveys), both negative and negative. This feedback can be used to improve the quality system, the testing and calibration process, and the service to customers.
4.8 Complaints
The Laboratory shall have policies and procedures for dealing with complaints from clients and others. A record of all complaints shall be kept, together with a record of investigations and corrective actions taken by the Laboratory in response to complaints (see 4.10)
4.9 Control of non-conformance with testing and/or calibration
4.9.1 When any aspect of testing and/or calibration, or any aspect of calibration, is not in accordance with the quality system, the Laboratory must ensure that the quality system is not compromised. calibration work, or any aspect of that work, or the results of that work do not conform to its procedures or to the requirements agreed to by the Client, the Laboratory shall implement an established policy and procedure. The policies and procedures shall ensure that:
a) responsibility and authority for the management of nonconforming work is established, specifying the actions to be taken when nonconforming work is identified (including suspension of work, if necessary, and withholding of test reports and calibration certificates);
b) the severity of the nonconformity of the nonconformity of the nonconformity of the nonconformity of the nonconformity of the nonconformity of the nonconformity of the nonconformity of the nonconformity of the nonconformity of the nonconformity of the test and/or calibration work is assessed;
c) corrective actions are taken immediately, with a decision made on the acceptability;
d) If necessary, notify the customer and cancel the work;
e) Determine responsibility for authorizing resumption of work.
Note: The identification of non-conforming work or problems with the quality system or testing and/or calibration activities may take place at various points in the quality system and technical operations, such as customer complaints, quality control, instrument calibration, verification of consumable materials, visits to or supervision of employees, verification of test reports and calibration certificates, management reviews and internal or external audits.
4.9.2 When the evaluation indicates that nonconforming work is likely to recur, or when there is doubt about the Laboratory's operation in terms of compliance with its policies and procedures, the corrective action procedures specified in 4.10 shall be implemented immediately.
4.10 Corrective Action
4.10.1 General
The Laboratory shall have policies and procedures, with corresponding authority, to implement corrective action when nonconforming work, deviations from policies and procedures in the quality system or technical actions are identified.
Note: Problems in the Laboratory's quality system or technical operations can be identified through a variety of activities, such as nonconforming work controls, internal or external audits, management reviews, customer feedback, or employee observations.
4.10.2 Cause Analysis
The corrective action process should begin with an investigation to determine the root cause of the problem.
Note: Root cause analysis is the most critical and sometimes the most difficult part of the corrective action process. Often the root cause is not obvious, so all potential causes of the problem need to be carefully analyzed. Potential causes may include: customer requirements, samples, sample specifications, methods and procedures, employee skills and training, consumables, equipment and its calibration.
4.10.3 Selection and Implementation of Corrective Action
When corrective action is required, the Laboratory should identify the corrective activities to be undertaken and select and implement those that will best eliminate the problem and prevent its recurrence.
Corrective actions should be appropriate to the severity of the problem and the magnitude of the risk.
The Laboratory should document and implement any changes required by the corrective activity investigation.
4.10.4 Monitoring of Corrective Actions
The Laboratory shall monitor the results of corrective actions to ensure that the corrective activities undertaken are effective.
4.10.5 Additional Audits
When the identification of a nonconformance or deviation leads to doubt about the Laboratory's procedures for conforming to its policies, or for conforming to this Standard, the Laboratory shall, as soon as possible, conduct an audit of the relevant area of activity in accordance with the provisions of 4.13.
Note: Additional audits are often conducted after corrective action has been implemented to determine the effectiveness of the corrective action. Additional audits are only necessary if the problem is proven to be serious or harmful to the business.
4.11 Preventive Measures
4.11.1 Potential causes of nonconformity and required improvements, either technical or related to the quality system, shall be identified. Where preventive measures are required, a program of such measures shall be developed, implemented, and monitored to reduce the likelihood of similar nonconformities occurring and to provide opportunities for improvement.
4.11.2 The preventive measures program shall include the initiation and control of measures to ensure their effectiveness.
Note 1: Preventive action is the process of proactively identifying opportunities for improvement in advance, rather than the identification of problems or complaints.
Note 2: In addition to reviewing operational procedures, preventive measures involve the analysis of information including trend and risk analysis and proficiency testing results.
4.12 Control of Records
4.12.1 General
The Laboratory shall establish and maintain procedures for identifying, collecting, indexing, accessing, archiving, storing, maintaining, and purging quality and technical records.4.12.1.1 Quality records shall include reports from internal audits and management reviews and records of corrective actions.
4.12.1.2 All records shall be legible and stored and maintained in an easily accessible manner in a facility with a suitable environment that prevents damage, deterioration, loss, etc. The records shall be kept for a specified period of time. A retention period for the records shall be specified.
Note: Records may be stored on any form of carrier, such as hard copy or electronic media.
4.12.1.3 All records shall be kept secure and confidential.
4.12.1.4 The Laboratory shall have procedures to protect and back up records stored in the above forms and to prevent unauthorized access or modification.
4.12.2 Technical Records
4.12.2.1 The Laboratory shall maintain for a specified period of time records of original observations, exported data, sufficient information to conduct follow-up audits, calibration records, employee records, and a copy of each test report or calibration certificate issued. If possible, the record of each test or calibration shall contain sufficient information to identify the factors influencing uncertainty and to assure that the test or calibration is reproducible as close as possible to the original conditions. The record shall include the identification of the person responsible for sampling, the person performing each test and/or calibration, and the person verifying the results.
Note 1: In some areas, it may not be possible or practical to keep all original observation records.
Note 2: The technical record is an accumulation of data (see 5.4.7) and information obtained from performing tests and/or calibrations, which indicate whether the tests and/or calibrations were performed to a specified quality or within specified process parameters. Technical records may include forms, contracts, work orders, workbooks, checklists, work notes, control charts, external and internal test reports and calibration certificates, customer correspondence, documentation, and feedback.
4.12.2.2 Observations, data, and calculations shall be recorded as the work is performed and shall be identifiable by specific task categories.
4.12.2.3 When an error is made in a record, each error shall be scratched out, not erased, so as not to blur or disappear, and the correct value shall be entered next to it. All changes to the record shall be signed or initialed by the person making the change. Equivalent measures should be taken for electronically stored records to avoid loss or alteration of the original data.
4.13 Internal Audits
4.13.1 The Laboratory shall conduct internal audits of its activities on a regular basis according to a predetermined schedule and procedures to verify that its operations continue to meet the requirements of the quality system and this Standard. The internal audit schedule shall address all elements of the Quality System, including testing and/or calibration activities. The Quality Supervisor is responsible for planning and organizing internal audits in accordance with the requirements of the schedule and the needs of management. Audits shall be performed by trained and qualified personnel, who shall be independent of the activity being audited, as long as resources permit.
Note: The periodicity of internal audits is usually one year.
4.13.2 When an audit identifies issues that raise questions about the effectiveness of the operation, or the correctness or validity of the Laboratory's testing and/or calibration results, the Laboratory shall take prompt corrective action. If the investigation indicates that the Laboratory's results may have been compromised, the Client shall be notified in writing.
4.13.3 The areas of audit activity, audit findings and resulting corrective actions shall be documented.
4.13.4 Follow-up audit activities shall verify and document the implementation and effectiveness of corrective actions.
4.14 Management Review
4.14.1 The Laboratory's executive management shall periodically review the Laboratory's quality system and testing and/or calibration activities in accordance with predetermined schedules and procedures to ensure their continued suitability and effectiveness and to make necessary changes or improvements. The review shall take into account:
- application of policies and procedures;
- reports from management and supervisory personnel;
- results of recent internal audits;
--Corrective and preventive actions;
--Reviews by external agencies;
--Interlaboratory comparisons or results of proficiency testing;
--changes in workload and type of work;
--client feedback;
--complaints;< /p>
- other relevant factors such as quality control activities, resources, and staff training.
Note 1: The typical cycle for a management review is 12 months.
Note 2: The results of the review are entered into the Laboratory Planning System and include goals, objectives, and activity plans for the following year.
Note 3: The management review includes the examination of relevant topics in daily management meetings.
4.14.2 Problems identified in management reviews and the measures taken as a result shall be documented. Management shall ensure that these measures are implemented within an appropriate and agreed schedule.