Quality management handbook acc. iso 17025

ISO applies to all laboratory environments, regardless of the number of employees or the extent of the testing. Demonstrate that you understand and adhere to international standards and improve efficiency and the integrity of your laboratory environment.

Committed to quality Achieving an ISO standard demonstrates that your company is serious about delivering quality systems through tested processes. Internally ISO standards provide focus and discipline and externally you will achieve credibility, authority and recognition. ISO is the general standard which specifies the requirements for a quality management system. Laboratories which meet the requirements of ISO also operate in accordance with the requirements of ISO that are relevant to calibration and testing activities.

In the context of quality management, this may involve giving a quality manager authority on quality matters over a line management superior. The superior, in supporting the quality policy, should respect this authority. QSE Academy reminds laboratories to be careful in writing a quality manual by creating policies or procedures that are bound to fail.

However, flexibility should still be within the limits of the standard. For instance, your laboratory may describe preferred courses of action while allowing alternatives under defined circumstances, but there should be clarity about who has the authority to approve the alternative action.

Another case is when a supplier policy states that alternatives may be used where the goods are not available from preferred suppliers who are ISO certified.

Furthermore, the quality manager may approve the use of an alternative if the goods are checked before their usage. What to Avoid.

This means your laboratory will still have a non-conformance if you fail to meet a commitment in your documentation that goes beyond the requirements of the standard , even if what you are doing is within the standard. If your laboratory were to enter a commitment to a six-monthly review in your quality manual, but what you do is review annually, you would be meeting the standard but would still have a non-conformance against your documentation. In this way, your laboratory gets the flexibility and conformance with the standard.

However, it is not necessary that the information included appearing explicitly in the manual since subsidiary documentation can be used and referred to. This part must be at the level where decisions on resource allocation are made. It contains:. Accreditation bodies insist on a single level of service since, otherwise, a laboratory might use its accreditation to attract the work and then offer an inferior and cheaper service.

Yet, it is possible to be accredited for the same calibration or test to various levels of accuracy, but it is difficult to see any advantage in this in most cases. The policy statement should be comprised of the name, position, and signature of the senior management body. The chief executive is the ideal person for this task because he or she will explicitly give authority to the quality manager and laboratory manager to implement and operate the quality system.

It should be followed by a reference to any accreditations held by your laboratory. A reference to an appendix containing the scope of accreditation or the scope must be included as well. Finally, this section obliges all personnel to familiarise themselves with the quality documentation and to follow its requirements. QSE Academy reminds it is a good idea to include an organizational chart to prove that the quality manager has access to the highest level of management and the laboratory manager.

This area requires each level of staff to be described, with an outline of the level of experience and qualifications. It aims to set a minimum acceptable level of expertise at each level, which the laboratory undertakes to maintain. Although, the description should provide flexibility to hire employees with specialized but narrow capabilities, where required.

Likewise, your laboratory must create a statement of the policy on the use of employees undergoing training and a requirement for their direct supervision. For instance, an assistant chemist must always work under the direct supervision of a chemist or higher, and the limits of authority and responsibility of each grade should be clearly explained.

Bear in mind that the reference should be made to the staff records or equivalent source as containing a list of the current post holders.

This part identifies precisely, either by name, seniority or post, the individuals who are authorized to take responsibility for the data of your laboratory. Their job contains authorizing the release of work and signing calibration or test certificates. This section must clarify exactly who may accept work and commit the laboratory to the delivery date. Also, the formal contract review process can be outlined here. Quality documentation.

This area determines the structure of the quality documentation. This will traditionally be a hierarchy, headed by the quality manual, which refers to the methods manual or equivalent technical and other procedural documentation. Additionally, your laboratory should refer to mandatory records and documentation such as :. Quality documentation should identify:.

Similar to the other sections of the suggested outline, employees must be instructed to abide by the documented procedures. Staff unwittingly deviating from documented procedures should inform the laboratory manager, who must conclude whether the quality is compromised and what action to take.

For example, the laboratory manager permits departures from documented procedures where technical considerations make this expedient provided that he or she is confident that quality will not be undermined as a result. There must be an instruction that all such departures must be noted and recorded on reports, where relevant.

Moreover, writing a thorough quality manual means containing or referring to a list of typical sources for methods appropriate to the scope of activities of your laboratory. QSE Academy suggests developing a description of the procedure for introducing a new method. The laboratory manager should then be involved in arranging to validate and document the method. Meanwhile, the quality manager should approve the validation and documentation before the laboratory manager releases the method.

Similarly, the procedure for the withdrawal or amendment of a method must be described. This can be expounded in general terms and references made to the equipment logs as a full inventory. It should describe the following:. In your quality manual, this section ensures your laboratory has a statement of the policy to achieve traceability of all measurements by the use of traceable standards of measurement and certified reference materials.

If not possible, a commitment to interlaboratory calibration exercises and similar measurement audits should be accounted for. However, your laboratory should state the policy that references are to be used for calibration only and not for routine purposes. QSE Academy reminds us that this part must ensure your laboratory follows a procedure in the case of a suspicion that faulty data has been released.

Likewise, your laboratory must indicate instructions on the use of ink and the way of making corrections. This segment covers the laboratory policy on the retention of records, as well as the procedure to be followed in the disposal of records. This should establish who may authorize disposal and require that an inventory be kept of the records disposed of. Your laboratory must state the policy on the security of records, including computer data and the person responsible for archiving and computer backup.

Your laboratory must provide the minimum requirement for the contents of a report see section Furthermore, your laboratory must detail the requirement to identify sub-contracted results. This part must state where the laboratory holds accreditation and a stated procedure for identifying the results of methods not included in the accreditation scope.

Besides, your laboratory must set out the procedure for retaining confidentiality when reporting results other than by post.

Moreover, your laboratory must identify:. Moreover, this section must encompass the assignment of responsibility for ensuring work is suspended pending an investigation and the carrying out of corrective action.

As a result, the person responsible for allowing work to continue needs to be identified. Similarly, no such information is left out in the laboratory overnight or in an unattended room.

In this area of the quality manual, your laboratory must write the operation of the staff records, including their use for recording new staff and changes in the training or status of existing staff. It must describe the following:. Hence, staff should be instructed of their responsibility to carry out only operations for which they are authorized. It should also clearly instruct that staff is entitled to refuse to do work for which they are not authorized. To write a comprehensive quality manual, this segment must describe the procedures for the audit and review of the quality system.

Besides, your laboratory must include the records to be kept and the policy on the frequency of audits and reviews. According to ISO , a quality manual should describe:. This part should describe the laboratory premises and a plan. To write it successfully, your laboratory must draw attention to:. Likewise, you must describe the facilities provided to ensure necessary segregation if there are activities conducted by your laboratory that are incompatible.

This must also identify the persons authorized to hold keys, establish the procedure for granting authorization, and determine the person with overall responsibility for security. This area must also identify a list of all controlled documents and subsidiary documentation together with their scope of issue or storage locations. It must incorporate examples of recording quality issues like client complaints, audits, and corrective and preventive actions.

Should your laboratory struggle to write a quality manual that follows ISO standards, QSE Academy has toolkits that can aid you in developing every part of the quality manual.