ISO 17025 has not set a format on how to write a quality manual. However, laboratories should develop a quality manual because it defines their Quality Management System and the procedures which implement it.
There are accreditation bodies that provide guidance and format in creating a quality manual document. The risk is that the manual could veer away from your laboratory’s ideas and point of view. On the bright side, assessors could easily understand this format.
Whether your laboratory chooses to write a quality manual on your own or by getting the services of accreditation bodies (Click here to download a quality manual sample), your laboratory must know what should be included as per ISO 17025 requirements.
To help you get started, QSE Academy has prepared this list to guide you in creating a quality manual. You can also acquire our toolkits that will save you time in writing an ISO/IEC 17025 compliant quality manual.
THE BASICS OF WRITING A QUALITY MANUAL
Keep in mind that the basis for all audits and assessments of the quality system will be based on the contents of your laboratory’s quality manual and the documents to which it refers.
- The quality manual should describe the system as it is operated.
- The quality manual should be a working document.
- The quality manual should not be a description of an ideal world.
Make Sure to Include All Eventualities
When writing a quality manual according to ISO/IEC 17025, remember that assigning responsibilities and appropriate authority work hand in hand.
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.
- The quality manual will need to give an alternative, such as a deputy or another point of reference when a post holder or a member who has a responsibility is not available.
- Your laboratory must provide a statement that all responsibilities ultimately revert to the laboratory manager who may delegate them again if necessary.
- The laboratory should always try to ensure that the laboratory manager and his or her deputy are never unavailable at the same time.
Provide Flexibility When Writing a Quality Manual
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 9001 certified. Furthermore, the quality manager may approve the use of an alternative if the goods are checked before their usage.
What to Avoid
- Writing a complex documentation structure, which is difficult to maintain.
- Duplicating information across various documents because it is hard to ensure that versions in the different documents remain consistent and are all maintained together.
- Committing to anything beyond the standard, even if you intend to go beyond the standard.
An assessment will be against your laboratory’s quality documentation in addition to the standard. 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.
For instance, ISO/IEC 17025 requires an annual review of the quality system. 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.
Therefore, the quality manual should indicate that your laboratory will review ‘at least annually’. 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.
In the next parts of this post, QSE Academy explains each part of a suggested outline for a quality manual that describes an ISO/IEC 17025 compliant system to ensure your laboratory won’t experience the example provided above.
Complete Outline for a Quality Manual According to ISO 17025
Quality policy statement and accreditation
ISO/IEC 17025 requires the most senior management body for the laboratory to create this section. This part must be at the level where decisions on resource allocation are made.
- Commitment to good professional practice.
- Commitment to impartiality.
- Commitment to confidentiality.
- Commitment to a quality management system based on ISO/IEC 17025.
- Commitment to provide resources to support this level of quality.
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.
Organization and Management
Organization and Management should show your laboratory’s internal organization, as well as the relationship between the laboratory and any organization of which it is a part.
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.
In line with ISO/IEC 17025, the organization and management must establish the supervisory requirements at each grade. 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.
Acceptance of work
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.
It should ensure that:
- The person accepting the work is under an obligation to make sure your laboratory has the expertise and equipment to execute the work.
- The person accepting the work must not enter into a commitment unless they can be certain on this point.
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.
Mandatory documents for ISO/IEC 17025 2017 version
Additionally, your laboratory should refer to mandatory records and documentation such as :
- Document and Record Control Procedure (Clauses 8.2.1, 8.3 & 8.4)
- Quality Policy (Clauses 8.2.1 & 8.2.2)
- Competence, Training and Awareness Procedure (Clause 6.2.5)
- Addressing Risks and Opportunities Procedure (Clauses 8.5.2 & 8.5.3)
- Externally Provided Products and Services Procedure (Clause 6.6.2)
- Facilities and Environment Procedure (Clause 6.3)
- Equipment and Calibration Procedure (Clauses 6.4.3 & 6.5)
- Customer Service Procedure (Clauses 7.1.1 & 8.6)
- Test and Calibration Method Procedure (Clauses 7.2.1 & 7.2.2)
- Quality Assurance Procedure (Clauses 7.7.1 – 7.7.3)
- Sampling Procedure (Clauses 7.3, 7.5 & 7.8.5, applicable only to laboratories that do sampling)
- Handling of Laboratory Test or Calibration Items Procedure (Clause 7.4)
- Complaint, Nonconformity and Corrective Action Procedure (Clauses 7.9 – 7.10 & 8.7)
- Testing Report Procedure (Clauses 7.8.2 & 7.8.3, applicable to testing laboratories that write test reports)
- Calibration Report and Certificate Requirements Procedure (Clauses 7.8.2 and 7.8.4, applicable to calibration laboratories that write calibration certificates)
- Internal Audit Procedure (Clause 8.8.2)
- Management Review Procedure (Clause 8.9)
- List of Internal and External Documents (Clauses 8.2.4 & 8.3.1)
- List of Types of Records (Clause 8.4)
- Registry of Records for Detention/Central Archive (Clauses 8.3.2f & 8.4.1)
- Quality Objectives (Clauses 8.2.1 & 8.2.2)
- Training Program (Clause 6.2.3)
- Training Record and Performance Monitoring (Clause 6.2.2)
- Record of Attendance (Clause 6.2.2)
- Approval and Authorization Record (Clauses 5.6 & 6.2.5e)
- Supplier Evaluation and Approval Record (Clause 6.6.2a)
- List of Approved Suppliers of Products and Services (Clause 6.6.2a)
- Record of Laboratory Environmental Controls (Clause 6.3.3)
- List of Laboratory Equipment (Clause 6.4.13a)
- Calibrated Equipment Record (Clause 6.4.13a)
- Calibration Record (Clause 6.4.13e)
- Equipment Maintenance Record (Clause 6.4.13g)
- Customer Order Review (Clause 7.1.1a)
- Report of Customer Satisfaction (Clause 8.6.2)
- Method Verification, Validation and Development Record (Clauses 7.2.1 & 7.2.2)
- Sampling Plan (Clause 7.3.1) (as applicable)
- Sampling Report (Clause 7.3.3) (as applicable)
- Corrective Action Report (Clause 8.7.3)
- Complaint, Nonconformity and Corrective Action Report Log (Clause 8.7.3)
- Measurement Uncertainty Record (Clause 7.6.3)
- Audit Nonconformity Report (Clause 8.8.2d)
- Internal Audit Report (Clause 8.8.2e)
- Management Review Record (Clause 8.9.2)
Quality documentation should identify:
- The purpose of each piece of documentation.
- The person is responsible for maintaining and authorizing documentation to be issued.
- The availability of each document, including where it is kept, whether it is issued and to whom, who has the right of access, and in whose custody it is kept.
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.
Validation of methods
This segment should specify the laboratory’s policy to use globally recognized methods wherever possible, enhanced by completely documented and validated internal processes.
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.
To comply with ISO/IEC 17025 standards, an outline of the format for in-house documented methods should be provided. Similarly, the procedure for the withdrawal or amendment of a method must be described.
Equipment and reference standards
To make sure your laboratory’s quality manual complies with ISO/IEC 17025, this part should detail the major items of equipment that you operate and the reference standards held. This can be expounded in general terms and references made to the equipment logs as a full inventory.
It should describe the following:
- The format and operation of the equipment logs.
- The procedure for checking and accepting a new piece of equipment into service.
- The procedure for the withdrawal of equipment.
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.
Uncertainty of measurement
According to ISO/IEC 17025, this segment must describe your laboratory’s procedures and policies in determining method performance validation and assessing the uncertainty of measurement.
It should entail:
- A description of procedures to be used at the initial validation of methods.
- A description of the laboratory manager’s responsibility for updating the information based on QC data.
- Guidance on the general policy of the laboratory on the frequency of running QC samples, spikes, and duplicates.
To be able to write a quality manual that complies with ISO/IEC 17025, your laboratory must create a general statement on which level of individuals or staff are allowed to judge whether results meet quality control criteria.
The statement should cover:
- Reference to the fact that methods documentation contains information on the quality control data to be collected and the criteria to be applied.
- The general laboratory manager’s responsibility to monitor and act upon quality control data.
- A commitment to interlaboratory proficiency checking exercises and/or measurement audits.
- A list of such exercises in which the laboratory typically participates.
Procedure when data is suspect
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.
- This usually requires your quality manager to conduct a probe and an audit. It may also require corrective action.
- Your laboratory’s policy must inform clients as soon as possible of suspect data.
- Your laboratory’s commitment to check the data.
- Your laboratory’s commitment to issue an amended report, if necessary.
Handling of samples and administration of work
When writing a quality manual with ISO/IEC 17025 standards in mind, your laboratory must provide a complete description of the following:
- Procedures for receiving, storing, and recording samples
- Sample numbering and labeling
- Allocation of work
- Recording of results
- Quality checking of results
- Preparation of reports
- Issuing reports
QSE Academy’s toolkits and services can help your laboratory describe in a systematic way how samples and results are managed.
We advise that your laboratory become aware of how the client’s requirements are communicated to the bench workers and how the bench workers pass the results back to the reporting process.
Recording of results
This section must explain the use of notebooks and/or worksheets. Likewise, your laboratory must indicate instructions on the use of ink and the way of making corrections.
Disposal of samples and other waste
In writing this area of the quality manual following ISO/IEC 17025, your laboratory must identify:
- The policy on the length of time samples is kept.
- The policy on disposal.
- The commitment to the responsible disposal of toxic materials.
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 back-up.
Reporting of results
Your laboratory must provide the minimum requirement for the contents of a report (see section 13.2) and include an example of the preferred layout.
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. In the case of amendments, your laboratory can produce a statement that this can only be done by the issue of a completely new version with an endorsement such as ‘Amendment to Certificate No…….’
Quality incidents, complaints, and control of non-conforming work
When writing a quality manual that adheres to ISO/IEC 17025 standards, your laboratory must cover the policy to treat complaints positively and as a source of useful information.
Moreover, your laboratory must identify:
- The persons authorized to deal with complaints.
- The procedure for recording complaints.
- A follow-up of the complaints.
- The requirement for corrective action.
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.
Writing a quality manual according to ISO/IEC 17025 requires your laboratory to retain confidentiality.
This means staff must be instructed to take all reasonable precautions to keep the client’s data and other information confidential. Similarly, no such information is left out in the laboratory overnight or in an unattended room.
Staff appointment, training and review
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:
- The mechanism for selecting staff for training, carrying out the training.
- The mechanism for assessing competence.
- The mechanism for issuing authorizations to carry out calibrations, tests, and other procedures.
- The mechanism for an annual review of staff capabilities and the means of recording the results.
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.
Procedures for audit and review of the quality system
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 17025, a quality manual should describe:
- The procedure for agreeing and recording corrective action.
- The procedure for a follow-up to ensure corrective action is complete and has been effective.
Premises and environment
This part should describe the laboratory premises and a plan. To write it successfully, your laboratory must draw attention to:
- Any parts of the premises to which access is restricted and who is authorized to grant access.
- Any areas subject to special environmental controls as well as the mechanism for monitoring, recording, and maintaining such control.
Likewise, you must describe the facilities provided to ensure necessary segregation if there are activities conducted by your laboratory that are incompatible.
Security of premises
Writing a quality manual in line with ISO/IEC 17025 requires this section to describe the arrangements for the security of the premises during and outside working hours.
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.
Finally, for your quality manual to comply with ISO/IEC 17025 standards, there should be appendices covering a list of the scope of accreditation held or applied for, as well as a list of holders of the quality manual.
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. An example of your laboratory’s proposed report format should be accounted for.
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