Outline A Quality Manual That Is Entirely Compliant with ISO 17025 Standard

Posted by Charles Wilson on April 3rd, 2023

A policy establishes the laboratory's commitment to implementing ISO/IEC 17025. The Quality Manual is the most important document in the document hierarchy. It explains the methods for obtaining high-quality data. It also includes policy statements indicating the laboratory's intention to meet ISO/IEC 17025 requirements. A policy statement could say, for example, that all workers participating in calibration and testing should be competent for the task at hand. The ISO 17025 standard does not specify a format for writing a quality manual. Yet, laboratories should create a quality manual since it specifies their Quality Management System and the methods that will be used to put it into action. These are some summaries for a Quality Manual in compliance with the ISO 17025 standard.

Accreditation and a quality policy statement: According to ISO/IEC 17025, this section must be created by the laboratory's highest senior management authority. This section must be at the level where resource allocation choices are made. Which contains a commitment to good professional practice, as well as assurance of impartiality, also confidentiality, along with the commitment to a quality management system based on ISO/IEC 17025 and a commitment to providing resources to support this level of quality.

To prevent laboratories from using their certification to get business and then providing a subpar and less expensive service, accreditation authorities insist on a single level of service. Therefore, it is usually difficult to perceive any benefit in being accredited for the same calibration or test to different levels of accuracy.

The senior management's name, title, and signature should be on the policy statement. The chief executive is the best candidate for this position since s/he will clearly allocate power to the quality manager and laboratory manager for the implementation and management of the quality system. A description of any accreditations your lab may have should come after that. Moreover, a mention of an appendix providing the scope of certification or the scope is required. Last but not least, this component requires all employees to be conversant with the quality documentation and to adhere to its guidelines.

Organization and Management: Organization and Management should outline the organizational structure of your laboratory as well as the connections it has with any external organizations. Each level of personnel must be described in this part, along with an overview of their degree of training and credentials. It tries to establish a minimally acceptable standard of proficiency at each level, which the laboratory agrees to uphold. Yet, the job description should allow for the option to hire staff members with specialized but limited skills when necessary.

Similarly, the lab has to establish a statement of policy regarding the use of learners and the necessity for their direct supervision. The organization and management are required to set the supervisory requirements for each grade by ISO/IEC 17025. For instance, the scope of authority and responsibility for each grade should be made crystal clear, and an assistant chemist must always operate directly under the supervision of a chemist or higher. Also, keep in mind that a list of the current post holders can be obtained in the staff records or an equivalent source, which should always be acknowledged.

Quality documentation:

The quality documentation's structure is established in this section. It will typically be organized in a hierarchy, with the ISO 17025 quality manualat the top and the methods manual or comparable technical and other procedural documentation.

Approved signatories: This section specifically defines the people who have the authority to be in charge of the laboratory's data, either by name, seniority, or post. Their duties also include signing calibration or test certifications and approving the release of work.

Acceptance of work: This part needs to be very specific about who can take the work and bind the lab to the delivery deadline. The formal contract review procedure is also described here.

It's your responsibility to make sure that:

• The individual accepting the work has a responsibility to ensure that your laboratory is equipped with the knowledge and tools necessary to complete the work.
• Until they are certain on any point, the person accepting the work must not make a commitment.

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