How to Write an ISO 17025 Quality Manual

ISO 17025 does not specify how to write a quality manual. However, laboratories should create a quality manual since it specifies their Quality Management System and the processes that implement it.

There are certifying agencies that provide assistance and format for writing a quality manual document. The risk is that the manual will deviate from your laboratory's ideas and point of view. On the plus side, assessors could easily understand this structure.

Whether your laboratory chooses to produce an ISO 17025 quality manual on its own or hire accreditation organizations, it must understand what should be included in ISO 17025 regulations.

The Essentials of Creating a Quality Manual

Keep in mind that the contents of your laboratory's quality manual and the documents to which it refers will serve as the foundation for all audits and assessments of the quality system.

• The quality manual should define how the system works.
• The quality manual should be considered a living document.
• The quality manual should not be a utopian vision of the world.

Include Every Situation

When creating an ISO/IEC 17025 quality manual, keep in mind that delegating tasks and delegating suitable authority go hand in hand.

In the context of quality management, this could imply delegating power over quality matters to a quality manager rather than a line management superior. The superior should respect this authority to support the quality policy.

• When a post holder or a member with authority is not available, the quality manual must provide an alternative, such as a deputy or another point of reference.
• Your laboratory must provide a statement stating that all tasks eventually return to the laboratory manager, who may reassign them if required.
• The laboratory should always make every effort to ensure that the laboratory manager and his or her deputy are never unavailable at the same time.

When Writing a Quality Manual, allow for a Little Variance.

Laboratories should use caution when creating policies or procedures which are destined to fail. However, adaptability should remain within the parameters of the standard.

For example, your laboratory may identify preferred courses of action while allowing alternatives under certain conditions, but it should be clear who can approve the alternative activity.

Another example is when a supplier policy indicates that alternatives may be employed if the goods are not available from preferred ISO 9001 certified suppliers. Furthermore, if the goods are verified before use, the quality manager may approve the use of an alternative.

What to Avoid

• Creating a complex documentation structure that is difficult to maintain.
• Duplicating information across multiple documents because it is difficult to verify that versions in the various documents remain consistent and are all maintained together.
• Commit to everything above and beyond the standard, even if you plan to go beyond and above the standard.

What to Remember?

In addition to the standard, an assessment will be made against your laboratory's quality documents. This implies that your laboratory will still receive a non-conformance if you fail to meet a pledge in your ISO 17025 documents that goes above and beyond the criteria of the standard, even if what you are doing is within the standard.

For example, ISO/IEC 17025 demands an annual evaluation of the quality system. If your laboratory commits to a six-monthly review in your quality manual but only reviews once a year, you will fulfil the requirement but have a non-conformance with your documentation.

As a result, your laboratory's quality manual should state that it will be reviewed "at least annually." As a result, your laboratory gains flexibility and standard compliance. However, it is not required that the information included in the manual be specifically in the manual because supplementary material can be used and referred to.

Complete Quality Manual Outline According to ISO 17025

Quality policy statement and accreditation ISO/IEC 17025, this component must be created by the laboratory's most senior management body. This section must be at the level where resource allocation choices are made.

It includes:

• Commitment to ethical professional behaviour.
• Commitment to objectivity.
• Commitment to maintaining confidentiality.
• Commitment to an ISO/IEC 17025-based quality management system.
• Commitment to providing the resources needed to maintain this level of quality.

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Michel Adrien has published so many articles regarding ISO Certification Documentation. As ISO Consultant profession since last many years Michel has rich experience in preparing such certification documents within ISO guideline to his global clients