Agriculture Reference
In-Depth Information
Re-accreditation audits by the accrediting body typically take place every three years and often include
on-site visits. Between audits, laboratories may be expected to perform internal audits or participate in other
activities that provide evidence of continuing compliance.
Quality Management Systems
Quality systems are based on the principle “Say what you do and do what you say.” Organizations have
to explain in their documentation how they do each task. They must then do exactly what they state, and
provide proof in the form of records. Quality systems require standardized procedures and records for
essential management functions, ensuring consistency across all areas of operation within a laboratory. The
appointment of a quality manager or individual responsible for the maintenance of the quality system is an
essential requirement of every quality system.
A quality system is deined by its standard and described by its quality manual. This is the top-level
document and describes the overall structure, management and responsibilities within the organization. It
contains the quality policy and objectives, statements that describe an organization's primary focus and
goals. A quality manual summarizes the entire quality system, providing a map describing how the organi-
zation meets the requirements of the standard. The quality manual also contains or refers to procedures for
the following critical systems:
• Document control:
this system ensures that documentation is maintained systematically and
regularly. Changes to documents are made by authorized persons and a history of changes is kept,
and manuals are kept up to date so that staff has access only to the most current procedural docu-
ments. Proper document identiication combined with a master list of documents ensures that the
currency and validity of any document can be veriied. A document control system includes both
internal and external (reference) documents.
• Record control:
this system ensures that the records generated are retained for the appropriate
length of time required by the standard and other regulations such as state and federal law, typi-
cally between three and six years. Records must be legible and accessible, and approved forms
are used to collect data. Electronic records are protected and steps taken to prevent loss of data.
• Training:
this system ensures that staff members are adequately trained to perform their jobs.
Staff receives relevant training, levels of competence are deined, and only competent staff per-
forms work independently. Records are kept of each staff member's training and education.
• Equipment:
this system ensures that equipment is maintained properly and calibrated regularly
to national or international standards. Operational instructions are available and staff members
are trained before being allowed to operate sensitive equipment. Malfunctioning equipment is
identiied and not used until it is ixed or replaced. Detailed records are kept to ensure traceability
of measurements.
• Suppliers:
this system ensures that the supplies used in the lab are obtained from approved sup-
pliers and adequately tested or otherwise veriied before use in testing. Only suppliers that provide
good service and products may be used.
• Customer complaint:
this system ensures that complaints from customers are recorded and
timely action taken to address them.
• Corrective and preventive action:
this system ensures that non-compliances are identiied,
investigated and a root cause determined, corrected, followed-up, and records are kept. Non-
compliances (also called non-conforming work) can originate in any part of the quality system
when an organization fails to follow the standard or its own stated procedures. Non-compliances
may also result from customer complaints.
• Internal audits:
this system ensures that the organization regularly reviews its own methods and
procedures and updates or corrects them if necessary. Generally, internal audits are conducted
prior to management review, which is a required, periodic summary of the entire system.
