QMS Documentation
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QMS Manuals and Documentation
• Your core QMS Documentation is intended to be
stored, read, and edited on your computer
because you may:
– backup and protect your work/files on CD.
– prevent unauthorized access or editing of documents
through file security options (i.e., read only or
password protected documents).
– Ensure that the most current version of the
documentation is available to your employees and
customers, and that other obsolete documents are
appropriately managed/controlled.
QMS Manuals and Documentation
The majority of your QMS documentation is
retained in 2 manuals on your computer:
*Quality Manual
*Procedures Manual
You should have already
downloaded these by
following Exercise 0.1 in
your Workbook.
*Quality Manual
• An introduction to your farm business, including the
SCOPE of your QMS.
• A description of your farm’s processes and their
interactions (i.e., PROCESS FLOW DIAGRAM)
• Your Farm’s commitment to quality management
(i.e., QUALITY POLICY)
• Allegiance to ISO 9001:2000 for your QMS. (i.e.,
SECTIONS 4-8 of the Quality Manual)
*Procedures Manual
• The 6 PROCEDURES that are required
by ISO 9001:2000
• 14-19 RECORDS that are required by
ISO 9001:2000
• Additional documentation that is
needed to ensure effective planning,
operation, and control of farm
processes.
*Procedures Manual
1. Document Control 4. Control of Non-Conforming Product
2. Record Control 5. Corrective Actions
3. Internal Audit 6. Preventative Actions
Some of these procedures have already been added to your
Manual (e.g., #1,2). Example procedures are also provided in the
Ag-ISO WebPages.
You will learn more about each of these while you work through
the exercises.
*Procedures Manual
1. Management review records
2. Records of personnel education, training, skills, and experience
3. Records demonstrating that the products (and realization processes) meet all customer
and legal requirements.
4. Records of the review of product requirements — prior to realization
5. Supplier evaluation and selection records
6. Validation of process for production and service provision records
7. Product Identification and traceability records
8. Records of loss or damage to customer property
9. Calibration verification
10. Internal audit records
11. Records of product conformity to requirements and release to customer
12. Records of Nonconforming products
13. Corrective action records
14. Preventative action records
*Procedures Manual
1. The 6 procedures and 14-19 records that are required
according to ISO 9001:2000
2. Additional documentation that is needed to ensure
effective planning, operation, and control of farm processes
*Procedures Manual
“that are needed to ensure effective planning, operation, and control of farm processes”.
• The addition of procedures and records beyond those that are required by
ISO 9001:2000 is completely up to you.
• You will start your QMS by meeting the minimum documentation
requirements (shown on previous slide).
• You will then decide how additional documentation may be used to
improve your QMS on an “as needed” basis.
• The Ag-ISO Workbook and WebPages will lead you through the
development of your manuals. Keep in mind that you MUST put into practice
what you document in your QMS. Your documentation should be useful, but
don’t write yourself into a corner by being too detailed or specific.
QMS Document Organization
You should have already downloaded the Quality and
Procedures Manual templates following Exercise 0.1 of the
Ag-ISO Workbook.
The following slides illustrate one method of QMS
document organization that may help you to effectively keep
track of your files.
QMS Document Organization
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