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 Control2. Record Control3. Internal Audit

4. Control of Non-Conforming Product5. Corrective Actions6. 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 records2. Records of personnel education, training, skills, and experience3. Records demonstrating that the products (and realization processes) meet all customer

and legal requirements. 4. Records of the review of product requirements — prior to realization5. Supplier evaluation and selection records6. Validation of process for production and service provision records7. Product Identification and traceability records8. Records of loss or damage to customer property9. Calibration verification10. Internal audit records11. Records of product conformity to requirements and release to customer12. Records of Nonconforming products13. Corrective action records14. 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.

Local Disk C:\

QMS Documentation

QMS Document Organization

The core of your QMS Documentation is generated, stored, and/or referenced in two manuals on your computer’s hard drive.

*Quality Manual

*Procedures Manual

Manuals

QMS Records (electronic)

When you set up your QMS you may want to organize your documentation into a main folder.QMS documentation will be stored in either the Manuals, or in separate electronic files. These may be organized into 2 subfolders.When you download the Quality Manual and Procedures Manual templates from the Ag-ISO WebPages, save them with a name appropriate to your farm (e.g., XYZ Farms Quality Manual.doc) in the Manuals subfolder.

In some cases, the data you collect as part of your QMS will be referenced in your manuals, but stored in separate electronic files (e.g., yield maps). Organize these in the QMS Records subfolder.

Some of your records will be printed hard copies of forms or external records (e.g., checklists, receipts). They should also be referenced in the Procedures Manual and organized in a file cabinet that is in a safe location.

reference

QMS Records (hard copies)

One of the benefits of this method of organization is that you can back-up your QMS files in one step by copying the “QMS Documentation” folder to a disk or CD.