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 farms processes and their interactions (i.e., PROCESS FLOW DIAGRAM) Your Farms 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 2. Record Control 3. Internal Audit

4. 5. 6.

Control of Non-Conforming Product Corrective Actions 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 dont 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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Local Disk C:\ QMS Documentation Manuals

*Quality Manual *Procedures Manual

QMS Records (electronic) reference

QMS Records (hard copies)