1 |GroupGAP QMS Guidance

Agricultural Marketing Service, Specialty Crops Program, Specialty Crops Inspection Division

Guidance for Writing a GroupGAP Quality Management System 

The GroupGAP certification program requires that all Groups write and implement a Quality 

Management System (QMS) that is based on ISO 9001, or an equivalent process management 

system. The principles of ISO 9001 are outlined on the International Standards Organization 

(ISO) webpage. Each Group’s QMS also must adhere to the GroupGAP Basic Requirements for 

Groups. This document provides helpful tips in interpreting basic requirements for GroupGAP 

applicants who are writing their Group’s QMS. A full list of the Basic Requirements for Groups

appears in Appendix I of the GroupGAP User's Guide.

Quality Management System (GroupGAP User’s Guide, Appendix 1, Item 1)

Requirement 

The Group must establish, document, implement, and maintain a QMS, and continually improve 

its effectiveness in accordance with the requirements of the USDA GroupGAP Certification 

Program. The QMS establishes the system by which the Group will ensure that its members are 

in compliance with the chosen Good Agricultural Practices (GAP) and/or Good Handling 

Practices (GHP) audit service.

Guidance

A QMS is a formalized system that documents the processes, procedures, and 

delegations of responsibilities an organization uses to achieve its quality policies and 

objectives. For GroupGAP, a QMS is a set of business practices that dictates how a

Group functions and ensures it is delivering consistent, safe produce to customers.

Your QMS will describe how your Group plans to meet your customers’ new and 

evolving requirements, and the resources you need to do that. Your Group should 

continually assess potential improvements both to your business processes and your QMS

to ensure that the QMS helps your Group meet customers’ and regulatory requirements, 

and continually improves the Group’s effectiveness and efficiency.
2 |GroupGAP QMS Guidance

Outsourcing Requirements (GroupGAP User’s Guide, Appendix 1, Item 2)

Requirement

The Group must ensure control over any process it chooses to outsource that affect the 

GroupGAP certification. Control of the process must be identified in the QMS. 

ISO 9001 and Equivalent Systems (GroupGAP User’s Guide, Appendix 1, Item 3)

Requirement

The QMS must be modeled on ISO 9001, a system that meets other recognized industry quality 

standards, or a process control system that is equivalent to or better than ISO 9001.

Guidance

ISO 9001 is an international standard that provides criteria for a QMS. The standard is 

based on quality management principles, including a strong customer focus, management 

commitment and involvement, a process-based approach, and continuous improvement. 

Using ISO 9001 helps ensure that your Group delivers consistent, high-quality products 

and service to your customers. 

ISO 22006 is a process control system that contains guidelines for applying ISO 9001 

principles to crop production. This system is considered equivalent to ISO 9001, and may 

be more applicable for GroupGAP groups. 

More information about international process control systems is available at 

http://www.iso.org/iso/home/standards.htm.

Guidance

Outsourced processes include anything that is not directly in control of the group (e.g., 

farm audits, education, and shipping). If a Group outsources any processes or 

responsibilities, it must demonstrate any function it does not directly perform will still 

meet the requirements of the chosen audit, GroupGAP, and the Group’s QMS. The 

Group’s QMS must describe who is performing the outsourced function(s), how they will 

be selected, the requirement(s) they must meet, the qualifications they must have, and 

how the Group will verify the requirements are met, including the effectiveness and 

oversight of the outsourced process(es). 
3 |GroupGAP QMS Guidance

Quality Policy and Quality Objectives (GroupGAP User’s Guide, Appendix 1, Item 4.a)

Requirement

The QMS must state the Group’s quality policy and quality objectives.

Quality Manual (GroupGAP User’s Guide, Appendix 1, Item 4.c)

Requirement

The QMS must include a quality manual.

Responsibilities and Authorities (GroupGAP User’s Guide, Appendix 1, Item 5.d)

Requirement

The Group must ensure that responsibilities and authorities are defined and communicated within 

the organization, including creating an organizational chart or similar document that lists all 

personnel, and their responsibilities and authorities.

Guidance

A quality manual is a written document that outlines the QMS’ policies and procedures

the Group will be required to follow, and establishes the scope of your Group’s 

certification. Your quality manual must identify how Group membership will be defined, 

the products and processes that will or will not be covered by the QMS, and the rationale 

for any exclusions from the QMS.

Guidance

The Quality Policy is the Group’s mission statement: a brief description of the Group’s 

commitment to meeting its customers’ needs and to continual improvement. 

Quality objectives are measurable outcomes related to customer requirements that the 

Group will use to measure its success. Your quality objectives lay out your Group’s goals 

and are the starting point for your QMS. The remainder of the QMS outlines how your 

Group will achieve those goals. 

For GroupGAP, the quality policy and quality objectives should relate to the Group’s 

food safety goals, and must be communicated to all Group members.

Guidance

Your QMS must describe the responsibilities of both the Group’s members and 

management as related to the QMS, and identify the individual(s) with authority to 

ensure adherence to the policies and procedures in the QMS. A GroupGAP QMS must 

include a visual representation (e.g., organizational chart) that shows all personnel who 

work within the QMS, and their responsibilities and authorities. The Group must 

communicate this information to all members.
4 |GroupGAP QMS Guidance

Necessary Competencies (GroupGAP User’s Guide, Appendix 1, Item 5.e)

Requirement

The Group must outline the necessary competencies for personnel performing work affecting the 

quality of product, including the criteria for training.

Product Requirements (GroupGAP User’s Guide, Appendix 1, Item 5.f)

Requirement

The QMS must specify product requirements, including the GAP and/or GHP audit selected for 

the food safety audit service.

Control of Documents ((GroupGAP User’s Guide, Appendix 1, Item 6.a)

Requirement

The QMS must include a procedure to control documents.

Guidance

The QMS must outline the minimum competencies needed for all roles within the Group 

that relate to the QMS and food safety. Competencies can include work-experience, 

education, training, personal attributes, and ongoing job duties. The Group also must 

state how they will ensure the continued competence of their personnel, including how 

they will ensure the objectivity of personnel (e.g., internal auditors who serve as 

educators or consultants), achieve uniformity across auditors, and review auditors’ 

performance.

Guidance

Product requirements are the minimum standards a product must meet to be considered 

acceptable by your Group. For GroupGAP, product requirements will include successful 

completion of the GAP & GHP audit the Group has chosen to use, and any addendums 

that have been required by the Group. This also could include any additional buyer 

requirements, or any additional requirements/procedures the Group has placed on its 

members. 

Guidance

Your QMS must include procedures for controlling documents, including the Quality 

Manual, written policies and procedures, templates, and standard forms. Your policy 

should outline the process for developing new documents and editing existing 

documents; and, identify who has authority to change and approve documents, how and 

where master copies of documents will be kept and secured, and how outdated/obsolete 

versions will be discarded. The Group also must have a process for ensuring all Group 

members and staff are trained on and are using the most current document versions. 
5 |GroupGAP QMS Guidance

Control of Records (GroupGAP User’s Guide, Appendix 1, Item 6.b)

Requirement

The QMS must include a procedure to control records.

Internal Audit (GroupGAP User’s Guide, Appendix 1, Item 6.c and 6.g)

Requirement

The QMS must include an internal audit procedure.

Guidance

Your Group must perform two types of internal audits: a QMS audit and an annual 

producer audit of each member. Your QMS should outline how you will carry out these 

audits.

For the QMS audit, the policy will outline the frequency of internal audits, competencies 

required of an internal QMS auditor, the individual(s) authorized to perform the audit,

and how the audit findings will be addressed (see Corrective Action below).

For the producer audit, the policy will identify required competencies for internal 

auditors and the individual(s) authorized to perform the audits. If an internal auditor 

performs other functions within the Group (e.g., food safety education or training), the 

plan must identify precautions taken to ensure the individual’s objectivity when 

functioning in the auditor role. If the Group has more than one internal auditor, the plan

should include any measures that the Group takes to ensure uniformity in auditing 

practices across all of them. Finally, the plan should identify any review process for, or 

oversight of, the audits prior to being finalized, and the personnel responsible for these 

functions. 

The Group also must outline how it will perform any required unannounced audits for 

each member, as determined by the USDA unannounced audit policy; and, any required 

follow-up audits on members whose initial or unannounced audit fails to meet the USDA 

acceptance criteria. 

Guidance

Your QMS must include a policy for controlling records, which are defined as 

documented proof of an event or process. Unlike documents, records are any forms or 

templates that are completed on a regular basis and show how the Group, or its members,

are functioning. The master copy of a blank form is a document; the completed form is a 

record. The policy must identify your Group’s records, and may also include members’ 

records, at the Group’s discretion. The policy also must indicate how and where records 

are stored and secured. If records must be approved, the policy should identify the 

personnel with this authority.
6 |GroupGAP QMS Guidance

Control of Non-Conforming Product/Farms (GroupGAP User’s Guide, Appendix 1, Item 6.d)

Requirement

The QMS must include a control of nonconforming product procedure.

Corrective Action (GroupGAP User’s Guide, Appendix 1, Item 6.e)

Requirement

The QMS must include a corrective action procedure.

Guidance

Under GroupGAP, non-conforming product includes non-conforming farms. Your QMS 

must include a procedure for handling any farms that are no longer in compliance with 

the Group’s food safety practices. Farms could be non-conforming based on the results of 

an internal or external audit, or reported issues in the operation. The procedure should 

outline how a non-conforming member will be identified, how the Group will treat that 

member’s certification status, how product from this member will be segregated (if the 

Group takes physical control of product), and the steps a member can take to return to 

conformity. The QMS must identify the personnel authorized to decide the status of a 

non-conforming member, and to ensure the member and their product are segregated 

from the Group’s. The procedure must describe the point at which a non-conforming 

member will be removed from the Group, the process for removal, and the procedure for 

notifying the member, the USDA, and customers. As part of this procedure, the Group 

may choose to address how members are to handle product that is determined to be nonconforming to Good Agricultural Practices, either by themselves or by an auditor.

Guidance

Corrective actions are taken by the Group, or by a member, to correct the cause of an 

identified issue. Issues can be identified by an audit (internal or external), customer or 

member complaints or feedback, Group staff observations, and management reviews. 

The QMS should contain procedures for documenting corrective actions by members and 

the Group, and identify personnel responsible for ensuring corrective actions are 

implemented, and, if applicable, who is authorized to approve the action. If the Group

chooses to enforce timelines on corrective actions, the timelines and repercussions of not 

meeting them should be outlined in the procedure. 
7 |GroupGAP QMS Guidance

Preventive Action (GroupGAP User’s Guide, Appendix 1, Item 6.f)

Requirement

The QMS must include a preventive action procedure.

Membership List (GroupGAP User’s Guide, Appendix 1, Item 7.a)

Requirement

The QMS must include a record of participating producers/members.

Guidance

Preventive actions are taken by the Group, or by a member, to preclude an identified 

potential issue from occurring. Potential issues can be identified by an audit (internal or 

external), customer or member complaints or feedback, Group staff observations, and 

management reviews. The QMS should contain procedures for documenting preventive 

actions by members and the Group, and identify personnel responsible for ensuring 

preventive actions are implemented, and, if applicable, who is authorized to approve the 

action. If the Group chooses to enforce timelines on preventive actions, the timelines and 

repercussions of not meeting them should be outlined in the procedure. 

Guidance

For each member, the Group’s membership list must include:

• Member name

• Street address (mailing), city, state, zip code

• Member telephone and email contact information

• List of fruits and/or vegetables produced

• Physical location of the production area, including acreage of each fruit and/or 

vegetable and/or nut, or production site in square footage

• Harvest season (start and stop months for the year)

• Labor (contract or direct hire)

• Harvest type (mechanical or manual)

• Specific audit service type and scope covered by certification (e.g., Harmonized 

Field and Harvest Operations, USDA GAP&GHP Farm Review, Field Harvesting 

and Field Packing Activities, or House Packing Facility) 

• Last date of USDA GAP and/or GHP individual audit certification for the member 

locations
8 |GroupGAP QMS Guidance

Written Membership Agreement (GroupGAP User’s Guide, Appendix 1, Item 7.b)

Requirement

The QMS must include a record of a written agreement or contract with each member that grants 

permission for personnel authorized by the USDA Agricultural Marketing Service (AMS) to 

enter any and all farms and/or facilities covered by the specific audit program to conduct an 

audit.

Records Associated with Product Realization (GroupGAP User’s Guide, Appendix 1, Item 7.e)

Requirement

The QMS must include records associated with product realization.

Guidance

The Group’s written membership agreement should outline what it means to be a member 

of the Group, including the roles, responsibilities, and expectations related to food safety 

and the Group’s QMS for each member and the Group as a whole. The written agreement 

must grant the Group’s internal auditor(s) and AMS-licensed auditors access to each 

member’s operation. Each member must sign the written membership agreement. Copies 

of all written membership agreements should be retained with the Group records.

Guidance

Product realization is the work the Group does to develop, grow, and deliver the products 

desired by their customers. The QMS must include a comprehensive approach to getting 

from product concept to finished product. These steps include:

• Review the requirements of specified audit standard (i) to ensure the Group is 

aware of changes to the audit requirements, audit checklists, and internal auditor 

guidance, and incorporates these changes into its system.

• Review of inputs related to production and food safety requirements (ii) to 

identify and set requirements for shared inputs or resources (including service 

contracts), how the requirements are communicated to the supplier, and records of 

conformance to these requirements.

• Verification and validation of food safety control measures (iv), including records 

of internal audits, any records of food safety measures the Group uses, and member 

GAP audits. 

Continued on next page
9 |GroupGAP QMS Guidance

Procedures and Records Required by Chosen Audit Standard (GroupGAP User’s Guide, 

Appendix 1, Item 8)

Requirement

The QMS must include, at a minimum, the procedures and records required by the chosen GAP 

or GHP audit standard. The audit services available for the USDA GroupGAP Certification 

Program are located at www.ams.usda.gov/gapghp.

• Review of results of evaluations of suppliers’ goods and services (vi) to ensure that 

suppliers meet the Group’s minimum requirements. This includes supplier evaluations 

of any shared products and services that are purchased for or on behalf of Group 

members, and for outsourced processes. 

• Maintenance of customer property, accounting for property that is lost, 

damaged, or unsuitable for use (viii) to demonstrate the Group is properly caring for 

any customer property (e.g., packaging and equipment) of which it has taken control. 

• Calibration and verification of measuring/monitoring equipment (ix) to record the 

calibration of the Group’s measuring and monitoring equipment, including any 

calibration done for or on behalf of members. This might include temperature devices, 

agricultural chemical application devices, and water treatment equipment. 

Guidance

The QMS should include a means of ensuring that Group members have the documents 

they need to meet the requirements of the audit service that the Group has selected. 

Groups can choose to (1) provide their members with a food safety plan based on the 

chosen audit service type and any additional Group requirements, or (2) make a food 

safety plan template available to their members that be adapted for each member’s 

operation.