To perform a GAP analysis and verify compliance with Clause 8.1 on Operational Planning and Control, you should assess whether your organization has effectively planned, implemented, and controlled the processes necessary for delivering products and services that meet requirements. Here’s a step-by-step guide to verify compliance with each part of this clause:

1. Determining Requirements for Products and Services (8.1a)

Review Documentation of Requirements

Start by reviewing any documentation where product and service requirements are defined. This could include customer contracts, design specifications, order forms, or internal documents detailing quality standards. To ensure compliance, check that these documents are clear, complete, and accessible to the relevant personnel involved in production or service delivery.

Evaluate Requirement Communication

Verify that these requirements are consistently communicated to all relevant teams or departments. Look for communication records, such as emails, process instructions, or internal handbooks, that clarify requirements to avoid misunderstandings and ensure alignment. Compliance is demonstrated if all relevant teams can access up-to-date requirements for the products or services they’re involved in.

2. Establishing Criteria for Processes (8.1b1)

Examine Defined Process Criteria

Check that your organization has defined clear criteria for each operational process to guide how work should be carried out. This might include performance metrics, quality standards, timing requirements, or safety guidelines. Compliance here means having clear, established criteria for each step of the process that contribute to the desired outcomes.

Review Supporting Process Documentation

Examine any standard operating procedures (SOPs), work instructions, or flowcharts used by the organization to see if they align with the established criteria. These documents should be accessible, up-to-date, and detailed enough to guide employees on how to meet process standards.

3. Establishing Criteria for the Acceptance of Products and Services (8.1b2)

Verify Defined Acceptance Criteria

Confirm that the organization has set specific acceptance criteria to determine when products and services meet quality and customer requirements. These criteria could be in the form of inspection checklists, quality control standards, testing protocols, or benchmarks for performance.

Evaluate Records of Product or Service Acceptance

Check records of quality inspections, test results, or final approval forms to confirm that products and services are evaluated against the defined acceptance criteria before delivery. Consistent use of these criteria in quality checks is essential for compliance, as it ensures only conforming products and services reach customers.

Through this GAP analysis, you can assess if your organization complies with ISO 9001 requirements for operational planning and control. Evidence of compliance includes well-documented and communicated requirements, defined process and acceptance criteria, and routine use of these criteria in evaluations and quality checks.