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Auditing ISO 9001:2015 Clause 8.5 Production and Service Provision
by Walt Prystaj

Auditing Production and Service Provision (Clause 8.5 of ISO 9001:2015) is crucial for ensuring that the organization’s operations produce outputs that meet customer and regulatory requirements. This clause focuses on managing and controlling the processes related to producing goods or delivering services, ensuring quality is maintained throughout production and service delivery.

Here’s a detailed guide for auditing Clause 8.5:

Understanding Clause 8.5 Requirements

Clause 8.5 includes various sub-clauses that address different aspects of production and service provision:

1. Control of production and service provision (8.5.1)

2. Identification and traceability (8.5.2)

3. Property belonging to customers or external providers (8.5.3)

4. Preservation (8.5.4)

5. Post-delivery activities (8.5.5)

6. Control of changes (8.5.6)

Each of these sub-clauses involves specific controls and considerations that an auditor should focus on.

Pre-Audit Preparation

Before the audit, the auditor should:

Review process maps: Understand how production and service provision are structured, from inputs to outputs.
Examine customer requirements: Look at contracts, specifications, and other requirements that affect production and service provision.
Review previous nonconformities: Check for any issues identified in previous audits related to production or service activities.

1. Control of Production and Service Provision (Clause 8.5.1)

This clause requires organizations to control the conditions under which production and service provision occur. Key controls include:

Availability of documented information
Use of suitable infrastructure and equipment
Implementation of monitoring and measurement activities
Use of competent personnel

a. Production Process Control

Audit Checklist Questions:
Are documented procedures and instructions available for production and service provision processes?
Are production and service provision activities performed under controlled conditions?
How does the organization monitor key process parameters, such as temperature, pressure, or speed, during production?
Audit Objective:
Verify that production processes are well-documented and that workers have access to relevant procedures and instructions. The organization should demonstrate effective control over production variables that affect quality.

b. Infrastructure and Equipment

Audit Checklist Questions:
Is the infrastructure (e.g., buildings, utilities) appropriate for production and service provision?
Is equipment regularly maintained and calibrated according to a documented plan?
Are there records of equipment maintenance, repairs, and calibration?
Audit Objective:
Ensure that the organization has the appropriate infrastructure and equipment to maintain quality during production and service provision. Maintenance and calibration should be carried out according to a schedule, and records should be readily available.

c. Monitoring and Measurement

Audit Checklist Questions:
How does the organization monitor and measure product characteristics during production or service provision?
Are there records of inspections, tests, and other forms of verification?
Audit Objective:
Confirm that the organization monitors and measures product characteristics during production to ensure that outputs meet customer requirements. This could include in-process inspections, final inspections, or testing.

d. Use of Competent Personnel

Audit Checklist Questions:
Are personnel who are involved in production and service provision competent and properly trained?
Are there records of training and qualifications for staff involved in these processes?
Audit Objective:
Verify that staff involved in production or service provision are competent, based on training records and documented qualifications.

2. Identification and Traceability (Clause 8.5.2)

The organization must identify products throughout production and service provision and, where necessary, maintain traceability.

a. Product Identification

Audit Checklist Questions:
How does the organization ensure that products are identified at every stage of production? Are there specific methods used for product identification (e.g., labels, barcodes, or tags)?
Audit Objective:
Confirm that the organization has a system for identifying products throughout the production process to prevent mix-ups or confusion.

b. Product Traceability

Audit Checklist Questions:
How does the organization maintain traceability of products, especially in cases where it is a requirement (e.g., regulatory compliance)?
Are records of traceability maintained, and are they accessible when needed?
Audit Objective:
Verify that the organization can trace products back through the production process, especially for regulated industries (e.g., aerospace, automotive, medical devices). Traceability records should include details such as lot numbers, materials used, and production dates.

3. Property Belonging to Customers or External Providers (Clause 8.5.3)

Organizations must exercise care over property belonging to customers or external providers, such as materials, tools, and intellectual property.

a. Control of Customer Property

Audit Checklist Questions:
How does the organization manage and protect property provided by customers or external providers (e.g., tools, materials)?
Are there documented procedures for managing customer property, including storage and handling?
Audit Objective:
Ensure that the organization has controls in place for managing and protecting customer-owned property. This includes documenting its condition when received and ensuring it is stored and used appropriately.

b. Nonconforming Customer Property

Audit Checklist Questions:
What actions does the organization take if customer or external provider property is damaged, lost, or found to be unsuitable?
Are customers informed when their property is damaged or found to be nonconforming?
Audit Objective:
Verify that the organization has a process for handling customer property that is damaged or unsuitable for use and that customers are informed when issues arise.

4. Preservation (Clause 8.5.4)

The organization must ensure that products are preserved throughout internal processing and delivery to prevent deterioration.

a. Product Preservation

Audit Checklist Questions:
How does the organization ensure that products are preserved during storage, handling, and transport?
Are there specific methods used for product preservation (e.g., packaging, environmental controls, or labeling)?
Audit Objective:
Confirm that the organization uses appropriate methods to preserve the condition of products during production, storage, and transportation to prevent damage or deterioration.

5. Post-Delivery Activities (Clause 8.5.5)

Post-delivery activities, including warranty provisions, maintenance services, and repairs, must be controlled and managed.

a. Post-Delivery Obligations

Audit Checklist Questions:
Does the organization provide any post-delivery services, such as installation, maintenance, or repairs?
Are there documented procedures for managing post-delivery services, including customer complaints and warranty claims?
Audit Objective:
Verify that the organization has controls in place for managing post-delivery activities, such as warranty services or customer support. Post-delivery services should meet customer expectations and comply with contractual agreements.

b. Handling Customer Complaints

Audit Checklist Questions:
How does the organization handle customer complaints related to post-delivery issues?
Are there records of complaints and the actions taken to address them?
Audit Objective:
Ensure that the organization has a process for managing and responding to customer complaints regarding post-delivery issues, and that corrective actions are documented.

6. Control of Changes (Clause 8.5.6)

Changes to production and service provision processes must be controlled and reviewed to ensure they do not negatively affect product quality.

a. Control of Process Changes

Audit Checklist Questions:
How does the organization control changes in production or service provision processes?
Are changes reviewed, validated, and communicated to relevant personnel before implementation?
Audit Objective:
Verify that the organization controls changes to production and service provision processes in a systematic way. Changes should be reviewed and approved before implementation to prevent unintended consequences.

b. Documentation of Changes

Audit Checklist Questions:
Are changes to production processes documented and traceable?
Are there records of the justification for the change and its potential impact on product quality?
Audit Objective:
Confirm that changes are documented, and that their impact on product quality and customer requirements is assessed before they are implemented.

Auditing ISO 9001:2015 Clause 8.5 Production and Service Provisionby Walt Prystaj

Here’s a detailed guide for auditing Clause 8.5:

Understanding Clause 8.5 Requirements

Clause 8.5 includes various sub-clauses that address different aspects of production and service provision:

1. Control of production and service provision (8.5.1)

2. Identification and traceability (8.5.2)

3. Property belonging to customers or external providers (8.5.3)

4. Preservation (8.5.4)

5. Post-delivery activities (8.5.5)

6. Control of changes (8.5.6)

Each of these sub-clauses involves specific controls and considerations that an auditor should focus on.

Pre-Audit Preparation

Before the audit, the auditor should:

Review process maps: Understand how production and service provision are structured, from inputs to outputs.

Examine customer requirements: Look at contracts, specifications, and other requirements that affect production and service provision.

Review previous nonconformities: Check for any issues identified in previous audits related to production or service activities.

1. Control of Production and Service Provision (Clause 8.5.1)

This clause requires organizations to control the conditions under which production and service provision occur. Key controls include:

Availability of documented information

Use of suitable infrastructure and equipment

Implementation of monitoring and measurement activities

Use of competent personnel

a. Production Process Control

Audit Checklist Questions:

Are documented procedures and instructions available for production and service provision processes?

Are production and service provision activities performed under controlled conditions?

How does the organization monitor key process parameters, such as temperature, pressure, or speed, during production?

Audit Objective:

Verify that production processes are well-documented and that workers have access to relevant procedures and instructions. The organization should demonstrate effective control over production variables that affect quality.

b. Infrastructure and Equipment

Audit Checklist Questions:

Is the infrastructure (e.g., buildings, utilities) appropriate for production and service provision?

Is equipment regularly maintained and calibrated according to a documented plan?

Are there records of equipment maintenance, repairs, and calibration?

Audit Objective:

Ensure that the organization has the appropriate infrastructure and equipment to maintain quality during production and service provision. Maintenance and calibration should be carried out according to a schedule, and records should be readily available.

c. Monitoring and Measurement

Audit Checklist Questions:

How does the organization monitor and measure product characteristics during production or service provision?

Are there records of inspections, tests, and other forms of verification?

Audit Objective:

Confirm that the organization monitors and measures product characteristics during production to ensure that outputs meet customer requirements. This could include in-process inspections, final inspections, or testing.

d. Use of Competent Personnel

Audit Checklist Questions:

Are personnel who are involved in production and service provision competent and properly trained?

Are there records of training and qualifications for staff involved in these processes?

Audit Objective:

Verify that staff involved in production or service provision are competent, based on training records and documented qualifications.

2. Identification and Traceability (Clause 8.5.2)

The organization must identify products throughout production and service provision and, where necessary, maintain traceability.

a. Product Identification

Audit Checklist Questions:

How does the organization ensure that products are identified at every stage of production? Are there specific methods used for product identification (e.g., labels, barcodes, or tags)?

Audit Objective:

Confirm that the organization has a system for identifying products throughout the production process to prevent mix-ups or confusion.

b. Product Traceability

Audit Checklist Questions:

How does the organization maintain traceability of products, especially in cases where it is a requirement (e.g., regulatory compliance)?

Are records of traceability maintained, and are they accessible when needed?

Audit Objective:

Verify that the organization can trace products back through the production process, especially for regulated industries (e.g., aerospace, automotive, medical devices). Traceability records should include details such as lot numbers, materials used, and production dates.

3. Property Belonging to Customers or External Providers (Clause 8.5.3)

Organizations must exercise care over property belonging to customers or external providers, such as materials, tools, and intellectual property.

a. Control of Customer Property

Audit Checklist Questions:

How does the organization manage and protect property provided by customers or external providers (e.g., tools, materials)?

Are there documented procedures for managing customer property, including storage and handling?

Audit Objective:

Ensure that the organization has controls in place for managing and protecting customer-owned property. This includes documenting its condition when received and ensuring it is stored and used appropriately.

b. Nonconforming Customer Property

Audit Checklist Questions:

What actions does the organization take if customer or external provider property is damaged, lost, or found to be unsuitable?

Are customers informed when their property is damaged or found to be nonconforming?

Audit Objective:

Verify that the organization has a process for handling customer property that is damaged or unsuitable for use and that customers are informed when issues arise.

4. Preservation (Clause 8.5.4)

The organization must ensure that products are preserved throughout internal processing and delivery to prevent deterioration.

a. Product Preservation

Audit Checklist Questions:

How does the organization ensure that products are preserved during storage, handling, and transport?

Auditing ISO 9001:2015 Clause 8.5 Production and Service Provision
by Walt Prystaj