ISO 9001 Outsourced Process Control Procedure Template

Introduction

Today, outsourcing has become a popular way to reduce costs, improve efficiency, and leverage expert skills. However, for a company that is under the obligation to maintain the quality of its products and services, there is a need to consider if and how a process can be handed over to an external provider with due quality control. Any organization that implements ISO 9001 in its QMS aims to ensure that its products and services are of high quality and correspond to the needs of its customers. Therefore, when choosing between internal and external processes, an organization needs to choose the one that is most capable of meeting the quality requirements. Thus, the ISO 9001 outsourced process control procedure template provides a reliable set of instructions for controlling those processes provided by an external party and thereby ensuring quality.

ISO 9001 and Outsourced Processes

ISO 9001 is the world’s most popular quality management standard that specifies requirements for demonstrating the capability of an organization to consistently provide products and services that meet customer and applicable regulatory requirements.

Clause 8.4 of the ISO 9001 standard deals with the control of externally provided processes, products, and services. It makes it clear that the external provider’s processes and products can be subject to the QMS of the organization, which means they shall be controlled as if they were carried out within the organization.

What Does “Outsourced Process” Mean in ISO 9001?

An “outsourced process” is a process for which an organization needs to obtain the provision of an external party. Thereby, an external party can be responsible for the creation of some elements of an organization’s products and services, such as parts, information technology, calibration, training, and even design and development.

However, even if the process takes place outside the organization, the company that needs the process to be carried out is obliged to ensure that this process conforms to ISO 9001 requirements.

Why is it Important to Control Outsourced Process in the Context of QMS?

An organization that does not adequately control an external process may suffer quality problems, nonconforming products, and damage to its reputation. In addition, poor quality from external providers can lead to additional costs for the organization. Therefore, controlling an external process helps an organization ensure the quality of its products and services, manage supplier-related risks, and prevent negative consequences for the business such as reputation damage and increased costs.

ISO 9001 Requirements for Controlling External Providers (Clause 8.4)

As mentioned above, clause 8.4 of ISO 9001 deals with the control of externally provided processes, products, and services.

Clause 8.4 of ISO 9001 specifies the following requirements for controlling external processes:

1. Determine the control applicable to externally provided processes, products, and services in the following cases:

   • Those to be incorporated into the organization’s products and services.

   • Those to be provided to the customer by the external provider on behalf of the organization.

   • Those provided by an external provider in the form of a process or part of a process as a result of a decision by the organization.
     
     

2. Apply criteria for evaluating, selecting, and re-evaluating external providers, based on demonstrated ability to provide processes or products and services in accordance with the specified requirements.
   
   

3. Ensure that the provision of externally provided processes, products, and services does not adversely affect the ability of the organization to consistently provide products and services that are consistent with requirements.|
   
   

4. Communicate the requirements to the external provider.

However, it is not enough just to understand that external processes need to be controlled. For each particular case, it is necessary to determine what particular controls need to be applied. ISO 9001 emphasizes the need for a risk-based approach, the application of which shall help determine the type and extent of control.

What Factors Influence the Type and Extent of control Necessary?

Type and extent of control shall depend on:

• The potential impact of externally provided processes, products, and services on the organization’s ability to consistently provide products and services that are consistent with requirements.
  
  

• The effectiveness of the control applied by the external provider.
  
  

• The risks associated with the process, the product, or the service provided by an external party.

The controls selected shall be appropriate to the level and nature of risk.

ISO 9001 Outsourced Process Control Procedure Template

Within the framework of this ISO 9001 outsourced process procedure template, particular attention is drawn to the following key elements of an effective procedure for controlling external processes:

1. Scope, Purpose, and Responsibilities

• Scope: define what applies to this procedure (externally provided processes, products, and services).
  
  

• Purpose: a statement of the purpose of this procedure for controlling external processes, for example, to ensure that externally provided processes, products, services conform to specified requirements.
  
  

• Responsibilities: define the roles and responsibilities for the control of external processes (responsible for external processes: QMS Manager; responsible for purchasing: the Purchasing; responsible for process owner: process owner; responsible for management: Top Management).

2. Identification and Risk Assessment of Outsourced Processes

• Process identification method: define how the organization identifies processes, products, and services that are externally provided.
  
  

• Risk assessment method: define how the level of risk associated with the external process is determined (risk impact on product quality, customer satisfaction, and compliance with legal and regulatory requirements).

3. External Supplier Selection, Evaluation, and Reassessment

• Selection criteria: define the selection criteria for choosing an external provider (requirements for documentation, financial and technical capabilities, and past experience).
  
  

• Initial evaluation: define the initial assessment procedure (audits, questions, trials).
  
  

• Performance monitoring: define the monitoring procedure (performance appraisal, scoring system, and Key Performance Indicators).
  
  

• Re-assessment: define how and when the organization reassesses the external provider (review procedure, frequency, and criteria).

4. Specify the Requirements and Communicate Them Correctly

• Specific specification: define how the requirements shall be specified (product specification, service level agreement (SLA), quality requirements, product acceptance criteria, quality management system requirements).
  
  

• Communication with suppliers: define how the communication with the external provider takes place.

5. Performance Monitoring, Measuring, and Verification

• Methods for monitoring the performance of external processes.
  
  

• Verification activities: define what verification activities shall be carried out (incoming inspection, testing, validation, and audit of external provider’s site).

6. Handling of Nonconformities and Corrective Actions

• Reporting of nonconformities: define how nonconformities related to external processes shall be reported.
  
  

• Corrective action requirements: specify what corrective actions shall be taken by the external provider and how their effectiveness shall be verified.
  
  

• Escalation: define what escalation procedure shall be followed in the event of ongoing nonconformities with external providers.

7. Documented Information and Records

• Records: specify what records shall be retained (supplier evaluation records, performance reviews, contracts, nonconformity records, corrective action records).
  
  

• Documents control: specify how documented information related to external processes shall be controlled.

8. Review and Improvement of the Procedure

• Procedure review: specify the procedure for reviewing this procedure (frequency and responsible party).
  
  

• Opportunities for improvement: define the opportunities for improving the control of external processes.

Advantages of Using a Comprehensive Outsourced Process Control Procedure Template

Using an ISO 9001 outsourced process control procedure template provides many benefits for the company.

• Full compliance with ISO 9001 requirements: First, when creating a document according to the given template, one can fully comply with the requirements of ISO 9001, in particular clause 8.4.
  
  

• Reduced quality risks: In addition, using a ready-made solution reduces the risk of problems with the quality of products and services.
  
  

• Improved external supplier performance and standardized work: Moreover, the use of such a template contributes to the improvement of the performance of external suppliers, as well as the standardization of the work of the company itself in relation to the control of external processes.
  
  

• Reduced document preparation time: The implementation of such a procedure also allows for reducing the time required for the preparation of this document, since the user receives ready-made instructions that only need to be adapted to the specific features of the company.
  
  

• Improved customer satisfaction: Thus, using an ISO 9001 outsourced process procedure template, one can ensure the quality of products and services, which contributes to the satisfaction of the company’s customers.

Implementation of the ISO 9001 Outsourced Process Control Procedure

To implement a procedure for the control of external processes:

1. Customize the ready-made document to the particular needs of the organization.
   
   

2. Train employees who need to deal with external processes (e.g., the purchasing department) on the newly implemented procedure.
   
   

3. Integrate the created procedure into the existing quality management system in accordance with ISO 9001.
   
   

4. Communicate the new procedure to the external suppliers.
   
   

5. Evaluate the effectiveness of the implemented procedure, and review and update the procedure as necessary.

Conclusion

In particular, the control of external processes helps the company to ensure the quality of its products and services and thereby contribute to their satisfaction. Therefore, a company that wishes to operate in accordance with ISO 9001 and ensure the quality of its products and services needs a well-documented procedure for controlling external processes. The procedure for controlling external processes based on the ISO 9001 standard helps the company to determine what controls to apply to the external processes and thereby ensure the quality of the goods or services provided by the external supplier.