ISO 9001:2015 Clause 8.4 Control of Externally Provided Processes, Products and Services
Introduction
Navigating ISO 9001:2015 Clause 8.4 is crucial for any business that relies on external partners. This guide breaks down the requirements for controlling externally provided processes, products, and services, ensuring they meet your quality standards. By understanding these requirements, you can effectively select, evaluate, and monitor suppliers to protect your brand and deliver consistent quality to your customers. It’s about ensuring that your supply chain is a seamless extension of your own quality management system, minimizing risks and upholding your commitment to excellence.
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8.4.1 General
The organization shall ensure that externally provided processes, products and services conform to requirements.
The organization shall determine the controls to be applied to externally provided processes, products and services when:
- products and services from external providers are intended for incorporation into the organization’s own products and services.
- products and services are provided directly to the customer(s) by external providers on behalf of the organization.
- a process, or part of a process, is provided by an external provider as a result of a decision by the organization.
Evaluation and Monitoring of External Providers
The organization must establish and apply criteria for the evaluation, selection, performance monitoring, and re-evaluation of external providers. This ensures that all outsourced processes, products, and services meet specified requirements.
This is a critical step in maintaining a robust quality management system, as a weak supply chain can compromise the final product or service. The criteria used should be based on the provider’s ability to consistently deliver in accordance with requirements.
- Evaluation and Selection: Establish clear criteria for initial provider assessment. This could include quality certifications, past performance, technical capability, and financial stability.
- Performance Monitoring: Continuously monitor the performance of selected providers. Methods can include quality audits, delivery time tracking, and analysis of customer feedback or complaints related to their products.
- Re-evaluation: Periodically re-evaluate providers to ensure they continue to meet your standards. The frequency and rigor of re-evaluation should be based on their performance and the risks they pose.
Documented Information: Retain documented information of all these activities, including the evaluation results, performance data, and any corrective actions taken. This is essential for demonstrating compliance with ISO 9001:2015 Clause 8.4.
ISO 9001:2015 Clause Guide Panel
- Clause 1
- Clause 2
- Clause 3
- Clause 4 – Sub-clause 1
- Clause 4 – Sub-clause 2
- Clause 5 – Sub-clause 1
- Clause 5 – Sub-clause 2
- Clause 5 – Sub-clause 3
- Clause 6 – Sub-clause 1
- Clause 6 – Sub-clause 2
- Clause 7 – Sub-clause 1
- Clause 7 – Sub-clause 2
- Clause 7 – Sub-clause 3
- Clause 7 – Sub-clause 4
- Clause 8 – Sub-clause 1
- Clause 8 – Sub-clause 2
- Clause 8 – Sub-clause 3
- Clause 8 – Sub-clause 4
- Clause 8 – Sub-clause 5
- Clause 8 – Sub-clause 6
- Clause 8 – Sub-clause 7
- Clause 8 – Sub-clause 8
- Clause 8 – Sub-clause 9
- Clause 8 – Sub-clause 10
- Clause 8 – Sub-clause 11
- Clause 8 – Sub-clause 12
- Clause 9 – Sub-clause 1
- Clause 9 – Sub-clause 2
- Clause 9 – Sub-clause 3
- Clause 9 – Sub-clause 4
- Clause 10
Understanding Clause 8.4
Clause 8.4 addresses all forms of external provision, whether:
- purchasing from a supplier,
- arrangements with associate companies,
- outsourcing of processes and functions, or
- by any other means.
Clause 8.4 should be understood broadly as a requirement about the use of external ability, not only a requirement generally understood as purchasing.
As clause 8.4’s object is all forms of external provision, in 8.4.1 it is classified into three forms:
- (8.4.1 a) Products and services are provided by external providers for incorporation into the organization’s own products and services.
Examples:- ingredients provided by an external provider to cook dishes,
- parts to manufacture electric products,
- tools to maintain equipment,
- printing paper to print textbooks, etc.
- (8.4.1 b) Products and services are provided directly to the customer(s) by external providers on behalf of the organization.
Examples:- outsourced providers performing final operations like painting, coating, packing, and delivery.
- (8.4.1 c) A process or part of a process is provided by an external provider as a result of a decision by the organization to outsource a process or function.
Examples:- outsourcing part of manufacturing,
- outsourcing reception desk to call centers,
- outsourcing specimen inspection to medical laboratories.
According to 8.4.1 a)–c), you will need to identify what you must source externally that can affect product quality and select external providers capable of meeting your requirements.
Most organizations have reasons for dealing with particular external providers and can continue using existing providers when developing a quality management system. The standard requires that selection be done in a controlled manner.
Selecting and Using External Providers
You need to:
- Identify what to source externally which affects product quality.
- Select external providers capable of meeting your requirements.
Reasons for choosing particular providers vary, but selection must be controlled.
Criteria for Provider Selection
Questions to consider:
- How reliable are they?
- Can they provide what you want?
- Do they have necessary resources (equipment, personnel)?
- Is delivery time and price acceptable?
- Do they have a quality management system?
- Have you worked with them successfully before?
- Do they have a good reputation and credit rating?
Other Considerations for Suppliers
Where a proprietary or brand name product and service is to be purchased, a frequent source is a distributor, wholesaler or retail outlet.
A wide range of products and services are available from such sources, like electrical and plumbing supplies, lumber, raw materials, components, and catering food.
In those cases, criteria for selection and records may be minimal. Trial periods and reviews may be used to assess performance and acceptability.
Monitoring and Re-evaluation
You should regularly monitor and re-evaluate the performance of external providers to ensure they still meet your original or new/revised selection criteria.
The extent of monitoring depends on the criticality of the product or service within your quality system.
Examples of Monitoring Level
- In a printing organization, the paper quality could be critical and must be closely monitored to maintain expected print quality.
- A travel agency might use normal commercial stationery without needing special quality purchasing controls.
Conclusion
In today’s interconnected business world, very few companies operate in isolation. ISO 9001:2015 Clause 8.4 is a critical reminder that your quality management system extends beyond your own walls. By carefully evaluating, selecting, and monitoring your external providers, whether they are suppliers, contractors, or partners, you maintain control over every part of your process. This proactive approach ensures that all externally provided components, products, and services meet your high standards, protecting the integrity of your final offering and building a reputation for consistent quality and reliability with your customers.
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FAQ
What are the three types of external provision covered by ISO 9001 Clause 8.4?
ISO 9001 Clause 8.4 applies when an external provider supplies:
- Products for incorporation into your own products.
- Products or services directly to your customer on your behalf.
An outsourced process as a result of a business decision.
How do you determine the level of control needed for an external provider?
The level of control depends on the importance and complexity of the provided product or service and the potential consequences of a failure. Higher risk requires more rigorous controls.
What criteria should an organization use for selecting its external providers?
Organizations should select providers based on their ability to consistently meet requirements. This includes their reliability, technical capability, and resources.
Does ISO 9001 Clause 8.4 apply to all suppliers, even simple ones?
Yes, it applies broadly. However, for low-risk purchases from common sources like distributors, the criteria for selection and monitoring may be minimal.
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