0% found this document useful (0 votes)
1K views3 pages

ISO 9001:2015 Clause 8.4 Overview

Clause 8.4 of ISO 9001 concerns controlling externally provided processes, products, and services. It requires companies to evaluate and monitor critical suppliers against criteria like technology, quality, responsiveness, delivery, cost, and environmental impact. It also mandates defining controls for suppliers in documents like purchase orders, agreements, or contracts. Controls should be tailored based on supplier risk level. Finally, companies must inspect incoming products and services to check for issues like damage, quantity, or nonconformance.

Uploaded by

Tamhane Navnath
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
1K views3 pages

ISO 9001:2015 Clause 8.4 Overview

Clause 8.4 of ISO 9001 concerns controlling externally provided processes, products, and services. It requires companies to evaluate and monitor critical suppliers against criteria like technology, quality, responsiveness, delivery, cost, and environmental impact. It also mandates defining controls for suppliers in documents like purchase orders, agreements, or contracts. Controls should be tailored based on supplier risk level. Finally, companies must inspect incoming products and services to check for issues like damage, quantity, or nonconformance.

Uploaded by

Tamhane Navnath
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
  • 8.4.1 Purchasing
  • 8.4.2 Controls for Suppliers
  • 8.4.3 Communication with Suppliers
  • Takeaways

Clause 8.

4 of ISO 9001: Controlling


Externally Provided Processes,
Products and Services
Posted by Craig Thornton
Way back in Part 8 of this blog series I discussed the importance
of relationship management in developing your quality management system. 
In that blog I said that “when I was a Senior Auditor for a Certification Body
and auditing companies for ISO 9001 or ISO 14001, supplier management
especially was always an area that companies were very weak in.” 
Over the years ISO and its technical committees have recognised this fact
and in 2015 they significantly strengthened the requirements for this critical
area. 
Deming believed that your suppliers aren’t rivals or problems to be solved – in
fact, he said that we should “ask our suppliers to come and help us solve our
problems”.  Clause 8.4 is a tool to help you do that. Let’s take a look at the
detail.
 
8.4.1 - Purchasing 
The standard talks about an external provider.  Let’s call them a supplier.
This list could be in your ERP system, your accounting system, in Mango (if
you use it) or in a spreadsheet.
You must evaluate the critical suppliers against a fixed set of criteria.  As an
example, I have used the following criteria for over 20 years and it has stood
up well over time:

 Technology - do they have the technology to supply what you want?


 Quality - what quality standards do they meet?
 Responsiveness - are they responsive to your needs?
 Delivery - can they deliver on time?
 Cost - is the price acceptable?
 Environmental impact - what is their impact on the environment
and society

As you use these suppliers you will need to monitor their performance against
your requirements.  It takes some effort to ensure that they are performing,
but it is time and resources very well spent.  As you regularly talk with your
critical suppliers about your issues and requirements a relationship will be
built, one which is mutually beneficial, and more likely to be long-term.
 
8.4.2 - Controls for Suppliers
1. You need to ensure outsourced processes are controlled.  For example,
here at Mango we have partners that do implementations of our software at
the customer's sites for us.  So we have procedures and training that provide
the knowledge to partners on how to undertake and manage this important
process.
2. you need to define the controls for the supplier.  These controls could be
defined in various documents like: purchase orders; in agreements; or in
contracts.  In addition you need to have controls on the actual product or
service they provide.  You could ask for a certificate of conformance, or a test
report or a third-party test.  For example, here at Mango we have formal
Partner Agreements in place that define controls around things like marketing,
sales, implementation and support for customers.
3. don’t have “one-size-fits-all” controls for suppliers.  For the critical suppliers
that have a significant risk to your business, put tighter controls in place.  For
others - not so much.  Don't forget that you also need to make sure that your
suppliers meet local laws and regulations.
Finally for 8.4.2 you need to inspect the product or service from the supplier. 
This could be your inwards goods receiving inspection process.  When you
receive the product you need to check it against the order and ask:

 Was it what was on the order?


 Was it the right price?
 Was it delivered on time?
 Was it damaged?
 Was it the right quantity?

 
8.4.3 - Communication with Suppliers 
This is typically done with a purchase order but it could also be by contract or
agreement.  I have also seen other methods of spelling our requirements for
suppliers, such as inspection and test plans, work briefs, statements of
work and even forecasts are used in the communication process.  The
standard says that you don’t have to write these down in a document but I
think it’s best practise to do so.
Takeaways
In working through clause 8.4, the standard asks you to consider the following
questions:

 What do you actually want to be supplied?


 How will you approve the:
o Product or service prior to delivery;
o Methods, processes and equipment the supplier will use;
o Release of the product or service to you?
 What is the competence of the supplier’s staff?
 How will the supplier will interact with you?
 How will you control and monitor their performance prior to delivery?
 How will you verify and validate the supplier’s premises?

The answers to these questions are in essence the base structure for a long-
term relationship that will be beneficial to all involved.  Make the most of it.

Common questions

Powered by AI

ISO 9001 Clause 8.4.2 emphasizes the necessity of controlling outsourced processes and suppliers. It advises defining specific controls in documents like purchase orders, agreements, or contracts. For critical suppliers, tighter controls should be applied due to their potential significant risk to business operations. These controls could include certificates of conformance, test reports, or third-party tests. Additionally, products or services from suppliers should be inspected thoroughly to ensure they meet order specifications, price, delivery timeliness, and quantity expectations. These controls ensure quality and consistency in supplier-provided goods or services, supporting the company's quality management goals .

Verifying and validating a supplier’s premises is crucial as it ensures that the supplier has the appropriate infrastructure, facilities, and capabilities to consistently meet quality and production requirements. This step is part of a thorough supplier qualification process that helps in assessing the risk associated with using a particular supplier. It ensures that suppliers can maintain compliance with defined standards and that any issues related to the supplier's environment or operations can be preemptively identified and managed to protect the quality and integrity of the products or services provided .

Clause 8.4 of ISO 9001 emphasizes tailored controls because different suppliers pose varying levels of risk to the business. Critical suppliers, who have significant potential to impact the business, require stricter controls to manage these risks effectively. Tailoring is important because it allows a company to allocate resources and attention proportionate to the supplier's impact, ensuring high-risk suppliers are tightly managed while optimizing less-intensive management for lower-risk suppliers. This approach facilitates balancing thorough oversight with efficiency in supplier management .

ISO 9001 Clause 8.4 suggests that companies should evaluate critical suppliers against a set of criteria such as technology, quality, responsiveness, delivery, cost, and environmental impact. This ongoing evaluation helps ensure suppliers meet necessary standards, supporting effective relationship building through regular communication about issues and requirements. This relationship is emphasized as mutually beneficial and likely to be long-term, as it aids in solving problems collaboratively rather than competitively .

Before approving a supplier's product or service, ISO 9001 Clause 8.4 advises companies to consider what exactly they want to be supplied, how they will approve the product or service before delivery, the methods and processes the supplier will use, the competence of the supplier’s staff, and how they will monitor and control the supplier's performance prior to delivery. These considerations help ensure the product or service meets quality expectations and aligns with the company's standards before integration into the business operations .

The ISO 9001 framework promotes long-term supplier relationships by emphasizing regular evaluation and monitoring of suppliers against set criteria, continuous communication, and collaboration to solve mutual problems. By encouraging companies to regularly interact with suppliers about issues and requirements, and by advocating for a partnership-driven approach rather than a purely transactional one, the standard fosters a mutually beneficial relationship. This approach helps establish trust and reliability, which are essential for sustaining long-term partnerships .

Communication is crucial in supplier management under ISO 9001 Clause 8.4.3. It is typically conducted through purchase orders, contracts, or agreements, but the standard also recognizes the use of methods such as inspection and test plans, work briefs, statements of work, and forecasts. These communication methods are vital for clearly conveying requirements and expectations to suppliers, ensuring all parties understand quality standards and delivery expectations. This clarity promotes effective and efficient transactions, reducing misunderstandings and errors .

Formalized partner agreements in supplier controls, as suggested by ISO 9001 practices, provide a clear, documented framework for the relationship and expectations between a company and its suppliers. These agreements define specific controls around areas like marketing, sales, implementation, and support, ensuring all parties are aligned with the business's strategic goals and quality requirements. This formalization enhances communication clarity and accountability, reduces the likelihood of misunderstandings, and ensures consistent quality across the board .

ISO 9001 suggests several steps for inspecting products or services from suppliers to ensure quality and compliance. Upon receiving a product or service, the company should check whether it matches the order specifications, ensure the correct pricing, verify timely delivery, inspect for damages, and confirm the received quantity is as ordered. This comprehensive inspection process helps verify that the supplier meets all contractual and quality expectations, thereby maintaining the company's quality management standards .

ISO 9001 recommends evaluating suppliers based on technology, quality, responsiveness, delivery, cost, and environmental impact. These criteria help ensure that suppliers have the capabilities required to meet the company's needs effectively. By assessing these factors, a company can better select and monitor suppliers that align with its quality standards, ultimately contributing to a more robust and reliable quality management system .

You might also like