ISO 9001: 2015 Clauses 4.1 and 4.2

Question

Let’s start with clause 4.2. What level of detail is required here? Is “supplier” or “customer” sufficient, or is it required to drill down from there to specific suppliers or customers? We have hundreds of suppliers and many more customers. Regarding 4.1, thinking about working this from the bottom up. Each Leader (supervisor, manager, director) will review processes under their control and identify issues related to those processes. Those processes can have internal and externally related issues. It’s the hope (plan) that this approach will cover all relevant issues (internal & external) that would impact our ability to meet the needs of the QMS -and- meet the needs of the interested parties (we are adding a column that identifies which interested party would be affected by the issue). As a side note, we’ll also do our risk analysis on all of the noted issues and roll the top items into the CAR/CI process. I feel I may be missing something with this approach, but it seems to mostly meet the requirements of 4.1 and 4.2.

Answer

4.2:  What level of detail?  The standard states, “the organization shall determine:

  1. the interested parties that are relevant to the quality management system;
  2. the requirements of these interested parties that are relevant to the quality management system. The organization shall monitor and review information about these interested parties and their relevant requirements.  [emphasis added]

Is “supplier” or “customer” sufficient?  It would be if all had the same requirements.  Assuming that they do not, you are required to “drill down.”  Customer satisfaction cannot be achieved unless you understand the individual requirements and monitor and review those requirements (which are an input to Management Review).

Furthermore, the list of interested parties goes beyond “customers & suppliers.”  Owners, employees, regulatory agencies, financial institutions, etc. to name a few have requirements as interested parties. These need to be addressed, as well.

“We are adding a column that identifies which interested party would be affected by the issue.” This is a good approach if the requirement is also addressed and you go beyond customer and supplier.

“Regarding 4.1, thinking about working this from the bottom up.” Once again, the standard states, “The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction…”

The key in this requirement is “strategic direction.”  If from working from the bottom up, you ultimately tie these external and internal issues to the organization’s strategic direction, there should not be a problem.

Be aware that your approach will not be familiar to your auditor.  In that case, you will need to fully explain your approach.

George Hummel

Customer ISO Status In Jeopardy?

Question

My customer wants to get ISO 9001:2015 certified. He refuses to create a first-article, in-process, and final-inspection report. He has a router sheet that has a tiny space for final inspection brief information and the operator’s initials; no inspection data is available.
In his quality manual and processes he addresses “Time Studies” and “Statistical Process Control” but he refuses to record his inspection data because this “complicates and delays” his production. I told him this is a weakness in his QMS but he says it’s not. Will this issue jeopardize his ISO certification?

Answer

I would ask how the organization could present objective evidence with the requirements of Clause 8.5.1 including  – ‘shall implement production and service provision under controlled conditions.’

Charlies Cianfrani

Use of Correction Fluid to Modify ISO 9001 QMS Documents

ISO documentation practices, requirements

Q: During a recent audit, I discovered that my supplier was using correction fluid and scrubbing out the training records of its employees with no control over the documents. I said that would be a major finding, but they state that there is nothing in ISO/ANSI/ASQ 9001:2008 Quality management systems–Requirements specifically telling them that they can’t correct records on the fly without any control.  Can you clarify this practice for me? I can’t find anything definitive in the standard.

A: This is an interesting question. Sometimes, people complicate standards rather than recognize them for the friendly guides they can be. It is true, as written in clause 6.2.2 of ISO 9001:2008,  that records for education, training, skills and experience need to be maintained per clause 4.2.2. However, the standard does not designate a specific process for this.

Clause 4.2.4 expresses a requirement to establish a documented procedure, and also states that the records should be legible. While the practice of using correction fluid or scrubbing out training records is probably not the best and most professional way of handling things, it’s not a cause for a finding of nonconformance.

Records which have a direct affect on customer products would definitely need better controls. However, I think in this case, you might find it wise to work with the supplier to find a better way of recording employee training. The records must remain legible, readily identifiable and retrievable. If that is what they are doing and product quality is not affected, there should be no major finding. A recommendation for continual improvement would be appropriate.

I hope this helps.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Related Content:

Browse the free, open access resources below, or find more in the ASQ Knowledge Center.

Related Content:

Browse the articles below, or find more open access articles and resources about documentation practices in ASQ Knowledge Center search results.

Geometrica Builds ISO 9001 QMS on Wiki, ASQ Knowledge Center

Geometrica, a manufacturer of domes and free-style structures, used a wiki to document its ISO 9001:2008 quality management system. The company attributes its fast track to certification—nine months from beginning to certification—to the ease and efficiency of wikis. Read the case study.

Consultants’ Style: Sometimes Less Is More, Quality Progress

Many small to medium sized organizations hire consultants to help them attain ISO 9001 and ISO 14001 registration. Consultants who base their advice on the organization’s existing practices and do less documentation are usually more effective. Ten companies share their experiences. Read the article.

Explore the ASQ Knowledge Center for more case studies, articles, benchmarking reports, and more.

Browse ASQ magazines and journals here.

QMS Documentation Management

About ASQ's Ask the Standards Expert program and blog

Q: I was wondering if ASQ has any good information on managing QMS documentation.  My company is working right now on finding a solution for a better way to manage QMS documentation.  We have previewed some QMS document management software but think we can do all of the programming in house with Microsoft SharePoint. If you have any suggestions I would love to hear them.

A: Thank you for contacting ASQ.  According to The Quality Improvement Glossary by Donald L. Siebels, a quality management system is “a formalized system that documents the structure, responsibilities, and procedures required to achieve effective customer satisfaction levels”.  The ASQ Knowledge Center has over 100 resources on the topic of quality management systems and documentation.

  • One of ASQ’s resources that you may find particularly helpful is a recent case study on a company that used a wiki to document its QMS:

Geometrica Builds ISO 9001 QMS on Wiki

For more information, please see the references listed at the end of the case study, including the following:

“After Geometrica attained ISO 9001:2008 certification in 2009, it wrote—and improved—this case study on a wiki. Visit Geometrica’s “living” case study

  • A little older resource, but this eBook might be helpful:

The Practical Guide to People-Friendly Documentation

  • You may also want to take a look at this October 2010 Quality Progress article:

Get Your Ducks in a Row: A step-by-step guide to implementing an ISO 9001 quality management system” (See section on “Gathering, managing information”)

 (See section 4 on Documentation)

I hope that this information is helpful.  Please feel free to contact me with any questions or if you need additional assistance.

Best regards,

ASQ Research Librarian
Milwaukee, WI