Clauses vs. Elements in ISO Standards

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Question

What, if any, is the difference between the words “clause” and “element” in ISO standards?
Specifically, “customer shall conduct an internal audit addressing all elements of the management system.”  And, at what level is this in the standard, eg, 4 or 4.1 or 4.2.1

Answer

1) The difference between the words “clause” and “element” in ISO standards? – No difference.

2)”Customer shall conduct an internal audit addressing all elements of the management system”. –  Customers do not perform internal audits on suppliers.  If this person means that  customer requires a full QMS audit, so does the standard.  “All elements” probably means all QMS processes.

3) At what level is this in the standard, eg, 4 or 4.1 or 4.2.1 – 4 is the clause/element; 4.1.& 4.2 are “sub-clauses”

George Hummel
Voting member of the U.S. TAG to ISO/TC 176 – Quality Management and Quality Assurance
Managing Partner
Global Certification-USA
www.globalcert-usa.com/
Dayton, OH

ISO Certification and Suppliers

Mr. Pareto Head and Supply Chain comic strip

Question

I work for a small family company that purchases items and potentially processes or packages them into heat protection materials. One of my existing customers is asking for ISO certification for some materials that I will sell to them. The material I’m trying to sell him comes from my supplier who is ISO 9001 certified, but my company is not. How can I show my customer that my supplier is ISO certified without the customer knowing who my supplier is?

Answers

The company is doing a value added process, and not a distributor.  As a result, if the customer is demanding ISO 9001 certification from the company, they need to make the decision, do they want to do business with the company? If so they need to pursue certification. If they do not want to pursue certification, they should tell the customer they do not want to pursue certification.  The customer can make the decision whether they will purchase product from the company.  I have had an experience where I did not want to do an audit with a company.  We told the customer, we will not do it.  The customer responded and came back with a reasonable proposal.  They wanted the business.

John G. Surak, PhD
Surak and Associates
Clemson, SC
A member of Stratecon International Consultants
www.stratecon-intl.com/jsurak.html

First, ISO certification is for a company’s quality management system, not for particular materials.  I would let the customer know, on company letter head, that:  “We certify that the materials we purchased are from ISO 9001 certified suppliers only.  The name of these suppliers is company confidential.”

James D. Werner
Principal Consultant
MDQC
Medical Device Quality Compliance, LLC