by: Quality Institute of America (QIA)   |   published on: Apr 05, 2017

The word Shall in Quality Management Standard has been used in many places. We all know that in the English language the word Shall is used when an activity must be performed, therefore whenever you see word Shall, you must do what the Quality Management Standard demands if you desire certification to the Quality Management Standard. A popular exercise is to identify the places in the standard where "Shall" is used, and then address what follows that word. Some logical methods for "Engineering" the procedures needed to address the requirement can be derived from the "Shall" word, and will be offered soon in these blogs, articles and white papers.

Suggestions followed by this word are not mandatory. These notes in the Quality Management Standard are provided for the convenience of the user. Actually the notes are just an advisement or suggestion.

This is the combination of activities and resources like equipment, personnel. Process is set of interrelated or interacting actives which transforms inputs into outputs.

  • a)  Inputs to a process are generally outputs of other processes.
  • b)  Processes in an organization are generally planned and carried out under controlled conditions to add value.
  • c)  A process where the conformity of the resulting product cannot be readily or economically verified is frequently referred to as a "Special Process".

Product is a result of a process (set of interrelated or interacting actives which transforms inputs into outputs). A good way to define a product is that it is what the organization offers to its customers, usually for a price. A free county library rents books at no charge to its customers, while a commercial book store sells the books for money. For the vast majority of organizations, product is what the customer is paying you for.

There are four generic product categories, as follows:

  • 1)  Services (e.g.: Transport, Call Center)
  • 2)  Software (e.g.: Computer Program, Dictionary)
  • 3)  Hardware (e.g.: Engine Mechanical Part)
  • 4)  Processed Materials (e.g.: Lubricant)

As you can tell, most organizations sell products that cover more than one category of product.

It can have a combination of tangible and intangible attributes (benefits, features, functions, uses) that a seller offers a buyer for purchase. For example a seller of a toothbrush not only offers the physical product but also the idea that the consumer will be improving the health of their teeth.

A product is conforming when it fulfills specified requirements.

Non Conformity:
When the product does not fulfill specified requirements.

This is an agreement to supply a product or service. This agreement may be verbal, electronic, written or transmitted by any means. An "order" or "agreement" are common examples of a contract.

Organization or person that provides a product or services. Producer, Distributor, Retailer or Vendor of a product, or provider of a service or information.

  • 1)  A supplier can be internal or external to the organization.
  • 2)  In contractual situation, a supplier is sometimes called “contractor”.


QIA offers a wide variety of professional services, such as, ISO 9001:2015 consulting and training to assist in transitioning from ISO 9001:2008 to the new 2015 standard. In addition, We offer consulting, Auditing and Training for a wide variety of standards.

  Quality Institute of America

8951 Ruthby Street #15,
Houston, TX 77061, USA

Tel : (281) 335-7979
Fax : (832) 582-8504
E-mail :,
Business Hours : 8:00 AM - 5:00 PM

  Asia Office

House# 14, Road# 1/A, Block# J,
Baridhara, Dhaka, Bangladesh

Tel : (880-2)-9854911
E-Mail :
Business Hours : 9:00 AM - 5:00 PM

Copyright © 2014 - QIA