It is commonplace nowadays to check out reviews on products before we make a purchase. We want to know what other people thought of the product. Did it accomplish what it was intended to? Did it last? Did it arrive on time? Is it made from quality materials? Will the piece that I buy be like the one that someone else purchased?
A QMS, or quality management system, is a program that an organization follows to answer many of these questions. There is more than one option as to who may be used as a certifying authority for the licensing of this program. One program that may be followed is ISO 9001:2015.
What is a quality management system, and how does it work? Most QMS programs are driven by a continuous improvement mentality. This means asking yourself: How can we do better, how can we become more efficient, how can we reduce the number of non-conformances without adversely affecting the quality of our product?
The following is a list of topics that are common to any business and are part of the requirements of an ISO 9001 quality management system:
- A Quality Policy must be in place that states the intent or mission of the company.
- Quality Objectives are measureable goals for the company to strive for. Where can we improve, where are our weaknesses so that we may address them?
- Leadership of an organization is important from the fact that they make the ultimate decisions. What are their responsibilities, who has authority to make changes, who above them signs off on changes?
- How does the company address risks and opportunities? Is there a plan in place for unexpected events?
- If a company makes changes either to product or procedures, how are the employees notified, are the employees trained accordingly, when are the employees deemed competent?
- Another very important area has to do with orders. Is this product in conformity with codes or specifications, are there technical requirements, dimensional requirements. If this is the case, how does the company process these inputs into a product that meets these expectations?
- If a company provided outside services, a quality management system will cover this also.
- Many products require certain types of raw materials. Does this company have a procedure in place for traceability of material from the time it is received and inspected until it ships out the door?
- What inspections are required to release a product for shipment?
- If something goes wrong in the manufacture of a product, what procedures are in place either to identify the problem, make a decision to scrap and start over, or repair it?
- It goes without question that every manufacturing process has to do some type of measurement. Those articles used for inspection: are they identified with a unique marking, are they checked against a standard that has traceability to a NIST (National Institute of Standards and Testing)?
- All QMS programs should have some type of internal audit program in place. This can be done with in-house employees as long as they aren’t checking or auditing an area that they are personally responsible for.
- A QMS should undergo a Management Review at least once a year. This is a process where top management addresses all the areas of the management system. Questions likely asked would be, is everything still relevant, what risks and opportunities need to be addressed, do we need to update the quality objectives, are there trends to react to, are the resources we have still adequate?
Can a business operate well without a quality management system? Yes, it is possible. Is it likely? Probably not! A Quality Management System is an invaluable tool to help in running a company.