Where Do Manufacturing Strategists Get Their Information?

Manostaxx The text that follows is owned by the site above referred. Here is only a small part of the article, for more please follow the link SOURCE: http://www.manufacturing-operations-management.com/manufacturing/2015/03/where-do-manufacturing-strategists-get-their-information.html A German survey showed that strategists working on Industrie 4 and related initiatives like IIoT and Smart Manufacturing are getting their information this way:   These numbers […]

Lean KPI’s – Key Performance Indicators and performance metrics

Manostaxx The text that follows is owned by the site above referred. Here is only a small part of the article, for more please follow the link SOURCE: http://www.leanmanufacture.net/kpi.aspx Lean KPI’s and Process/performance metrics help managers, engineers and process improvement leaders in the following: -Determining the current performance of the system or process being evaluated […]

Overall Equipment Effectiveness: Benchmark Data by Industry

Manostaxx The text that follows is owned by the site above referred. Here is only a small part of the article, for more please follow the link SOURCE: http://blog.lnsresearch.com/bid/155988/Overall-Equipment-Effectiveness-Benchmark-Data-by-Industry Posted by Matthew Littlefield Overall Equipment Effectiveness (OEE) is an important metric for many companies’ initiatives in Operational Excellence. As of September 5th, 2012 we have now benchmarked […]

ISO 9001 vs Six Sigma: How they compare and how they are different


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Author: Mark Hammar

Have you considered adding Six Sigma methodologies as a way of focusing the improvement activities in your quality management system? If so, yours is one of several companies that see the benefits of process improvement as a way of saving time and money. Although continual improvement is a key principle of the ISO 9001 standard, the standard does not explain how to implement or maintain this improvement. The Six Sigma method provides this how-to information. Six Sigma is a collection of process improvement techniques and tools which can be used to improve the processes, and can be applied to processes within the quality management system that is defined by the ISO 9001 standard.


There are several requirements that are common to the ISO 9001 standard and the Six Sigma methodologies; as such, these can be done together to meet the requirements of both within the processes defined in the QMS:

Process Approach. Both ISO 9001 and Six Sigma use a process approach in applying their methodologies. ISO 9001 involves looking at an overall system as smaller, interrelated processes to focus efforts toward more consistent and predictable results on the individual processes of the system. This is done because controlling and improving the individual processes can be a much easier and more effective way to control and improve the entire system. Six Sigma is used on an individual process in order to control and improve it using a SIPOC diagram (an abbreviation for Supplier, Inputs, Process, Output, and Customers). SIPOC is a way of representing the process in order to better understand how it works, and how improvements are effective on the process.

Cycle of Improvement. Both systems have an underlying methodology of using a cycle for improvement. ISO 9001 is based on a Plan-Do-Check-Act cycle that is used to focus efforts on improvement in the system. This allows for an ongoing cycle where changes are made to improve an aspect of the system, then checked and acted upon to either correct for problems or cement improvements that are realized. I have explained this further in another post on Plan-Do-Check-Act in the ISO 9001 Standard. The core tool used in Six Sigma for process improvement projects is the DMAIC project methodology (an abbreviation for Define, Measure, Analyze, Improve and Control), which is an improvement cycle based on data that is used to improve, optimize and stabilize business processes. With both systems, all phases of the cycle must be followed for the cycle to work; skipping steps can cause failure.

With these common elements it would seem logical that Six Sigma can be used as one of the main methodologies for attaining process improvement within the ISO 9001 quality management system.

Differences between Six Sigma and ISO 9001

The main difference between ISO 9001 and Six Sigma is in the scope. The ISO 9001 standard is an internationally recognized set of requirements to use as the basis to develop an entire quality management system, including all aspects of the business such as management responsibilities, resource management and all aspects of providing the product or service. Additionally, the implemented QMS can be certified against the ISO 9001 requirements (See ISO 9001 Certification). Meanwhile, Six Sigma is solely a set of tools and methods used to improve business processes, and which are not meant as a means of developing an entire quality management system. In addition, there is no standardized set of requirements that are recognized worldwide, as this is primarily implemented in North America. This limited scope can make the Six Sigma methodologies very useful as the tool used within the quality management system, designed to the ISO 9001 requirements, for process improvement.

Additionally, Six Sigma has a subset project methodology used for design, which is referred to as Design for Six Sigma (DFSS). This project replaces the DMAIC cycle used above and replaces it with a cycle more focused on the design, which is the DMADV project methodology. These five stages stand for Define design goals, Measure and identify critical characteristics, Analyze to develop and design alternatives, Design an improved alternative, and then Verify the design. This methodology is not equivalent to the design process defined in ISO 9001 (see The ISO 9001 Design Process Explained), but could be used as a method of design improvement, which would then feed into the design change requirements of the ISO 9001 quality management system.

Some elements of Six Sigma will require new processes not already implemented in a quality management system, but the addition of the processes should complement the process improvement requirements of the system already in place. There are no fundamental conflicts between the requirements, only additions to what would already be present.

Using system synergies to save time and money

It is not an either/or choice between ISO 9001 and Six Sigma; both can be used. ISO 9001 will provide the QMS framework, and Six Sigma can help provide the process improvements required by the quality management system. Integrating Six Sigma into your ISO 9001 quality management system can help to focus the resources used for improvement by using a set of tried and trusted tools and techniques, saving both time and money for a company. Improvement for cost and time savings is one of the main reasons for implementing a quality management system in the first place, and having a set of tools to guide you in this endeavor can mean the difference between success and failure.

List of Quality Management Standards and Frameworks


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Author: Mark Hammar

The ISO 9000 Family of Standards

The ISO 9000 family of standards has three documents, with one additional supplementary document attached to the family. ISO 9000, ISO 9001 and ISO 9004 compose the family of ISO 9000 documents; ISO 19011, guidelines for auditing management systems, is attached, as it is the auditing requirements document used to audit an ISO 9001 quality management system.

ISO 9000: This is a standard that is referenced in ISO 9001, ISO 9004, AS9100 and many other documents regarding a quality management system. ISO 9000 is the first document in the ISO 9000 family of standards and has two main purposes. Firstly, it is used to define the many terms that are used throughout the quality management system standards. Secondly, it describes the fundamental quality management principles that are behind the ISO 9001 standard for implementing a quality management system. It is not, however, a document containing requirements against which a company can certify its quality management system; this is available through the ISO 9001 standard.

ISO 9001: The most commonly used set of requirements for designing a QMS, it includes requirements for developing and implementing a quality management system based on improving customer satisfaction. The requirements are aligned in a PDCA improvement cycle (Plan-Do-Check-Act cycle) of Planning for the work of the QMS, Doing the work of the QMS, Checking the work of the QMS against requirements and Acting to correct any problems that occur which will feed back into the next round of planning. For more information on how this works, see Plan-Do-Check-Act in the ISO 9001 Standard. ISO 9001 provides the information necessary for a company to implement a quality management system, and a QMS certification against ISO 9001 is recognized worldwide.

To find out more about the ISO 9001 quality management system standard, see What is ISO 9001 and ISO 9001 Certification.

ISO 9004: This is a standard that can accompany ISO 9001 for implementing a quality management system, but is not necessary to do so. This document is designed to provide guidance to any organization on ways to make their quality management system more successful. Unlike ISO 9001, ISO 9004 is not intended for certification, regulatory or contractual use. This means that you cannot certify your quality management system to ISO 9004. It also means that the use of ISO 9004 is not intended to be mandated as a legal or contract requirement. The standard is, however, a good reference to turn to for ideas in how to make your implementation of ISO 9001 more effective and successful. For more information on this standard, see ISO 9004, which explains the structure in greater detail.

ISO 19011: This is also a standard published by the international organization for standardization, and includes the requirements for auditing a management system. The standard defines all the requirements for an audit program, as well as how to conduct successful audits. It is used as a resource to train anyone who audits quality and environmental management systems, and the auditors who certify that companies have met the requirements of standards such as ISO 9001, ISO 14001 and the like are trained using this standard.

Other Common Quality Management System Standards

Below are some of the more common quality management standards that are specialized for certain industries. These systems, like ISO 9001, provide requirements that can be used to design and create a quality management system for a company.

AS9100: This is a standard that is based on ISO 9001 and has additions designated for use in the Aerospace Industry. The additions include such main topics as Risk Management and Configuration Management. A QMS can be certified by a third party to comply with this standard. For more, see AS9100: What it is and how it relates to ISO 9001.

ISO 13485: This is a standard published by the ISO organization for use by companies that want to design a QMS for medical devices and the requirements for regulatory purposes surrounding them. A third party can certify a company’s QMS to this standard.

ISO/TS 16949: This document includes requirements for the application of ISO 9001 for automotive production and service part organizations. The requirements include all additional QMS requirements agreed by the main automotive manufacturers to accompany ISO 9001. In addition, though, each main automotive customer that a company works with has an addendum to the TS 16949 requirements that are specific to that customer. A QMS designed using these requirements can also be certified against them.

MBNQA: The Malcolm Baldridge National Quality Award recognizes U.S. organizations for performance excellence. The award has a set of requirements against which a company could design and assess a QMS built around the criteria for promoting business excellence. Apart from external assessments to attain the award, there is no ongoing certification against these requirements.

Quality Frameworks that support Quality Management

The following items are quality concepts that support an organization in pursuing improvements and quality excellence, but they are not designed as sets of requirements against which to create a quality management system, and a QMS cannot be certified against these guidelines.

Lean: The core idea is to maximize value by eliminating waste. The main concept is that anything that adds cost to a product, but not value, is waste and should be controlled or eliminated. Lean concepts are used to improve processes by removing waste, thus making them more efficient. The concept of lean (also referred to as lean manufacturing, lean enterprise or lean production) was derived in the 1990s mostly from the Toyota Production System, which used a concept of the reduction of “seven wastes” to improve customer value.

Six Sigma: This is a set of tools and techniques used for process improvement by focusing on using the statistical outputs of the process to improve the process. It is used in many organizations to support the QMS by helping to improve processes, but Six Sigma does not define a QMS. The tools of Six Sigma were developed by Motorola in 1986 as a means of improving the quality of processes and their outputs by identifying and eliminating the causes of defects.

TQM: Total Quality Management consists of practices designed to improve the process performance of a company. The techniques help improve efficiency, problem solving and standardization of processes. These techniques are used to aid in quality management, but do not provide a framework for a Quality Management System. The concept of TQM was originated in the early 1980s and became widespread near the end of that decade. It was mostly supplanted by ISO 9001, Lean and Six Sigma by the late 1990s; however, many of the concepts are still used in conjunction with these other philosophies.