Quality Management Systems (QMS) Consultants
What is a Quality Management System?
A Quality Management System (QMS) is an assemblage of processes, procedures, and polices for achieving customer requirements and customer satisfaction. These systems, when appropriately applied, can provide an enterprise with increased operational consistency and profitability.
Although originally created for manufacturing endeavors, QMS are also applicable for service industries. There has been a marked increase in the adoption of QMS across a wide sector of industries. In fact, in many industries, it is a requirement to have a viable quality system. Today QMS is practiced in areas such as forestry, food processing, aerospace, construction, legal services, retail, and financial services.
Types of QMS
QMS are built around standards because of the requirement for uniformity of application. One of the earliest and most popular standards is ISO 9001. Its current revision is ISO 9001:2015. This standard is applicable to a wide variety of industries and is being increasingly implemented by businesses.
As quality systems have evolved a variety of other standards have emerged to meet the specific needs of business sectors. Some of these ISO standards include:
- AS 9100D for Aerospace
- ISO 13485 for Medical Devices
- ISO 14971 for Medical Devices
- ISO 27001 for Information Technology
- ISO 22000 for Food
- ISO TS 16949
- ISO 200000 for Services
Certification in any of these standards provides a level of assurance among businesses working together in their respective fields. It provides evidence that their products and or services will meet the requirements for their industries and thereby meet customer expectations.
The Benefits of Adopting a Quality System
As previously mentioned, a QMS can provide assurance that a given product or service consistently meets or exceeds customer requirements. In turn this can expand an organizations client base, ensure repeat customers, and increase sales.
It can also, however, can increase the efficiency of an organization by reducing waste, preventing product recalls, and streamlining processes. Furthermore, it can ensure that the organization’s requirements are harmonized with the specific regulations of its industry thereby eliciting trust in its partners and protecting its reputation.
Other benefits of using a QMS include:
- Increased accountability of that encourages participation of employees
- Organizational flexibility to meet changes in the marketplace
- Establishment of goals that encourage growth
- Improved company morale
The Dynamics of Quality
An important feature of managing quality is continuous improvement. Continual improvement is, as one might surmise, is an ongoing effort to improve the processes involved in producing a quality product. These improvements can occur incrementally or be introduced in a large “breakthrough”.
Regardless of how they are implemented, they are instituted through analysis of metrics. These same metrics can then be used to monitor the effectiveness of those changes. In a well-designed program, this feedback is conducted by all stakeholders so that a complete analysis can be provided.
With advances in technologies, many manufacturing floors are being upgraded to include intelligent sensors which can provide information to systems which can instantly monitor, analyze, and diagnose production. Often this can be accomplished independent of human interaction.
This transformation, often referred to as Industry 4.0, is providing an increasingly dynamic input to QMS by increasing the scope and pace of monitoring and analysis.
Requirements for Implementing an Effective QMS
As with any tool, desired results are a product of implementation. The first requirement for implementing a QMS is to tailor the program to meet the specific needs of the organization.
This process is described in ISO 9001 as context of the organization. It includes assessments of the internal and external issues that would affect the governance and implementation of the program. These would include organizational structures, standards adopted by the organization, product, social and cultural issues, market issues and trends, and external stakeholder relationships.
This process also includes capturing the specific requirements for an organization. This would include customer requirements and expectations, applicable regulatory requirements, and desired levels of financial performance.
Creation of the QMS
Once an assessment has been conducted policies, and procedures can be constructed that incorporate a strategy to meet the identified requirements. During this phase, key stakeholders are identified who will assume responsibility for various functions of the system. Inclusion of top management is especially important because by in from the top is essential for a QMS to produce favorable results.
Certification and Auditing
Once a QMS has been created, a third party can evaluate the program and its documents to ascertain if the program meets the requirements of the standard, thereby my meriting certification.
Having acquired certification the organization is then required to perform periodic internal audits and external audits to ensure that the program stays on track or can benefit from corrections.
The History of Quality
The original versions of Quality Management System (QMS) Standards (eventually merged to ISO 9001) were designed to contract manufacturers to produce better products, consistently and were focused on Producing, Checking and Control.
An increased focus on QMS has promoted a general perception that quality is about procedures and documentation. The emergence of tools like 6 Sigma and Lean are interesting developments in the application of quality principles in business. A QMS is fundamental to any activity and having a clear understanding of the five aspects, measuring performance and taking action to improve is essential to an organizations survival and growth.
Our experience with ISO 9001:2015 , AS9100D, ISO 27001:2013, AAR M-1003 and ISO 13485:2016 adds value to your Quality Management System implementation. Our services include training, document creation and guidance to your management team and all employees.
CVG Strategy quality experts focus on processes and process improvement in all our work. Understanding quality systems is a fundamental aspect of our work as consultants, helping our customers make their business run more efficiently and to improve customer satisfaction.
CVG Strategy Quality Management experts are Exemplar Global certified as Lead Auditors for ISO 9001:2015, ISO 13485, FDA QSR, and ISO 27001. We also provide essential training in an engaging format.
How Can We Help?
Take a look around our site and contact us for more information on how we can help you meet your challenges.