What is a QMS? And How Do I Implement One?
An organization striving to improve efficiency and effectiveness in its operations, increase customer satisfaction, and grow their business may benefit from implementing an established quality management system. According to Praxiom, a Quality Management System is “a set of interrelated or interacting elements that organizations use to formulate quality policies and quality objectives.” Quality management systems are documented with the organization and the customer in mind. A well-documented QMS will ensure the customers’ requirements are considered throughout operations and quality products and services are delivered. Implementing a QMS will help an organization achieve goals that align with the organization’s policy and growth strategy.
The most well-known and widely used QMS standard was created by the International Organization for Standardization (ISO) and is comprised of the ISO 9000 family standards.
The Most Popular QMS in the World- ISO 9001
There are 16 standards in the ISO 9000 family including 9004 and 19011, but of these, ISO 9001 is the only standard that an organization can be certified in. It is implemented by over 1,000,000 companies in 170 countries according to the American Society for Quality (ASQ). It is a generic standard, meaning it can be used by an organization in any sector and is not industry-specific. Anyone can purchase the document online and start implementing the ISO 9001 standards. The most recent version is a new revision released in 2015.
Benefits of ISO 9001:2015
The rationale behind an organization’s decision to implement an ISO 9001:2015 QMS may vary. However, some of the most common reasons include customer requirements, industry requirements, or an organization’s choice to maintain a competitive advantage. Regardless of the motive for implementation, there are many benefits to becoming compliant with ISO 9001:2015.
Employing an ISO 9001:2015 QMS can ensure that your organization’s goals are considered in internal operations and practices from the design and onward. Becoming compliant with ISO 9001:2015 can assist an organization that has a need for standardizing practices dealing with customers and suppliers in a B2B environment. Additionally, ISO 9001:2015 certification can establish credibility and provide a competitive advantage, which increases customer’s and prospective customer’s confidence in the organization to supply them with compliant goods and services.
A defined and controlled organizational process flow will increase an employee’s job satisfaction and facilitate the growth of a positive work environment. When internal processes are followed and a positive work environment is maintained, the quality of products and services that are delivered to customers improves, which benefits not only the organization, but customers and the end users as well.
Certification Process Overview
In order for organizations to become certified in ISO 9001: 2015, they must undergo an external audit. The organization must develop and implement its own QMS that takes into account the organization’s uniqueness and infrastructure, and also complies with the requirements of the ISO standards. A few of these requirements for ISO 9001 include:
- Organization structure
- Who should record information and what information is recorded
- Responsibilities of employees
- Lines of communication throughout the company
- What actions are required
- How continuity will be maintained as staff change
Having the infrastructure to implement an ISO 9001 compliant QMS may require company-wide changes to ensure all departments are working towards the common goal of fulfilling the requirements set forth by the ISO 9001 standard. Some common factors to keep in mind are:
Management of Documentation — Ensuring that all employees keep records and maintain documentation. This allows the organization to be certain that all employees are using the latest versions of their QMS.
Corrective measures — Undoubtedly organizations will make mistakes and deviate from the QMS at times. It is important to track when these problems occur and to have programs in place to rectify them. Having systems in place to identify problem areas can help prevent them before they occur.
Ongoing support — Parameters should be put in place so that personnel are suitable to perform their job functions. There must be records of employees’ past experience, education, and training to prove this. In addition, training programs should be clearly stated and put in place for employees who are lacking in certain areas to supplement their gaps in competency, experience and/or skill.
Regular internal auditing — To ensure the business follows all of these requirements, it is important to perform periodic internal audits, ideally by auditors who are independent of the function(s) being audited.
Once an organization has their own Quality Management System in place, a 3rd party certification body, such as NQA or DQS, will audit the organization and ensure that its QMS adheres to ISO 9001 standard. If the organization passes the audit, they are given an ISO certification by this body. There are many different organizations that accredit for ISO 9001 in the US and globally.
ISO 9001:2008 to 9001:2015 — What’s New?
ISO standards are revised about every seven years, and ISO 9001:2015 released on September 23, 2015 is the latest update since 2008. Fortunately, organizations that are ISO 9001:2008 certified are allotted a three-year transition period. This new version takes into account the vast changes in technology and business over the past seven years, and with these changes, the increasing demands for quality. First and foremost, it will have a much greater emphasis on risk management; as well as sustainability, social responsibility, organizational resiliency and health, change and knowledge management. There is a greater focus on the need for quality management in service-based industries, and the need to integrate Quality Management Systems into overall business management rather than specific program elements according to The 9000 Store.
Some essential changes in structure were made for ISO 9001:2015, with the addition of two new sections: performance management and evaluation. This was done in part to move away from the classical corrective/preventative action approach to more of a general risk management model. In addition, the new standard follows a high-level structure, which enables an identical structure for all management systems. The new version changed its terms “documents” (ISO 9001:2008 Clause 4.2.3) and “records” (Clause 4.2.4) to “documented information,” (Clause 9.2 of ISO 9001:2015 Committee draft) which seems to be more accepting of electronic documents and document control approaches.
The 2015 revision requires organizations to implement strategies for risk and other requirements that they have not been prepared for in the past.
How to Manage Competencies and Risk
As you can see, implementing an ISO 9001 system is quite the undertaking, although the benefits of having a company-wide Quality Management System definitely make it worthwhile. It can be difficult to keep all of the records and documentation required to pass an ISO audit in an organized manner, and ISO 9001:2015 will bring its own new set of challenges.
While many companies use outdated methods such as paper certifications or excel sheets, the need for organization, efficiency, and a more forward-thinking approach is becoming increasingly necessary. The trend now is many organizations are starting to use software such as Competency Tools and Competency Managers to automate and streamline this audit process, while also making sure all employees have the necessary skills.
CABEM’s Competency Manager
CABEM Technologies’ Competency Manager addresses all of these challenges and more. It is designed specifically for ISO-compliant quality management systems, regulated industries, and other progressive quality and HR systems. The web based tool’s configuration is designed to easily communicate with HR, ERP, and legacy systems.
For the employee, CABEM’s Competency Manager will allow standard users to see their status and satisfy requirements for their assigned competency elements and roles. For the Manager or SME, the Competency Manager allows them to assign and approve requirements, post documentation using the native document and file manager, and see status by individual, roles, departments, divisions and the organization at large.
All of these functions and more are put in place to help organizations pass ISO audits. Having all of the necessary documentation and data in the software makes this job easier for auditors as well as the companies themselves. In addition, CABEM’s Competency Manager includes a Risk Management feature that correlates with the ISO 9001:2015 standard. Ease your organization’s transition from ISO 9001:2008 to ISO 9001:2015 with software that has been designed for regulated industries and with the customer in mind.
Learn more about the Competency Manager!