Implementing a Quality Management System: Best Practice
Implementing a Quality Management System (QMS) is as much an art as it is a science. It takes data, a methodological approach, and the ability to engage people.
This article will discuss implementing a QMS and answer your frequently asked questions on the subject.
Here at Ideagen, we’ve been helping organizations for over 25 years achieve quality and operational excellence. We have experience implementing and consulting organizations of all sizes, so we offer an expert perspective on successfully implementing a new quality management system.
In this article, you will discover:
- What a Quality Management System is
- Why it is important to all organizations who want to succeed
- The benefits of implementing a QMS
- The requirements of a QMS
- The logistics of operating a QMS in a highly regulated environment
- The importance of a hierarchical culture
- Crucial steps to implementation
What is a Quality Management System (QMS)?
A QMS is a coordinated set of values and processes implemented by an organization to ensure that it meets the standards demanded by its customers and any key stakeholders. The ISO 9001:2015 standard is the relevant international standard that sets out the broad requirements of a quality management system.
Why is a QMS important?
A fully operational QMS will help an organization to meet key operational targets and demonstrate to any interested parties that it has achieved those goals. Broadly speaking, it will show that your organization:
- Consistently meets customer requirements
- Consistently manages internal requirements
- Consistently manages external requirements, e.g. the effective allocation of resources
What are the benefits of implementing a QMS?
Implementing a quality management system will result in a number of long-term commercial gains. Here are just a few benefits of effectively implementing a QMS:
- Achieve organizational goals with ease
- Reduce costly errors and wastage
- Boost customer satisfaction
- Market your business more effectively
- Manage growth more effectively
- Improve documentation availability
- Protect sensitive data
- Correct issues to continually improve products and services
- Grow market share in new territories and market sectors
- Create a culture of quality
- Embed vision into all projects
- Better internal communications
- More consistent products
- Effectively measure performance of individuals and teams
- Improve compliance
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How does a QMS support an organization to manage cultural issues?
Implementing a quality management system can be a big change for your employees. It can take them out of their comfort zone and away from institutionalized processes. This is why support from operational and executive management from the outset is critical to the implementation of a quality management system.
Ideagen has worked with hundreds of quality managers and always found that it is best practice to get management to promote quality. It is strongly advised that managers readily employ positive reinforcement during the early stages of the system’s life. Not only will this promote system use, but it will motivate staff too.
To be effective, a quality management system needs to be robust, intuitive, and flexible. Ideagen’s software modules interact to reinforce a holistic QMS, driving positive change from top to bottom in your organization.
Under a QMS, processes should be subjected to tighter management. It is wise to expect changes in the way staff interact, as well as changes to the distribution of responsibility and accountability. You should also consider staff perception and recognize existing employee attitudes. Taking care to dispel any concerns they hold should be a vital part of your managerial strategy when implementing a QMS.
Building on the theme of staff communication, an organization should not shut its ears to employee suggestions when implementing a QMS. Employees are the ones who will use the quality management system, so making any necessary amendments to fit their needs and improve usability is a sensible course of action.
It is also advisable for an organization to allow an initial “lag phase” before improvements become the norm. A QMS offers peace of mind that regulatory requirements are being complied with and that the organization is continually adopting a customer-centric approach.
What does a QMS require?
A quality management system requires a number of essential elements. Probably the six most important are:
- A framework and tool for communication, usually QMS software.
- A quality policy and quality objectives. These statements must be documented.
- A quality manual including scope, justifications for any exclusion, documented procedures, and process interaction descriptions. This will specify how a QMS will be observed and emphasize the company's commitments to both continuous improvement and quality.
- Any documented procedures required by the compliance standard.
- Any documents needed to ensure the effective operation, planning, and control of company processes.
- Records such as evidence of conformity to requirements and of effective QMS operation will be required by the compliance standard.
Operating in a controlled environment:
Many organizations deploy a quality management system to demonstrate compliance with regulatory requirements. A QMS can support an organization operating in a controlled environment in a number of ways:
- To ensure compliance standards are met, all company documents should conform to QMS processes.
- This will ensure conformity in staff behavior when performing their duties, a uniform data recording method, and consistency in staff training.
- The keeping of records such as audit findings, data monitoring, non-conformance reports and corrective actions etc. can be used as proof of QMS use and effectiveness.
- A QMS can be used to enforce the required approval and disposition of documents and records.
- It is important that only the most up-to-date version of documents are available to company users. To be compliant, documents should have unique identity and version control when subjected to change.
- The signatures of authors and approvers of the document may be required.
- A summary of document history showing changes and dates of revision may be required.
To ensure that all records are both traceable and retrievable, records must be managed and controlled in a similar manner to documents. It is advisable to assign them unique identifiers, which will be supplied by an electronic QMS tool.
The importance of hierarchical organization:
Organization is vital when dealing with controlled documents. A suggested hierarchy for managing QMS documentation is:
- Quality Manual
- Work Instructions
Any additional document types may be used at a company’s discretion.
Implementation of a QMS is a multi-faceted challenge. Here is a rough plan for getting a QMS implemented:
- General templates for all controlled documents that the company plans to use should be drawn up before QMS documents are written. Templates should have consistent styles and formats, making them easy to read and navigate. All template procedures and instructions should have purpose, scope, and responsibilities sections. Templates must also meet controlled document requirements, for example by having a unique identifier etc. It is optional for a company logo to be included in a document header.
- Many companies will have written procedures already in place. However, these current procedures may not be up to the required standard in terms of being out of date or incomplete. There may be some areas of the business, such as finance, that are not considered to fall under the scope of the QMS. Consequently, existing procedures may be seen as the best option to achieve compliance. Companies need to ensure these areas do not impact overall quality management.
- Companies should undertake a flowchart-style mapping of quality framework management processes. This helps to include all stakeholders in the process, highlights areas of non-compliance and missing documents, and is a great method of identifying areas where change is needed.
- It is useful to map your QMS documents and structure according to hierarchy, using process or document maps and organization charts.
- Documents should be drafted according to the specifications in the document maps. Be aware of your audience and use appropriate language accordingly. A large international company with multi-lingual staff may need to publish documentation in several languages.
- Electronic drafts should be managed appropriately. They should be documented and filed so that they can easily be identified, retrieved, reviewed, tracked, and managed. The process used in the document control mechanism should be consistent with that used in the drafting process.
- It is important for all documents to be reviewed by “Subject Matter Experts” across any area affected by the details of the document. Failure to review documents may result in a reduction of compliance, increased risk of deviation from the QMS, and could create friction between staff or departments.
- It is important to obtain the appropriate approval level for an issued document which will be dictated by the compliance standard. Once issued and approved, a hard copy of the document must be filed at a secure location. Once documents are published, staff can be trained to use them.
- Evaluate your existing business
- Ensure implementing a QMS is necessary
- Make sure that the processes are working
- Revise these processes where necessary and undertake continuous reviews
- Investigate Electronic Quality Management Solutions (EQMS) as a way of automating and simplifying the process
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