Quality is at the core of an organization’s business. Quality Management Systems (QMS)are well-defined processes that help organizations build quality into their products and services.
Organizations can do this by adhering to QMS guidelines issued by various standards such as those laid out by the ISO. Individual organizations, based on their type of business, build quality processes based on these guidelines. Relevant aspects of these guidelines have to be implemented into the organization. Respective guidelines of appropriate standards have to be applied depending on which suits their organization the best.
Broadly, these are what organizations can seek to achieve by implementing an effective set of QMS guidelines:
- They can systematically develop and communicate a customer-focused mission;
- They can put in place strategies and action plans required for this;
- Referring to these guidelines helps employees understand and respond to their customers’ needs and expectations better and thus increase their satisfaction since there is improved work processes and environment;
- These guidelines serve as a tool with which to gather and analyze key performance indicators that are vital for improving organizational and process results.
Benefits of adhering to QMS guidelines
Quality Management System guidelines serve as a reference point for organizations to look up to and continuously improve their processes and quality. QMS guidelines help organizations in the following ways:
What should the quality management system cover?
The QMS in a medical device organization should cover the following:
- Control of documents
- Control of records
- Management review
- Internal audits
- Corrective and preventive action
General requirements for organizations that audit
GHTF lists a few general requirements from auditing organizations. These include:
Apart from describing the audit scope and methodology in detail; the GHTF also has a description of the types of quality audits for the medical device industry. They are:
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