Quality Management System
According to American Society for Quality (ASQ) at https://asq.org/quality-resources/quality-management-system
“A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements.”
QMS overall goals of meeting the customers’ and regulatory requirementsand improve compliance company’s performance and efficiency on a continuous basis.
The QMS elements all systems have in common include:
- The organization’s quality policy, objectives and manual
- Procedures, instructions, records and data management
- Internal and external processes and controls
- Continuous improvement
The basic steps to implementing a quality management system are as follows:
1. Attitude: Top management and companywide commitment to quality
2. Attribute: Company must recognize its weakness and strength, and conduct risk, gap and impact assessments to appreciate its standing of meeting the customer and regulatory requirements
3. Aptitude: Define, plan, design, deploy, control, measure, and improve processes. Train and qualify the resources.This is all to come up with the blueprint and take actions to achieve the QMS objectives
4. Altitude: Climb through continuous improvement and comply with recognized standards. The USFDA recognized standards can be found at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
QMS shall comply with applicable regulations and standards such as USFDA 21 CFR 820 and/or ISO 13485 for EU.FDA conducts compliance inspections and holds the legal authority to prevent or stop companies from selling their products in the US market.Competent Authorities to conduct inspections of medical device manufacturers. You’ll find them listed in the New Approach Notified and Designated Organisations(NANDO) database at https://ec.europa.eu/growth/tools-databases/nando/. Notified Bodies are not government agencies, but they can exert power to grant or deny ISO certification and/or CE Marking. In Canada, these are called Registrars, but nearly all Registrars are also Notified Bodies. Under the new MDSAP scheme, Registrars are referred to as Auditing Organizations. There are also AuthorizedRepresentative (Europe), Sponsor (Australia), D-MAH (Japan), and US Agent. For a US company selling in Europe without a local office, a regulatory representative in that country (or countries) has to be appointed. Notified Bodies will most certainly inspect the company’s QMS during their audits.