ORDIN nr. 309 din 17 martie 2015 pentru aprobarea Normelor metodologice de aplicare a titlului XIX din Legea nr. 95/2006 privind reforma in domeniul sanatatii, referitoare la avizarea activitatilor in domeniul dispozitivelor medicale

Quality ensures: Sustained success Long term growth of every business organization Increase the efficency and quality of your products and services Ensure protected rights of your consumer and users Improve and increase the credibility of your product or service and can help build a bond of mutual trust and satisfaction Why is important to have a Quality System To:
Increase customer and suppliers confidence in the products and services offered by your company Improving efficency of your process Significant cost reduction Increasing competitivness, maintaining market position and the conquest of new clients/ markets/ niches Increase customer satisfaction Benefits the company's image associated with proffessionalism and high standards.

Medicinal products

Good Pharmacovigilance Practices

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp#section2

Good Distribution Practices

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:343:0001:0014:EN:PDF

Others

National Agency for Medicines and Medical Devices
European Medicines Agency

Medical devices

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices

"A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements."

It is expressed as the:

• Quality policy
• Quality objectives
• Quality manual
• Organizational structure and responsibilities
• Data management
• Processes
• Product quality leading to Customer satisfaction
• Continuous improvement including Corrective and preventive actions needed to implement quality management.

Source: http://en.wikipedia.org/wiki/Quality_management_system#Elements_of_a_Quality_Management_System

“An audit is a systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and suitable to achieve objectives” (Source: ISO – 8402)

Types:

• “First party quality audit (Internal audit): when an organization conducts an audit on its own quality system using its own staff / external consultants
• Second party quality audit (external quality audit): The second party quality audit is performed by the purchasing organization upon the supplier organization and can be performed by the trained personnel of the purchasing organization or an outside agency hired by them.
• Third party quality audit (extrinsic audit): this audit is performed by the certification bodies (ISO registered bodies) on the applicant organization seeking such certification”.

Source: Total Quality Management – II, Chapter – 13: Quality audit, Dr. Shyamal Gomes

“A one-off ISO standards transition audit is an audit dedicated to transitioning an already certified organization from the old version of the standard to the revised version of the same standard.”

Source: http://revision2015.com/one-off-transition-audit/

Categories:

“System Audits are looking at a particular system which includes multiple processes and can spread across several employees and departments. The audit of your calibration system can be consider a system audit.

Conformance Audits are audits to define system requirements. These are global in nature. For example a 3rd party audit of your ISO 9001 SYSTEM is a conformance audit.

Compliance Audit is an audit to regulatory requirements. This includes government agency audits.

Process Audit is a focused audit on a set of processes within your organization. It examines adherence to procedures and specifications during production or service activities.

Product Audit is a focus audit on the product itself. This may be an inspection activity or an out of the box audit.

Department Audit is a focus audit on one department that looks at the processes, specifications, and systems in one department only. It will look at the different operations with in that department. It will also examine department organization and training”.

Source: Total Quality Management – II, Chapter – 13: Quality audit, Dr. Shyamal Gomes

Abreviationss:

QMS-Quality Management System

QA-Quality Assurance

GxP-Good Practices

GPvP-Good PPharmacovigilance Practice

GMP -Good Manufacturing Practice

GDP-Good Distribution Practice

GCP-Good Clinical Practice

ISO-International Standardised Organisation