eu quality management system certificate


3 5 Quality: The totality of features and characteristics that bear on the ability of a product to satisfy fitness for use including safety and performance [( 820 3 (s)] 3 6 Quality System: The organizational structure responsibilities procedures processes and resources for implementing quality management


The company aims at the quality management being integrated into the general management of the company as a whole in order to achieve the quality objectives A process approach defines the duties and responsibilities of each employee A system approach helps in understanding the interconnection of the processes taking place The company's products are certified We keep in close contact with

Internationally recognised Integrated Management System

We are constantly striving to enhance our services through the effective application of our Integrated Management System (IMS) which embraces quality management principles and practices It is our intention to ensure compliance with the applicable management standards namely the EASA Management Standards that TongWei into account the ISO 9001 requirements and the Internal control

Free webinar: Compliance with the MDR: Most significant

Free webinar: Compliance with the MDR: Most significant adjustments to Technical File Quality Management System April 07 2020 - April 07 2020 sol Virtual Date: 7th of April 2020 Time: 16:00h - 17:00h CEST Location: Virtual Language: English Trainer: Stefan Menzl Regulatory Affairs Expert Introduction During this one hour free webinar Regulatory Affairs Expert Stefan Menzl

Commission Regulation (EU) No 73/2010 of 26 January

QUALITY SAFETY AND SECURITY MANAGEMENT REQUIREMENTS REFERRED TO IN ARTICLE 10 PART A Quality management system 1 A quality management system supporting the origination production storage handling 2 An EN ISO 9001 certificate issued by an appropriately accredited PART B Safety management objectives 1 The safety management

Environmental management

We TongWei part in the EU Eco-Management and Audit Scheme (EMAS) a management tool for evaluating reporting on and improving organisations' environmental performance We achieved EMAS registration in March 2017 and we successfully operate an environmental management system in line with EMAS Regulation (EC) No 1221/2009 as amended by Regulation (EU) No 2017/1505 and ISO 14001 For

ISO 13485

ISO 13485 - Quality Management Systems for Medical Devices ISO 13485 is the globally recognised standard for medical device quality management Published February 25 2016 ISO 13485:2016 focuses on quality management systems and is recognised and used as a framework by the medical device industry regulators programs including the Medical Device Single Audit Program (MDSAP)

LimaCorporate is very proud to announce that the company has obtained the EU Quality Management System Certificate under Medical Devices Regulation (MDR) for Class III Custom-Made devices and is therefore the first medical device company in Italy and among the first in Europe to complete the process one year ahead of the new May 26 2021 deadline LimaCorporate has always been

Quality Management System Certification

quality management system building blocks of success Medical Device Single Audit Program The Medical Device Single Audit Program (MDSAP) is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP

ISO 9001:2015 Quality management systems

FREE DOWNLOAD - PREVIEW ISO 9001:2015 PDF ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and b) aims to enhance customer satisfaction through the effective application of the system including

EU (GMP) Guidelines

Q9 Quality Risk Management Q10 Note for Guidance on Pharmaceutical Quality System MRA Batch Certificate Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use (Version 2 January 2013) Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal

Quality management system Železiarne Podbrezov

- Quality management system certification acc to international standards ISO 9001 - Certification of quality management system acc to specific technical regulations - Product certification and approvals of products This section consists of three areas: 1 Product certification - confirmation that the products meet the requirements of various regulations (eg EU legislation) 2 Products for

Presentation on EU Regulatory Quality System

The requirement for the written confirmation can only be waived If the third country is included by the European Commission after assessment in a list of countries with an equivalent system of supervision and inspection or Exceptionally in order to ensure availability of medicines in the EU market if a GMP certificate for the site has been issued by an EU competent authority after

Management system certification (ISO)

Management system certification is an endorsement of the entrepreneurial capability of organisations that have chosen to optimise their structure and equip themselves with efficient management systems suitable skills and appropriate internal tools and processes (such as performance indicators) It provides evidence of the professionalism of the work culture shared by the whole company It


quality management system by an accredited certification body of his choice in order to ensure the conformity of his quality system to the standard EN ISO 9001: 2015 for the activities in relation with the legal metrology field When this is the case the notified body for approval and surveillance of the quality system may TongWei this external certification according to EN ISO 9001: 2015 into

ISO 9001 QMS documentation – How to structure it

Author and experienced quality management consultant Carlos Pereira da Cruz has written this book with one goal in mind: to offer you a practical and straightforward way to adapt your quality management system to your business while meeting the standards of


EU-Supply's Complete Tender Management (CTM) is a comprehensive tool that allows tenders to be created distributed and evaluated without the need to create and manage paper documents CTM makes the tendering process easier for both buyers and suppliers and covers the entire process including the contract management phase Tender Management is used by government organizations and general


MANAGEMENT SYSTEM CERTIFICATE Certificate No: 149438-2014-AQ-ITA-ACCREDIA Initial certification date: 30 January 2014 Valid: 31 January 2020 - 30 January 2023 This is to certify that the management system of INTESI GROUP Spa has been found to conform to the Quality Management System standard: ISO 9001:2015 This certificate is valid for the following scope: Design

Commission Regulation (EU) No 73/2010 of 26 January

QUALITY SAFETY AND SECURITY MANAGEMENT REQUIREMENTS REFERRED TO IN ARTICLE 10 PART A Quality management system 1 A quality management system supporting the origination production storage handling 2 An EN ISO 9001 certificate issued by an appropriately accredited PART B Safety management objectives 1 The safety management

European Foundation for Quality Management (EFQM

The EFQM Excellence Model was introduced at the beginning of 1992 as the framework for assessing applications for The European Quality Award It is a widely used organisational framework in Europe and has become the basis for a series of national and regional Quality Awards The EFQM model's is used as a management system that encourages the discipline of organisational


realization of high-quality services and products using materials with a quality certificate in planned and supervised conditions application of rational working methods and implementation of technical progress We realize our Quality Policy through: maintaining the existing very high competitive position on the market that offers products and provides services identifying the company

Quality Management and RF Metrology Systems

It is our pledge to continually improve an effective Quality Management System assuring our customers' satisfaction This responsibility lies within every team member who affects quality by the performance of their work A2LA Accreditation Accreditation Certificate No 2626 01 Scope Of Accreditation To ISO/IEC 17025:2017 ANSI/NCSL Z540-1-1994

ISO Training

The Management System Training Programmes are led with a plan to build up a solid culture of execution of the ISO Standards in enterprises It causes the association to comprehend the essential requirements of the standard ISO Training encourages association how to actualize the ISO standard and makes an enthusiasm to the general population engaged with the ISO Standard Implementation


The requirements for the purposes of legal provisions concern quality management systems in the manufacture of medical devices More ISO 14001 International standard for environmental management systems More EN 14065 Management system ensuring microbiological quality of textiles after treatment in the laundry More ISO 45001 Occupational Health and Safety Management System

Quality Management – Fukuda

We have also been focusing on establishing an international quality management system such as by obtaining certifications based on the European Medical Device Directive (93/42/EEC) and the Canadian Medical Devices Conformity Assessment System (CMDCAS) Under our quality policy we continue to work for quality assurance activities with strict standards putting effort into the development of

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