Conformity Assessment - Informative FREE book by ISO & UNIDO

Sidney Vianna

Post Responsibly
Staff member
Admin
#1
A very informative and FREE book on conformity assessment is available from the ISO website. Be aware, it is almost 9MB in size. >>DOWNLOAD<<


http://www.iso.org/iso/pressrelease.htm?refid=Ref1305
The fruitful partnership between ISO (International Organization for Standardization) and UNIDO (United Nations Industrial Development Organization) has just produced a new handbook, Building trustThe Conformity Assessment Toolbox.
Building trust is a comprehensive, user-friendly handbook covering all aspects of conformity assessment and its role in international trade, and will be useful for business managers, regulators and consumer representatives.
The book's Preface is contributed by ISO Secretary-General, Rob Steele, and UNIDO Director-General, Kandeh K. Yumkella, who write: "Businessmen, consumers and public officials have certain expectations about the quality, safety, reliability, interoperability, efficiency, effectiveness and environmental sustainability of products and services.
"Conformity assessment provides the means for testing the compliance of such products and services with these expectations, in accordance with relevant standards, regulations and other specifications. It helps to ensure that products and services deliver on their promises. In other words, conformity assessment builds trust."
However, non-acceptance of test reports and certificates of conformity continues to be an obstacle to international trade. Successive reviews of the World Trade Organization's Agreement on Technical Barriers to Trade have noted the usefulness of the conformity assessment standards and guides developed by ISO and the International Electrotechnical Commission (IEC) in harmonizing conformity assessment practices and as benchmarks for the technical competence of assessment bodies.
The use of these standards and guides therefore helps to overcome trade barriers. UNIDO, meanwhile, has acquired more than 40 years of experience in supporting the establishment and upgrading of standards and conformity assessment structures worldwide.

Building trust covers the following aspects of conformity assessment:
  • Basic concepts
  • Conformity assessment techniques
  • Conformity assessment schemes and systems
  • Conformity assessment bodies
  • How UNIDO can help with setting up a quality infrastructure
  • Case studies
  • ISO Committee on conformity asssessment, ISO/CASCO
  • Coordination of accreditation bodies
  • Conformity assessment and the WTO Agreement on Technical Barriers to Trade.
The handbookis the latest in a series of joint publications issued by ISO and UNIDO, and is the result of the long-standing and fruitful partnership between the two organizations to strengthen the standardization and quality infrastructures of developing countries and countries with economies in transition. Although aimed specifically at this group of countries, these publications are also intended to serve as handy reference tools for all who are involved or interested in conformity assessment and trade.
Building trustThe Conformity Assessment Toolbox is available in English (189 pages, ISBN 978-92-67-10511-6) and French (211 pages, ISBN 978-92-67-20511-3) editions. It is available free of charge (fee for postage and handling) from the ISO Central Secretariat through the ISO Store or by contacting the Marketing, Communication & Information department (see right-hand column). It can also be obtained from ISO national member institutes (see the complete list with contact details). The handbook can also be downloaded as a PDF file free of charge from the ISO (www.iso.org) and UNIDO (www.unido.org) Websites.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
H Pedicle screw system Conformity Assessment Other Medical Device Related Standards 2
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
M Informational US FDA – Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
M Informational USFDADraft Guidance – Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Medical Device and FDA Regulations and Standards News 0
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
M Informational TGA – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 Medical Device and FDA Regulations and Standards News 0
chris1price MDR Conformity Assessment for a Class 2a device - Production Quality Assurance EU Medical Device Regulations 2
S EU conformity assessment - Certify to MDD or MDR? EU Medical Device Regulations 3
S Class II Medical Device Conformity Assessment Route according to Annex V only CE Marking (Conformité Européene) / CB Scheme 7
S Conformity assessment routes in MDR EU Medical Device Regulations 3
B CISPR 11 - Assessment of Conformity Other Medical Device Related Standards 4
Sam Lazzara Using MDD Annex III + V Conformity Assessment Pathway EU Medical Device Regulations 2
S RoHS Conformity Risk Assessment - Medical Devices RoHS, REACH, ELV, IMDS and Restricted Substances 2
C CE Mark Conformity Assessment Annex II vs. Annex VII+ CE Marking (Conformité Européene) / CB Scheme 10
T Declaration of Conformity acording to the ZLC 3.9 A4 Conformity Assessment EU Medical Device Regulations 5
E Conformity Assessment under Australian Medical Device Regulations Other Medical Device Regulations World-Wide 3
E Conformity Assessment choices for a Contract Manufactured Class IIa Medical Device Other US Medical Device Regulations 1
Z Conformity Assessment Route from the Medical Devices Directive (93/42/EEC) Help EU Medical Device Regulations 6
Sidney Vianna ISO CASCO (Conformity Assessment Committee) e-Newsletter Other ISO and International Standards and European Regulations 0
Ajit Basrur Presentation on Standardization and Conformity Assessment Bodies General Measurement Device and Calibration Topics 1
C CMDCAS (Canadian Medical Devices Conformity Assessment System) for drugs ISO 13485:2016 - Medical Device Quality Management Systems 3
G ISO 13485 IAF Medical Device Conformity Assessment System IAF-MDCAS ISO 13485:2016 - Medical Device Quality Management Systems 10
Q ISO 17011 (Conformity assessment - General requirements..) Internal Audit Tips wanted Internal Auditing 12
S Conformity of 1 batch vs other Statistical Analysis Tools, Techniques and SPC 5
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
CharlieUK Informational ADCO MED EU DECLARATION OF CONFORMITY TEMPLATE CE Marking (Conformité Européene) / CB Scheme 0
Aymaneh Traditional 510(k) Declaration of Conformity Other Medical Device Regulations World-Wide 3
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 5
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 4
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
L MDR 745 - EU Declaration of Conformity - Signature Requirements EU Medical Device Regulations 3
A EC declaration of conformity - In the event clients ask for a copy CE Marking (Conformité Européene) / CB Scheme 12
L Content of Declaration of conformity (MDR) EU Medical Device Regulations 1
qualprod Non conformity, do nothing? Employee experiencing "hard times" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
J COC (Certificate of Conformity) when NOT purchasing medical devices direct from the Manufacturer Other Medical Device Related Standards 2
N Declaration of Conformity for Product from Supplier ISO 13485:2016 - Medical Device Quality Management Systems 6
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
I Who is responsible for signing the Declaration of Conformity and what is their liability Imported Legacy Blogs 0
J Medical Devices in Japan - Conformity of QMS to ISO 13485 Japan Medical Device Regulations 1
S Conformity vs. 8130-3 tag creation date Federal Aviation Administration (FAA) Standards and Requirements 1
D Root Cause on Non-Conformity Against Quality Manual Problem Solving, Root Cause Fault and Failure Analysis 9
Q Signatures on C of Cs (Certificate of Conformity) Supplier Quality Assurance and other Supplier Issues 2
D Determining Critical Components for conformity with IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 21
H Meaning of Annex II, excluding point Clause 4 conformity CE Marking (Conformité Européene) / CB Scheme 4
A Certificate of release/certificate of conformity/certificate of compliance Other Medical Device and Orthopedic Related Topics 3
T ER Checklist - Method(s) of conformity EU Medical Device Regulations 1

Similar threads

Top Bottom