ISO Philippines

Producing any part of a product includes validation and verification in its design and development .  ISO 13485 Certification requirements are a great way to start, since it’s targeted specifically to medical device manufacturing. According to the American Society for Quality, the definition of validation in a quality environment is the act of confirming that a product or service meets the need for which it was created. The definition of verification is the act of determining whether a product or service can meet a specific requirement. One of the most critical and fundamental components of product creation includes ensuring the product will perform as intended. For more about process validation in ISO 13485 read the article  The roles and responsibilities of  ISO 13485 according to QMS What does product design mean within ISO 13485 Certification According to ISO 13485 Certification , product design includes both validation and verification of the medical device. A ma

CE marking  is a  certification mark  that indicates conformity with health, safety, and environmental protection standards for products sold within the  European Economic Area  (EEA). The CE marking is also found on products sold outside the  EEA  that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense similar to the  FCC Declaration of Conformity  used on certain electronic devices sold in the  United States .   General principles of the CE Marking Certification Services The CE marking shall be affixed only by the manufacturer or his authorized representative. The CE marking Certification shall be affixed only to products to which it's affixing is provided for by specific Community harmonization legislation, and shall not be affixed to any other product. By affixing or having appendant the CE marking, the manufactur

“What is ISO 45001 ?” Are you looking for a simple answer to this question? This question arises very often and this overview is meant to provide you with information on the benefits of ISO 45001 Certification as well as the requirements of the standard, its structure and the steps towards certification. Origins of ISO 45001 ISO 45001 Certification , Occupational Health and Safety Management Systems–Requirements with guidance for use, is an ISO standard for occupational health and safety management systems that is recognized and implemented worldwide. This standard was published in 2018 in order to replace OHSAS 18001:2007. Before the development of a management system standard by the ISO committee, a “Justification Study” was prepared in order to present a case for the proposed project. In relation to the development of ISO 45001, user needs are identified from the following: A.    User demands for the requirements of management system standards to be better aligned,