Compliancehelp Consulting, LLC

 The international accreditation for testing and calibration centers is ISO 17025 and there are a lot of factors that lead to its formulation. This blog explains the origin of the ISO 17025 certification and how it benefits laboratories. The ISO (International Organization for Standardization) recognized the need to ensure quality assurance services by the testing and calibration laboratories. The purpose was to ensure confidence in the organizations, individuals, and agencies regarding the accuracy of the data produced by the labs after testing and calibrating. Hence, achieving the ISO accreditation by a laboratory shows the trustworthiness of their measurement results and so organizations or agencies using their services can fully rely on them. Designed for this sole purpose, ISO 17025 provides the requirements for establishing the Quality Management System (QMS) and improving the competence of their testing and calibration activities.  Though getting the accreditation would...

The ISO 13485 standard is the specifically devised standard for medical device manufacturing businesses, regardless of the size or type of devices they deal in. The standard enforces strong quality management practices in medical device companies to ensure that their products are completely safe for use by the patients. Just like any other ISO standards, ISO 13485 is based on the continuous Plan-Do-Check-Act or PDCA methodology. It is a continual cycle that medical device businesses should follow to plan the implementation of a QMS, deploy various activities underlined by the standard, improve the effectiveness and ensure consistent improvement of the quality aspects. Clearly, the ISO 13485 standard defines the requirements for establishing a QMS and making it effective in your medical device organization. In the latest version, the requirements are compactly outlined in eight sections. The first three sections include the general requirements that must be followed for establishing a Q...

Implementation of an Environmental Management System (EMS) is a necessary measure for businesses today owing to the ever-increasing impacts of business activities that are threatening natural resources, climate, and habitats of those living in the environment, including humans. To control those impacts at present, many global environmental authorities are issuing guidelines for businesses and governmental agencies are imposing regulations on the businesses. Complying with those guidelines and requirements is hence essential for any business to prove their social responsibility, uphold their reputation in the industry, and get a competitive position. Achieving the ISO 14001 certification helps them to eventually comply with all statutory and regulatory obligations, local and international. The standard mentions the compliance with all types of environmental regulations as a key requirement.  Clearly, to implement the EMS and achieve the ISO 14001 certification for your business, you...