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...

 As with any ISO certification journey, the ISO 14001 certification for Environmental Management System (EMS) requires an organization to have clear understanding of their context. This simply means knowing where to start from and what you want to get out of the ISO 14001 standard in your organization. This makes defining of the ‘organizational context’ very crucial if you want to achieve the ISO standard for your EMS. Organizational context is actually defined as a thorough understanding and underlining of the external and internal issues that can directly impact your organization or its goals. Explaining it more simply, the ISO 14001 standard is meant to improve the overall environmental performance of an organization. Defining its context in your organization means finding out how ISO 14001 works to improve your environmental performance.  Although there is no prescribed method for determining the organizational context for ISO 14001 or for any other standard, here we are a...

Organizations today are seeking to have a definite Environmental Management System (EMS) accredited with the ISO 14001 certification to prove their environmental efforts and compliance with key environmental obligations. ISO 14001 is the benchmark standard when it comes to the management of environmental impacts. Designed by the ISO (International Organization of Standardization) it lays down the ground rules and structure of the EMS, implementing which helps organizations to efficiently reduce their harmful impacts and boost sustainability. If you are reading this, it probably means you are interested in achieving the ISO 14001 certification for your business and achieving your environmental goals. This blog provides you helpful guidiance on the process of achieving the certification. It points out the key steps that you need to follow to make your EMS compliant with the requirements of ISO 14001. Step-by-Step Procedure to Achieve ISO 14001 Compliance Assessing the Gaps The p...

 Environmental management is now an indispensable part of every organization’s strategy because of adverse effects of business activities on nature and its resources. It puts emphasis on the implementation of the ISO 14001 environmental management standard , which promotes best measures and regulations for preventing environmental risks and reducing the impacts. An Environmental Management System (EMS) is a framework encompassing the practices for environmental management. It helps organizations to reduce the negative impacts and increase sustainability. The ISO 14001 standard provides them with key requirements for establishing the right EMS framework. In short, achieving the ISO 14001 standard verifies that your EMS is effective in controlling your environmental impacts and meets the organization’s goals regarding environmental sustainability.  However, to develop an appropriate and suitable EMS for your business, what you first need is to understand the fundamentals of EMS....

While quality assurance is a non-negotiable concept for medical device manufacturers, the ISO 13485 standard is the specific standard for medical device quality management systems.  The standard helps medical device organizations to manage the design, development, manufacturing, installation, repairing, maintenance, and sales of the medical devices. The standard specifies the requirements for establishing the QMS (Quality Management System) which encompasses the processes of medical device manufacturing and ensures that customer expectations and product regulations are met. Regulatory requirements for medical devices are also increasing often to enhance product safety because of growing public scrutiny. ISO 13485 also has gone through several changes throughout the years with the latest update completed in 2016.  If you have a medical device manufacturing organization, then you should learn about the necessary changes introduced in the latest version, which are intended to str...