Obtaining quality management certification is widely touted as a way for life science companies and other regulated manufacturers to gain a competitive edge in today's crowded global marketplace, and with good reason; International Standards Organization (ISO) and International Electrotechnical Commission (IEC) standards set the benchmark for product safety and success. Regardless of which regulated industry you operate in, becoming certified by a third-party certification body or registrar, either on your own or with the help of experienced quality process or ISO consultants, assures potential customers that you value quality, and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages.
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Being certified in quality management has many benefits; one of the biggest is the worldwide recognition your company will gain for its commitment to quality, safety, and sound quality management processes. Whether you opt to obtain certification using in-house resources/consultants, or enlist the services of external quality and/or ISO consultants to guide you through the certification process, demonstrating compliance with an internationally recognized standard, such as ISO 13485 or IEC 60601-1, will make it easier to conduct business in foreign markets and overcome many of the technical barriers to trade. Because more and more companies are looking to emerging markets (APAC, South America, India, and China, for example) for growth opportunities, quality management certification consultants and ISO consultants who are familiar with international standards and accreditation procedures can be of great value to regulated organizations hoping to leverage certification to stand out from the crowd. Here are just a few of the benefits certification may bring to your organization:
There are many different types of quality management certification available. ISO, for example, has established more than 19,500 standards, covering almost every topic or process imaginable, and comprises over 140 national standards bodies. In addition to ISO, there is a whole strata of national and international standards organizations. Knowing what certification / accreditation is right for your business can be difficult to determine, which is why many companies rely on ISO consultants and other quality experts to help them navigate the arduous and time-consuming path to certification.
ISO Certifications - Undoubtedly the most influential standards body in the world, ISO's mission is to promote “the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technical and economic activity.” Some of its most popular standards are ISO 10993, ISO 13485, ISO 14155, ISO 14971, ISO 9001, but there are many others.
The benefits of certification are undeniable, so why isn't every company pursuing it? It addition to not knowing which certification is right for their business; many companies simply do not have the time, resources, or expertise to assess their entire QMS and identify and correct the issues and potential barriers to achieving certification success. Preparing for a third-party accreditation audit is a long and tedious process. Forming an alliance with an experienced, well-respected team of ISO consultants and/or quality management certification experts, such as MasterControl Quality and Compliance Consulting (QCC) will dramatically simplify the process. You'll enjoy the business and operational benefits of certification without the added stress and disruptions. QCC is comprised of a highly experienced team of QMS experts, auditors, certifiers, process engineers, and educators who not only know the life sciences and manufacturing industries inside and out, but also understand your business and the unique demands of regulated companies like yours. Our ISO consultants and quality experts provide guidance in seven core regulatory, compliance, and quality disciplines:
QCC offers you access to a global team of accreditation partners, ISO consultants, and other quality management experts. Your QCC expert will sit down with you to determine the scope of your needs and certification goals. After this initial assessment, we'll create a custom proposal that will guide you through every stage of the certification process. Whether you're interested in new product certification, quality system certification, or a host of other certifications, we can help you by customizing the quality management certification process to suit your business. But our work doesn't stop there; we can also provide you with on-going to support to ensure that you maintain your certification. Post-certification services include: internal auditing, training, and acting as a liaison between you and accreditation bodies.
Whether you're starting the quality management certification process, still weighing the benefits, or just want to discuss options for your business, contact us today.