Standard Operating Procedures (SOPs) are written instructions that a worker follows to perform a given task consistently and effectively. These documents communicate who will perform the task, what materials are necessary, where and when when the task must be performed, and how the worker will execute the task. Well-written SOPs are a cornerstone of quality system documentation, and they contribute to the scalability of a company.Read More
The Novatek Blog
Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.
For companies in regulated industries, effective Standard Operating Procedures (SOPs) are important to the ability to manage quality control and process protection. Below we share best practices and tips for developing and managing an SOP process that can help companies meet the challenges that come with regulation standards.
Being ISO certified offers manufacturers many benefits and opens up new opportunities, but planning for the costs of operating under these standards is an important factor of the certification. From the documentation to the training and implementation that ISO requires, manufacturers can face several recurring expenses. Appropriate preparation can save manufacturers from exceeding their budget, as well as, help determine the most cost-effective ways to achieve ISO certification.Read More
To meet regulatory requirements and establish a quality system, many manufacturers employ the International Organization for Standardization certifications (ISO). These standards are not specific to a single industry, ensuring the shared knowledge, best practices, and technology advances are applicable to any company looking to be ISO certified.Read More
For manufacturers in regulated industries, Quality Management Systems (QMS) are a necessity. To ensure consistent quality products, and demonstrate that to customers, most manufacturers follow ISO 9001, the flagship quality management systems standard. However, even manufacturers that are not ISO certified must comply with quality management standards to meet industry-specific regulations.Read More
High product quality and minimal liability all begin with well-established and well-documented business processes. Standard Operating Procedures (SOPs) are one of the cornerstones of business documentation. They direct employees on proper approaches to completing tasks, ensuring quality deliverables regardless of who performs the work. SOPs are highly beneficial to maintaining consistency across company practices.Read More
Amy Castronova, President of Novatek Communications, Inc. and Michele Nichols, President of Launch Team, Inc., are teaming up again this fall to bring you the latest in product launch, technical documentation, training, and marketing trends in medical device and manufacturing. In a series of blog posts, we’ll share industry and economic trends, emerging regulatory and business challenges, and best practices for overcoming those barriers to new product launch and adoption.Read More
The International Organization for Standardization, or ISO, develops and publishes international standards for industries in which there is a clear market requirement. These standards ensure sustainability and a consistent level of quality, safety, and efficiency. They also share knowledge, management best practices, and advances in technology.Read More
In regulated industries, quality assurance is a top priority. Buyers value partners who they can trust to consistently manufacture products that meet their needs. Manufacturers maintain this consistency by following established standards for quality management.
Certification to ISO 9001:2008 or ISO 13485:2003 quality management standards is one way to demonstrate competence and compliance. While a company might already adhere to the ISO standards, earning certification from a registrar adds a level of credibility that customers appreciate. This official designation is also a useful marketing tool.Read More
Topics: Quality System documentation
In the past 15 years, Novatek’s technical writing team has worked side by side with Peggy Ley, former technical writer, customer service support specialist and trainer for Ortho Clinical Diagnostics (OCD). Novatek provides outsourced technical writing services and training to help OCD launch medical device products, as well as documentation support for existing products. Last week, we introduced our three-part blog series inspired by Peggy’s unique perspective and lessons learned from her experiences at OCD.Read More