Monitoring & Measurement of Processes

A manufacturing company is required to have suitable methods in place for monitoring and measuring the processes involved in their quality management system.  According to ISO 9001, “These methods shall demonstrate the ability of the processes to achieve planned results.”  Essentially, what this requirement is asking you to do is to confirm that you’re having…

Customer Satisfaction

ISO 9001 has identified the evaluation of customer satisfaction as one of the key measurements regarding the performance of a company’s quality management system.  There are many organizations that consider this a key indicator of corporate health. The goal of this requirement is to establish if the customer perceives that the company has met their…

Production & Service Control

ISO 9001 and ISO 13485 address the concept of Control of Production and Service.  In ISO 9001, it states “The organization shall plan and carry out production and service provision under controlled conditions.”  ISO 13485 expands on this by saying “The control must be performed and achieved according to the planning requirements specified…”.  Essentially, a…

Management Responsibility

One of the main requirements in ISO 9001 is to have a demonstrated commitment from upper management to support the quality management system (QMS) that is in place, along with working to continually improve the effectiveness of the QMS.  In this case, “upper management” refers to the individual at the top of the organization (such…

What is ISO 9001?

ISO 9001 is an internationally recognized standard that provides guidance in creating, and maintaining, a Quality Management System (QMS) within your company.  This standard can be applied to any size company, across all industry sectors.  It requires an organization to meet its own requirements, along with those of its customers and regulators.  A QMS should…

Statistical Techniques

There is a requirement in both the 21 CFR 820 and ISO 9001 to utilize statistical techniques.  According to the FDA, “Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.  Sampling plans, when used, shall be…

Quality System Record

While similar in content to a Quality Manual, the Quality System Record is a requirement for the FDA’s 21 CFR 820.  This document must “include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s)…”  Specifically, the FDA is…

Handling, Storage, Distribution

Once product has been manufactured and packaged, there are requirements for how you handle, store and distribute the finished product.  21 CFR 820 breaks down the requirements for each of these processes.  A manufacturing company should establish procedures that will deter mix-ups, damage, deterioration or contamination from happening during handling and storage of product.  These…

Document Control

Both FDA’s 21 CFR 820 and ISO 9001 have requirements for document control.  The goal with this section of the standards is to demonstrate that your quality system is compliant, that you design and manufacture products to meet design controls, and that your company is addressing risk management concerns.  The FDA typically takes the approach…

Quality Policy

Another item that is required by both 21 CFR 820 and ISO 9001 is the Quality Policy.  Though it is jointly written by management and quality experts, the process of writing a Quality Process is a beneficial exercise for management as it has them focus on systems and how the company operates.   This document…