Developing a Quality Management System

A Quality Management System is an essential part of delivering a consistent product to your customers. Whether you need help reviewing your existing QMS or creating a new QMS around your current processes, we are here to help.

Our experience includes bringing up QMS systems from scratch as well as adapting existing systems to a particular standard or set of regulations. Some of our expertise includes:

- ISO 13485 – Medical Devices
- IS0 9001 – Quality Management
- 20 CFR 820 – FDA – Medical Device – Quality System Regulations
- MDSAP (Medical Device Single Audit Program)
  - United States, Brazil, Japan, Canada, Australia
- Good Manufacturing Practices (GMP)

Each of these has its own unique requirements. Do not try to navigate them alone. Let us help.

Many firms ofter package templates for a fixed fee. We believe a QMS needs to be tailored to your company’s process. If the QMS is not customized for your company, then policies and procedures will not be followed or adopted. This leads to findings and extra work later on.

We fell that buying a prepackaged QMS and expecting it to be easy to implement or passing the first audit is asking for trouble. We feel that using our existing base templates can speed the process along as use those to fill in the gaps to your existing process.

Gap Analysis and Action Plan

Part of moving forward with any QMS is determining where the organization is today and planning where you want to be in the future. Most companies are not starting from scratch, so auditing their current processes against the desired regulations is the first step.

After the initial evaluation, a comprehensive action plan is developed and given to you to bring the team into compliance. This plan can then be executed by members of your team, or we can help create or augment your existing documentation.

QMS Migration

Is your company already certified for ISO 9001, but wants to move into the medical space? Are you currently compliant with 21 CFR 820 and wish to move to ISO 13485, or MSDAP? Let us help you close the gaps. Our approach allows you to fill the gaps in your existing procedure without rewriting your entire set of documents.

QMS Documents and Templates

Do you need a few documents written to be in compliance with the standard of your choosing? We can help decrease the time spent on developing the QMS by using our existing templates. We will not sell you a batch of templates that do not meet your process. Instead, we review your QMS so that we can merge our models into your existing QMS. This mixed approach gives your company a faster time to market and better compliance with the regulations or standards you are trying to follow without the time commitment required of starting from scratch.