QUALITY SYSTEMS MANAGEMENT SERVICES
MARKET READINESS
ALIGNED WITH STRATEGY
COMPETITIVE ADVANTAGE
COMPREHENSIVE TRAINING
WHY A QMS
You likely know about a QMS, already. You may have learned that a QMS is a mandatory element to have in place to get your product to market. However, you may not know how or why a QMS will benefit your organization and the products or services you develop.
NeedlerQMS will shine a light on that…
A well-constructed QMS provides essential standardization that reaches into all aspects of your organization. Its primary focus ensures that quality, and even safety, is consistently maintained in all key processes that support your product development. It even drives the product development process itself through Risk Management, Compliance, and Data-driven decision-making.
The positive impact of Continuous Improvement will elevate your organization through Resource Optimization and a high degree of Staff Engagement, all resulting in a strong Competitive Advantage. This may make complete sense, but you may now be uncertain as to how to actually implement a QMS, and do so successfully…
NeedlerQMS is your partner to make that happen.
WHY NeedlerQMS
Working with NeedlerQMS means that your Quality System is built by experience. Experience that ensures your system is built efficiently and that it applies to the context of your organization. NeedlerQMS works collaboratively with your staff to build the procedures to meet the needs of your organization, all the while remaining compliant with the QMS requirements.
A QMS is a well-documented system and not a system that is a collection of documents.
There may be many online resources offering pre-packaged document kits that claim to be an easy way to build a QMS. However, what they don’t mention is that these documents and the resulting ‘system’ won’t be of much value to you. NeedlerQMS provides thorough training via live online working sessions throughout the development of your QMS so that you and your staff understand working in a regulated environment.
BENEFITS
As a founder, one challenge is to know how and when your start-up can even begin to work on a QMS. NeedlerQMS takes on this task for you ensuring it is done at the right time for your organization.
A QMS is not to be an afterthought that is quickly assembled at the end of your product development to satisfy a market application. Doing so will surely save you time-to-market. A QMS is such an integral part of the product strategy that it must be factored into the planning early, and be given as much importance in the development plan as the product itself. This helps to avoid unexpected costs and unnecessary timeline delays and shows a high degree of confidence to stakeholders.
The success of the QMS depends on how well you know how to use it. Always answering the question of ‘Why’, the training provided by NeedlerQMS will allow you to gain knowledge of how your QMS works, the requirements dictated by relevant standards, and what it all means for your key processes.
STRENGTHENING PRODUCT DEVELOPMENT
STANDARDIZATION
CONTINUOUS IMPROVEMENT
VALUE
TRAINING
SUCCESS
A COMPREHENSIVE PROGRAM THAT DRIVES STRATEGY
NeedlerQMS is a proven process to build your Quality System so that it works for your organization. In a timeline of 18 weeks, you will be part of a new team that shares knowledge, translates requirements, creates meaningful procedures, and gains a clear vision toward certification and market submission. Here is how that is accomplished:
- Two, 1-hour Knowledge Transfer sessions to learn about your business and to introduce the standard your QMS will be compliant to
- All essential Standard Operating Procedures and Forms that are customized for your business
- Collaborative document writing and approval process
- Integration into many management platforms and e-QMS tools
- 10 online, live training sessions on each element of the QMS, the requirements for compliance, and their relevance to your business
- Best practices built-in taken from first-hand experience
- Introduction to Risk Management
- Introduction to certification preparation
ONGOING MANAGEMENT SERVICES
Although NeedlerQMS specializes in Quality Systems, these additional services are offered to provide a clearer outlook on your product development strategy and further strengthen the process of getting to market:
- Management Representative for External Audit Support
- Interpretation of Regulations and Statutory Requirements
- Regulatory Pathway Report
- Ongoing QMS Support
- Certification Preparation
- Risk Management