Product Design
We bring creativity to Design Thinking from Initial Concept (back-of-napkin-doodle) to realize a Robust Marketable Product. Our focused approach is based on an initial deep understanding of the design/risk and market need/value propositions, followed by rapid iteration of potential solutions through testing and learning, until arriving at a Robust and Compliant Product.
Our process of empathetic design innovation is based on:
· Design thinking
· Lean Start-up movement
· Business model generation
· Design sprints
QMS Implementation
QMS Implementation, Maintenance & Continuing Improvement Services for ISO 9001, 13485, 14001, 17025, and Global IATF 16949.
Our Team-oriented approach to Effective Implementation of QMS is customized for:
· Focused training utilizing technical competencies:
· Furthering a culture and environment of quality.
· Creating and monitoring quality and environmental metrics to evaluate effectiveness of Business Processes.
· Utilizing technical competencies for adhering to applicable quality system procedures and regulations.
Internal & External Audits
We establish and conduct In-depth Internal and External Audits in realizing the full potential of underutilized auditing tools, such as:
· Appreciative and effective Audits across all your value streams
· Monitoring and containment of OBF/OBD (>0.5% industrial average)
· Production Audits
· Supply Chain Evaluations and sustained improvements
· Management Reviews to monitor value stream performance
CAPA
Revitalize and energize your QA/RA Value Streams across the Enterprise:
· CAPA: creatively transition from 'Death by CAPA' to a monetized 'CAPA to the Rescue' mindset
· NCR processes
ISO 9001 Details
ISO 9001 (originally published in 1987) was most recently updated in 2015 and is now used worldwide by more than one million organizations in more than 160 countries, as the basis of their Quality Management System, QMS. Using the ISO 9001 standard helps organizations to define and organize processes, improve process efficiencies, and to continually improve to meet their customers' requirements and regulatory requirements
Compliance on Tap specializes in implementing Quality Management Systems in organizations, regardless of size or industry, and is ready to assist you in getting started. If you already have an established ISO 9001 QMS and require assistance with maintaining it or transitioning to the latest standard edition, don't hesitate to contact us.
ISO 13485 QMS with optional QSR & MDSAP extensions
ISO 13485:2016 is globally the leading quality management system, QMS, standard globally for organizations which provide medical devices and related services. It covers the requirements for medical devices over their life-cycle, including design and development, production, storage and distribution, installation, or servicing, as well as the design and development or provision of associated activities (e.g. technical support, post-market surveillance, complaint handling, regulatory reporting, etc). ISO 13485:2016 applies to all medical device manufacturers regardless of their size and the type of medical device or related service provision, except where it is explicitly excluded. ISO 13485:2016 also applies to suppliers and other external parties that provide products and services to medical device manufacturers, when their products and services have an impact on the safety and effectiveness of the finished medical devices.
QSR (USA)
The quality system regulation, QSR (21 CFR 820), is required from medical device manufacturers or distributors, whether they're located within the USA or foreign-based. This regulation defines the minimum requirements for a quality management system and manufacturers are subject to periodic audits by FDA (or by an MDSAP-approved registrar, where the manufacturer is registered for MDSAP) to ensure their compliance. The QSR can be implemented as a stand-alone QMS (if a manufacturer is only providing products and services within the USA), however in practice and due to the continuing harmonization of global standards, a medical device manufacturer will obtain the greatest return from implementing an ISO13485:2016 QMS which also addresses the requirements of QSR.
The team at Compliance on Tap has many years of experience implementing ISO 13485 & QSR-compliant quality management systems and maintaining their effectiveness. We also help manufacturers transition to MDSAP.
We stand ready to be of assistance and to provide the highest value to your organization, whether you're a medical device startup company or an established manufacturer.
ISO 14001 Environmental Management Systems
ISO14001:2015 specifies the requirements for environmental management systems, EMS, for organizations seeking to manage their environmental responsibilities through the application of systematic procedures to enhance their environmental performance and to strive towards environmental sustainability.
It helps the organization, regardless of size, type or nature, to define its intended outcomes towards:
- enhancement of environmental performance
- fulfillment of compliance obligations
- achievement of environmental objectives
ISO14001:2015 leaves it up to an organization to define its specific environmental performance criteria in terms of its activities, products and services over which it exerts control or influence. This standard can be applied partially or in whole over the life-cycle of an organization's processes, products and services.
Compliance on Tap stands ready to assist you at every stage of your ISO 14001 EMS implementation and its follow-up maintenance, to assure a robust, effective, and cost-effective outcome for your entire organization.
ISO 17025 General requirements for the competence of testing and certification laboratories
ISO 17025 is the globally-recognized standard governing the establishment, qualification and accreditation of testing and certification laboratories. It is also the basis upon which manufacturers' testing facilities are qualified, when the manufacturer participates in shared certification programs such as witnessed manufacturers' testing (WMT), supervised manufacturers' testing (SMT), and testing at manufacturer's premises (TMP) under the CB Scheme. ISO 17025 provides both administrative and technical requirements for these testing facilities.
The team at Compliance on Tap has significant experience with the implementation of ISO 17025 testing laboratories at manufacturers' premises and can be of assistance with determining environmental requirements for specific sites, identifying and procuring test equipment, as well as initiating contact with a suitably-accreditated test laboratory, where the client intends to participate in one of the international manufacturer's testing programs. Compliance on Tap can also assist a manufacturer designing products to implement test methods and procedures for their in-house engineering verification purposes, which will provide the most meaningful outcome towards the product's subsequent submission to a certification agency.
IATF 16949 Quality management system for organizations in the automotive industry
IATF 16949:2016 harmonizes the different assessment and certification systems in the global autootive supply chain and it is one of the automobile industry's most widely used international standards for quality management. IATF 16949:2016 is designed to be used together with ISO 9001:2015 and contains supplemental requirements for the automotive industry, rather than being a stand-alone QMS standard.
Whether you're a supplier or manufacturer in the automotive industry, Compliance on Tap can assist you with implementing and maintaining your QMS towards assuring that your organization is able to achieve the highest levels of customer satisfaction and competitive advantage.