Bio-Edge, a manufacturing company based in San Diego, California specializes in the production of polymer based medical device components. With a commitment to achieving certification of their QMS to ISO 9001:2015 Standard, Bio-Edge retained a local consultant to assist them with the development and implementation of QMS. This consultant coached Bio-Edge until stage 1 external audit which resulted in 5 major NCRs and 3 minor NCRs.
Bio-Edge was disappointed with the performance of this consultant but still wanted to continue with the ISO 9001:2015 certification project. Jack Sekhon and Associates was retained by Bio-Edge to overcome the issues that arose in stage 1 audit and to pave the way for a successful stage 2 implementation audit leading to certification of their QMS to ISO 9001:2015 Standard.
Bio-Edge recognized the need for an experienced consultant who understood the interpretation of ISO 9001:2015 Standard and their business processes to come up with the design and implementation of the QMS that will completely conform to requirements of ISO 9001:2015 Standard, comply with applicable statutory and regulatory requirements, stand-up to the scrutiny of external auditor, meet/exceed customer requirements and add value that will provide an competitive edge as well as process and business improvements.
- Risk Based Thinking: The understanding of risk-based thinking and its execution in QMS documented information was extremely poor.
- Process Approach: Process approach concept, the foundation of QMS, was largely ignored leading to poor value and ineffective control over QMS processes.
- Organizational Context: This was covered at a very high level and in a such a vague manner that it did not provide a long-term direction to the purpose of the organization.
- Monitoring/Measurement of QMS: KPIs that add tremendous value to the effectiveness and efficiency of were not practical, measurable and value adding.
- Awareness of ISO 9001:2015 Standard: ISO 9001:2015 awareness was not to the extent needed for appropriate, suitable, adequate and effective QMS.
- Implement a process approach at all functional groups/departments with inputs, outputs, checks and balances with associated acceptance criteria and controls.
- Design and execute risk identification, assessment and prioritization methodology that will provide prevention approach.
- Implement an effective methodology for internal and external environmental scanning using tools such as SWOT and PESTLE.
- Establish and implement KPIs at the product, process and system levels to gauge the effectiveness of QMS in order to drive business performance enhancement through continual improvement.
- Trigger enhanced awareness of ISO 9001:2015 requirements both at management and employee’s levels to enhance their contribution to the design and implementation of QMS.
- Analysis of Stage 1 audit findings: Analyzed Stage 1 audit findings conducted by an external registrar to determine their nature, level of non-conformances and immediate and long-term corrective actions.
- ISO 9001:2015 Awareness: ISO 9001:2015 Requirements, Internal Auditor and Lead auditor Exemplar Global certified training was provided to the senior management with case-studies to connect the ISO Standard with Bio-Edge business and processes to pave the way for smoother and disciplined approach for design and implementation of QMS.
- Process Approach: Identification of processes and their control/evaluation at each functional level with management and employee engagement resulted in functional Process Lists that formed the framework for QMS.
- Risk Based Thinking: A risk identification and assessment methodology implemented to prioritize risks at each functional level led to Functional and Organizational Risk Registers that assisted in establishing a focus for developing core documented information for the QMS.
- Organizational Context: SWOT and PESTLE analysis tools were employed to conduct internal and external environmental scanning followed by risk assessment, leading to strategic objectives/operational plan which is paramount for suitable, adequate and effective QMS
- KPIs: Process, product and system level KPIs were established in alignment with QMS objectives to evaluate on-going evaluation of QMS and to keep it on track and aligned with strategic objectives/targets.
- Internal Audits: A process and risk based non-embarrassing and on intimidating internal audit was conducted to evaluate the conformance of documented information to ISO 9001:2015 and effective implementation of QMS consistent with requirements of ISO 9001:2015 Standard. A large number of NCR findings were raised and addressed to provide evidence to stage 2 external auditor that continual process was in place.
- ISO 9001:2015 Certification: Bio-Edge successfully achieved ISO 9001:2015 certification with only one minor NCR
- Resolution of internal audit findings: All NCR findings raised during internal audit were addressed through correction and corrective actions.
- Enhanced Regulatory Compliance: Bio-Edge’s recently developed Legal Register will assist in consistently meeting applicable statutory and regulatory requirements relevant to its products and services.
- Improved Customer Satisfaction: With a focus on prevention based QMS through process approach and risk-based thinking, product defects and delays are expected to be minimized, resulting in increased customer satisfaction and loyalty.
The work done by Jack Sekhon and Associates for Bio-Edge not only led to successful and hassle-free ISO 9001:2015 certification but also brought about positive changes in the organization’s culture and processes as well as opening doors for increasing market share. By addressing challenges related to process variability, regulatory compliance, and customer satisfaction, the company positioned itself as a leader in the industry, setting a standard for quality and continuous improvement. The success of this QMS implementation serves as a case study for organizations looking to enhance their quality management practices, achieve certification, establish strategic direction, enhance process approach and risk-based thinking and execute appropriate, measurable and value adding KPIs at the product, process and system levels.
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