ISO 9001 GENERAL MANUFACTURING
Today’s competitive business environment has placed tremendous pressure on manufacturing companies to lower operating costs, address complex product design, outsource development and seek global expansion plans. Beyond this pressure there is a major opportunity for companies to build a competitive advantage through an integrated risk and compliance management approach, that ensures all features are working together effectively, enabling superior visibility into the value chain.
What is the significance of ISO 9001
Manufacturing processes and supply chain management that were once easy to handle is now much more complex. What used to be controlled and contained within the manufacturing plant is now monitored, run and maintained globally. Given this situation, building an effective risk and quality compliance system that conforms to management standards like ISO 9001 among others, is imperative for companies that want to work efficiently and win over smarter customers.
ISO 9001:2015 is one of the most significant updates in ISO standards. It affects almost every industry and their standards (AS9100D:2016, IATF 16949:2016, etc.) and every supplier. Instead of creating generic quality management systems that apply to all certified companies, ISO 9001:2015 takes a new approach about an Organization. Organizations are required to design their quality management systems based on the context (Industry) in which they operate. With more than 1 million organizations in more than 170 countries certified in ISO 9001, all encouraged to transition and upgrade their certificates to ISO 9001:2015 as soon as possible to meet the September 2018 deadline.
What are the considerations for ISO 9001
Recertifying to comply with ISO 9001:2015 might at first glance appear to be an overwhelming project. However, the new standards make workflow easier. ISO 9001:2015 matches quality management processes with the current business environment, taking technology, globalization, and other factors into consideration.
While ISO 9001:2015 is still based on the same seven quality principles, there is increased attention to the transformation of business methods over the past decade. ISO 9001:2015 changes the focus from documentation to managing processes with risk-based thinking. The new standards place heightened emphasis on the importance of formal risk analysis. Companies are now tasked with using risk analysis to identify management challenges in their business processes.
Source: ISO 9001:2015(en)-Clauses 4 to 10 grouped in relation to Plan-Do-Check-Act (PDCA) cycle.
ComplianceQuest – A 100% modern cloud Enterprise Quality & Compliance Management System (EQMS) goes above and beyond the requirements for ISO 9001:2015 while automating your entire quality management system requirements. CQ significantly reduces the effort involved in maintaining your ISO 9001:2015 Quality System by making the required processes to be automated while maintaining full traceability. In addition, it provides a complete view of your organization’s data concerning the performance and effectiveness of your quality and compliance management system.
ComplianceQuest – ISO 9001:2015 Compliance Chart
|4. Context of the Organization||4.1 Understanding the organization and its context||⦁ Internal / External Audit ⦁ Nonconformances ⦁ CAPA ⦁ Supplier Ratings / Scorecards ⦁ Dashboards & Reports||ComplianceQuest provides several solutions that help organizations capture, monitor and review information about both internal and external issues including performance of the organization, through reports, as well as suppliers with overall supplier ratings & scorecards.|
|4.2 Understanding the needs and expectations of interested parties||⦁ CQ EQMS Platform ⦁ Dashboards & Reports ⦁ Supplier Ratings / Scorecards||CQ EQMS platform provides the ability for all interested and accountable parties (internal or external) to participate in quality & compliance activities and to monitor these parties’ effectiveness and performance.|
|4.3 Determining the scope of the Quality Management System||⦁ CQ EQMS Platform||CQ EQMS Platform provides solutions to manage the scope and requirements of an organization’s quality management system.|
|4.4 Quality management system and its processes||⦁ CQ EQMS Platform ⦁ Dashboards & Reports ⦁ Document Management||CQ EQMS Platform provides solutions to meet the necessary processes throughout an organization including monitoring, resource competency, risk assessments, change control and document control to maintain documented information to support the operations of its processes.|
|5. Leadership||5.1 Leadership and commitment||⦁ CQ EQMS Platform ⦁ Audit ⦁ Supplier Portal ⦁ Customer Complaints ⦁ CAPA ⦁ Chatter, Collaboration ⦁ Dashboards & Reports||CQ EQMS Platform provides solutions that help Leadership with the oversight of their quality management system and processes embedded in their organization by: – monitoring internal and supplier audits findings; – insight into employee training competency and gaps; – using CAPA to monitor and execute plans for continuous improvement; – looking at trends in customer complaints to understand both product issues and customer satisfaction; -and general collaboration/communication tools, such as Chatter and Social Media, used throughout the organization along with applicable dashboards & reports.|
|5.2 Policy||⦁ Document Management ⦁ Training Management||ComplianceQuest provides a tightly integrated Document Management and Training solution to ensure that all quality and compliance documents are maintained and available with the latest revisions to applicable permissioned employees to sign off that they have read and understood the information.|
|5.3 Organization roles, responsibilities and authorities||⦁ CQ EQMS Platform ⦁ Dashboards & Reports||ComplianceQuest provides the ability for creating dashboards & reports about an organization’s operational performance based on key metrics.|
|6. Planning||6.1 Action to address risks and opportunities||⦁ CQ EQMS Platform ⦁ CAPA||ComplianceQuest provides risk assessments as part of its solutions to help organizations assess risk impact and provide the opportunity to mitigate them or initiate a change to adopt new practices.|
|6.2 Quality objectives and planning to achieve them||⦁ Dashboards & Reports ⦁ Document Management||ComplianceQuest provides the ability for an organization to create reports for its key metrics/measurements and provide on-going monitoring to give insight on whether the organization is meeting its quality objectives. All information about quality objectives can be maintained within the Document Management solution.|
|6.3 Planning of changes||⦁ Change Control||ComplianceQuest’s Change Control provides the ability to capture all the information for the change, identify the relevant tasks to be completed and assign the tasks to appropriate resources. Organizations can do a risk assessment on the impact and any potential consequences from the change.|
|7. Support||7.1 Resources||⦁ CQ EQMS Platform ⦁ Document Management ⦁ Equipment ⦁ Audit ⦁ Nonconformances ⦁ CAPA ⦁ Dashboards & Reports||ComplianceQuest provides several solutions to help an organization determine the resources needed to ensure that quality have valid and reliable results. CQ Equipment Management allows an organization to manage the schedule for equipment maintenance and allow the capture of equipment calibration output to determine their status and overall lifecycle performance. All information about equipment lifecycle and SOPs can be maintained within the Document Management solution. Results from internal audits or nonconformances and CAPAs can be easily shared to provide documented evidence on organizational knowledge. ComplianceQuest provides the ability for an organization to create reports for its key metrics/measurements and provide on-going monitoring to give insight on whether the organization is meeting its operational effectiveness.|
|7.2 Competence||⦁ Training ⦁ Document Management||ComplianceQuest provides a training management system for both job function and compliance whether classroom sessions, online/SCORM content or documents. All training is captured providing insight into an employee’s compliance for their role(s). Assessments/exams can be taken by the trainee to determine level of competency on the specific subject. Through tight integration with Document Management, Training can include SOPs whereby Trainees can easily read and sign off that they understand the document without or with Manager approval.|
|7.3 Awareness||⦁ Document Management ⦁ Training ⦁ Dashboards & Reports ⦁ Document Management||ComplianceQuest provides a complete platform for enterprise quality system. All records and documents can easily be accessed with the latest status and version to provide awareness of the quality system structure.|
|7.4 Communication||⦁ Chatter, Social Media||ComplianceQuest provides the ability to use latest technology in communication and collaboration through Salesforce “Chatter” for discussions and Social Media to easily follow certain records and chat and receive notifications when changes occur.|
|7.5 Documented information||⦁ Document Management||ComplianceQuest provides document management solution that enables an organization to create, collaborate, revise and maintain all controlled documents and can provide the latest version to appropriate permissioned users on any device anywhere, anytime.|
|8. Operation||8.1 Operational planning and control||⦁ CQ EQMS Platform ⦁ Document Management ⦁ Dashboards & Reports||ComplianceQuest provides an enterprise quality management platform that captures data concerning the processes and nonconformities of products and services. All documents about operational planning can be controlled and maintained in the Document Management solution. Trends can be easily monitored through Dashboards & Reports on all aspects of the quality system and operational controls.|
|8.2 Requirements for products and services||⦁ Complaints ⦁ Change Control ⦁ CAPA ⦁ Nonconformance ⦁ Document Management ⦁ Report and Dashboards||ComplianceQuest’s complaints management solution can capture inquiries, cases, and product quality issues and adverse events. Complaints can have active investigations to understand the problem and provide action plans for both the customer and product quality issue. Any issues that were derived from problems in the production process or a suppler part can be reviewed. Results of the review, can initiate Changes or CAPA actions to help resolve the issue and to improve the process for the future. All relevant documentation concerning changed requirements to product and services can be controlled and maintained in the Document Management solution. Trends can be easily monitored through Dashboards & Reports on aspects of the quality system status and customer complaints.|
|8.3 Design and development planning||⦁ Document Management ⦁ CAPA ⦁ Change Control||ComplianceQuest helps an organization document and maintain the latest information about a company’s product specifications and design controls. Any issues identified during reviews, verification, or validation activities can be escalated to a CAPA to take necessary action on the problem identified. Any changes identified during the design and development process can be managed through ComplianceQuest Change Control having the ability to capture all the information for the change, perform a risk impact assessment, identify the relevant tasks to be completed and assign the tasks to appropriate resources.|
|8.4 Control of externally provided processes, products and services||⦁ Supplier Management||ComplianceQuest provides an organization a complete set of solutions for managing Suppliers including supplier evaluation and selection, supplier audit, approved supplier list, receiving inspections, supplier corrective action (SCAR), supplier portal for document exchange and supplier ratings/scorecard for monitoring a supplier’s quality performance.|
|8.5 Production and service provision||⦁ Document Management ⦁ Inspections ⦁ Training ⦁ CAPA ⦁ Complaints ⦁ Change Control ⦁ Dashboards & Reports||ComplianceQuest helps an organization document and maintain the latest information about a company’s product specification/characteristics. Inspections can be performed at appropriate stages to verify that the criteria for the product have been met. Training management will ensure that only qualified operators are performing the operation of processes. On-going monitoring can be performed, and any problems identified in the reports about production can be escalated to a CAPA to prevent recurrence. Complaints can enable organizations to quickly respond to a customer and help escalate any customer disposition to applicable ERP system. Change Control enables any identified problem from CAPA and Complaints to go through a formal review and control of any changes for production.|
|8.6 Release of products and services||⦁ Document Management||Companies can maintain a system of record for as-built BOMs, DHRs, EBRs and other Batch/Product Release information in the Document Management system providing evidence of the resulting review and authorization of release.|
|8.7 Control of nonconforming outputs||⦁ Nonconformances||ComplianceQuest Nonconformance solution enables organizations to streamline recording and management of all types of quality events from single or multiple sites in one centralized system. Organization can quickly triage and perform risk assessment impact of all quality events and instances of nonconformance. When a quality event or a nonconformance is determined to impact production, organizations can document and enforce containment activities related to lots, units and batches. Enforcement of containment activities ensures that nonconforming material is controlled and prevented from improper usage.|
|9. Performance evaluation||9.1 Monitoring, measurement, analysis and evaluation||⦁ CQ EQMS Platform ⦁ Dashboards & Reports||ComplianceQuest provides Dashboards & Reports for a company to fully monitor quality processes across its organization based on key company metrics/goals, regulatory requirements and customer satisfaction.|
|9.2 Internal Audit||⦁ Audit management software||ComplianceQuest’s Audit solution allows for audits to be planned and scheduled. Auditors can take notes and categorize findings from any device during an Audit. Auditors can perform a risk assessment on the findings during the audit to understand its impact and initiate escalation to a CAPA if needed. The final detailed Audit Report can be generated based on templates and the information entered into the Audit solution. Final audit report can be routed for approvals and then issued to the auditee. Auditees receive notification that findings require relevant responses including the action to be taken as part of the response.|
|9.3 Management Review||⦁ CQ EQMS Platform ⦁ Dashboards & Reports||ComplianceQuest provides the ability to run and schedule reports about different aspects of the processes and operations of quality system for management reviews.|
|10. Improvement||10.1 General||⦁ CQ EQMS Platform ⦁ CAPA ⦁ Change ⦁ Dashboards & Reports||ComplianceQuest provides a comprehensive suite of quality and compliance solutions along with reports to help companies determine opportunities for improvement. Both CAPA and Change Control provide the organization to identify and track correcting, preventing or reducing issues while implementing plans for continuous improvement and effectiveness checks.|
|10.2 Nonconformity and corrective action||⦁ Non-conformance ⦁ CAPA||ComplianceQuest Nonconformance solution enables organizations to streamline recording and management of all types of nonconformances. Organization can quickly triage and perform risk assessment impact of all instances of nonconformance as well as determine if similar nonconformities exist. Any nonconformances can be escalated to a CAPA to take necessary action on the problem identified. Any changes identified can be managed through Change Control having the ability to capture all the information for the change, perform a risk impact assessment, identify the relevant tasks to be completed and assign the tasks to appropriate resources.|
|10.3 Continual improvement||⦁ CQ EQMS Platform ⦁ Dashboards & Reports||ComplianceQuest provides on-going monitoring of quality trends across the organization allowing management to have a 360-degree view of the status of their quality and compliance across the entire company.|