This structured approach, outlined in the table below, ensures that organizations not only comply with ISO 9001 but also drive continuous improvement:
ISO Clause | Clause (Sub)Title | Requirement | Outputs |
4.1 | Understanding the organization and its context | Determine external and internal issues relevant to its purpose and strategic direction. | Context analysis report, SWOT analysis, PESTLE analysis. |
4.2 | Understanding the needs and expectations of interested parties | Determine relevant interested parties and their requirements. | Stakeholder analysis report, register of interested parties. |
4.3 | Determining the scope of the quality management system | Establish the boundaries and applicability of the QMS. | Scope statement, documented scope of QMS. |
4.4 | Quality management system and its processes | Determine processes, interactions, and criteria for effective operation. | Process maps, documented procedures, process interactions chart. |
5.1 | Leadership and commitment | Demonstrate leadership and commitment to the QMS. | Leadership statement, meeting minutes, management review records. |
5.2 | Quality policy | Establish, implement, and maintain a quality policy. | Approved quality policy, communication records. |
5.3 | Organizational roles, responsibilities, and authorities | Assign and communicate responsibilities and authorities. | Organizational chart, job descriptions, responsibility matrix. |
6.1 | Actions to address risks and opportunities | Determine and take actions to address risks and opportunities. | Risk assessment report, risk register, mitigation plan. |
6.2 | Quality objectives and planning to achieve them | Establish measurable quality objectives. | Documented quality objectives, monitoring reports, action plans. |
6.3 | Planning of changes | Consider the impact of changes on the QMS. | Change management records, impact assessment report. |
7.1.3 | Infrastructure | Determine and provide the necessary infrastructure. | Maintenance records, infrastructure register, investment plan. |
7.1.4 | Environment for the operation of processes | Provide a suitable environment for QMS processes. | Workplace condition assessment, employee surveys, compliance reports. |
7.2 | Competence | Ensure necessary competence of personnel. | Training records, competency matrix, qualification records. |
7.3 | Awareness | Ensure employees are aware of the QMS requirements and their role. | Awareness training records, induction program materials. |
7.4 | Communication | Ensure effective internal and external communication. | Communication plan, records of meetings, internal memos. |
7.5 | Documented information | Create, update, and control documented information. | Document control procedure, document register, controlled documents. |
8.1 | Operational planning and control | Plan and implement processes to meet requirements. | Operational plans, work instructions, standard operating procedures (SOPs). |
8.2 | Requirements for products and services | Ensure customer requirements are met. | Customer requirement specifications, contract review records. |
8.3 | Design and development of products and services | Implement a controlled design and development process. | Design plans, review records, verification & validation reports. |
8.4 | Control of externally provided processes, products, and services | Ensure that external providers meet specified requirements. | Supplier evaluation records, contracts, purchase orders. |
8.5 | Production and service provision | Control production and service operations. | Production schedules, process control records, inspection reports. |
8.6 | Release of products and services | Implement controlled release processes. | Inspection and test records, acceptance criteria, release approvals. |
8.7 | Control of nonconforming outputs | Manage nonconformities to prevent unintended use. | Nonconformance reports, corrective action records, rework logs. |
9.1 | Monitoring, measurement, analysis, and evaluation | Determine and apply monitoring and measurement processes. | Performance reports, audit results, KPI dashboards. |
9.2 | Internal audit | Conduct internal audits at planned intervals. | Internal audit schedule, audit reports, nonconformity logs. |
9.3 | Management review | Top management shall review the QMS at planned intervals. | Management review minutes, action plans, performance trends. |
10.1 | Improvement | Identify and implement improvement opportunities. | Continual improvement reports, lessons learned, best practices documentation. |
10.2 | Nonconformity and corrective action | Take corrective actions to eliminate nonconformities. | Corrective action reports, root cause analysis, effectiveness reviews. |
10.3 | Continual improvement | Continually improve the QMS. | Improvement initiatives, innovation projects, process enhancement plans. |
By following this structured approach and maintaining these key outputs, businesses can ensure compliance with ISO 9001:2015 while continuously improving quality, customer satisfaction, and overall operational efficiency
Comments