ISO Navigator Pro™

Guidance for ISO 9001, ISO 14001 and ISO 45001

ISO Navigator Pro™ is a free tool that provides practical, expert guidance for businesses wishing to interpret the fundamentals of ISO 9000:2015 to help understand, and better implement, the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018. The free ISO Navigator Pro™ database divides the requirements into four iterative stages; Plan, Do, Check and Act.

Our range of ISO 9001:2015 quality manuals and integrated manual templates cover the requirements of ISO 14001:2015 and OHSAS 18001:2007, and offer an easy way to implement and document your organization's quality management system or integrated management system.

Process approach and PDCA

The process approach is promoted as one of the seven principles of successful quality management. The process approach and the iterative, four-step PDCA cycle are central themes in management system standards like ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018. ISO standards can be purchased and downloaded from their on-line store.

The plan, do, check, act (PDCA) cycle provides a methodology that assists with the development and implementation of a process orientated management system. The PDCA cycle should be applied to all functions, processes and levels within your organization.

The development of a quality management system, using ISO 9001:2015 as a framework, will enable any organization to identify and integrate the processes needed to achieve planned results (and achieve customer satisfaction), employ risk-based thinking to continually monitor risks and opportunities (cause and effect), and manage your processes and quality management system using the 'PDCA' cycle.

How to implement the process approach

Plan - Criteria & Methods

This is the 'Plan' part of the PDCA process. Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizational policies. This is often implemented using stated objectives, work instructions or procedures as required for consistent process output.

Process approach stage
Clauses and requirements
Stage 1 Identify external and internal issues relevant to the organization's operational and strategic direction and monitor and review these issues for change. 4.1 Understanding Context
Identify interested parties (stakeholders), their requirements, and their impact on the QMS. Monitor and review stakeholder requirements for change. 4.2 Interested Parties
Base the scope of the QMS on the external and internal issues - 4.1, stakeholder needs - 4.2, and the types of operational activity - 8.0. 4.3 Determining Scope
Define the QMS processes, their sequence and interaction, and the quality performance indicators as needed to monitor process performance. 4.4 Management System Processes
Stage 2 Demonstrate leadership by encouraging positive commitment and providing direction. Ensure processes exist to achieve customer satisfaction. 5.1 Leadership and Commitment
Ensure that any changes in context, or interested party requirements are reflected in the quality policy. 5.2 Policies
Develop an organization chart and job descriptions to define roles, responsibilities and authorities. 5.3 Roles, Responsibility and Authority
Stage 3 Risks and opportunities should be relevant your organization's context 4.1, and any interested parties 4.2. Integrate risk-based thinking into processes 4.4. 6.1 Address Risk and Opportunity
Establish quality objectives and targets, at each relevant function and level within the organization. 6.2 System Objectives and Planning
Identify risks and opportunities associated with change that could affect the QMS. Deploy plans to monitor the effectiveness of the QMS after change. 6.3 Planning for Change

Do - Support & Operations

This is the 'Do' part of the PDCA process. Ensure the availability of resources and information necessary to support the operation and monitoring of your processes. This may be through management review or other methods that define resource requirements.

Process approach stage
Clauses and requirements
Stage 4 Determine internal and external resources required for implementation, maintenance and improvement of the quality management system. 7.1 Resources
Establish and document levels of competence, and that ensure staff are competent by undertaking competency-based training. 7.2 Competence
Ensure all persons working under the remit of the QMS are fully briefed on aspects such as the quality policy, objectives, and the overall QMS. 7.3 Awareness
Undertake internal communication with employees, and external communication relating to the quality management system with relevant parties. 7.4 Communication
Retain documented information to demonstrate effective operation of the QMS. 7.5 Documented Information
Stage 5 Plan, implement and control operational processes, e.g. planning, engineering, operations, purchasing, delivery. 8.1 Operational Planning and Control
Establish arrangements to provide the customer with product information, enquiry handling and orders, and a method for handling customer comments. 8.2 Requirements for Products and Services
Implement and maintain a design and development process, appropriate to the types of products or services provided. 8.3 Design & Development of Products and Services
Ensure that externally provided processes, products or services meet quality requirements and monitor the performance of external providers. 8.4 Control of Externally Provided Products and Services
Control the manner by which your products are produced and services provided. This relates to clauses 5.2, 7.1, 7.2, 7.4 and 8.2. 8.5 Product and Service Provision
Ensure planned arrangements are completed prior to the release of the product or service. Verify that product and service requirements have been met. 8.6 Release of Products and Services
Identify products or services that do not conform to their intended requirements. Records of product non-conformity should be periodically reviewed. 8.7 Non-conforming Outputs
Outline the methodology for controlling emergency environmental situations. Periodically test emergency response plans where practicable. 8.8 Emergency Preparedness and Response
Outline the methodology for establishing processes for reporting and investigating all accidents, incidents and near misses. 8.9 Accident and Incident Investigation

Check - Monitor, Measure & Analyse

This is the 'Check' part of the PDCA process. Monitor, measure and analyse process performance. Monitor and measure processes and products against policies, objectives and requirements, and report the results. The methods employed and the timing of such analysis should be based upon priorities established by the organization.

Process approach stage
Clauses and requirements
Stage 6 Develop a process to identify, collect and analyze QMS performance data and information from both internal and external sources. 9.1 Monitoring, Measurement, Analysis and Evaluation
Implement an internal audit programme to collect and analyze customer and QMS data to ensure valid results and effective performance. 9.2 Internal Audit
Conduct management review meetings at planned intervals to ensure continuing quality management system effectiveness. 9.3 Management Review

Act - Implement Actions

This is the 'Act' part of the PDCA process. Implement the actions necessary to achieve the planned results, and for the continual improvement of those processes. Auditors will expect to see evidence that corrective action is taken when measurable objectives fall below target or a defined action level.

Process approach stage
Clauses and requirements
Stage 7 Ensure improvement is underpinned by meeting customer needs and enhancing satisfaction, improving products and services; including future demand and changing needs or expectations. 10.1 General
Any non-conformities and subsequent actions to prevent the reoccurrence and the effectiveness of the corrective action, must be documented and retained. 10.2 Non-Conformity and Corrective Action
Use the outputs from analysis and evaluation (9.1.3) and management review outputs (9.3.3) to drive improvement. Monitor improvement activities and the effectiveness of their results. 10.3 Continual Improvement

Free internal audit checklists

Check out our free internal audit checklists. The audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure your audits address the necessary requirements.

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