ISO Navigator Pro™

Guidance for ISO 9001 & 14001:2015 and ISO 45001:2018

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 ISO 45001:2018, 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 development of a quality management system, using the ISO 9001:2015 clauses as a framework, will enable any organization to identify and integrate the processes needed to achieve planned results (achieve customer satisfaction), employ risk-based thinking to continually monitor risks and opportunities (cause and effect), and manage your quality management system processes using 'PDCA'.

Applying the process approach to your management system

Plan - Context, leadership and planning

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.

As well as the quality management principles and the ISO 9001:2015 clauses, the guidance is also aligned to the requirements from 'Section 4.4 Quality management system and its processes'. The action summary outlines ways to comply, whist the links in the guidance column provide more detailed information on meeting each ISO 9001:2015 clause requirement.

ISO 9000:2015 principle
ISO 9001:2015 Base clause
Action summary
ISO 9001:2015 Clauses
Process approach and Relationship management 4.4.1 Processes (a, b, & c) Identify external and internal issues relevant to the organization's operational purpose and strategic direction. Monitor and review these issues for change. 4.1 Understanding Context
Identify interested parties (stakeholders), their requirements and their impact the management system. Monitor and review stakeholder requirements for change. 4.2 Interested Parties
Base the scope of the management system on the external and internal issues - 4.1, stakeholder needs - 4.2, and the types of operational activity that your organization undertakes - 8.0. 4.3 Determining Scope
Define the management system processes, their sequence and interaction, and the quality performance indicators needed to monitor process performance. 4.4 Management System Processes
Leadership and customer focus 4.4.1 Responsibilities (e) 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 commitments written in the management system policy. 5.2 Policies
Develop and communicate an organization chart and job descriptions to define roles, responsibilities and authorities. 5.3 Roles, Responsibility and Authority
Evidence-based decision making 4.4.1 Risks and opportunities (f) 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 management system (quality, environmental or OH&S) 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 management system. Deploy plans to monitor the effectiveness of the management system after change. 6.3 Planning for Change
 

Do - Support and 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.

ISO 9000:2015 principle
ISO 9001:2015 Base clause
Action summary
ISO 9001:2015 Clauses
Leadership 4.4.1 Resources (d) Determine internal and external resources required for implementation, maintenance and improvement of the quality management system. 7.1 Resources
Engagement of people 4.4.1 Resources (d) Establish and document levels of competence, and that ensure staff are competent by undertaking competency-based training. 7.2 Competence
Leadership 4.4.1 Resources (d) Ensure all persons working under the remit of the management system are fully briefed on aspects such as the policy, objectives, and the overall management system. 7.3 Awareness
Engagement of people and relationship management 4.4.1 Resources (d) Undertake internal communication with employees, and external communication relating to the quality management system with relevant parties. 7.4 Communication
Process approach 4.4.2 Processes (a & b) Create, update and retain documented information to demonstrate effective operation of the management system. 7.5 Documented Information
Process approach 4.4.1 Processes (a, b, c & d) Plan, implement and control operational processes that generate customer output, e.g. planning, engineering, operations, purchasing, warehousing, and delivery, etc. 8.1 Operational Planning and Control
Customer focus 4.4.1 Processes (a, b & c) 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
Customer focus 4.4.1 Processes (a, b & c) 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
Customer focus and relationship management 4.4.1 Risks and opportunities (f) 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
Customer focus 4.4.1 Processes (a, b & c) Control the manner by which your products are produced and services provided. This also relates to clauses 5.2, 7.1, 7.2, 7.4 and 8.2. 8.5 Product and Service Provision
Customer focus and Evidence based decision making 4.4.1 Processes (a, b & c) Ensure planned arrangements are completed prior to the release of the product or service. Verify that product or service requirements have been met. 8.6 Release of Products and Services
Customer focus and Improvement 4.4.1 Evaluate (g) 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
Improvement 4.4.1 Evaluate (g) Outline the methodology for controlling emergency environmental situations. Periodically test emergency response plans where practicable. N.B. ISO 14001 only. 8.8 Emergency Preparedness and Response
Improvement 4.4.1 Evaluate (g) Outline the methodology for establishing processes for reporting and investigating all accidents, incidents and near misses. N.B. ISO 45001 only. 8.9 Accident and Incident Investigation
 

Check - monitor, measure, analyse and evaluate

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.

ISO 9000:2015 principle
ISO 9001:2015 Base clause
Action summary
ISO 9001:2015 Clauses
Customer focus and Evidence based decision making 4.4.1 Evaluate (g) Develop a process to identify, collect and analyze management system performance data and information from both internal and external sources. 9.1 Monitoring, Measurement, Analysis and Evaluation
Evidence based decision making 4.4.1 Evaluate (g) Implement an internal audit programme to collect and analyze customer and management system data to ensure valid results and effective performance. 9.2 Internal Audit
Customer focus and Evidence based decision making 4.4.1 Evaluate (g) Conduct management review meetings at planned intervals to ensure continuing quality management system effectiveness. 9.3 Management Review
 
     

Act - implement improvement 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 and performance indicators fall below target or a pre-defined action level.

ISO 9000:2015 principle
ISO 9001:2015 Base clause
Action summary
ISO 9001:2015 Clauses
Improvement and customer focus 4.4.1 Improve (h) 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
Improvement and Evidence based decision making 4.4.1 Improve (h) 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
Improvement 4.4.1 Improve (h) 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
 

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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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