Management system guidance

Process approach

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The process approach and the PDCA cycle

PDCA Cycle

The process approach and the iterative, four-step plan-do-check-act (PDCA) cycle, also known as the Deming Cycle, are central themes in management system standards like ISO 9001:2015, 14001:2015 and 45001:2018.

The process approach is promoted as one of the seven principles of successful quality management. ISO standards can be purchased and downloaded from their on-line store.

Key benefits of the process approach

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.

Use the process approach, coupled with the PDCA cycle and risk-based thinking, to align and integrate your management system with the requirements of the standards. The plan, do, check, act (PDCA) cycle provides a methodology to develop and implement process orientated management systems. The PDCA cycle should be applied to all functions, processes and levels within your organization.

ISO 9001:2015 Process approach

For an organization to function effectively, it has to identify and manage a number of linked activities. All activities use resources (e.g. people, plant, equipment) to transform a process inputs into a process outputs (products). The output of one process is often the input of the next process.

The quality management system (QMS) should be regarded as an inclusive system that describes your business and provides you with useful information (e.g. data analysis), rather than some strange, set of books that the Quality Manager runs exclusively for the benefit of the Certification Body.

ISO 9001:2015 includes specific requirements necessary for the adoption of processes when developing, implementing and improving a management system. This requires your organization to systematically define and manage processes and their interactions so as to achieve the intended results in accordance with both the policy and strategic direction. Certification Auditors will want to determine:

  1. How well is the ‘process approach’ understood in your organization?
  2. Is the quality management system in line with your organization’s context, and requirements of interested parties?
  3. Is it likely the established management system will achieve its intended outcomes and enhance quality performance?
  4. Does it include the enhancement of quality management system performance?
  5. Does it include the desire to fulfil of compliance obligations and objectives?

Some documented information can be used to verify that your organization has implemented all required management system processes. If these are working well for your organization then there is no need to replace them.

Existing operational procedures, turtle diagrams, work instructions, process maps and flow charts are valid examples of documented information and can be used to evidence the requirement for ‘documented information to support the operation of processes is being met’.

Check that process inputs and outputs are defined and review how each of the processes are sequenced and how they interact. Click here if you want to read more about the benefits of turtle diagrams and process maps. Look for evidence that your organization has:

  1. Assigned duties/process owners; (Clause 5.3)
  2. Assessed risks and opportunities; (Clause 6.1)
  3. Provided resources; (Clause 7.1)
  4. Maintained and retained documented information. (Clause 7.5.1)
  5. Implemented measurement criteria; (Clause 9.0)
  6. Improved the management system and its processes; (Clause 10.3)

Your organization should begin using quality performance indicators to control and monitor issues, and associated risks and opportunities. These types of objective evidence will indicate that your organization has successfully integrated the quality processes into its business processes.

Evidence may include management reviewing KPI’s as part of regular business reviews, awareness of contractors and employees of QMS goals and expectations, etc.

How to apply the process approach to your management system

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

The management system requirements are divided into four sequential stages; Plan, Do, Check, Act. Each stage is linked to the underlying ISO 9000:2015 quality principle and the related ISO 9001:2015 clauses to explain them in plain English with practical guidance. The action summary outlines ways to comply, whist the links in the guidance column provide more detailed information on meeting each requirement.

Planning - Context, leadership and management system 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.

ISO 9000 Principles ISO 9001 Base Clauses Action & Compliance Summary ISO 9001 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
 

Doing - 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 Principles ISO 9001 Base Clauses Action & Compliance Summary ISO 9001 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
 

Checking - monitoring, measuring, analysing and evaluating

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 Principles ISO 9001 Base Clauses Action & Compliance Summary ISO 9001 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
 
                  

Acting - implementing 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 Principles ISO 9001 Base Clauses Action & Compliance Summary ISO 9001 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
 

More information on quality management principles

Customer focus Meeting customer requirements and exceeding expectations
Leadership Establishing strategic direction and operational purpose
Engagement of people Training, knowledge, competence, and empowerment
Improvement Innovation, opportunities, root cause analysis, and ability to react to change
Evidence‐based decision making Data analysis, process performance assessment, and risk-based thinking
Relationship management Maintaining relationships with intertested and providers in the supply chain
 

More information on PDCA

Planning

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
4.1 Organizational Context 4.1 Organizational Context 4.1 Organizational Context
4.2 Relevant Interested Parties 4.2 Relevant Interested Parties 4.2 Relevant Interested Parties
4.3 Management System Scope 4.3 Management System Scope 4.3 Management System Scope
4.4 QMS Processes 4.4 EMS Processes 4.4 OH&S Management System
 
ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
5.1 Leadership & Commitment 5.1 Leadership & Commitment 5.1 Leadership & Commitment
5.2 Quality Policy 5.2 Environmental Policy 5.2 OH&S Policy
5.3 Roles, Responsibilities/Authorities 5.3 Roles, Responsibilities/Authorities 5.3 Roles, Responsibilities/Authorities
    5.4 Consultation & Participation
 
ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
6.1.1 Address Risks & Opportunities 6.1.1 Address Risks & Opportunities 6.1.1 Address Risks & Opportunities
6.2.1 Quality Objectives 6.1.2 Environmental Aspects 6.1.2 Hazard Identifcation
6.2.2 Planning to Achieve Objectives 6.1.3 Compliance Obligations 6.1.3 Legal & Other Requirements
6.3 Planning for Change 6.1.4 Planning Action 6.1.4 Planning Action
  6.2.1 Environmental Objectives 6.2.1 OH&S Objectives
  6.2.2 Planning to Achieve Objectives 6.2.2 Planning to Achieve Objectives
 

Doing

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
7.1.1 Resources - General
7.1 Resources 7.1 Resources
7.1.2 People 7.2 Competence 7.2 Competence
7.1.3 Infrastructure
7.3 Awareness 7.3 Awareness
7.1.4 Operational Environment 7.4.1 Communcation - General 7.4.1 Communcation - General
7.1.5 Monitoring & Measuring 7.4.2 Internal Communcation 7.4.2 Internal Communcation
7.1.6 Organizational Knowledge 7.4.3 External Communcation 7.4.3 External Communcation
7.2 Competence 7.5 Documented Information 7.5 Documented Information
7.3 Awareness    
7.4 Communcation    
7.5 Documented Information    
 
ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
8.1 Operational Planning & Control
8.1 Operational Planning & Control 8.1.1 General
8.2.1 Customer Communication 8.2 Emergency Preparedness 8.1.2 Eliminating Hazards
8.2.2 Determining Requirements
  8.1.3 Management of Change
8.2.3 Reviewing Requirements   8.1.4 Outsourcing
8.2.4 Changes in Requirements
  8.2 Emergency Preparedness
8.3.1 Design Development - General    
8.3.2 Design Development - Planning
   
8.3.3 Design Development - Inputs    
8.3.4 Design Development - Controls    
8.3.5 Design Development - Outputs    
8.3.6 Design Development - Changes    
8.4.1 External Processes - General    
8.4.2 Purchasing Controls    
8.4.3 Purchasing Information    
8.5.1 Production & Service Provision    
8.5.2 Identification & Traceability    
8.5.3 3rd Party Property    
8.5.4 Preservation    
8.5.5 Post-delivery Activities    
8.5.6 Control of Changes    
8.6 Release of Products & Services    
8.7 Nonconforming Outputs    
 

Checking

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
9.1.1 Performance Evaluation 9.1.1 Performance Evaluation 9.1.1 Performance Evaluation
9.1.2 Customer Satisfaction 9.1.2 Evaluation of Compliance 9.1.2 Evaluation of Compliance
9.1.3 Analysis & Evaluation 9.2 Internal Audit 9.2 Internal Audit
9.2 Internal Audit 9.3 Management Review 9.3 Management Review
9.3 Management Review    
 

Acting

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
10.1 Improvement - General 10.1 Improvement - General 10.1 Improvement - General
10.2 Nonconformity & Corrective Action 10.2 Nonconformity & Corrective Action 10.2 Incident, Nonconformity & Corrective Action
10.3 Continual Improvement 10.3 Continual Improvement 10.3 Continual Improvement
 

How to apply the latest quality management principles

The latest and current quality management principles (QMPs), stated in ISO 9000:2015, are intended to provide the foundation by which any organization can continually improve its performance.

You can learn to apply the latest quality management principles in the context of your business's own particular operations by reviewing and documenting its activities in the context of each quality management principle.

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