Breda Kearney

Consultant Lead

Understanding the Process Approach per ISO 9001:2015

August 15, 2018

ISO 9001:2015 based Quality Management Systems (QMS) are composed of a series of processes which work together to enable the organization to achieve its intended results in line with its strategic direction. The processes describe how the business functions, or in other words, how the organization gets things done.

Process Definition:

A process is a series of inter-related activities which convert an input into an output.

Process Categories:

Processes can be categorized as being Core/Value Chain, Support or Management.

Core/Value Chain – Represent the organizations core functions and are responsible for generating financial revenue for the organization and delivering value to external customers. These processes are made up of the organizations core functions which provide products or services to its customers and may include Sales & Marketing and Production/Service related processes.

Support – Represent the organizations functions that provide resources and infrastructure needed to operate the processes. Support processes deliver value to internal customers. These processes typically consist of: Purchasing, Finance, Human Resources, IT, Maintenance, Facilities management

Management – Represent the organizations functions that plan, measure, monitor and control the organization. Management processes are needed to ensure that the organization runs effectively and efficiently. These processes typically consist of: Executive Management, Quality Management, Regulatory/Statutory Compliance

Process Mapping:

Mapping of each process, provides a high-level overview of how the entire organization operates and helps to identify inter-dependencies, communication channels, value adding activities, and potential bottlenecks in the organizations operations. There are several tools available for process mapping including but not limited to: Turtle Diagrams, Swim Lanes, SIPOC.

SIPOC is the ISO 9001:2015 referenced methodology:

The SIPOC acronym stands for:  Suppliers, Inputs, Process Activities, Outputs and Customers and can be illustrated as follows:

SIPOC diagram

Suppliers – Provide each of the process inputs. Suppliers can be external, for example a vendor will supply a raw material or internal, for example the sales process will supply the production process with the sales orders.

Inputs – Outline what is needed to operate the process

Examples of process inputs can include but are not limited to: Customer orders, Customer specifications/requirements, Regulatory/Statutory Requirements, Raw materials, Procedures and work instructions, Resource Requirements (e.g Competent personnel, Calibrated and maintained equipment, Financial Budget, Work environment)

Process Activities – Represent the sequence of steps that are used to convert the inputs to outputs.

Note: Activity steps provide a high-level overview of how the process works. Procedures and work instructions are used to describe how each activity step is performed and provide detailed instructions for how the process works. As a general guideline, the number of activity steps in a process is 6-7, up to a maximum of 10.   

Outputs – Outline what is created following completion of the activity steps.

Examples of process outputs can include but are not limited to: Product or Service, Records, Non-Conforming material, Updated schedules and plans

Note: An output from one process, can become an input to another process.

Customers – Defines who receives each of the outputs. Customers can be external, for example an external customer will receive the packed and shipped product or internal, for example warehousing will receive purchased materials.

Process Approach: What does ISO 9001:2015 Require?

For each process, ISO 9001:2015 requires organizations to:

  • Determine process inputs, outputs, sequence and interactions
  • Assign responsibility and authorities
  • Ensure that resources required to operate the process are available
  • Identify and address risks to the process achieving its intended results
  • Monitor and measure process performance and make changes if required
  • Identify and implement process improvement initiatives
  • Determine what procedures, work instructions etc are needed to describe how the work is performed
  • Determine what records are required

To learn more about the process approach as per ISO 9001:2015, we offer CQI and IRCA Certified public training courses on ISO 9001 Internal Auditor Training and ISO 9001 Lead Auditor Training which will give you a comprehensive understanding of the Process Approach and ISO 9001 Auditing.

 

 

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