Question

Company Name :

Describe your Products /Services :

In your Organization you have been assigned as a Process owner for implementing ISO 9001: 2015 in a new Premises for existing Products/Services or existing and new Products/Services.

1. How have you complied with the requirements of Clause No 4 ( Internal issues, External issues, Needs and expectations of Interested parties , Scope , QMS system and Processes) and Clause No 6 of ISO 9001:2015 with respect to your organization?   [Marks 3]
2. What tools and techniques have you used it ? [Marks 3]
3. What are the documents (only names ) that you can use to prove it ? [Marks 1]
4. Please give examples of 4 SIPOC processes from four different functions in your organization. [Marks 2]

1 Mark will be given for Presentation. Hence total marks is 10.

Note: Processes for Clause No 4.4 are covered in Question No 4. So you need not give process details again. However, you need to describe the process how your organization is complying with clause 4.4.

Tools can be SWOT analysis, Porter’s Five forces analysis, PESTLE Analysis, etc.

Wherever it is confidential, you need not provide that information. However please ensure that you are providing the necessary information to make it very clear. (For eg, if your supplier name for Pipes is confidential , then in the list of interested parties you can mention as Supplier of Pipes)

This assignment has to be submitted in PDF.

Answer 1

As per ISO 9000, the definition of Context of the Organization is “business environment“, “combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products, services and investments and interested Parties“. The note states that this concept of Context of Organization is equally applicable to Not for profit organization, public service organization and governmental organization. Also in normal language, this concept is also known as the business environment, organizational environment or ecosystem of an organization.

Introduction:

The implementation of QMS should be the strategic decision of the organization and is influenced by the context of the organization and the changes in that context. The changes in the context can be with respect to its specific objectives, the risks associated with its context and objectives, the needs and expectations of its customers and other relevant interested parties, the products and services it provides, the complexity of processes it employs and their interactions, the competence of persons within or working on behalf of the organization and its size and organizational structure. The context of an organization will include internal factors such as organizational culture and external factors such as the socio-economic conditions under which it operates. The scope of ISO DIS 9001:2015 states that an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and aims to enhance customer satisfaction.

Any interested party which is not relevant to the quality management system need not be considered and similarly, any requirement of the interested party not relevant to the quality management system need not be considered. Determining what is relevant or not relevant is dependent on whether or not it has an impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements or the organization’s aim to enhance customer satisfaction. The organization can decide to determine additional needs and expectations that will meet its quality objectives. However, it is at the organization’s discretion whether or not to accept additional requirements to satisfy interested parties beyond what is required by this Standard.

There is a new clause relating to the context of the organization,

Clause 4 Context of the organization

These clauses require the organization to determine the issues and requirements that can impact on the planning of the quality management system. Interested parties cannot go beyond the scope of ISO 9001. There is no requirement to go beyond interested parties that are relevant to the quality management system. Consider the impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements or the organization’s aim to enhance customer satisfaction. Organizations can go beyond the minimum requirements to determine additional needs and expectations for interested parties that would not be “relevant” at the discretion of the organization and should be clear in the quality management system. The “Context of Organization” clause has four sub-clauses ie

• Clause 4.1 Understanding the Organization and its context
• Clause 4.2 Understanding the needs and expectations of interested parties
• Clause 4.3 Determining the scope of the quality management system
• Clause 4.4 Quality management system and its processes

As per ISO 9000, the definition of Context of the Organization is “business environment“, “combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products, services and investments and interested Parties“. The note states that this concept of Context of Organization is equally applicable to Not for profit organization, public service organization and governmental organization. Also in normal language, this concept is also known as the business environment, organizational environment or ecosystem of an organization.

Introduction:

The implementation of QMS should be the strategic decision of the organization and is influenced by the context of the organization and the changes in that context. The changes in the context can be with respect to its specific objectives, the risks associated with its context and objectives, the needs and expectations of its customers and other relevant interested parties, the products and services it provides, the complexity of processes it employs and their interactions, the competence of persons within or working on behalf of the organization and its size and organizational structure. The context of an organization will include internal factors such as organizational culture and external factors such as the socio-economic conditions under which it operates. The scope of ISO DIS 9001:2015 states that an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and aims to enhance customer satisfaction.

Any interested party which is not relevant to the quality management system need not be considered and similarly, any requirement of the interested party not relevant to the quality management system need not be considered. Determining what is relevant or not relevant is dependent on whether or not it has an impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements or the organization’s aim to enhance customer satisfaction. The organization can decide to determine additional needs and expectations that will meet its quality objectives. However, it is at the organization’s discretion whether or not to accept additional requirements to satisfy interested parties beyond what is required by this Standard.

There is a new clause relating to the context of the organization,

Clause 4 Context of the organization

These clauses require the organization to determine the issues and requirements that can impact on the planning of the quality management system. Interested parties cannot go beyond the scope of ISO 9001. There is no requirement to go beyond interested parties that are relevant to the quality management system. Consider the impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements or the organization’s aim to enhance customer satisfaction. Organizations can go beyond the minimum requirements to determine additional needs and expectations for interested parties that would not be “relevant” at the discretion of the organization and should be clear in the quality management system. The “Context of Organization” clause has four sub-clauses ie

• Clause 4.1 Understanding the Organization and its context
• Clause 4.2 Understanding the needs and expectations of interested parties
• Clause 4.3 Determining the scope of the quality management system
• Clause 4.4 Quality management system and its processes

As per ISO 9000, the definition of Context of the Organization is “business environment“, “combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products, services and investments and interested Parties“. The note states that this concept of Context of Organization is equally applicable to Not for profit organization, public service organization and governmental organization. Also in normal language, this concept is also known as the business environment, organizational environment or ecosystem of an organization.

Introduction:

The implementation of QMS should be the strategic decision of the organization and is influenced by the context of the organization and the changes in that context. The changes in the context can be with respect to its specific objectives, the risks associated with its context and objectives, the needs and expectations of its customers and other relevant interested parties, the products and services it provides, the complexity of processes it employs and their interactions, the competence of persons within or working on behalf of the organization and its size and organizational structure. The context of an organization will include internal factors such as organizational culture and external factors such as the socio-economic conditions under which it operates. The scope of ISO DIS 9001:2015 states that an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and aims to enhance customer satisfaction.

Any interested party which is not relevant to the quality management system need not be considered and similarly, any requirement of the interested party not relevant to the quality management system need not be considered. Determining what is relevant or not relevant is dependent on whether or not it has an impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements or the organization’s aim to enhance customer satisfaction. The organization can decide to determine additional needs and expectations that will meet its quality objectives. However, it is at the organization’s discretion whether or not to accept additional requirements to satisfy interested parties beyond what is required by this Standard.

There is a new clause relating to the context of the organization,

Clause 4 Context of the organization

These clauses require the organization to determine the issues and requirements that can impact on the planning of the quality management system. Interested parties cannot go beyond the scope of ISO 9001. There is no requirement to go beyond interested parties that are relevant to the quality management system. Consider the impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements or the organization’s aim to enhance customer satisfaction. Organizations can go beyond the minimum requirements to determine additional needs and expectations for interested parties that would not be “relevant” at the discretion of the organization and should be clear in the quality management system. The “Context of Organization” clause has four sub-clauses ie

• Clause 4.1 Understanding the Organization and its context
• Clause 4.2 Understanding the needs and expectations of interested parties
• Clause 4.3 Determining the scope of the quality management system
• Clause 4.4 Quality management system and its processes

ISO 9001:2015 Clause 6 Planning

Key Requirements:

• Adding risk-based thinking and management to planning
• establishing quality objectives and how they will be achieved
• Planning actions when changes to the QMS are made
• Updating the QMS based on measuring ongoing effectiveness and any newly discovered risks or opportunities

Clause 6 Planning

Clause 6.1: Actions to Address Risks and Opportunities

A separate section named planning is new for the 2015 update of ISO 9001 (though planning is addressed in the ISO 9001:2008 standard in sections such as 8.5.3, 5.4.2 and 7.1), emphasizing planning as a key dictate in achieving and maintaining ISO 9001:2015 registration.

Building upon the need to include the influence of the wider elements of the organization (See Section 4: Context of the Organization ), planning now fully embraces the risk and opportunity management concept. This is to be implemented as a key activity to achieve quality goals on a continual basis, including an evaluation of the risk management process and a priority/scaling of when, how, where and to what level it should be applied.

• Learn more about ISO 9001:2015 Risk Management

Clause 6.2: Quality Objectives and Planning to Achieve Them

This subsection builds upon an accurate definition and plan to achieve specific quality objectives including:

• Being directly driven by the quality policy itself
• More accurate measuring, monitoring and updating
• Being applied to ensure product and service consistency and customer satisfaction
• Having a sufficiently wide scope to ensure quality performance success
• Specific quality objective documentation

There is to be a conscious approach to changing the QMS itself, using a controlled process that constantly considers the reason and impacts of the considered change, as well as how it may affect the level and allocation of resources and assignments

The standard requires taking the general concepts of planning into the operations realm by defining the needs associated with service or product provision, creating supportive processes, determining customer acceptance criteria and the needed assets to ensure compliance with quality standards.

• Learn more about Planning to Achieve Quality Objectives

Clause 6.3: Planning of Changes

When changes to the QMS are needed, they must be carried out in a planned manner. Examples of QMS changes include plans to transition from ISO 9001:2008 to 9001:2015 or make improvements to your existing QMS. Risks, resources needed, re-assignment of employee responsibility and the integrity of the QMS all need to be considered with developing plans for implementing changes.

Essential quality control tools: What are they?

If you are going to find ways to improve your QMS processes, you must first have data to understand how those processes are performing. Analyzing this data will, first of all, present you with areas that can be improved, and secondly, ongoing data collection will show you that improvement has actually happened after you take the necessary actions. The American Society of Quality (ASQ) recognizes seven essential quality control tools, and these are ideal for presenting data in an understandable way so that it can be analyzed for improvement. These tools are:

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1. Data tables – Data tables are a way to collect data in a tabulated format so that it can more easily be reviewed for trends. If you are tabulating defect type per supplier, it easily becomes visible which suppliers have which defects so that you can then work on improvement.
2. Pareto analysis – The Pareto diagram will take the data for many types of information, often different problems or defects, and present them in a graphical representation from highest frequency to lowest. This easily shows which problems occur most frequently, and you can quite simply tell which few defects comprise 80% of your problems.
3. Scatter diagrams – When using a scatter diagram, you compare two factors, such as defect quantity and time of day, to see if there is a correlation. In this example, if you have an increased number of defects at 1PM, right after lunch break, you can then further investigate the cause of this and fix it.
4. Trend analysis – Trend charts, also known as graphs or run charts, allow you to graphically plot data associated with a process over time against specification limits. These charts give the raw data to establish if there is evidence that a process might need investigation for improvement.
5. Histograms – Histograms plot the frequency of occurrence within data, converting a collection of data points into a distribution curve. Analyzing this curve can tell you if your process is functioning normally or not. If it is abnormal, then improvements might be needed.
6. Control charts – Control charts are an ongoing plotting of data for a process, and can indicate when the process outputs start to shift away from the expected measurements, and then allow for correction. They also will easily show if improvement activities have been effective, as there will be a sustained shift in the data after improvement work is done.
7. Cause and effect analysis – The cause and effect analysis, also called a fishbone diagram, is used mainly to investigate the cause of a problem or potential problem. With the problem in mind, you think through every possible cause on the six headings of machine, method, material, measurement, men/women, and environment. After tabulating all possible causes, you can then start to eliminate them until you come to the most likely cause, which can be corrected.

Essential supplementary quality control tools

In addition to the seven tools above, the ASQ also recognizes other supplemental QC tools, some of which are also useful in managing continual improvement activities within the QMS. The two that are the most useful for improvement activities are as follows:

• Process flowcharts and maps – When trying to understand a process in an effort to improve it, you will find it useful to map out how that process works in a flowchart. This will give you a step-by-step indication of what happens in the process, and by doing so, it can highlight where resources are wasted due to unnecessary steps. When the process flow is mapped out on the floor, it can even show where there is a waste due to excessive movement around the factory.
• Process improvement center – The process improvement center is a display board that incorporates many pieces of information to help employees and management understand the process. Some items commonly included are control charts, process flow charts, event logs, fishbone diagrams, and Pareto analysis. This gives everyone interested in the process one stop to see the current status of the process, and to be able to assess if there is an opportunity for improvement of the process, and if improvement activities are working as planned.

Are there other quality tools available?

In fact, there are many more tools that can be used within the process improvement activities of a company, and some have been talked about in previous blogs. For more information, see: ISO 9001 vs. Lean: How they compare and how they are different, and ISO 9001 vs. Six Sigma: How they compare and how they are different. These other, more complex tools that are within the function of quality management can be very helpful if you want to find the biggest benefit from your continual improvement activities, but many come with a cost.

However, it is important to remember that the application of quality tools to your continual improvement initiatives is completely up to you. No one can say, “You need to use Six Sigma to improve.” How you will ensure continual improvement within your organization is up to you to decide, and you have the choice to use quality tools within your improvement activities for the purpose that each serves. While many quality management tools can be useful on your path toward improvement of the QMS, it is your decision when and how you will use them. Find what is right for you to get the benefits you want from your QMS.

here are the mandatory records (note that records marked with * are only mandatory in cases when the relevant clause is not excluded):

• Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
• Records of training, skills, experience and qualifications (clause 7.2)
• Product/service requirements review records (clause 8.2.3.2)
• Record about design and development outputs review* (clause 8.3.2)
• Records about design and development inputs* (clause 8.3.3)
• Records of design and development controls* (clause 8.3.4)
• Records of design and development outputs *(clause 8.3.5)
• Design and development changes records* (clause 8.3.6)
• Characteristics of product to be produced and service to be provided (clause 8.5.1)
• Records about customer property (clause 8.5.3)
• Production/service provision change control records (clause 8.5.6)
• Record of conformity of product/service with acceptance criteria (clause 8.6)
• Record of nonconforming outputs (clause 8.7.2)
• Monitoring and measurement results (clause 9.1.1)
• Internal audit program (clause 9.2)
• Results of internal audits (clause 9.2)
• Results of the management review (clause 9.3)
• Results of corrective actions (clause 10.1)

What Is a SIPOC Model?

The Six Sigma methodology includes various stages, for instance, Define, Measure, Analyze, Improve, and Control. The short for Define [D], Measure [M], Analyze [A], Improve [I], and Control [C] is DMAIC. It is referred to as Six Sigma DMAIC.

Process management teams implement the SIPOC model during the ‘Measure’ stage of Six Sigma DMAIC, to determine relevant factors of process improvements before the work on a project starts.

The SIPOC model prompts teams to take into consideration crucial process elements, such as the suppliers [S] of the process, the necessary inputs [I] to the process, the different functions of the process [P], the expected outputs [O] from the process, and the customer [C] or the end-user, who receives the process outputs.  

A visual tool, SIPOC helps understand the entire process, from its start to the end. It offers valuable insights into areas where major issues persist. Problems can arise from the supplier’s end; they can be associated with input specifications or can be connected to processes and outputs not meeting customer requirements.

A SIPOC table, or a SIPOC diagram, presents an excellent opportunity for teams, the higher management, and all stakeholders to troubleshoot process-related issues, and accordingly, develop appropriate strategies for improvements.

Key Components of the SIPOC Model

Companies in the service industry usually follow the C [Customer] - O [Outputs] - P [Process] - I [Inputs] - S [Suppliers] approach. In the COPIS methodology, ‘Customers’ come first, and then, ‘Outputs’, ‘Process’, ‘Inputs’, and ‘Suppliers’.

This is because in the service sector, for example, restaurants, customers place their requirements first, and then they get the output (food), which gets facilitated by ‘Process’, ‘Inputs’, and ‘Suppliers’.

The manufacturing industry also implements the SIPOC model, but most organizations apply the P [Process] - O [Outputs] - C [Customers] - I [Inputs] - S [Suppliers] method. In the POCIS approach, ‘Process’ and ‘Outputs’ are the first two steps that generate requirements for ‘Customers’, supported by ‘Inputs’ and ‘Suppliers’.

Regardless of the mode of application, the key components of the SIPOC model - S [Suppliers] - I [Inputs] - P [Process] - O [Outputs] - C [Customers] - remain the same.

SIPOC Model Example

To prepare a SIPOC table, process teams must be capable of mapping the entire operation. They must be able to identify different elements of the process, including who the suppliers are, the inputs required for process execution, the final output, and the customer.

Here’s a simple SIPOC model example of a vehicle repair facility:

Supplier	Input	Process	Output	Customer
Repair kit suppliers Spare parts suppliers Original Equipment Manufacturer The vehicle owner Customer representative	Requisition for repair The vehicle for repair Work order to proceed Approved parts for repairs	Problem diagnosis Spare parts sourcing Performing repairs Service completion notification	Repair recommendation Cost estimates Delivery time and date Repaired vehicle Text message / email / Telephone to inform the customer	The vehicle owner Customer representative

When the SIPOC diagram is ready, process management teams should share it with all stakeholders for evaluation, rectification, and process improvements

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