Clause 4.1 Understanding the Organization and its context
The organization should determine external and internal issues for the organization relevant to its purpose, strategic planning and which affect the organization’s ability to achieve its objectives. The Organization should monitor and review the information about external and internal issues. The organization must consider issues related to values, cultural knowledge, and performance of the organization for the understanding of internal issues. The organization must consider issues related to arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local for the understanding of external context. For considering internal context as well as external factors both positive as well as negative factors must be considered.
- How has the organization determined external and internal issues relevant to its purpose and strategic direction?
- How do these affect the ability to achieve the intended result of the QMS?
- How do you monitor and review information about these internal and external issues?
- Internal issues are all positive and negative factors related to values, culture, knowledge, and performance of the
- External issues are all positive and negative external factors arising from the legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local.
- An organization’s internal context is the internal environment within which the organization seeks to achieve its sustainability goals.
- Internal and external context can also be defined as anything within the organization that may influence the way in which the organization manages its internal and
- Once the internal and external context is understood, one can conduct the macro-environmental external analysis using “PEST” (political, economic, social, and technological) analysis. This analysis determines which factors are can influence how the organization operates. The organization cannot control these factors, but it must seek to adapt to them. The PEST factors can be classified as opportunities and threats in a SWOT (strengths, weaknesses, opportunities, and threats) analysis. Alternatively, you might use Porter’s “Five Forces Model.” These methods are used to review a strategy or position or direction of an organization. Completing a pest analysis is simple and helps the individuals involved in the organization to understand and find ways to deal with the context.
- The organization must periodically review(min once in six months) the internal and external issues.
Clause 4.2 Understanding the needs and expectations of interested parties.
The organization shall determine relevant interested parties and relevant requirements of relevant interested parties. Relevant interested parties to be considered are those that could affect or potentially affect the organization’s ability to constantly provide products and services that meet customer and applicable statutory and regulatory requirements. Monitor and review information related to interested parties and relevant requirements.
- How have you determined what interested parties are relevant to the QMS?
- How have you determined what requirements those parties have that are relevant to the QMS?
- How has an impact or potential impact been determined?
- Does the organization monitor and review the information about these interested parties and their relevant requirement?
- Firstly, the organization will need to determine external and internal issues that are relevant to its purpose?
- Next, the organization has to determine relevant interested parties and relevant requirements of relevant interested parties. An interested party is a person or organization that can affect, be affected by, or perceive themselves to be affected by a decision or activity that’s within the scope of the management system.
- The organization must periodically review(min once in six months) the requirements of the relevant interested parties
Clause 4.3. Determining the scope of the quality management system
The organization must establish the scope of the quality management system by determining the boundaries and applicability of the quality management system. While determining the scope the organization must consider the internal and external issues determined in 4.1., the requirements of relevant interested parties in 4.2. and the products and services of the organization. Requirements from these International standards that can be applied by the organization shall be applied within the scope of the QMS. Requirements from this International standard that cannot be applied by the organization and which does not affect the organization’s ability or responsibility to provide product and services that meet the conformity of its product and services and enhancement of the customer satisfaction. The organization must make available the scope and must maintain scope as documented information stating the Products and services covered by the QMS and any Justification where a requirement of this International Standard cannot be applied.
- Has the organization established the scope of its QMS?
- How have the boundaries and applicability of the QMS been used to establish the scope of the organization?
- Does the scope state the types of products and services covered?
- While determining the scope, has the organization determined the external and internal issues, requirements of relevant interested parties, products, and services of the organization?
- How has the application of the International Standard within the scope been determined, and how has it been applied by the organization?
- How have any requirements of the International Standard been determined as not applicable? Can you justify how instances of requirements of the QMS cannot be applied? Show me how the conformity of products and services is not affected by this.
- Where is the scope available? Where is it maintained as documented information?
1) To start, there are three considerations to be included when determining the scope:
- External and internal issues that are relevant to the purpose of the organization, the strategic direction, and the ability to achieve intended results
- Requirements of relevant interested parties
- The product and service of the organization
2) the scope is to include any requirements of the ISO 9001 standard that can be applied, and if a requirement is determined to not apply,
Clause 4.4 Quality management system and its processes
The organization must establish, implement, maintain and continually improve its quality management system as per the requirement of this standard by determining the process needed and its application throughout the organization. While determining the processes, the organization must determine the inputs required and the outputs expected from these processes, the sequence, and interaction of these processes, The organization must control these processes to ensure its effective operation. The organization must establish the criteria and methods which include monitoring, measurements, and other related performance indicators to ensure the effective operation and control of these processes. The organization must determine and ensure the availability of the resources needed for the effective operation of these processes. The personnel having authority and responsibilities for these processes must be identified. As per clause 6.1, the organization must determine risks and opportunities, analyze them, and must take appropriate action to address them. There must be methods for monitoring, measuring, as appropriate, and evaluating these processes. The organization must make changes in its process if it fails to achieve the intended result. The organization must look for opportunities for improvement of these processes and for Quality management system as a whole.
The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.
- How has the QMS been established? Show how this is implemented. How is it maintained and continually improved? How have the processes been determined and how do they interact?
- How have the processes been determined for the QMS?
- What are the inputs and outputs for those processes?
- What is the sequence and interaction of the processes?
- What are the criteria, methods, measurement and related performance indicators needed to operate and control those processes?
- What resources are needed and how are these made available?
- How are responsibilities and authorities assigned for those processes?
- How are risks and opportunities considered and what plans are made to implement actions to address them?
- What methods are used to monitor, measure and evaluate processes and, if needed, what changes are made to achieve intended results?
- How are opportunities to improve the processes and the QMS determined?
- What documented information exists to support the operation of processes? How is this documented information retained? How confidence that the processes are being carried out as planned determined?
- Clause 4.4.1 requires the ‘Process Approach’ to be used in defining your QMS. QMS processes including processes for operations, management(leadership) activities, Planning which includes risk assessment, support processes (such provision of resources, communication, etc), Operation, performance evaluation, and Improvement
- Based on these factors, you must determine what processes need to be documented and how you will document them. Not all processes need to be documented; your documents must also include a description of the interaction between your QMS processes.
- A number of different methods can be used to document processes, such as graphical representations, written instructions, checklists, flow charts, visual media, or electronic methods, etc.
- Process flowcharts or block diagrams can show how policies, objectives, influential factors, job functions, activities, material, equipment, resources, information, people and decision making interact and/or interrelate in a logical order.
- Procedures may be an acceptable way to document processes provided they describe inputs and outputs, appropriate responsibilities, controls, and resources needed to satisfy customer requirements.
- the organization shall have to ensure that adequate responsibilities and authorities are assigned
- when planning its QMS, the top management must implement and promote a culture of risk-based thinking throughout the organization
Documented Information if applicable
- Internal Issues
- External Issues
- PEST Format
- SWOT Format
- Poter’s 5 Forces
- Needs and expectations of Interested Parties
- Steps to derive the scope of the organization
- Process definition
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