ISO 9001-Clause 4.1

1

4 Quality management system

Explanation:

The Quality Management System (QMS) is the means by which the organisation should be managed and controlled. How to do this is entirely up to the top management. However, the system should use processes to achieve this. Those processes consist of a balance between procedures and competencies. The current systems for control may already have much of the detail that is needed for the revised standard. There is an all embracing requirement to identify the processes, determine their interaction, and ensure that there is enough information to monitor them and to document them where they are needed to maintain control.
A process is described in the standard as a set of interrelated or interacting activities, which transform inputs into outputs. Put more simply they are those chains of activities that take place across an organisation and deliver the organisation’s products or services to either internal or external customers. Processes are what need to be done, which needs to do it and what is the result. Either procedures and/ or competencies will support processes. Procedures and other documents,work instructions etc. define how an activity is required to be done.In the past there has been a perception that the standard requires a detailed description of every activity undertaken by an organisation and this has led to cases of severe over documentation.A quality manual is needed. The standard allows flexibility in respect of its status and structure. It can be part of the overall system, and need only contain the scope of the QMS, processes and any related procedures. System processes need to be detailed. The standard requires control of documents and records per procedure.

ISO 9001-Clause 4.1
4.1 General requirements

ISO 9001 requirement:

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

The organization shall

  1. determine the processes needed for the quality management system and their application throughout the organization (see 1.2),
  2. determine the sequence and interaction of these processes,
  3. determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
  4. ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
  5. monitor, measure where applicable, and analyse these processes, and
  6. implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.
NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as

  1. the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements,
  2. the degree to which the control for the process is shared,
  3. the capability of achieving the necessary control through the application of 7.4.

Explanation:

The primary focus of clause 4.1 requirements is to manage and control all your QMS processes including product realization processes. QMS  includes processes for management activities, provision of resources, product realization, and measurement as part of QMS.  Clause 4.1 requires the ‘Process Approach’ to be used in defining your QMS.  Documentation of QMS processes and the need for and detail of specific process documentation is determined by  ISO 9001, customer, regulatory and your own organizational requirements, complexity of products and processes, effect on quality,risk of customer dissatisfaction, economic risk,effectiveness and efficiency, competence of personnel. Clause 4.2.1d requires you to have documents needed to ensure the effective planning, operation and control for QMS processes.  Based on these factors, you must determine what processes need to be documented and how you will document it. Not all processes need to be documented; however your quality manual must 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. Regardless of whether or not you document all of your processes, you must provide evidence of effective implementation of all your QMS processes. Such  evidence does not necessarily need to be documented.
Clause 4.1c requires you to determine criteria for effective process operation and control. You could determine criteria to control inputs, outputs and resources used. For example

      • Raw materials as an input to production would have acceptance criteria that it must meet before it can be used.
      • Finished product as an output of the production process must meet acceptance criteria before it can be shipped to the customer;
      • The equipment used to transform raw materials into finished product may have set-up and capability criteria or parameters that it must meet in order to produce conforming product.

These prevention based criteria (controls) must be established for each QMS process. Note that such controls may also come from the customer, regulatory or industry bodies. Equally important are the specific methods  required for effective operation and control of each process. These may include job travelers; work instructions; in process inspection sheet; specifications and drawings; SPC charts; set up checklist; machine manuals; etc. Note these control methods may apply to any or all of inputs, outputs or conversion activities.
Under 4.1d,  resources for QMS processes may include facility, material, equipment, labor, supplies, utilities etc. Every QMS process will require a different combination of resources. Resource details may be identified in specifications,production schedules, bill of materials, production travelers or routers, work instructions, etc. Information for QMS processes will vary from process to process and may include -production schedules, bill of materials, product acceptance and process performance criteria, production traveler or router, work instructions etc. Use clause 4.2.3 and other relevant clauses to control process information.
Clause 4.1e requires you to monitor and measure your QMS processes. Clause 8 provides requirements to plan and implement these controls for monitoring and measuring conformity to process performance criteria determined in 4.1c above. Ways to monitor and measure QMS processes may include – tracking against process parameters, goals and objectives, using tools and records such as process check-sheets; product acceptance criteria; SPC records; production records; maintenance records; labor records, etc. More details on monitoring and measuring controls are covered in clause 8.
Clause 4.1e requires analysis of QMS processes may be done through a review of measurement and monitoring records and performance indicators for each process. These reviews must identify opportunities to improve QMS processes, use of resources and product quality.
Under clause 4.1.f, when process nonconformities occur, then corrective action is required to bring the QMS process under control. Remember, the corrective action process is not just for product related nonconformities. Processes must be continually improved through setting of incrementally realistic, measurable objectives. Planning for continual improvement requires a review of process data, resources and controls to bring about the desired change.
Clause 4.1a – 4.1.f must be applied to all QMS processes. Note also that many ISO 9001 clauses (e.g. clause 7.2; 7.4; 7.6; etc.), require specific processes to be established within your QMS, These processes must also be identified and controlled in your QMS.
Make sure you include all outsourced processes affecting product quality, in the scope of your QMS. An outsourced process is any value-adding or conversion activity related to your product or service, that is performed by an external organization such as a subcontractor, sister facility, etc. Note that the external organization may perform the outsourced activity at their facility or yours. A manufacturing company may outsource welding, heat treatment or painting of product. A software company may outsource software development. A bank may outsource check clearing services. You must be able to demonstrate sufficient controls over outsourced processes to ensure that such processes are performed according to the relevant requirements of ISO 9001:2008. The nature and scope of such control will depend on the nature of the outsourced or subcontracted process and the risk involved.  Outsourced processes may be controlled in any number of ways, e.g., providing the vendor with product specifications; your supplier quality manual that they must meet; asking for inspection and test results or certificates of compliance; validation of outsourced process; conducting product and QMS audits of your vendor; etc. The expectation here is that you flow down to your vendor, the relevant ISO 9001 requirements that you would have to implement, had you performed the process at your own facility.
In systematically applying clause 4.1 requirements to each QMS process, we are intuitively using the PDCA approach to development of QMS processes.

PLAN will call upon sub-clauses 4.1.a – 4.1e as well as other applicable ISO 9001 clauses as shown above;
DO is required by 4.1.f as well as other applicable ISO 9001 clauses
CHECK is controlled by 4.1.e as well as other applicable ISO 9001 clauses;
ACT is governed by clause 4.1.e-f as well as clause 8.

Audit Checklist
  1. Does the QMS address all of the requirements within ISO 9001:2008?
  2. Is there evidence that the QMS has been improved over the past year?
  3. Have the processes of the business been identified? How have they been documented? Who developed/defined them? Are they reviewed?
  4. How do these processes connect or link to each other? Are outputs identified? Is it clear who the customer is of each process? The owner?
  5. How are the business processes monitored, measured and controlled?
  6. How are improvements identified for these processes?
  7. Are any of these processes (or sub-processes within them) outsourced to other organizations who carry them out? If so, how are they identified and how are they controlled? Have any outsourced processes been the root cause of problems either internal or external?

Mandatory Procedure: Not applicable
Mandatory record: Nor applicable
Process map or process flow chart( part of quality manual)

pdf Example of process flow chart

Evidence / Implementation document ( Not mandatory but helps in fulfillment of requirement): 

  • Different methods used to document processes: Quality manual, Graphical representations, written instructions, checklists, flow charts, visual media, or electronic methods. 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.
  • Methods for effective operation and control of processes: Process flowcharts, block diagrams, job travellers, work instructions, in process inspection sheet, specifications and drawings, SPC charts, set up checklist, machine manuals.
  • Resources for QMS processes may include – facility, material, equipment, labour, supplies, utilities,Resource details may be identified in specifications, production schedules, bill of materials, production travellers or routers, work instructions, etc.
  • Information for QMS processes will vary from process to process and may include – production schedules, bill of materials, product acceptance and process performance criteria, production traveller or router, work instructions,
  • Ways to monitor and measure QMS processes may include – tracking against process parameters, goals and objectives, using tools and records such as process check-sheets, product acceptance criteria, SPC records, production records, maintenance records, labour records, etc.
  • Outsourced processes may be controlled in any number of ways, e.g., providing the vendors with product specifications, your supplier quality manual that they must meet, asking for inspection and test results or certificates of compliance, validation of outsourced process, conducting product and QMS audits of your vendors, etc

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If you need assistance or have any doubt and need to ask any question  contact me at: preteshbiswas@gmail.com  or call at +971569882663. You can also contribute to this discussion and I shall be happy to publish them. Your comment and suggestion is also welcome.


2 Comments

  1. SEKAR.S says:

    Can you please share ISO 9001:2015 standard with clause by clause interpretations

    Sekar.S

  2. Inacio says:

    Dear all,
    Thanks your page have help me alot. Please help me with example if possible regarding to this:

    Clause 4.1c determine criteria for effective process operation and control.

    My Regards,

    Inácio

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Pretesh Biswas

Pretesh Biswas

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