Tag Archives: ISO 9001 consultants

Quality management system: The most important points we often neglect

Quality management is a management methodology. We often forget the basic management functions and principles, while adopting and implementing quality management system in an organization. Basic functions of management include goal setting, organizing, staffing, planning, coordinating, monitoring and controlling.

Quality Management system

Effective managerial leadership process also involves supervising and directing, motivating, problem solving and communicating with employees for ensuring that the company accomplishes the planned objectives and goals.

Planning and coordinating to ensure quality

The planning function creates process, activity and task schedules, along with resource allocation such as manpower as well as equipment, information and knowledge support, enabling the organization to operate successfully, for achieving its goals. What is often forgotten is the need to update and modify plans based on changes in customer requirements, changes in environment, progress in plan implementation and new constraints on resources?

The coordinating function has to interface with planning, organizing, as well as controlling functions, in line with goals of the organization which are driven by customer requirements. Coordinating is usually a weak link in the quality system and higher management must constantly monitor the coordination function.

Organizing and staffing

 Organizing involves allocating responsibilities and tasks to teams and individuals based on specific skill sets needed to complete the tasks. Agile organizations are able to respond fast to changing customer demands. Organizing also involves reporting and line of command. Organizing and staffing together involves complete talent management function involving sourcing and retention of talent and performance management. Non availability of the necessary skills in time can mean risks to the output of the processes and outcome of businesses. This aspect is normally neglected in quality system. Development of skills and monitoring of skill development could be a critical success factor for business organizations.

Motivating teams and involving people in improvement activities are other critical factors related to organizing and staffing.

Strategy for fulfilling quality objectives: role of ISO 9001 consultants

Organization’s strategic plans must take into account resources needed, including expertise, knowledge, updated information and skill requirements, and how to source the critical resources. Sourcing strategy for the critical resources is a major challenge for every organization. But this aspect is usually neglected and companies are often operating in the firefighting mode. ISO 9001 consultants can help you solve such issues and put in place the strategies for sourcing critical resources. 

Evaluating, Controlling and monitoring

The monitoring and controlling function acts as eye and ears of the management. This is to ensure that all the necessary functions of the business organization are operating as planned. Controls are exercised on the basis of process control criteria and other standards of performance and targets set for teams. Any deviations from control criteria must be investigated and risks to final outcome of the company must be evaluated. Measurement of process parameters and product and service characteristics must be utilized for statistical analysis to obtain trends of non-conformity. Impact of non-conformity on other related processes must be analyzed. Necessary corrective actions must be planned across the entire organization, so that learning action from failure can be initiated.

Based on the changes in customer expectations, as well as regulatory changes,   the process acceptance criteria must be changed and process owners trained on the new criteria.

Evaluating and controlling includes monitoring the status and measuring the attributes of a process as well as the output (product or service) and taking appropriate actions based on data and observations. Manager’s wakeup to the need to monitor only when there is a crisis.  If  process evaluation  is done even   when everything appears to be running smoothly, sales are growing along with profits, customers are happy,  then you are going to prevent an impending crisis due to customer complaints, by taking preventive actions.

Voice of the customer

 Top managements of the companies are unable to respond quickly to the changes in customer requirements and latest customer perceptions about company’s products and services. Employees as well as managers across the organization must listen directly to the voice of the customer. Changes in resources and processes required   to meet new expectations of customers and other interested parties, must be analyzed and evaluated. New strategic plans should incorporate necessary changes in processes and process criteria based on changes in customer needs. Risks and opportunities arising out of the voice of the customer must be assessed regularly.  Changes in market place occurring due to competitors coming up with new offerings of products and services need to be assessed.

Thus by following some of the management principles and functions, and listening to the voice of the customer, we can make the quality management system more effective.

Minimum Documented Information To Be Maintained For Achieving ISO 9001 Certification

Business organizations use documented information to train employees, for ensuring products and services produced are of consistent quality. It also provides evidence of compliance to various requirements.  As per clause 3.8.5 of ISO 9000 the minimum documented information required for achieving ISO 9001 certification is: a document can be based on magnetic, optical, electronic computer disc, a sample, a photograph or paper.

ISO 9001 Certification

According to requirements of ISO 9001:2015, the overall documented information to be maintained and retained will depend on the risk of nonconformity inherent in the processes or activities of a particular business organization.  Risk evaluation should include the likely impact of the risk, likelihood of non-conformity and interaction of the processes among one another as well as the type of controls required. (To maintain documented information means to have procedures, flowcharts as means of telling the methods and to retain documented information means records to be retained as evidence)

Minimum documented information to be maintained by the company is discussed below. (Based on the risk profile of the processes, products and services, more documented information may be required in many cases.)

Defining the scope of the QMS: role of ISO 9001 consultants

Scope should include details of the services, products and activities covered by Quality Management System. If some clauses of ISO 9001 cannot be applied to the company because of the nature of the business, the justification for excluding the requirements of relevant clauses should be furnished. ISO 9001 consultants can provide guidance on defining the scope and planning for documented information to be maintained. Scope will be part of documented information

QMS and its Process requirement (Clause 4.4.2A)

Documented information must be maintained as support for operation of the processes required for the QMS. Documented information may   cover

  • determination  of the  processes needed for the QMS,
  • process inputs, interaction  of processes  and   their  sequence,
  • how to address  risk of non-conformity, resource availability
  • process control and criteria for effective operation,
  • Evaluation and improvement of processes.

QUALITY POLICY (5.2.2)

Top management must establish and maintain Quality policy for the organization, which may be maintained as documented information.

QUALITY OBJECTIVES (6.2.1)

Organization must maintain the documented info about the quality objectives

Quality objectives will be a part of product/service realization planning and include:

  • What is to be achieved,
  • who will achieve it,
  • how to achieve it,
  • What are resources required and planned?
  • When will the objectives be achieved?
  • How will it be measured?

Thus status of attaining of quality objectives will be part of evaluation process.

Clause 7.5 explains that documented information to be maintained as support for operation of processes.

There is need to control all the documented information, but documented procedure is not mandatory. Control may include usage as well as the access of the information.

Claus 8.5.1   documented info for control of production processes and service provision

This is the basic Information that clarifies and defines product characteristics, and attributes of services, characteristics of activities and tasks to be performed, as well as the outputs as well as the results to be achieved.

Additional process specific documented info

Process specific documented information may be maintained separately by each process owner as support for individual activity, process or task, which could add value to QMS.

Such information could be in the form of

  • Flow charts,
  • Organization charts
  • Task  maps,
  • process  flow descriptions
  • work  Procedures
  • instructions
  • purchase Specifications
  • Departmental or corporate ( internal) communications
  • Operation  schedules
  • Authorized vendor lists
  • Test  plans
  • Detail  inspection plans
  • Quality control  plans
  • manuals
  • Strategic plans
  • Standard Forms

How is Systems Thinking as per ISO 9001 connected to Product Management?

Product management is a coordinating role that deals with design, planning, production, forecasting, marketing and sales of product during all stages of the product’s life cycle. As people and processes from different departments come together to form a product, so Systems Thinking as per ISO 9001 Quality management system which views the Organization as a combination of interacting processes which affect one another is a great tool to understand this complexity. The barriers across different departments have to be brought down to develop a product. Systems thinking greatly helps in achieving this objective.

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Don Norman says. “No product is an island. A product is more than the product. It is a cohesive, integrated set of experiences. Think through all of the stages of a product or service. Make them all work together seamlessly. That’s systems thinking.”

To develop a product, the product managers have to listen to the voice of the customer, the offerings of the competitors, technological change. The design team has its own considerations that take a product from a drawing to a prototype and a launch. Purchases have to be made and storage and production have to be organized and controlled. Selling of the product and market reaction and customer reaction have to be taken into account. How the customer experiences the product through its life cycle has to be observed. A television is more than a product, it is an experience and a family get together social phenomenon.

The product managers have to understand the eco-system in which a product exists, the peoples who shall interact with it and its life cycle. Product management is about working with and understanding, explaining and interpreting and fine tuning different sub-systems. Product management is about managing systems that become more complex and dynamic with evolution.

Systems thinking brings together all these discordant elements together in a whole and makes the different parts understandable to those dealing with product management. Product managers have to understand the whole of the product as well as its parts. Frequently, the design will change a component such as a processor of a Lap top or a hard drive or put in a screen with a new technology. Product management has to understand how the change in the part affects the whole and also the effect on the market response to the innovations and changes.

Systems thinking is important for Product Managers to fully understand the different stakeholders and other variables that affect the business of the product. How is the product discovered by the buyer, how is it purchased, first use, continued usage, returns and upgrades are functions handled by different parts of a company. But the product management is tasked with overseeing all these activities, and Systems thinking provides them with the tools to achieve them.

The Systems thinking is a great model for enabling Product management through product design, development, prototyping, development and launch. It is also used to understand competition or market reaction. ISO 9001 Consultants play an important role in creating awareness about Systems Thinking to their clients for its use in Product Development.