INCREASING THE POWER OF YOUR QMS – ACHIEVE PERFORMANCE EXCELLENCE THROUGH CONTINUAL IMPROVEMENT

K. R. Singhal

Hariharan Jairam once writes in the ‘Quality World’ – “Quality! Call it a concept, an approach, a way of life, a tool for achievement or merely a word. Whatever definition you give or whatever approach you take, this subject has made people think and think in a big way.” Girdhar J. Gyani says, “Quality today has many dimensions. Gone are the days when quality was identified with product alone.” Dr. R. H. G. Rau opines, “Management of quality is not a one-shot affair. It covers all transactions. Continuous creation of value addition is possible only when we manage change; that too proactively.” Continuous creation of value addition has now become the expectation of consumers. Presently ‘constant’ quality is no longer good enough and ‘continual improvement’ is needed.

There is a need of continual improvement in the effectiveness of the quality management system because:
- ‘Continual improvement’ is needed by customers because of their changing expectations
- ‘Continual improvement’ is one of the quality management principles on which your quality management system is based
- ‘Continual improvement’ is one of the requirements of ISO 9001:2008 QMS Standard and you are required to comply with it. Organizations, implementing ISO 9001:2008 QMS, must understand that continual improvement is a must requirement of the Standard.

‘Continual improvement’ is a recurring (step-by-step) activity followed by: (i) identifying opportunities for improvement and their justification, (ii) deciding how to improve on the available resources, and (iii) implementing (carrying out) improvement.

We need to improve the effectiveness of the quality management system, but how can we do such improvement, that’s a relevant question. In this regard ISO 9001:2008 QMS Standard mentions use of quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review to continually improve the effectiveness of the quality management system. Clause 8.5 of the ISO 9001:2008 QMS Standard specially deals with the requirements for improvement. Continual improvement is a defined requirement of the Standard. (Clause 8.5.1)

If you wish to improve the power of your quality management system, achieve performance excellence through continual improvement.

General requirements (Clause 4.1) of ISO 9001:2008 QMS Standard stipulate that the organization must continually improve the effectiveness of its QMS in accordance with the requirements of the Standard. The Standard also stipulates to ensure top management to include a commitment to comply with requirements and continually improve the effectiveness of the quality management system. (Clause 5.3)

Clause 5.5.2 of ISO 9001:2008 stipulates responsibility and authority of the management representative to report to the top management on the performance of the quality management system and any need for improvement. The requirements for management review (Clause 5.6.1) stipulate that management review must include assessing opportunities for improvement and need for changes to the quality management system, including the quality policy and quality objectives. Review input requirements (Clause 5.6.2) include information on recommendations for improvement. Review output requirements (Clause 5.6.3) include any decisions and actions related to improvement of the following:
- the effectiveness of the quality management system,
- the effectiveness of the processes, and
- product related to customer requirements.

ISO 9001:2008 QMS Standard takes care to determine and provide resources needed to continually improve the effectiveness of the quality management system. (Clause 6.1) The Standard also stipulates the requirements (Clause 8.1) for the organization to plan and implement monitoring, measurement, analysis and improvement processes. This is required to demonstrate conformity of the product, to ensure conformity of the quality management system and to continually improve the effectiveness of the quality management system.

Clause 8.5 of ISO 9001:2008 Standard specially deals with requirements for improvement. Continual improvement is a defined requirement of the standard (Clause 8.5.1). Accordingly, the organization is required to improve the effectiveness of the quality management system through the use of quality policy, quality objectives, audit results, analysis of data, corrective action, preventive action and management review.

Use of Quality Policy and Quality Objectives: Quality policy must include a commitment to comply with requirements and continually improve the effectiveness of the quality management system. It must also provide a framework for establishing and reviewing quality objectives. Quality objectives must be measurable and consistent with the quality policy of the organization. The organization must also ensure to review quality policy for continuing suitability. Framework for reviewing provides a way for improvement as review include assessing opportunities for changes to the quality management system, including quality policy and quality objectives. (Relevant Clauses of ISO 9001:2008 QMS Standard – 5.3, 5.4.1, 8.5.1)

Use of audit results: QMS audit is a systematic process and conducted at defined intervals. Audit evidences are input to QMS audit process and audit results are its output. Audit results become the input to management review process, which provides opportunities for improvement. When any nonconformity are detected during QMS audit, ISO 9001:2008 QMS Standard requires to eliminate such nonconformities and their causes. (Relevant Clauses of ISO 9001:2008 QMS Standard – 5.6.2, 8.2.2, 8.5.1)

Use of analysis of data: One purpose of analysis of data is to evaluate where continual improvement in the quality management system can be made. The organization is required to determine, collect and analyze appropriate data relating to customer satisfaction, conformity to product requirements, characteristics and trends of processes and products (including opportunities for preventive action), and suppliers. Analysis of data helps organization to solve problems and also helps to improve effectiveness and efficiency. Analysis of data can help organizations to determine the root cause of existing and potential problems, and therefore guide decisions about corrective and preventive actions needed for improvement. (Relevant Clauses of ISO 9001:2008 QMS Standard – 8.4, 8.5.1)

Use of corrective action: ISO 9001:2008 QMS Standard requires to take action eliminate the causes of nonconformities in order to prevent recurrence. Corrective action is a major tool in the quality management system to achieve improvement. It should be noted that corrective action is agenda item for management review. (Relevant Clauses of ISO 9001:2008 QMS Standard – 8.5.1, 8.5.2)

Use of preventive action: ISO 9001:2008 QMS Standard requires to take action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive action is a major improvement tool in the quality management system. (Relevant Clauses of ISO 9001:2008 QMS Standard – 8.5.1, 8.5.3)

Use of management review: Management review is conducted at defined intervals to ensure continuing suitability, adequacy and effectiveness of the quality management system. Management review includes assessing opportunities for improvement and need for changes to the quality management system. Output to management review to include any decisions and actions relating to – (i) improvement of the effectiveness of the quality management system, (ii) improvement of the effectiveness of the processes of the organization, (iii) improvement of product related to customer requirements, and (iv) resources needs of the organization. (Relevant Clauses of ISO 9001:2008 QMS Standard – 5.6, 8.5.1)

ISO 9000:2005, Quality management systems – Fundamental and vocabulary, identifies eight quality management principles to be used by the top management of the organization in order to lead the organization towards improved performance. Among eight principles stated in this fundamentals and vocabulary standard, continual improvement is one of the quality management principles. It states that continual improvement of the organization’s overall performance should be a permanent objective of the organization.

What is the aim of continual improvement? ISO 9000:2005 provides the answer. According to Clause 2.9 of ISO 9000:2005, the aim of continual improvement of the quality management system is to increase the probability of enhancing customer satisfaction and also satisfaction of other interested parties. Following actions are needed for improvement:
- Identifying areas of improvement through analysis and evaluation of the existing situation
- Establishing objectives for improvement
- Searching for and evaluating possible solutions to achieve the objectives
- Making a selection from the possible solutions and implementing the selected solution
- Measuring, verifying, analyzing and evaluating results of the implementation to determine whether the objectives have been met, and
- Formalizing changes

Results should be reviewed to determine further opportunities for improvement. Accordingly, improvement is a continual activity to be undertaken by the organization and the top management has the important role to play in this regard. To identify opportunities for improvement, following actions may be useful:
- Obtaining feedback from customers and other interested parties
- Audit results, and
- Review of the quality management system

Process for continual improvement is given in Annex B of ISO 9004:2000, a QMS guidelines Standard for performance improvement. It briefly describes the distinction between breakthrough improvement and small-step ongoing improvement. The distinction between the two may be understood as under:
(i) In small-step ongoing improvement there remains involvement of people working in the process, while in breakthrough improvement there remains involvement of cross-functional teams outside routine operation (such as managers, engineers, consultants)
(ii) In small-step ongoing improvement size of changes remain small, while these are big in breakthrough improvement.
(iii) In small-step ongoing improvement results show small improvements, while the results show big jump in performance in breakthrough improvement.
(iv) Cost is low (within operating budget) in small-step ongoing improvement, while cost is high (may involve additional capital investment) in breakthrough improvement.
(v) Types of changes in small-step ongoing improvement include modification in practices, procedures, equipment, elimination and simplification of activities, while types of changes in breakthrough improvement include process reengineering, major process upgrades, change in technology and addition of new equipment.

ISO 9004:2000 Standards provides steps involved in the method of continual improvement that include:
- Identification of a process problem
- Selection of area of improvement
- Noting the reason for improvement
- Evaluating effectiveness and efficiency of the existing process
- Collecting relevant data
- Analyzing relevant data to discover the generally occurring problems
- Selecting a specific problem
- Setting objective for improvement for such specific problem
- Identifying and verifying the root causes of the problem
- Identifying possible solutions as well as exploring alternative solutions
- Evaluating effects to conform that the problem and its root causes have been eliminated or their effects reduced
- Implementing and standardizing new solutions by replacing old process with improved process as a preventive action
- Evaluating effectiveness and efficiency of the process

Since the above steps provide improvement solution to a specific process problem, so the above steps should be repeated on remaining other identified problems, thereby making the improvement as real and effective.

John E. (Jack) West in his article ‘Continuous Improvement and Your QMS’ says, “Piecemeal improvements are no improvements at all.” He also suggests, “First, let’s review what continual improvement is and what it’s not. Continual improvement isn’t necessarily improving everything in the organization. However, it does not entail identifying and planning changes to those products, processes or systems that will improve the organization performance.”

John E. (Jack) West correctly opines, “Sometimes sustained improvement isn’t achievable unless several processes are changed. In the case of improving a product design, it might be necessary to change not only the design and development process but also the process for hiring designer’s, the capital allocation process and the process for understanding customer requirements. In such a case, overall systems changes are needed; just starting a new product design project may be the organization’s worst approach.”

It is necessary to create people awareness in the organization on continual improvement and this may be created by forming small groups, selecting their group leaders, allowing people to control and improve their workplace and developing people’s knowledge, experience and skills.

The role of the top management and management representative are important in continual improvement of the effectiveness of the quality management system and they should take effective steps to do so.


Courtesy Source References

- ISO 9001:2008 QMS Standard
- ISO 9004:2000
- ISO 9001 for small businesses – What to do (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001:2000 – A workbook for service organizations (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001 Fitness Checker – A practical, easy to use checklist designed to help SMEs assess their readiness for ISO 9001 certification
- Implementing ISO 9001:2000 Quality Management System – A Reference Guide, Dr. Divya Singhal and K. R. Singhal (Publication from PHI Learning Pvt. Ltd., New Delhi)
- Article ‘Standard Approach – Continuous Improvement and Your QMS’, John E. (Jack) West, Quality Digest, USA, April 2006
- Article ‘Increasing the power of quality management system: Performance excellence through continual improvement’, Publication series ‘Management Systems Awareness’ – Issue 5, August 2006
- Quality World, New Delhi
- Quality Striving for Excellence, NCQM, Mumbai

Note

Author’s profile may be seen at http://www.linkedin.com/in/krsinghal

INTERNAL AUDIT OF QUALITY MANAGEMENT SYSTEM

K. R. Singhal

Conducting internal audit is a vital tool to assess organization’s quality management system. The organization gets information in a planned way by conducting internal audit from a variety of sources. The purpose of conducting internal audit is to find out the answers to following questions:
- Is quality management system of the organization conformed to the planning of product realization carried out in the organization?
- Is the quality management system of the organization conformed to the requirements of ISO 9001:2008 QMS Standard?
- Is the quality management system of the organization conformed to the quality management system requirements established by the organization?
- Is the quality management system of the organization effectively implemented and maintained?

An internal audit is a tool to monitor and determine the health of the quality management system of the organization. For an organization, a properly conducted audit is beneficial and we need to conduct value added internal audit that is useful to the organization, auditee department, management representative and top management.

Clause 8.2.2 of ISO 9001:2008 QMS Standard deals with internal audit requirements. As per requirements of ISO 9001:2008 QMS Standard, an organization needs to conduct internal audit at planned intervals. An audit process should include the following aspects:
- Planning of internal audit – such as planning of audit schedule, assignment of auditors, auditee area, and scope of audit, status and importance of processes, results of previous audits.
- Examining and reviewing the quality management system documentation of the organization,
- Examining and reviewing other relevant information of the organization, such as production reports, failure trends, customer complaints, customer survey reports etc.
- Examining and reviewing the quality management system procedures and processes by visiting the audit area spot, interviewing relevant personnel and looking to relevant processes.
- Reporting the internal audit results (including corrective action requests from auditors).
- Verifying corrective actions taken.

An organization should have a documented procedure for conducting internal audit that define and narrate the following aspects:
- Audit criteria
- Scope of the audit
- Frequency of audit
- Audit methods
- Responsibilities and requirements for planning and conducting internal audit
- Relevant audit records (including results of audit) to be established and maintained
- Reporting results of the audit.


Chandrakant Agrawal, Manager (Risk and Compliance team), points out the following to add the value of internal audit:
(i) One more item that would be added is usage of checklist as a tool to make sure all aspects are covered. Also focus on documentation and continuous improvement should be there.
(ii) The Corrective action log would be the most valuable source to support the focus on Quality from the team's perspective.
(iii) The team awareness on policies and procedures and the feel of Quality should also be part of the audit process.
(iv) Sharing of Best practices should also be output of audit so that all involved are benefited.



Does ISO 9001:2008 QMS Standard mention specific frequency of internal audit? How frequently does an organization need to perform internal audits? Is it fair to conduct internal audit once in two years?
ISO 9001:2008 QMS Standard does not mention specific frequency of internal audit. Requirements of ISO 9001:2008 QMS Standard say conducting internal audit at planned intervals. As such the Standard binds the organization to conduct internal audit at planned intervals. It is up to the organization to decide the frequency of internal audit.

How frequently does an organization need to perform internal audits? It is very relevant question. Internal audits need to be performed to cover all quality management system activities the organization undertake and all the ISO 9001:2008 Standard requirements. In deciding the frequency of internal audits, the organization should consider following factors:
- Complexity of procedures and processes
- Maturity level of the organization’s quality management system
- Nature of business activity
- Problematic aspects and areas as per history
- Organization approach for monitoring and improvement
- Frequency of management review

Jan A. de Ridder, Senior Consultant, QA en Lean professional, says, “Frequency depends on many things. In my opinion it is fair to audit Clause 5.5 every two years, unless there are changes in the organization. Clause 8.3 should be audited more or less continuously. When requirements are not met, frequency should increase. I used to audit the whole system and every area in a 3 year cycle. Some places were visited more often than others. One should wonder how audits can be performed effectively, but also efficiently. I used to discuss frequency with the responsible manager. Is he/she happy with the outcome and the number of audits? After all he is the internal customer of the auditor.”

Richard Sledgister, an Engineer, says, “The frequency of a company’s internal audits should accomplish the following goals: 1) assess standard conformance, 2) drive RCCA (Root Cause Corrective Action) and 3) drive continuous improvement. Audits should measure the overall effectiveness of a QMS (Quality Management System) in a company and or a specific facility within a company. Audits should also focus on specific areas in which the planned method (standard work) is not being executed properly, high warranty costs are being incurred, a high scrap rate exists, processes are not in statistical control and or other performance metrics are not being achieved. These are all signs of poor quality. The audit frequency should be adjusted to focus on areas needing continuous improvement as this is an efficient use of resources. The cost of poor quality will be reduced and profitability will be enhanced.”

Sandeep Sharma, a Quality engineer, says, “I think it must be finished just before the external audit, if we will get the NC's, there will be time to resolve all the issues.”


On considering above points, it is now clear that it will be unfair to conduct internal audit once in two years as the time gap between two internal audits will be too long.

What should be done after getting results of internal audit?
The organization gets information about the areas which need correction and/or improvement from the results of internal audit. The information from internal audit results becomes input for the management review.

Who should perform internal audits?
Internal QMS auditors should perform internal audits. ISO 9001:2008 QMS Standard has two relevant important requirements:
- Selection of auditors must ensure objectivity and impartiality of the audit process
- An auditor must not audit his/her own work.

Clause 6.2.1 of ISO 9001:2008 QMS Standard mentions the requirement of competent personnel performing work affecting conformity to product requirements on the basis of appropriate education, training, skills and experience. Accordingly, the personnel conducting internal audit must be competent to audit for which the organization should refer to the relevant guidelines as mentioned in ISO 19011 Standard and take appropriate steps to provide appropriate training to personnel selected as auditors for internal audit.

Suggested Reading: Chapter 12 – Value Added Audit, Implementing ISO 9001:2000 Quality Management System – A Reference Guide, Dr. Divya Singhal and K. R. Singhal (Published by PHI Learning Pvt. Ltd., New Delhi – 110001, India)

Courtesy Source References
- ISO 9001:2008 QMS Standard
- ISO 9004:2000
- ISO 9001 for small businesses – What to do (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001:2000 – A workbook for service organizations (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001 Fitness Checker – A practical, easy to use checklist designed to help SMEs assess their readiness for ISO 9001 certification
- Implementing ISO 9001:2000 Quality Management System – A Reference Guide, Dr. Divya Singhal and K. R. Singhal (Publication from PHI Learning Pvt. Ltd., New Delhi)
- Discussion at Linkedin.com Groups



Note
Author’s profile may be seen at http://www.linkedin.com/in/krsinghal

QUALITY POLICY AND QUALITY OBJECTIVES IN ISO 9001:2008

K. R. Singhal

QUALITY POLICY

Let us begin with the concept of quality policy in QMS. The quality policy of an organization shapes approach of the organization to its customers. A quality policy establishes: (i) a commitment to quality, (ii) a commitment to continual improvement of the quality management system, (iii) the context for quality objectives, and (iv) how the organization’s objectives relate to customers’ requirements.

A quality policy of an organization must meet the following minimum criteria:
(a) It should be linked to overall organizational goals,
(b) It should be relevant to the needs and expectations of the customers of the organization.

Accordingly, the quality policy of an organization must provide a framework for establishing and reviewing organization’s quality objectives.

A quality policy should also include explicit commitments to customer satisfaction and continual improvement. Quality policy of an organization should have a clear statement of outcomes. The policy should have understood by the staff of the organization.

Product quality depends both on perceived customer satisfaction and on well motivated staff. Here it should be noted that the term ‘customer satisfaction’ could refer to both types of customers: (a) internal customers (staff of the organization), and (b) external customers (who buy product from the organization by paying the value).

There may be a situation that your organization may not have a quality policy, then you should try to develop a quality policy for your organization. It is often useful to first develop the overall organization’s policy, including policies for marketing, sales, production, finance etc. This exercise could make the quality policy easier to prepare. Organization’s commitment to quality should describe organization’s overall vision of what quality means to organization’s business and its customers. Clause 4.2.1 of ISO 9001:2008 Standard requires organization to document quality policy statement.

Clause 5.3 of ISO 9001:2008 Standard frames requirements with regard to quality policy, which include to ensure that quality policy is (i) appropriate to the purpose of the organization, (ii) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, (iii) provides a framework for establishing and reviewing quality objectives, (iv) is communicated and understood within the organization, and (v) is reviewed for continuing suitability.

Tony Johnston (AJ Quality Management Consulting, Ireland) describes his three fold approach to writing a quality policy – (i) Write quality policy in a language that anyone can understand, (ii) Quality policy should be relative to the organization and believe by its employees when they read it, and (iii) It should make reference to the eight quality management principles, namely customer focus, leadership (management commitment), process approach, continual improvement, factual approach to decision making, mutually beneficial supplier relationship, system approach to management, and involvement of people. The quality policy should be endorsed by the managing director and it should be reviewed at least annually for suitability and updated if necessary.

While the John’s approach is good for writing quality policy and in addition to his approach if a reference for establishing and reviewing quality objectives is given in the quality policy, then it will be better.

If your organization has a quality policy, then you should evaluate your quality policy. Evaluate, whether your quality policy clearly linked to your overall organizational goals. If quality policy of your organization is not linked to your organizational goals, then you need to re-examine your policy and goals. Also find out answers to following questions:
- Does the quality policy include commitment to customer satisfaction?
- Does the quality policy include commitment to continual improvement?
- Does the quality policy include aspects of service quality that are to be emphasized?
- Does the quality policy include benefits for customers (quality outcomes)?
- Is the quality policy focused on maximizing customer satisfaction with the services received?
- Is the quality policy focused on maximizing customer satisfaction with the service received?
- Is the quality policy focused on maximizing staff morale in providing client services?

On the basis of answers to above questions, you may wish to revise the quality policy of your organization.

An illustration of a Quality Policy

…. (name of the organization) …. is committed in achieving customer satisfaction by providing … (the quality characteristics of product provided by the organization) …. For our customers, in context of continual improvement, so that our customers will … (outcomes in relation to customers’ needs / expectations to be met) ….


Another illustration of Quality Policy

We, … (name of the organization) …, manufactures … (name of the products) …. We manufacture and market these products both for domestic and abroad markets. Our purpose is to produce products to satisfy needs of our customers. We continually improve our products and services to satisfy needs of our customers better. Our quality management system is designed to ensure the maintenance of the product quality through evaluation, inspection and verification processes at all stages of production.

We are committed to comply with customer as well as legal requirements and also committed to continually improve the effectiveness of our quality management system. Our organization has decided to achieve quality objectives as set in the documented statement of quality objectives. The top management of our organization in the meeting of board of directors, at least once in every six months, reviews the quality management system of our organization.


QUALITY OBJECTIVES

ISO 9001:2008 QMS Standard requires that organization develop measurable quality objectives, consistent with the quality policy of the organization. Internal and external auditors review quality objectives at each audit to see if they are being met. For planning of the quality management system, it is necessary to establish measurable quality objectives. Requirements with respect to quality objectives are mentioned in clause 5.4.1 of ISO 9001:2008 Standard.

The top management of the organization needs to establish quality objectives. Top management of the organization must ensure that quality objectives (including those needed to meet requirements for the product) are established at relevant functions and levels within the organization. The quality objectives must be measurable and consistent with the quality policy of the organization. Clause 7.1 (a) of ISO 9001:2008 QMS Standard lays down that in planning product realization, the organization must determine quality objectives and requirements for the product. It is evident from this clause that the ISO 9001:2008 Standard now calls for objectives not only for the quality management system but also for the product.

Now questions arise:
- How to set or develop quality objectives?
- How to monitor quality objectives?


Developing Quality Objectives

Developing quality objectives provides the organization with the opportunity to identify areas of inefficiency. The organization can address such areas to improve customer satisfaction. The Management Representative of the organization should frame a committee (with the approval of the top management) for developing quality objectives. This committee should have members from all departments of the organization. The committee members should have conceptual knowledge on ISO 9001:2008 QMS Standard and also on eight quality management principles.

Members of the committee should be advised to frame quality objectives for their respective departments. Management Representative should act as a convener and call a meeting to finalize the quality objectives. Quality objectives finalized in such meeting should be sent to the top management for considering the same in the management review meeting and finalizing them as organization’s quality objectives.

For developing measurable quality objectives for your organization, you may use a worksheet. Worksheet for creating quality objectives may be as under:
- List specific measurable activities that would improve customer satisfaction. Example – Responding to customer’s complaint on the day of its receipt, replying to letters within three days of receipt.
- List specific measurable activities that would improve staff morale. Example – Monthly staff feedback on their performance.
- List specific measurable activities that would improve staff efficiency. Example – Providing computer training to staff.

From the answers that you would have listed for above questions, you may select quality objectives clearly linked to the quality policy of the organization and for each quality objective, you should specify:
- What is to be done?
- How often the organization will achieve the level of performance?
- The date by which the organization will achieve that level of performance.

On careful study of clause 7.1 (a) of ISO 9001:2008 Standard, you will find that the standard calls for quality objectives not only for the quality management system but also for the product. Quality objectives need to be realistic and related to achievable outcomes, such as:
- Meeting agreed customer requirements for delivery or other product characteristics within a certain percentage of time.
- Meeting regulatory and other requirements for product and services.
- Meeting the planned schedule for achieving the quality objectives targets.
- Identifying opportunities for improvement.
- Minimizing the cost of poor quality, rework or scrap.
- Identifying new opportunities.

The Standard also requires that relevant objectives be established at appropriate parts of the organization. For example – Process performance targets, continual improvement targets be established at human resources, production, sales departments.

When setting up quality objectives, look for activities or indicators that employees can relate to and that can be measured. A few examples may be:
- Reducing the production time
- Achieving no failures or defects in production
- Achieving cost reduction
- Improving productivity
- Increasing market share

It is very important point that people in the organization must be aware of how they contribute to the achievement of the quality objectives. Therefore, employees in the organization must know and understand the specific quality objectives that have been set up for their functions and level and how they can achieve them. For awareness of quality objectives, specific training sessions or campaigns may be organized.

At the service delivery, customer interface or at the production line, quality objectives should be very simple and direct.

Think carefully about the quality objectives set by you for the organization and the timeframe you intend to allow for them to be achieved. Keep in mind that quality objectives must be measurable. The organization should be able to check that the organization is achieving the objective and, if not, what the organization is going to do about the quality management system.

Monitoring Quality Objectives

It is the intention of the ISO 9001:2008 QMS Standard that the organization is producing quality product. Monitoring and measurement activities are planned and carried out to carefully improve. Question arises – how to monitor quality objectives? If we carefully read clause 5.6.1 of ISO 9001:2008 QMS Standard, we will come to know that it is the responsibility of the top management to ensure continuing suitability, adequacy and effectiveness of the QMS and to review the organization’s quality management system at planned intervals. Review must include assessing opportunities for improvement and need for changes to the quality management system, including the quality policy and quality objectives.

Quality objectives may be monitored from the input information received from the following:
- Internal and external audits
- Customer feedback
- Process performance reports
- Product conformity reports

A Management Representative (MR) acts a link person between the top management and the organization. His role is very important for maintaining and improving the quality management system in the organization. It is the duty of the Management Representative to report to the top management on the performance of the quality management system and any need for improvement. Accordingly, he should monitor quality objectives from the input information received from various corners.

It is also important to tell employees in the organization regularly how well specified quality objectives are being met and where improvements are required. Quality objectives must be reviewed and revised from time to time as part of the continual improvement process.

Courtesy Source References

- ISO 9001:2008 QMS Standard
- ISO 9004:2000
- ISO 9001 for small businesses – What to do (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001:2000 – A workbook for service organizations (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001 Fitness Checker – A practical, easy to use checklist designed to help SMEs assess their readiness for ISO 9001 certification
- Implementing ISO 9001:2000 Quality Management System – A Reference Guide, Dr. Divya Singhal and K. R. Singhal (Publication from PHI Learning Pvt. Ltd., New Delhi)
- Comments from Mr. Tony Johnston (Ireland)

Note

Author’s profile may be seen at http://www.linkedin.com/in/krsinghal






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CALIBRATION IN ISO 9001:2008

K. R. Singhal

The purpose of this paper is to discuss calibration requirements as per ISO 9001:2008 QMS Standard and related issues.

A monitoring, measuring or testing activity is useful and effective only when measurement results are reliable. Measurement results should be sufficiently accurate with a known degree of uncertainty. For this purpose, there is a need to control monitoring and measuring equipment that have the desired level of accuracy and consistency under condition of actual use.

Clause 7.6 of ISO 9001:2008 QMS Standard deals with control of monitoring and measuring equipment. This clause interalia speaks about calibration of monitoring and measuring equipment. The purpose of requirements in clause 7.6 of ISO 9001:2008 QMS Standard is to ensure suitability of monitoring and measuring equipment.

Requirements of Clause 7.6

The organization must determine (i) what to monitor and measure, and (ii) the monitoring and measuring equipment needed. Monitoring and measuring equipment is helpful in providing evidence of conformity of product to determined requirements.

The organization must establish processes to ensure carrying out monitoring and measurement in consistent with the requirements. As such, it is necessary to have a detailed process system established and maintained for keeping the monitoring and measuring equipment accurate and good operating conditions.

Where necessary to ensure valid results – (i) monitoring and measuring equipment must be calibrated or verified, or both, at specified intervals (decided by the organization), or prior to use, against international or national measurement standard, (ii) monitoring and measuring equipment must be adjusted or re-adjusted as necessary, (iii) monitoring and measuring equipment must have identification in order to determine its calibration status – when the calibration or verification was done and what is the due date for calibration or verification, (iv) monitoring and measuring equipment must be safeguarded from such adjustment that invalidates the measurement result, and (v) monitoring and measuring equipment be protected from damage and deterioration.

Where no international or national standards exist for calibration or verification of the equipment, the basis used for calibration or verification must be recorded. It is better to record the process used and the personnel who carried out calibration and verification.

The organization must assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. In such case, the organization must take appropriate action on the equipment and any product affected.

The organization is required to maintain records of the results of calibration and verification.

Whenever computer software is used in the monitoring or measurement bof specified requirements, it is necessary to conform the ability of the computer software to satisfy the intended application. This must be undertaken prior to initial use and re-conformed as necessary.

Note at the end of clause 7.6 of ISO 9001:2008 clarifies that confirmation of computer software’s ability to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

Finding international or national standard for calibration or verification

To find out relevant international or national standard for calibration or verification, of monitoring and measuring equipment, it is suggested to refer to the latest ISO Catalogue of Standards for international standards and the latest BIS Catalogue for Indian Standards.

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