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Keshav Ram Singhal

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Saturday, August 22, 2009

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

Tuesday, August 18, 2009

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

Sunday, August 16, 2009

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






Where can I get more articles?
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Wednesday, August 12, 2009

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.

Comments may be sent to ncqmajmer@gmail.com

Thursday, June 18, 2009

Outsourcing and Exclusion Concepts in ISO 9001:2008 QMS

K. R. Singhal

Many organizations may find some confusion in outsourcing and exclusion concepts while implementing ISO 9001:2008 QMS.

Clause 4.1 (General requirements) in ISO 9001:2008 QMS Standard includes the outsourcing concept to highlight the fact that special attention is required when obtaining products and services from others that impact the product provided to customer. The requirements in this clause specially refer to outsourced processes to indicate that the organization must ensure control over such outsourced processes. It also requires that the type and extent of control to be applied to outsourced processes must be defined within the quality management system.

Some people may think that the requirement in clause 4.1 (General requirements) regarding outsourcing is not necessary to follow because requirements mentioned in clause 7.1 (Planning of product realization), clause 7.4 (Purchasing), and clause 7.5 (Production and service provision) contain adequate requirements to ensure the integrity provided to the customer.

An organization can’t exclude outsourcing requirements of clause 4.1 (General requirements), if it chooses to outsource any process that affects product conformity to requirements.

If we see the exclusion concept mentioned in clause 1.2 (Application), it states that exclusions are limited to requirements within clause 7 (Product realization). The requirements related to outsourcing concept are mentioned in clause 4.1 (General requirements) that relate to those activities that are essential to the quality management system of your organization, if you choose to outsource any process. When an organization may choose to outsource processes for management activities (related to clause 5), provision of resources (related to clause 6), product realization (related to clause 7), and measurement, analysis and improvement (related to clause 8) may be outsourced.

Who perform the outsourced process? Note 2 at the end of clause 4.1 (General requirements) provides the answer. It clarifies that an outsourced process is identified that process, which is needed for the quality management system, but the same process is performed by a party external to the organization.

Note 3 at the end of clause 4.1 (General requirements) clarifies points with regard to the responsibility of the organization to fulfill all customer, statutory and regulatory requirements and ensuring control over outsourced processes does not absolve the organization of such responsibility to fulfill all customer, statutory and regulatory requirements. This note also clarifies that there are various factors that may influence the type and extent of control on the outsourced process, such as – (i) potential impact of the outsourced process on the capability of the organization to provide product that conforms to requirements, (ii) the degree to which the control for the process is shared (between the organization and the party performing the process), (iii) the capability of achieving the necessary control through the application of clause 7.4 (Purchasing).

If we carefully read the exclusion requirements in clause 1.2 (Application), it also put the condition that such exclusion do not affect the ability or responsibility of the organization to provide product that meets customer and applicable statutory and regulatory requirements.

An organization, taking the benefit of exclusion provision mentioned in clause 1.2 (Application) that exclusions are limited to requirements within clause 7 (Product realization), must remember that when the organization outsource any process then according to clause 4.1 (General requirements), it is the duty of the organization to control such outsourced processes. Further the type and control to be applied to outsourced processes need to be defined.

Let us have following examples:
(i) An organization claimed exclusion from the requirements of clause 7.4 (Purchasing) since the purchasing activity of the unit (implementing ISO 9001:2008 QMS) is done at corporate level.
(ii) An organization claimed exclusion from the requirements of clause 7.1 (Planning of product realization) and clause 7.5 (Production and service provision) since the unit (implementing ISO 9001:2008 QMS) does not carry out any production process and same has been contracted to another organization.
(iii) An organization claimed exclusion from the requirements of clause 7.3 (Design and development) since the designing of the product is carried out at another unit of the organization.

In the above examples, the organization claimed exclusion on the basis that the related process not being carried out by the unit (implementing ISO 9001:2008 QMS). But if look to clause 4.1 (General requirements) then the unit can not ignore control over the processes of (i) purchasing carried out at corporate level, (ii) planning of product realization, and production and service provision, and, (iii) design and development carried out at another unit.

The process approach is having the central approach to ISO 9001:2008 QMS Standard and we have observed that during the last few years outsourcing activities in organizations have increased tremendously, so the new version has clarified its requirements by adding notes in clause 4.1 (General requirements).

Please have you comments to the above.

With kind regards,

K. R. Singhal

Friday, January 23, 2009

Upgrading the existing QMS to ISO 9001:2008 Standard

Upgrading the existing QMS to ISO 9001:2008 Standard

ISO 9001:2008 QMS Standard has been published on 15 November 2008 by the International Organization for Standardization (ISO). Organizations having the ISO 9001:2000 QMS certifications will upgrade their quality management system as per 2008 version. As per implementation plan jointly announced by International Organization for Standardization (ISO) and International Accreditation Forum (IAF), organizations should upgrade their ISO 9001:2000 QMS to ISO 9001:2008 QMS before 15 November 2010 (within two years from the data of publication of ISO 9001:2008 Standard). However, efforts of many management representatives will be to upgrade their quality management system and obtain certification as per ISO 9001:2008 QMS Standard as early as possible.

It’s good to upgrade the system, but how you can do it in an effective manner. The quality management system of your organization should be able to demonstrate continual improvement as well as changes as per new version. Following steps may be useful.

Step 1 – Get acquainted with ISO 9001:2008 QMS Standard

Nothing can be done without knowing the changes, so please obtain a copy of ISO 9001:2008 Standard. You can obtain the same from the ISO Central Secretariat or from the sales counter of the National Standards Body in your country. ‘Bureau of Indian Standards’ is the national standards body in India, from which you can obtain the equivalent Indian Standard to ISO 9001:2008 QMS. Read ISO 9001:2008 Standard carefully. You should also refer to other reading materials (such as books, articles) on ISO 9001:2008 QMS.

Start ISO 9001:2008 QMS Awareness Programme in your organization. Members of task force, members of steering committee and people, actively involved in ISO 9001 QMS implementation, should be encouraged to attend ISO 9001:2008 Awareness Programme.

Step 2 – Action Plan

Please prepare an action plan for up-gradation to ISO 9001:2008 from the 2000 version. The action plan should indicate the responsibilities of different departments and personnel and set target dates for completion of activities (such as target dates for completion of documentation, training of internal auditors, internal audit, management review etc.).

Step 3 – Revision of QMS Documentation

A few people should be selected for revision of QMS documentation as per ISO 9001:2008 QMS Standard. The Management Representative should be the coordinator of the QMS documentation revision task. Revision in documentation should be done and revised documents should be issued.

Step 4 – Implementation

Implementation should be carried out immediately upon issue of revised documentation as per ISO 9001:2008 QMS Standard.

Step 5 – Training of internal auditors

Internal auditors should be aware of ISO 9001:2008 QMS Standard, so please provide training to your internal auditors, so that they may be able to carry out value added internal audit as per ISO 9001:2008 QMS Standard.

Step 6 – Internal Audit

After implementation as per revised documentation, please carry out internal audit as per ISO 9001:2008 QMS Standard. Take corrective action for the nonconformity or nonconformities observed during the internal audit.

Step 7 – Management Review

After conduct of internal audit, carry out management review of the quality management system of your organization as per ISO 9001:2008 QMS Standard.

Step 8 – Inform Certification Body

After successfully completing all above steps, you should inform your certification body about the up-gradation of your quality management system as per ISO 9001:2008 QMS Standard, so that they may assess your quality management system and upgrade their certificate.

Support from NCQM Ajmer Centre

You can have following support from NCQM Ajmer Centre for up-gradation of your QMS:
Literatures in Hindi and English on ISO 9001:2008 QMS
Training programmes
Guidance for implementation

Monday, January 19, 2009

Understanding ISO 9001:2008 Quality Management System

Understanding ISO 9001:2008 Quality Management System

Chapter 9

DOCUMENTED PROCEDURES AND RECORDS REQUIRED BY ISO 9001:2008

Documented procedures required by ISO 9001:2008 are:
Control of documents (see clause 4.2.3)
Control of records (see clause 4.2.4)
Internal audit (see clause 8.2.2)
Control of nonconforming product (see clause 8.3)
Corrective action (see clause 8.5.2)
Preventive action (see clause 8.5.3)

However, in addition to above the organization may have documented procedures determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.

Records required by ISO 9001:2008 are:
Clause 5.6 (Management review) – Records from management reviews
Clause 6.2.2 (Competence, training and awareness) – Appropriate records of education, training, skills and experience
Clause 7.1 (Planning of product realization) – Records to provide evidence that the realization processes and resulting product meet requirements
Clause 7.2.2 (Review of requirements related to the product) – Records of the result of the review and actions arising from the review
Clause 7.3.2 (Design and development inputs) – Records of inputs relating to product requirements
Clause 7.3.4 (Design and development review) – Records of the results of the reviews and any necessary actions
Clause 7.3.5 (Design and development verification) – Records of the results of the verification and any necessary actions
Clause 7.3.6 (Design and development validation) – Records of the results of validation and any necessary actions
Clause 7.3.7 (Control of design and development changes) – Records of the results of the review of changes and any necessary actions
Clause 7.4.1 (Purchasing process) – Records of the results of supplier evaluations and any necessary actions arising from the evaluation
Clause 7.5.2 (Validation of processes for production and service provision) – Records as per requirements according to established arrangements
Clause 7.5.3 (Identification and traceability) –Where traceability is a requirement, record of unique identification of product
Clause 7.5.4 (Customer property) – Records of reporting to the customer, if any customer property is lost, damaged or otherwise found to be unsuitable for use
Clause 7.6 (Control of monitoring and measuring equipment) – (i) Records of the basis used for calibration or verification, where no international / national measurement standards exist (ii) Records of the results of calibration and verification (iii) Validity of the previous measuring results when equipment is found not to conform requirements
Clause 8.2.2 (Internal audit) – Records of the audits and their results
Clause 8.2.4 (Monitoring and measurement of product) – Records indicating the person(s) authorizing release of product for delivery to the customer
Clause 8.3 (Control of nonconforming product) – Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained
Clause 8.5.2 (Corrective action) – Records of the results of action taken
Clause 8.5.3 (Preventive action) – Records of the results of action taken

However, in addition to above the organization may have records determined by the organization to be necessary to ensure effective planning, operation and control of the processes of the organization.

If we go through the above list and requirements of ISO 9001:2000 QMS Standard, we find that there is no change in the requirements for documented procedures and records needed to keep as per ISO 9001:2008.


Questions

What are the documented procedures and records required as per clause 4 (Quality management system) of ISO 9001:2008?
What are the documented procedures and records required as per clause 5 (Management responsibility) of ISO 9001:2008?
What are the documented procedures and records required as per clause 6 (Resource management) of ISO 9001:2008?
What are the documented procedures and records required as per clause 7 (Product realization) of ISO 9001:2008?
What are the documented procedures and records required as per clause 8 (Measurement, analysis and improvement) of ISO 9001:2008?

Note from the author

The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.

The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.

Understanding ISO 9001:2008 Quality Management System

Understanding ISO 9001:2008 Quality Management System

Chapter 8

ANNEX, BIBLIOGRAPHY AND OTHER INFORMATION (including implementation plan for ISO 9001:2008 QMS Standard)


Annex A and Annex B have been updated.

Annex A provides informative details of correspondence between ISO 9001:2008 and ISO 14001:2004 For more details, reader should refer to the Standard document ISO 9001:2008.

Annex B provides informative details of changes between ISO 9001:2000 and ISO 9001:2008 in a Table form. For more details, reader should refer to the Standard document ISO 9001:2008.

Bibliography is also updated to reflect new standards and new editions of standards. For more details, reader should refer to the Standard document ISO 9001:2008.

In short, from the study of ISO 9001:2008, we come to a conclusion that ISO 9001:2008 will be an international standard with minor revision to ISO 9001: 2000 and changes are more as clarifications to the requirements.

There will be little impact of the revision. Only a few changes in the requirements may require revision in documentation and implementation. International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have announced schedule for implementation of accredited certification to ISO 9001:2008 QMS Standard. Details are mentioned below.

Implementation Plan for ISO 9001:2008 QMS Standard

International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have announced schedule for implementation of accredited certification to ISO 9001:2008 QMS Standard. Both organizations have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008 QMS Standard.

The ISO 9001:2008 QMS Standard has been published on 15 November 2008. ISO 9001:2008 QMS Standard replaces the year 2000 version of the Standard. Certification is not a requirement of the standard, however the quality management system (QMS) of about one million organizations have been audited and certified by independent certification bodies to existing ISO 9001:2000 QMS Standard. ISO 9001 certification is frequently used in both private and public sectors to increase confidence in the products and services provided by certified organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts.

International Organization for Standardization (ISO) is the developer and publisher of ISO 9001 Standard. ISO does not itself carry out auditing and certification to ISO 9001 Standard. These services are performed independently of ISO by certification bodies. ISO does not control such bodies. But ISO has developed voluntary International Standards to encourage good practice in their activities on a worldwide basis. ISO/IEC 17021:2006, developed and published by ISO, specifies the requirements for certification bodies carrying out auditing and certification of management systems.
Certification bodies that wish to provide further confidence in their services generally apply to be "accredited" as competent by an International Accreditation Forum (IAF) recognized national accreditation body। In India, National Accreditation Board of Certification Bodies (NABCB) is the IAF recognized national accreditation body। ISO/IEC 17011:2004, developed and published by ISO, specifies the requirements for carrying out such accreditation. International Accreditation Forum (IAF) is an international association, having membership of national accreditation bodies of 49 countries/economies. International Organization for Standardization (ISO) has a technical committee, known as ISO/TC 176, Quality management and quality assurance. This committee is responsible for the ISO 9000 family of standards. This committee is preparing a number of support documents explaining the differences between ISO 9001:2008 (forthcoming new version) and ISO 9001:2000 (the year 2000 version), why and what they mean for users. On getting approval, these documents will be posted on the ISO Web site – probably in October 2008.

International Organization for Standardization (ISO) and International Accreditation Forum (IAF) have agreed an implementation plan to ensure a smooth migration of accredited certification to ISO 9001:2008 QMS Standard, after consultation with international groupings representing quality system or auditor certification bodies, and industry users of ISO 9001 certification services. ISO 9001:2008 does not contain any new requirements. As such, ISO and IAF have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 QMS Standard. It also introduces changes intended to improve consistency with ISO14001:2004 EMS Standard. The implementation plan and validity of certification to ISO 9001 QMS, as agreed by ISO and IAF, in relation to accredited certification is as under:(i) Accredited certification to the ISO 9001:2008 QMS Standard shall not be granted until the publication of ISO 9001:2008 QMS Standard as an International Standard. ISO 9001:2008 QMS Standard has since been published as International Standard on 15 November 2008.
(ii) Certification of conformity to ISO 9001:2008 QMS Standard and/or national equivalents (such as, IS/ISO 9001:2008 QMS Standard, in India) shall only be issued after official publication of ISO 9001:2008 (i.e after 15 November 2008) and after a routine surveillance or recertification audit against ISO 9001:2008.
(iii) One year after publication of ISO 9001:2008 QMS Standard all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008 QMS Standard.
(iv) Twenty four months after publication by ISO of ISO 9001:2008 QMS Standard, any existing certification issued to ISO 9001:2000 shall not be valid.

Questions

1. What is your conclusion with regard to ISO 9001 revision?
2. What is the implementation plan for ISO 9001:2008 QMS Standard announced by International Organization for Standardization (ISO) and International Accreditation Forum (IAF)?

Note from the author

The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.

The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.

Wednesday, January 14, 2009

Understanding ISO 9001:2008 Quality Management System

Understanding ISO 9001:2008 Quality Management System

Chapter 7

MEASUREMENT, ANALYSIS AND IMPROVEMENT

Author – K. R. Singhal

There are following clauses under this section:
8.1 – General
8.2 – Monitoring and measurement
8.3 – Control of nonconforming product
8.4 – Analysis of data
8.5 – Improvement

General
(Please refer to clause 8.1 of ISO 9001:2008)

The organization must plan and implement the monitoring, measurement, analysis and improvement processes needed for the following:
to demonstrate conformity to product requirements,
to ensure conformity of the quality management system, and
to continually improve the effectiveness of the quality management system.

The organization must determine applicable methods (including statistical techniques) and extent of their use.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement, however there is editorial change in the wordings. As per ISO 9001:2008, monitoring, measurement, analysis and improvement processes needed ‘to demonstrate conformity to product requirements’, instead of ‘to demonstrate conformity of the product’ (as mentioned in ISO 9001:2000 QMS Standard).


Monitoring and measurement
(Please refer to clause 8.2 of ISO 9001:2008)

There are following clauses under this clause:
8.2.1 – Customer satisfaction
8.2.2 – Internal audit
8.2.3 – Monitoring and measurement of processes
8.2.4 – Monitoring and measurement of product

Customer satisfaction
(Please refer to clause 8.2.1 of ISO 9001:2008)

The organization must monitor information relating to customer perception to know whether the organization has met customer requirements. The organization must determine methods for obtaining and using information relating to customer satisfaction. This monitoring must be done by the organization as one of the measurements of the performance of organization’s quality management system.

Note at the end of this clause clarifies that monitoring customer satisfaction can include obtaining inputs from various sources, such as:
customer satisfaction surveys,
customer data on delivered product quality,
user opinion surveys,
lost business analysis,
compliments,
warranty claims, and
dealer reports.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.1 (Customer satisfaction), a note has been added that monitoring customer perception may include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports.


Internal audit
(Please refer to clause 8.2.2 of ISO 9001:2008)

The organization must conduct internal audits at planned intervals. Conducting internal audits must be done to determine whether the quality management system of the organization:
conforms to the planned arrangements,
conforms to the requirements of ISO 9001:2008 Standard,
conforms to the quality management system requirements established by the organization, and
is effectively implemented and maintained.

The organization must plan an audit programme by considering the status and importance of the processes, areas to be audited and results of previous audits. The organization must define audit criteria, scope, frequency and methods of internal audit. The organization must ensure objectivity and impartiality of the audit process in selecting internal auditors and conducting internal audits. Auditors must not audit their own work.

The organization must establish a documented procedure to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.

The organization must maintain records of the audits and their results.

The management (of the area or department being audited) must ensure that any necessary corrections and corrective actions are taken promptly (without undue delay) to eliminate detected nonconformities and their causes.

The organization must carry out follow-up activities including verification of the actions taken and the reporting of verification results.

Note at the end of this clause states to refer to ISO 19011 for guidance.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that the requirements of this clause reworded to give more clarity. The requirements in ISO 9001:2008 is very clear that a documented procedure must be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. It also requires that records of the audits and their results must be maintained. In Para 4 of sub-clause 8.2.2 of ISO 9001:2000 QMS Standard, before the word ‘actions’ phrase ‘any necessary corrections and corrective’ has been added in ISO 9001:2008 to give more clarity .A note at the end of sub clause 8.2.2 now refers to ISO 19011 for guidance in ISO 9001:2008, instead of ISO 10011-1, ISO 10011-2 and ISO 10011-3 as mentioned in ISO 9001:2000 QMS Standard.


Monitoring and measurement of processes
(Please refer to clause 8.2.3 of ISO 9001:2008)

The organization must apply:
suitable methods for monitoring of the quality management system processes, and
where applicable, measurement of quality management system processes.

Such suitable methods must demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, the organization must take correction and corrective action, as appropriate.

Note at the end of this clause suggests that organization should consider the type and extent of monitoring or measurement appropriate to each of its processes, when determining suitable methods, in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.3 the phrase ‘to ensure conformity of the product’ has been removed as was mentioned in ISO 9001:2000. A note added at the end of sub-clause 8.2.3 now clarifies that when deciding on appropriate methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and effectiveness of the quality management system.


Monitoring and measurement of product
(Please refer to clause 8.2.4 of ISO 9001:2008)

The organization must monitor and measure the characteristics of the product to verify that product requirements have been met. This must be carried out at appropriate stages of the product realization process in accordance with the planned arrangement. The organization must maintain evidence of conformity with the accepted criteria.

The organization must maintain records indicating the person(s) authorizing release of product for delivery to the customer.

The organization must not proceed to release product and delivery of service to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority of the organization and, where applicable, by the customer.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there are editorial changes, some additions and deletions. Requirement to maintain evidence of conformity with the accepted criteria is in Para 2 of ISO 9001:2000 QMS Standard, and this requirement has been deleted from this Para and added to Para 1 of this sub-clause in ISO 9001:2008. In Para 2 of this sub-clause in ISO 9001:2000 requires records to indicate the person(s) authorizing release of product, and this has been made more specific now in ISO 9001:2008 and records must indicate the person(s) authorizing release of product for delivery to the customer. The phrase ‘Product release and service delivery’ in Para 3 of this sub-clause (as mentioned in ISO 9001:2000 QMS Standard) has been substituted by the phrase ‘The release of product and delivery of service to the customer’ (in ISO 9001:2008).


Control of nonconforming product
(Please refer to clause 8.3 of ISO 9001:2008)

The organization must ensure that nonconforming product (the product which does not conform to product requirements) is identified and controlled to prevent its unintended use or delivery. The organization must establish a documented procedure to define the controls and related responsibilities and authorities for dealing with nonconforming product.

Where applicable, the organization must deal with nonconforming product by one or more of the following ways:
by taking action to eliminate the detected nonconformity,
by authorizing its use, release or acceptance under concession by relevant authority and, where applicable, by the customer,
by taking action to preclude its original intended use or application,
by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

When organization carries out correction in nonconforming product, such correction must be subject to re-verification to demonstrate conformity to the requirements.

The organization must main records of the nature of nonconformities and any subsequent actions taken, including concessions obtained.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that Para 1 of this clause has been reframed to provide more clarity. The term ‘where applicable’ is added in the beginning in Para 2 of this clause. The requirements of Para 3 and Para 4 of this clause (in ISO 9001:2000 QMS Standard) have been interchanged as Para 4 and Para 3 in ISO 9001:2008 without any change in wordings. The requirement mentioned in Para 5 of this clause (mentioned in ISO 9001:2000 QMS Standard) has been shifted in Para 3 Bullet d) with appropriate reframing of wordings (in ISO 9001:2008).

Analysis of data
(Please refer to clause 8.4 of ISO 9001:2008)

The organization must determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This must include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data must provide information relating to:
customer satisfaction,
conformity to product requirements,
characteristics and trends of processes and products, including opportunities for preventive action, and
suppliers.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of this clause, however, reference to clause has been changed or added. In clause 8.4 (b), reference to ‘(see 8.2.4)’ has been mentioned in ISO 9001:2008 instead of ‘(see 7.2.1)’ as mentioned in ISO 9001:2000 QMS Standard. In clause 8.4 (c), after ‘… preventive action’ the words ‘(see 8.2.3 and 8.2.4)’ have been added. In clause 8.4 (d), after suppliers the words ‘(see 7.4)’ added.

Improvement
(Please refer to clause 8.5 of ISO 9001:2008)

There are following clauses under this clause:
8.5.1 – Continual improvement
8.5.2 – Corrective action
8.5.3 – Preventive action

Continual improvement
(Please refer to clause 8.5.1 of ISO 9001:2008)

The organization must continually improve the effectiveness of the organization’s quality management system. This must be done through the use of the following:
quality policy,
quality objectives,
audit results,
analysis of data,
corrective action,
preventive action, and
management review.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of sub-clause 8.5.1 (Continual improvement).

Corrective action
(Please refer to clause 8.5.2 of ISO 9001:2008)

The organization must take corrective action, appropriate to the effects of the nonconformities encountered, to eliminate the causes of nonconformities in order to prevent recurrence.

The organization must establish a documented procedure that defines requirements for the following:
reviewing nonconformities,
determining the causes of nonconformities,
evaluating the need for action to ensure that nonconformities do not recur,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the corrective action taken.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.2 (Corrective action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. The word ‘cause’ (as mentioned in Para 1 of sub-clause 8.5.2 in ISO 9001:2000 QMS Standard) has been substituted by the word ‘causes’ (in ISO 9001:2008). Instead of ‘reviewing the corrective action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the corrective action taken’ (in ISO 9001:2008).

Preventive action
(Please refer to clause 8.5.3 of ISO 9001:2008)

The organization must determine preventive action, appropriate to the effects of the potential problems, to eliminate the causes of potential nonconformities in order to prevent their occurrence.

The organization must establish a documented procedure to define requirements for:
determining potential nonconformities and their causes,
evaluating the need for action to prevent occurrence of nonconformities,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the preventive action taken.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.3 (Preventive action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. Instead of ‘reviewing the preventive action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the preventive action taken’ (in ISO 9001:2008).


Questions

What are the key changes in clause 8.1 (measurement, analysis and improvement – General) in ISO 9001?
What are the key changes in clause 8.2.1 (Customer satisfaction) in ISO 9001?
What are the key changes in clause 8.2.2 (Internal Audit) in ISO 9001?
What are the key changes in clause 8.2.3 (Monitoring and measurement of processes) in ISO 9001?
What are the key changes in clause 8.2.4 (Monitoring and measurement of product) in ISO 9001?
What are the key changes in clause 8.3 (Control of nonconforming product) in ISO 9001?
What are the key changes in clause 8.4 (Analysis of data) in ISO 9001?
What are the key changes in clause 8.5 (Improvement) in ISO 9001?

Note from the author

The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.

The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.