7
Jun/11

The Implementation Steps Of ISO 9001 Standard Certification

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The Implementation Steps Of ISO 9001 Standard Certification

ISO 9001 implementation steps, and prerequisites for a successful ISO certification success of ISO 9001 quality management system depends on the entire implementation was carried out.  The implementation steps for ISO 9001 Standards are as below:

(1) with a well-defined awareness training program started. You have to separate awareness training programs for top management, middle management and lower management. You need to the quality management, ISO 9001requirements and how quality management is to discuss making a difference in your organization. You can hire an outside consultant / trainer for the confidence in a professional manner.

(2) The next step is to perform a gap analysis. Gap analysis is a detailed and complete study of the current business processes of your organization vs. the request of the ISO 9001 standard. This is the most important and crucial stage during the entire ISO 9001 implementation process. Whether you are a manufacturer or a service organization, you need to benchmark your current business processes with ISO 9001 requirements. Results of the gap analysis study was created generating a gap analysis, you need to be circulated to all process owners and department heads. It is always advisable that you appoint a reputable and experienced consultants to carry out gap analysis of your company as an external consultant as a management consultant.

(3) gap analysis, you must complete workshop for the derivation of quality policy and quality objectives as process. These tasks will be the driving force behind the organization to improve performance and measurement.

(4) Based on the gap analysis and process as quality goals, you need to develop various documents such as quality manual, functional Procedures (SOP), formats, instructions, systems and checklists .

(5) is being developed by the Documentation, Procedures should owners officially approved and issued by a board representative. You need to training for the employees of your organization have to provide documents and it’s effective implementation.

(6) Process owners are required together with department heads and representatives of management to monitor effective implementation of the ISO 9001 system of organization and their processes / departments. Type help / assistance to users on the new system and ISO 9001 requirement if necessary to facilitate the proper implementation of ISO 9001 in the organization.

(7) Choose to be a team of employees trained as internal auditors. Talk to your consultant or trainer for the implementation of a comprehensive quality internal auditor training. This training allows your employees Auditing skills to understand process-oriented approach to the implementation of audit according to ISO 9001 clauses and requirements.

(8) Plan an internal audit and ensure that ISO 9001 internal audit is carried out according to schedule. If you wish, to facilitate wire in an external consultant will first round of internal audit. MR and auditors should ensure coordination with the auditee that the non-conformities are found during the audit is closed and the corrective measures are effective in nature.

(9) to discuss organizing management review meeting several points such as quality and objectives of the audit results, supplier performance, customer complaints and their redressal, customer feedback, and it is analysis, customer requests and their status, education, and it is the effectiveness, change in process or QMS, etc. Agenda and minutes of MRM is to be worked out with an action plan.

(10) Select a CA depending on your budget and your specific requirements. They have a practical experience of your advisor in selecting the most appropriate certification body.

(11) It is advisable to do a pre-assessment test before the final certification audit. Under the supervision of the results of the preliminary examination of the final exam schedule and communicate to everyone in the organization.

(12) Get out of the final certification audit and ensure that you close all non-matches (if any) in the stipulated time.

(13) you get a recommendation for ISO 9001 quality management system and you will receive a certificate as an ISO 9001 certified company

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10
May/11

The Goals and Principles Of ISO 9001 Standards

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The ISO 9001:2008 revision was released in a digital format on November 14, 2008 and the printed version on November 25th. The revisions are explanatory and editorial in nature. The requirements remain principally intact from the 2000 revision. You can find an in depth review of the changes on our website.

The goals and principles of ISO 9000 still apply. There are eight goals/principles that were initially enumerated in the 2000 release of ISO 9000 that set the temperament and focus of today’s quality management techniques and application.

ISO 9000 addresses process quality standards, not product quality standards. It does not involve inspection to see if a part meets a specification. It addresses examining the process and the controls used during its manufacture. The concept is that if everything in the process is good, it will produce a good product.

The requirements in ISO 9001 do not call for any specific type of product inspection. It does state that if an organization includes product inspection in their production plans they must carry out the inspections as planned.

It’s important that we always keep in mind these goals and principles and focus our efforts on attaining them.

The Eight Goals/Principles of ISO 9000 are:

1) Customer Focused Organization

Take care of the customer first. Companies that focus their energies on customers outperform those that are inwardly focused. Customers don’t reward their suppliers for simply following a procedure. You depend on your customers. You should understand their requirements and expectations and work to exceed them.

2) Leadership

Top management should be leaders. Continual improvement and increased customer satisfaction are attainable when led by top management. Leaders provide direction and make sure everyone is steering the same course.

3) Involvement of people

People make quality a reality. The folks that do the work must know what their customer expects. And, everyone works toward the same goal … the customer’s satisfaction.

4) Process Approach

Plan and setup work the way it naturally flows. When operations and departments work together toward the same goals there is a structure for managing and improving. The whole must be greater than the sum of its parts.

5) System Approach to Management

A company will be more effective if they manage a system of interacting processes. Managing each process as stand alone operations causes conflicts among processes because they work toward individual goals and not what the customer wants.

6) Continual Improvement

Being world class isn’t achieved by accepting the status quo. Small improvements made on an ongoing basis makes world class a reality.

7) Factual Approach to Decision Making

Decisions about change are based on empirical information. Wishing something better doesn’t work. You have heard it before and it’s worth repeating “If you don’t measure it, you can’t manage it”.

8) Mutually Beneficial Supplier Relationships

Make suppliers partners in your efforts and theirs. You depend on suppliers so you should work toward win-win outcomes. They are the experts in their chosen area and product. Everybody prospers.

Bonus Goal

9) Defect Prevention

Controlling the input to processes through goal # 4 emphasizes the importance of good input resulting in good output. Thereby, theoretically reducing the need to rely on defect detection methods such as inspection. Defect prevention is cheaper than defect detection and correction. In reality the total absence of inspection in manufacturing seems impossible. However, an ongoing endeavor to reduce inspections to a minimum is truly continuous improvement.

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10
May/11

Benefits of Quality Management System

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These days, gaining ISO 9001 certification will almost certainly enhance an organization’s business reputation. The ISO 9001:2008 standard requires the implementation of a documented quality management system to facilitate enhanced performance and efficiency.

ISO 9001 certification is intended for any organization regardless of size, type or product including service. According to the ISO 9001 standard there a number of system requirements which an organisation needs to fulfill in order meet customer, regulatory and statutory requirements. Ensuring customer satisfaction through the quality management system is a key aim of the standard. The ISO 9001 standard also includes elements that require monitoring and measurement of processes and continual improvement.

In order to achieve certification an organization should have a documented quality management system and not a system of documents. The three main objectives of the documentation should be for communication of information, evidence of conformity and knowledge sharing. Quality management system documentation may be in any form or type of medium such as paper, electronic or picture. A compliant quality management system will need to address key elements of the standard. There are five sections that outline the requirements of a compliant system, section 4 Quality Management System, section 5 Management Responsibility, section 6 Resource Management, section 7 Product Realisation and section 8 Measurement Analysis.

ISO 9001 section 4 requires that an organisation has a documented system with procedures in place to control documents and records. Section 5 requires the quality management system to include a quality policy and for senior management to demonstrate management commitment, allocate responsibility and authority, and conduct management reviews

Section 6 of the standard requires your system to address and review requirements for resources, human resources and training, infrastructure and work environment. Section 7 of the standard defines the requirements for planning, design and development, purchasing, production, control of customer property and monitoring and measurement. Section 8 defines the quality management system requirements for measurement, monitoring and improvement and includes sub-clauses internal audit, control of non-conforming product, corrective action and preventative action, all of which are compulsory procedures as defined by the standard.

ISO 9001:2008 refers specifically to only 6 documented procedures, however, other documentation may be required by an organisation in order to manage the processes that are necessary for the effective operation of the QMS. In addition to the minimum document requirements the standard defines twenty one specific requirements for records.

There are several requirements of ISO 9001:2008 where value can be added to a quality management system by the preparation of other documents to demonstrate conformity such as process flow charts, process descriptions, organization charts, specifications, work instructions, approved supplier lists and inspection plans.

The documentation required in a system to achieve ISO 9001 certification is no longer as onerous as prior to 2000 and the value of ISO 9001 certification for an organisation has never been higher. Certification sends a clear message to all interested parties that an organization is committed to high standards and continual improvement.

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10
May/11

ISO 9001 Compliant Program

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Implementing an ISO 9001 system represents a major effort. However, all of that effort can represent a significant shift for a business – from quantity to quality. And this could make sure your business gets the desired results.

Shift Policy and Procedures Focus to Performance

Developing, implementing and maintaining your ISO 9001 program can be crucial to the core issues of a business. The focus is designed to help:

o Satisfy customer requirements for compliance

o Increase profits with more contracts

o Save money through efficiency

But to do this you need to put a framework in place that spotlights performance and performance improvement.

Get Management System Support

To effectively build a program and meet the requirements, your organization should carry out a strong process:

o Management Decision and Commitment

o Adequate Training and Evaluation

o Compliance with Appropriate Standards

o Audit and Registration

Once you’ve identified your company’s need for compliance, it is essential for top management to get on board. Management can ensure that quality is documented, demonstrable, effective and maintained.

Quality Systems and Procedures

The appropriate personnel should then review the standards for their industry and work to meet those requirements with organized documentation. Personnel can then develop, implement and maintain a set of quality systems and procedures to satisfy the ISO 9001 requirements.

Operations Training and Well-defined Processes

To build a program and meet the requirements, your organization should begin with effective training for how to create well-defined processes. You will first want to learn how to identify the objectives necessary to deliver top results. And then you will be ready to put those processes to work.

Internal Auditor Training

After you’ve implemented the ISO program, you should monitor and measure the processes against your own objectives. You can build an effective management system that objectively shows what you’re doing right and wrong. To learn how, you can take advantage of an Internal Auditor skills class and learn how to bridge the gap and move toward continual performance improvement.

Improve Business Process Performance

With ISO 9001 compliance you can improve the overall process performance of your business. And this can save money while satisfying your customers and increasing profit.

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10
May/11

ISO 14001 Standard

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1. ISO 14000 Control of documents

ISO 14000 Control of documents

Control of environmental management system documents is important to ensure

2. Possible information sources for determining environmental aspects and environmental impacts

Possible information sources for determining environmental aspects and environmental impacts

3. Initial environmental review

An organization with no existing environmental management system should assess its current position with regard to the environment by means of a review. The aim of this review should be to consider the environmental aspects of the organization’s activities, products and services as a basis for establishing its environmental management system.

4. Methods of examining existing environmental management

Methods that can be used to examine existing environmental management practices and procedures include:

5. Environmental policy

An environmental policy establishes the principles of action for an organization. It sets the level of environmental responsibility and performance required of the organization, against which all subsequent actions will be judged. The policy should be appropriate to the environmental.

6. Prevention of pollution solutions

Prevention of pollution can be incorporated into the design and development of new products and services, as well as into the development of associated processes. Such strategies can, for example, help an organization to conserve resources and reduce waste and emissions associated with products and services.

7. Instructions of environmental policy

Instructions of environmental policy
The environmental policy should recognize that all activities, products and services within the defined scope of an organization’s environmental management system can cause impacts on the environment.

8. ISO 14000 Planning

Planning is critical to the fulfillment of an organization’s environmental policy and the establishment, implementation, and maintenance of its environmental managementsystem. An organization should have a planning process that includes the following elements:

9. Identifying environmental aspects

To identify and have an understanding of its environmental aspects, an organization should collect quantitative and/or qualitative data on the characteristics of its activities, products and services such as inputs and outputs of materials or energy, processes andtechnology used, facilities and locations, transportation methods and human factors.

10. Determining significant environmental aspects

Significance is a relative concept; it cannot be defined in absolute terms. What is significant for one organization may not be significant for another. Evaluating significance involves applying both technical analysis and judgment by the organization.

11. Legal requirements

Legal requirements of ISO 14000
Legal requirements refer broadly to any requirement or authorization that is related to an organization’s environmental aspects as issued by a governmental authority (including international, national, state/provincial and local authorities) and has legal force.

12. Other requirements

Depending on its circumstances and needs, an organization may subscribe voluntarily to requirements, other than legal requirements, that apply to the environmental aspects of its activities, products and services. Such other environmental requirements, if applicable, can include

13. Setting objectives and targets

In setting objectives and targets, an organization should consider several inputs.

14. Performance indicators

Performance indicators of ISO 14000 (KPIs)
Progress towards an objective can generally be measured using environmental performance indicators.

15. Environmental responsibilities of management levels

1. Establish overall direction
2. Develop environmental policy
3. Develop environmental objectives, targets and programs
4. Monitor overall environmental management system performance
5. Assure compliance with applicable legal
6. requirements and other requirements to which the organization subscribes

16. ISO 14000 communication

1. General guidance — Communication
An organization should establish, implement and maintain procedures for communicating internally and externally on its environmental policy, performance or other information, based on its own needs and the needs of interested parties.

17. Environmental training

Types of training include raising awareness of the importance of environmental management.

18. ISO 14000 Documentation

a) statements of policy, objectives and targets,
b) description of the scope of the environmental management system,
c) descriptions of programs and responsibilities,
d) information on significant environmental aspects,
e) procedures,

19. Operational control of ISO 14000

An organization needs to apply some type of operational controls to meet its environmental policy commitments, achieve its objectives and targets, comply with applicable legal requirements and other requirements to which the organization subscribes and manage its significant environmental aspects.

20. Emergency preparedness and response

It is the responsibility of each organization to establish (an) emergency preparedness and response procedure(s) that suits its own particular needs.

21. Monitoring and measurement

An organization should have a systematic approach for measuring and monitoring its environmental performance on a regular basis. Monitoring involves collecting information, such as measurements or observations, over time. Measurements can be either quantitative or qualitative.

22. Evaluation of compliance

ISO 14000 Evaluation of compliance
An organization should establish, implement and maintain a procedure for periodically evaluating its compliance with the legal requirements that are applicable to its environmental aspects, as part of its commitment to compliance. The organization should record the results of this evaluation.

23. Control of records

Records provide evidence of the ongoing operation and results of the environmental management system. A
key characteristic of records is that they are permanent and are, typically, not revised.

24. Review of the environmental management system

An organization’s top management should, at intervals that it determines, conduct a review of its environmental management system to evaluate the system’s continuing suitability, adequacy and effectiveness. This review should cover the environmental aspects of activities, products and services that are within the scope of the environmental management system.

25. ISO 14000 Opportunities for improvement

An organization should continually evaluate its environmental performance and the performance of its environmental management system processes to identify opportunities for improvement. Top management should be involved directly in this evaluation through the management review process.

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10
May/11

ISO 9001 Standards in Education and Training

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While usually associated with manufacturing and service activities, ISO 9001 should be considered equally as effective as a management system for education and training programs. If we consider the desired outcome (learning), education and training is just another form of service; the product is the knowledge, skill and/or ability that is achieved by the program attendees. As with other services, the delivery of education and training incorporates the processes of design, development, verification, validation, delivery, subsequent correction and ongoing improvement. Therefore, when we try to apply the requirements of ISO 9001 to education and training activities, we find that it aligns exceptionally well with generally accepted practices.

A fundamental objective of any quality management system is to ensure that customer needs are met. In order to define these needs as they relate to education and training, we must first define the primary customer of this service – the program attendee. I’ve used the term “primary customer” in this discussion, as numerous ancillary customers may also be involved, including the parents of the attendee, the state which provides funding to the institution, and possibly even the country in which the activity is performed (as skill development contributes to the national economy). In the case of corporate training, we must also consider the needs of the individual’s employer, the industry they serve, as well as regulatory bodies or other interested parties. The list of potential customers can be as varied as the number of offerings that are available; identification of both primary and ancillary customers is a critical part of the initial needs assessment process, and is essential to the overall success of any education or training effort.

Once the above customers have been defined, their needs must be translated into terms that can be understood by the organization, and that can be further developed to serve as a measurement of an individual’s competency. Typically, these needs are reflected through the establishment of learning outcome statements, commonly referred to as learning objectives. Upon completion of specific portion of a program (or upon the completion of the program as a whole), the participant should be able to demonstrate a defined level of mastery of the course content, or be able to demonstrate the ability to perform a specific task or activity. To determine if these needs are satisfied, the participants performance throughout this entire process is monitored, and at defined intervals, the individual’s ability to meet a defined learning objective is measured against an established set of criteria (be it quizzes, examinations, demonstrations or other evaluation methods). Once the criteria established for competency is met, the objective is considered to be achieved. This process then continues until all established objectives have been met for the program, at which point a certificate or other form of recognition is awarded.

When considering what would be required to properly design, develop and document such a system to meet the requirements of ISO 9001, we find that there is very little difference between the approach needed to develop a system for this application, in comparison to approaches commonly used to develop systems which address manufacturing activities and other services. Proper design should begin with a review of the key processes used by the institution or organization, their ability to meet the customer needs established above and their overall degree of compliance with the requirements of the ISO 9001 standard.

System documentation required by the ISO 9001 standard, including a quality manual, and the six “system” procedures required by the ISO 9001 standard – the control of documents, the control of records, internal audits, the control of nonconformances, corrective action and preventative action all have a place in this system (as do the 19 types of records addressed in the ISO 9001 standard); they are just as relevant in this application as they are with their counterparts in other industries. Additional documentation, addressing the various activities performed by the organization will also be needed, as necessary to address the critical nature of the activities performed, as well as to ensure the customer needs defined above are met.

While the ISO 9001 standard does allow for an organization to take exclusion to the requirements found in Clause 7, there are relatively few instances where such exclusion would be justified. Typical education and training activities encompass Design and Development (instructional design), Purchasing (materials and services) Validation of Processes (pilot programs and peer reviews), Customer property (information) and even the Control of Measurement and Monitoring Devices (quizzes and examinations). While the specific processes used may vary between different organizations and offerings, almost every clause of ISO 9001 could conceivably apply.

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10
May/11

ISO 9001 Standards Requirements Checklist

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ISO 9001 Standards Requirements checklist

1. Has the organization established, documented, implemented and maintained a quality management system in accordance with the requirements of ISO 9001?

2. Is the effectiveness of the quality management system continually improved?

3. Has the organization:
a) Identified the processes needed for the quality management system including theirapplications throughout the organization?

b) Determined the sequence and interaction of these processes?

c) Determined the criteria and methods needed to ensure that both the operation and control of these processes are effective?

d) Ensured the availability of resources and information necessary to support the operation and monitoring of these processes?

e) Measured, monitored and analyzed these processes?

f) Implemented actions needed to achieve planned results and continual improvement of these processes?

4. Does the organization manage these processes in accordance with the requirements of ISO 9001?

5. Where processes that affect product conformity with requirements are outsourced, are the controls for these processes identified within the quality management system?

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2
Apr/11

Management of the Audit Function In ISO 9001

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Management of the Audit Function In ISO 9001

An effective audit function should provide all levels of management an independent appraisal of their operations andassist them in achieving maximum efficiency while achieving overall organizational goals (Institute of Internal Auditors, “Standards for the Professional Practice of Internal Auditing”). However, before the manager of the organization’s audit function can begin to promote the audit department’s positive contributions to the organization, improve upon the products generated by auditing (i.e., audit reports, analysis), or contribute to the overall continuous improvement of the organization in general, the audit department’s leadership must seek feedback on its own performance. There are many sources of feedback; both internal and external to the audit department.

Feedback from Management

Certainly one of the most important sources of feedback is from senior management. It is critical the audits scheduled to be performed by the audit department closely match the interests of the company’s senior leadership. The audit department’s mission statement must be in line with organizational policies, special interests, and short-term and long-term goals.

Feedback from the Auditee

You might think it unusual for the auditor to ask for feedback from the auditee, however, it is important that his or her voice be heard. There is nothing quite so difficult as requesting an assessment of your performance by those whose management and leadership abilities you’ve just reviewed and critiqued. Nevertheless, it is important to know how you and your work were perceived by the auditee. From the initial contact, to the audit entrance conference, through to the exit briefing, you need feedback regarding the auditee’s perception of you (and the team). Without this feedback, you will not have the information you need to improve your future performance.

Feedback from Audit Team Members

Almost as difficult as asking for performance feedback from the auditee is requesting it from your own audit team members. No one is as tough on a quality auditor’s performance as a fellow auditor. Obtaining feedback, and evaluating team effectiveness, is usually best achieved in the Process Review and Action Team (PRAT) setting. The PRAT is one avenue that may be used to determine not just whether the audit team’s performance (or audit function, for that matter) can be improved upon, but how it can be improved upon. Methods such as brainstorming; nominal group technique; cause and effect analysis; and so on, work well in this forum.

Customer Feedback Regarding Product and Service Quality

Customer feedback in the form of survey data, interviews, complaint rate, etc., is a vital source of feedback. This information is critical to the audit function in that the quality system elements designed to assure product quality (e.g., process control, corrective and preventive action) were probably assessed by the internal audit department at one time or another and found to be acceptable. Negative customer feedback may be indicative of:

  • One or more quality system elements having gone awry since the last assessment.
  • The quality system element(s) previously assessed may have been done so incorrectly.
  • Management’s “pencil whipping” of corrective and preventive actions to earlier audit findings.
  • A lack of, or insufficient follow-up action in response to audit findings by the quality audit function.

Audit Function Effectiveness Rating

The overall effectiveness rating of the audit team usually comes from one or both of the following sources:

  1. External customers-the suppliers, distributors, manufacturers, etc., whose quality system, process, and/or product you have assessed, and/or;
  2. Internal “customers”-your supervisor, his or her supervisor, and those responsible for managing and maintaining the daily internal processes and products within the company.

Quality auditors are judged on their performance. Specifically, their appearance, their conduct, their approach to the audit. Within this sphere of professionalism, “customers” of the audit department generally judge auditors using one particular type of criteria: the “quality” of audit findings and observations to include the soundness of the logic supporting the auditor’s recommendations to correct those findings and observations. Nothing is more frustrating to an auditee than to be the recipient of an audit write-up that has no apparent impact upon the quality system, process, or product.

Setting Management Goals for Continuous Improvement

Setting organizational goals for continuous improvement is a necessity. Continuous improvement certainly applies to quality auditing as well. As technology and the way in which it is managed and manipulated advances, quality auditors need to become experts not only in their area of expertise, but also in the latest management theories and practices, as well as in state-of-the-art technology. Continuous improvement involves knowing what type of management your company (or the audited organization) is practicing (i.e., integrated process teaming, concurrent engineering, etc.), as well as the hardware and software in use, especially as it applies to automated procedures, work instructions, engineering drawings, and revisions. As a minimum, quality auditors need to educate themselves on the latest in:

  • Quality auditing philosophy, techniques and practices;
  • Management philosophy, techniques and practices, as well as:
  • Computer hardware and software.

To add maximum value to the organization, the audit function must ensure its auditors are proficient in all three areas.


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2
Apr/11

How To Meet ISO 9001 Quality Standards?

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In order to meet the ISO 9001 Quality Standards, the business organization need to fulfill the following:

Standardizing Quality Systems

The ISO, or International Organization for Standardization, was established in 1947 to develop international standards for everything from electronics to management systems. Having over 13,000 standards currently in place, ISO has created the auditing and certification process known as ISO 9001. This began the drive toward quality standards.

Improving Customer Satisfaction

Companies choose to implement ISO 9001 and get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their business. And if an area of the company’s program appears to be too bureaucratic and non-value-adding, then it might also be an area for continuous improvement efforts.

Enhancing Company Performance

Both customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verification process, customers can gain assurance of their suppliers’ products. And as a supplier becomes certified, the testing requirement is waved, which saves the company both time and money.

Developing Best Practices

Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” continuous improvement cycle to achieve requirements. This process approach centers around eight quality management principles used by management as a guide toward improving performance and identifying the main elements needed in a good quality system:

  1. Customer Focus
  2. Leadership
  3. Involvement of People
  4. Process Approach
  5. Systems Approach to Management
  6. Continuous improvement
  7. Factual Approach to Decision-Making
  8. Mutually Beneficial Supplier Relationship

Building Stable Processes

ISO 9001 policies, procedures and forms can provide employers, managers and employees with a systematic and consistent approach to implementing policies, plans, procedures and work routines. Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies and procedures to help on the way to certification.

Auditing a Company System

In the certification process, an independent registrar will perform an on-site audit of a company’s operations to verify that it complies with the ISO standard. If the business complies, then that company will be registered as ISO 9001 compliant.

Meeting Company and Customer Needs

On the way to certification, a business can meet its ISO needs by:

  • Using well-defined processes and procedures to build stable processes
  • Training in the audit and certification process
  • Continuously improving with ISO 9001 standards

Noticing the Difference

With complete procedures manuals for ISO 9001 Quality Management System, required HR procedures, and an ISO training class, a template like an ISO 9001 Quality Manager Procedures Manual Series can help a business on its way to ISO 9001 certification. Sometimes the effort can be very great, but companies typically notice a remarkable difference in efficiency and effectiveness after the first year.

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2
Apr/11

Identification of processes In ISO 9001

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Identiication Of Processes In ISO 9001 Standards

1. Distinguishing between the concepts of a process and an activity
If an auditee cannot distinguish between the concepts of a process and an activity, the auditor can briefly explain the differences by using the guidance (clause 2.4) and definition ((3.4.1) in ISO 9000 as background information. The auditor must be able to adapt to the auditee’s situation. It is the auditor’s responsibility to understand the auditee’s systems and approach.
During the audit, the auditor should determine whether there is a problem of difference of terminology only, or whether there is a lack of real implementation of the process approach by the auditee. There may be a need to issue an NCR if the auditee is not fully implementing the requirements stated in ISO 9001, Clause 4.1. If this is simply a terminology problem, there should be no need to issue an NCR, if all the requirements of in Clause 4.1 are satisfied.
The auditee has the right to use its own terminology, provided the requirements of the standard are met. The auditor should mentally develop a cross-reference list to ensure consistency and better understanding.
2. A process has defined objective(s), input(s), output(s), activities, and  resources If the auditee does not understand that a process must have defined (but not necessarily measurable) objective(s), input(s), output(s), activities, and resources, the auditor should try reformulating the questions to the auditee avoiding the use of QM jargon, e.g. Can you explain to me your operations here? What are the basic jobs carried out in your department? What information do you need to start your work? Where does it come from? Who receives the result of your work? How do you know if you’ve done your job correctly? etc..
This should help the auditor to establish whether the processes (as per ISO 9001) are already defined, have clear inputs, outputs, objectives and so on.
3. Processes should be analysed, monitored and/or measured, and improved
If after applying the audit techniques outlined above, there is an absence of any records or other proof to demonstrate that the processes are analysed, and/or monitored, and/or measured, and/or improved, there would appear to be non-conformity with part of ISO 9001 Clause 4.1.
4. The auditee/auditor considers that each clause or sub-clause of ISO 9001
must be defined as a separate process If the auditor considers this as the right approach, he should refer to relevant ISO documents,
(notably the ISO/TC 176/SC 2 document N544 ISO 9000 Introduction and Support Package:
Guidance on the Concept and Use of the Process Approach) which clearly indicates the contrary.
If the auditee considers this as the right approach, it is recommended that the techniques outlined
in section 2 (above) should be used.
5. Is the process approach as described in the ‘Introduction’ to ISO 9001 a requirement of the standard?
The description of the process approach in the ‘Introduction’ to ISO 9001 is purely informative and does not introduce a set of additional requirements by itself. Clause 4.1 specifies the steps necessary to implement a process approach with regard to quality management system processes, the Notes to clause 4.1 providing examples of processes needed for the quality
management system. Audit methodologies must be oriented, accordingly, towards analyzing the processes of the organization.
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