ISO 9001 auditor

Who is ISO 9001 Auditor?

Internal Audit is a mandatory requirement according to ISO 9001 Standards.

An ISO 9001 Auditor must participate in a training course about internal audit and must be certified with auditor certificate by authorized training organization.

There are two kinds of auditor:

1. Normal Auditor; and

2. Lead Auditor

Basic Content of a training course on ISO 9001 Internal Audit

A training course about ISO 9001 will help participants understand the basic principles and necessary practical skills to perform an internal audit and make an effective report on the implementation and maintenance of quality management system in an organization.

1. General Introduction to Quality and quality management;

2. Introduction to 8 principles in quality management;

3. Introduction to and explanation of ISO 9001:2008 Standards;

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ISO 9001 audit report

ISO 9001 Audit Report

Audit Report isn’t necessary to be long but must be general and objective on the current condition of the audited organization. The report must address good practices that should be recognized, visible risks and identified problems.

An audit report should involve the following contents:

1. The Date of the Audit

When was the Audit performed? This is a proof that the audit has been performed according to a planned schedule. If the managers want to know about the use of personnel for the audit or timeline of the audit, it is good to mention them in the Audit. All of these will help answer the question “How much time and money have been spent on internal audit activity?”

2. Audited areas

This is very important, especially when the organization has got many operation offices.

3. Applied Standards

When performing an audit on a third party, audit standards to be applied should be those on quality management system such as ISO 9001, ISO 14001, etc. In internal audit, auditing standards are often a list of documents relating to the audited activities such as procedure, guidance, or forms, etc.

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ISO 9001 2008 requirements

ISO 9001:2008 requirements are available at ISO 9001 standard such as:

1. ISO 9001 GENERAL

1.1. Index and revision status
1.2. Purpose and scope
1.3. Exclusions

2. COMPANY BACKGROUND

2.1. Company background and history
2.2. Activities

3. DEFINITIONS AND CONVENTIONS

3.1. Definitions and conventions
3.2. Abbreviations

4. QUALITY MANAGEMENT SYSTEM

4.1. General requirements
4.2. Documentation and records

5. MANAGEMENT RESPONSIBILITY

5.1. Management commitment
5.2. Customer focus
5.3. Quality policy

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ISO 9001:2008 changes

Some new points in ISO 9001:2008

On 14th January 2008, International Standard Organization officially published ISO 9001:2008 standards, which is the latest version of Quality Management System applied in 175 countries all over the World.

ISO 9001:2008 remains the same in structure with little change in accordance with ISO 9001:2000. It includes the following sections:
Standard structure

1. Scope
2. Normative Reference
3. Terms and Definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement

However, in content, there are some new points as below:

1. Identify in the quality system approach and method of controlling external processes;

2. Clearer details on the control of external processes;

3. Change in document structure in quality management; the importance of files increases in equal to procedures;

4. Emphasis on analysis and improvement of processes;

5. Clearer representation of procedures; one procedure may involve many processes or many procedures represent a process;


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ISO 9001 questions

Auditors may use the following method to ask questions in an ISO 9001 internal audit. Following are some tips that need consideration:

1. Remember that the audited individuals are not recruited to answer the auditor’s questions

They are paid to do their jobs. Therefore, they are not likely to tell you exactly what you expect to hear, but instead, they will describe their own working processes in their understanding and experience which shows that they are qualified for the jobs.

2. Ask open-ended questions instead of close-ended questions

Let the audited employees explain their own performance. One will be more likely to give the most sufficient response if he or she is not subjectively suggested of the answer by the auditors.

3. Ask the audited employees how their jobs are performed

An auditor will not only want to know which tasks were done but also how correctly they were done in conformity with procedures. A non-conformance report will help the auditor know the wrong actions, but the audit may also be good to help identify which the root cause to wrong actions is.

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ISO 9001 quality policy

ABC Corporation strives to become the leading company in XYZ market in the areas of manufacturing engineering and construction services in the following commitments:

• ABC Company is ready to meet satisfactorily all the requirements of the customer contract has been signed as well as statutory requirements and regulatory.

• Applying scientific advances and new technologies in production and installation to:
– Ensure quality of mechanical products and construction services.
– Optimization of costs to achieve a competitive price.
Transactions and convenient delivery.


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ISO 9001 quality manual

An ISO 9001 quality manual must follow structure of ISO 9001 standard. So that you can ref more information for ISO 9001 quality manual at table of contents as follows:

1. ISO 9001 GENERAL

1.1. Index and revision status
1.2. Purpose and scope
1.3. Exclusions

2. COMPANY BACKGROUND

2.1. Company background and history
2.2. Activities

3. DEFINITIONS AND CONVENTIONS

3.1. Definitions and conventions
3.2. Abbreviations

4. QUALITY MANAGEMENT SYSTEM

4.1. General requirements
4.2. Documentation and records

5. MANAGEMENT RESPONSIBILITY

5.1. Management commitment
5.2. Customer focus

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ISO 9001 implementation

Steps to apply ISO 9001:2000

a professional support organization with the knowledge, skills and business experience will help a lot in advance to shorten the time of certification, to help businesses track and avoid the negative effects due process operation of the waste and inefficiency

ISO 9001:2000 applies to an organization will be conducted in 9 steps:

Step 1:
Learn the criteria and determine the scope of application. Leaders need to understand the meaning of ISO 9000 in organizational development and orientation activities, identify goals and specific conditions apply

Step 2:
Project steering ISO 9000. The application of ISO 9000 is a big project, so it needs a steering committee of ISO 9000 in the enterprise, including leaders and representatives of the departments represented in the scope of ISO 9000. The representative should be appointed leader instead of quality leadership in directing the application of ISO 9000 management system and responsible leadership on quality activities.

Step 3:
Assessment of business situation compared with the standard requirements. Should review the activity-oriented process, to consider any applicable requirements and meet the current level of activity in the enterprise. This assessment as the basis for determining the activities to change or supplement so that the implementation plan details

Step 4:
System design and establish the quality system documents. The documentation must be built and completed to meet the requirements of standards and operating requirements of the business including:
- Quality Manual
- The processes and procedures related
- The work instructions, rules and regulations necessary

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ISO 9001 history

ISO 9001 History
Overview

ISO 9001 Quality Management System, as know as ISO 9001, is one of ISO 9000 standards. This system sets up requirements for organizations those design, develop, manufacture, assemble or supply any kind of product or service and want to apply that system to improve their product and service quality.
ISO 9000

ISO 9000 Standards include many standards, in which the main standard is ISO 9001: Quality Management System which sets up requirements that organizations have to meet with their quality system. Besides, there are additional and guide standards which are:

1. ISO 9000: Terms and Definitions

2. ISO 9004: Guidelines for Performance of Management System Assessment

3. ISO 19011: Guidelines on principles of auditing a management system
ISO 9001 Versions

4. ISO 9001:1987 – Quality Systems

Quality management – quality management models in design/implementation, manufacturing, installment and technical service


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ISO 9001 certification bodies

ISO 9001:2008 requirements are available at ISO 9001 standard such as:

1. ISO 9001 GENERAL

1.1. Index and revision status
1.2. Purpose and scope
1.3. Exclusions

2. COMPANY BACKGROUND

2.1. Company background and history
2.2. Activities

3. DEFINITIONS AND CONVENTIONS

3.1. Definitions and conventions
3.2. Abbreviations

4. QUALITY MANAGEMENT SYSTEM

4.1. General requirements
4.2. Documentation and records

5. MANAGEMENT RESPONSIBILITY

5.1. Management commitment
5.2. Customer focus
5.3. Quality policy
5.4. Quality system planning
5.5. Organization and communication
5.6. Management review


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Guide to ISO 9001 - BS EN ISO 9001:2008 Explained

The Origins of ISO 9001:2008

BS EN ISO 9001:2008, to give it its full title, is an internationally recognised standard for quality management systems requirements, formerly know as BS 5750. During the First World War it was noted that some munitions were particularly unreliable. This meant that not only were they ineffective, but also in some cases, they caused loss of life to those attempting to deploy them. This lead to the development of a defence standard for the management of quality in the production of munitions.

Over the following 60 years this standard evolved into BS 5750, which was widely adopted by industry (both commercial and military). In a move towards the globalisation of standards, BS 5750 was combined with international standards and evolved into BS EN ISO 9000 in 1987.

Recognition for the need of quality management systems in all areas of business (i.e. service industries as well as the traditional manufacturing sector) throughout the 1990's lead to the demands on the standard (ISO 9000 series) changing. Because it had its roots in the manufacturing industry, it was difficult for other industries (the service sector in particular) to adopt the standard.

In the year 2000 this was addressed in the most significant amendment to ISO 9001 since its inception. It re-evaluated the principles of quality management and the result was a restructuring of the standard. The most recent review of the standard was published in 2008, but this revision was not a major change.

The principles of ISO 9001:2008

There are eight management principles that underpin the standard. These are all recognised principles of good management and ISO 9001 brings them together to form the model for a robust and effective management system.

The principles are:

* Customer focus
* Leadership
* Involvement of people
* Process approach
* System approach to management
* Continual improvement
* Factual approach to decision making
* Mutually beneficial supplier relationships

When developing any element of a management system each of these principles needs to be considered.

What is required

The 2008 version of the standard adopts a business process management approach. Only

four core elements now exist in the standard and these apply equally to any business

process whether engaged in the manufacturing or service industries.. These elements

are:

* Management responsibilities
* Resource management
* Product realisation
* Measurement, analysis and improvement

In summary, this means that the standard requires that your management systems cover the following issues:

1. Management responsibilities

The roles and responsibilities of management and staff need to be clearly defined and understood. This includes an understanding of the structure of the organisation and how the groups within it interrelate. This enables adequate planning, objective setting and effective management of the organisation.

2. Resource management

Adequate resources (including human resources) need to be made available and managed to ensure the implementation of a quality management system. These include:

* Providing methods for identifying the level of resource required for key tasks and functions.
* Understanding the knowledge and skills required to effectively manage the business, both now and in the future.

3. Product realisation

These are the controls employed to ensure that any product or service delivered to the customer meets their requirements. These include the traditional controls for manufacturing and the definition of customer requirements for services. This will usually form the largest part of a management system and will identify how the organisation controls its business from identifying customer requirements, through contract review, planning and execution of the tasks that deliver the product or service to the customer. These controls will contain a definition of the checks and balances that are in place to ensure that each stage of the process achieves what is required to deliver satisfaction to the customer.

4. Measurement, analysis and improvement

For the effectiveness of any management system to be monitored it is necessary to measure its performance. The need to continually improve is now integral to ISO 9001.

Gaining third party certification

ISO 9001:2008 provides an internationally recognised model for quality management systems. There are many tangible benefits to adopting the ISO 9001 model. These include improvements to organisation effectiveness, efficiency and the continual improvement of the business. Gaining third party certification can also bring benefits. It allows you to demonstrate to your customers and potential customers that you are a well organised, capable supplier who provides consistently high levels of customer satisfaction and operates best practice in business management. Certification means using an accredited independent third party to objectively assess your management system to certify that it complies with the standard. It is achieved by having an independent third party assessor audit your management system. There are a number of certification companies in the UK and worldwide who provide this service. In the UK these assessment bodies are regulated by the United Kingdom Accreditation Service (UKAS http://www.ukas.com ). This organisation provides the assessment bodies with an accreditation service that regulates the process and provides the industry with assurance that consistent standards are applied. Any organisation can issue a certificate that claims compliance with the standard but this only has independent credibility in the UK if the issuing authority is a UKAS accredited body. The process of certification typically takes the form of a pre-assessment followed by an initial assessment that is maintained by ongoing periodic surveillance audits.

* Pre-assessment - takes place 3 to 6 months after the management system has been established. This allows time for records to be generated as evidence of the operation of the system. The pre-assessment allows the assessment body assessor to familiarise themselves with the system and identify any major omissions in the system before the assessment.
* Time Period - usually 6-12 weeks between the pre-assessment and initial assessment to allow amendments to the system to be completed and implemented.
* Initial assessment - formal assessment of the management system against the standard. This involves an examination of the documentation that forms the management system plus an assessment of the evidence gathered. This demonstrates that the documented system is working in practice.
* Initial assessment process - involves interviewing a number of managers and staff. An assessment is carried out on a sample basis, so not all records will be examined and not all staff will be interviewed. When issued, a certificate is only valid for a limited period of time and can be removed or cancelled by the certification company at any time. A certificate is normally valid for three years.
* Maintenance of certificate - the certification body re-visits and carries out surveillance audits to ensure standards are maintained. These are typically conducted every 6-9 months, dependent upon the size and complexity of the business under assessment. Where an initial assessment will need to evaluate the entire system, a surveillance audit is likely to be of more limited scope and will sample areas of the system in rotation. Over the 3-year period it is necessary for the certification body to have re-visited all areas of the system.
* Renewal of certificate - a full reassessment of the system is required after three years.

A copy of the standard can be obtained from the International Organisation for Standardisation (ISO) or British Standards Institute (BSI). Certification services are offered by a large number of companies worldwide. A full list is available from UKAS. What to do next If you are considering implementing ISO 9001:2008 or are simply looking to develop a quality management system and think you may need help and advice, please contact The Quality Team today for an informal no obligation chat.


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How to Implement ISO 9001 - 2008 Quality System

Keys for Success

Implementing a new Quality System takes time and resources. Your new ISO 9001 Quality Manual and Quality System will become your road map to success. There are many resources that can help keep an implementation on the right track. The International Organization for Standards has a wealth of information at your disposal. ISO has some of the most valuable resources available in the form of guidance documents. Some of these resources are listed below:

* Guidance on ISO 9001:2008
* Guidance on the documentation requirements of ISO 9001:2008
* Guide to the Terminology used in ISO 9001 and ISO 9004
* Guidance on the concept and use of the process approach for management systems
* Guidance on "Outsourced processes"
* Implementation guidance for ISO 9001:2008

The following keys for success will help you keep on track to accomplish a successful implementation.

1. Management Commitment

Implementing a new quality system takes time, effort and resources. If you are launching a project to implement ISO 9001, make sure you have the full support form your Management Team. Commitment from the Management Team will not only help achieve your implementation schedule but will help sustain the cross functional ownership of the system once it is implemented. A single person cannot be responsible for implementation. Engage the Management Team early by defining a mission statement and quality policy.

Discuss the following benefits of ISO 9001 with the Management Team

* Improved Customer Satisfaction
* Improved Internal Communication
* Measurable Objectives
* Reduced Non-Conformances and Scrap
* System to correct and prevent problems
* World recognized standard for Quality
* Continuous Improvement objectives

2. Create a Project Team

The success of any project requires effective Project Management. Project Management will establish project priorities, time lines and resource allocation. The ISO 9001 Project Manager should be a member of the Management Team who is supported by the Management Team. The Project Manager should have the responsibility and authority to keep the team on track.

* Assign a cross functional team to the project to win buy in
* Assign members from each functional area in the company even though their contributions may be limited.

3. Launch the Project

The Project Manager should launch the project by announcing it to the company so that everyone in the organization is aware of the new Quality System requirements the company is implementing. Announce the team and set incentives like a company lunch, team certificates, etc. The monetary value is not as important as the recognition and satisfaction personnel will feel if they are involved along the way

* Try to set up a training webinar or internal training session on ISO 9001 so that the team and/or company can get acquainted with the concepts.
* Post signs with updates on progress
* Have periodic meetings with employees to get their feedback

4. Conducting an ISO 9001 Gap Analysis

Conducting a Gap Analysis of a quality system is a formal way for a company to evaluate where they are and where they need to be. The goal is to understand how to improve the current quality system to meet the regulatory requirements of the ISO 9001 Standard. A Gap Analysis Checklist can be written or purchased to accomplish this task. Each section of the standard is checked to determine if the current system meets the requirements of the standard. Upon completion of the Gap Analysis, the scope of the project can be understood. ISO 9001 requires specific documented procedures and records to comply with the standard.

5. Team Meetings

Team Meetings should be planned around each quality system requirements as it relates to each functional area in the company. For instance, Supplier Controls and Purchasing requirements should be discussed with the Purchasing Team. Non-Conforming Material Control could involve manufacturing as well as receiving inspection. The system which will be implemented needs to work in both departments. The meetings should be short and to the point reviewing progress, time lines, and accomplishments. Ensure the time lines are realistic. Keep everyone informed with bulletins, or progress reports so the project does not loss its momentum.

6. Create the Quality System Documentation

The first document that should be written is the Quality Manual. The ISO 9001 Quality Manual is the overriding policy statement and the document which will identify the quality system requirements that your company will implement. The Quality Manual also documents exclusions and justification for not complying to a requirement. Some requirements are not relevant to your company's business. The Quality Manual will be used moving forward as the upper level policy document which should be consistent with each Standard Operating Procedure written. Remember, ISO 9001 is a process approach.

Using the Gap Analysis, the project plan can be updated to include all the Standard Operating Procedures which need to be created or modified to comply with the standard. As the procedures are written, a central repository should be created to save the documents electronically. Each document will require review and approval to determine if the requirements have been met. As the project progresses, each procedures created will fill a gap identified during the gap analysis.

There are five sections in the standard that specify activities that need to be considered when you implement your system:

* Overall requirements for the quality management system and documentation
* Management responsibility, focus, policy, planning and objectives
* Resource management and allocation
* Product realization and process management, and
* Measurement, monitoring, analysis and improvement.

When creating a quality system from the ground up, Standard Operating Procedure Templates can be very useful and save a lot of time. There are various debates regarding if using a template is an effective way to implement a Quality System. Each company needs to evaluate the pros and cons. Using a good template can save thousands of dollars, establish a consistent format and give the company a solid foundation to build on. Remember, templates are to be modified to meet the company's core competencies and organization structure.

7. Implement the System and Train Staff

A lot of work has been done to get to the point of implementation. The ISO 9001 Quality System will be successful once the company understands the new requirements, documentation and their new roles in complying with the standard. Training all personnel is the key to success. Although this process is cumbersome, if effective training is not accomplished the system will not be effective. It takes commitment from the company and the Management Team to make it a successful launch.

8. Verify the Effectiveness of the Quality System

Now that your system is in place and the company is using the system, it is time to verify the effectiveness of the system. The best way to verify effectiveness is to audit the new processes. This can be accomplished by using an external third party auditor or your own Internal Audit Team. Using your Internal Audit Team provides many benefits. It reinforces the understanding of the requirements and keep the employees working together on compliance. Creating an Internal Audit Checklist can be very helpful since the Internal Audit Team will have difficulty recalling all the requirements that need to be verified during an audit. The audit results should be discussed at Management Review to determine is corrective actions need to be taken to address any issues that may have been identified.

9. Manage the Quality System

Managing a new Quality System is challenging after a launch. The focus on customer satisfaction is critical as well as the core requirements of the ISO 9001 Quality System.

* Monitor and measure the progress of your Quality Management System
* Strive for continual improvement
* Consider implementing goals and objectives in the company operation

10. Find a Registrar

There are many companies that can certify organizations to the ISO 9001 Standard. Interview several registrars to determine which company is right for you. Consider their location, travel costs and other administrative fees. There are a lot of resources available, talk to other companies and ask for referrals.


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The ISO 9001:2008 Standard Isn't a Suggestion

I've just completed an assignment that has brought the kind of insight into management behavior that has to be shared. And if you're reading this, you most probably have similar experience and will resonate with these thoughts. In today's business environment, the understanding of continual incremental improvement is an absolute. Somebody, somewhere is studying how to develop and deliver your product with more benefits. Its called competition by some, and free trade by concept, but it absolutely determines whether you give your equity away or are able to grow and continue to prosper.

The majority of companies doing the kind of work I focus on were started with massive passion and very little capitol. Over time, a way of doing what they do evolved that seemed to work for them, because at the end of the year there was some money left after paying the bills. There is a concept I'll introduce here called workmanship that is most often used when a certain level of consistency must be realized from an activity. It implies profound knowledge of the end result, and capturing events in advance that might cause the end result to be less than what is expected. It is easily recognized in trade work and appreciated as a personal discipline that is offered to exceed a customers expectations. For some reason it is not as easily recognized in business management, and the results display themselves as a percentage of non-conforming products, inability to meet scheduled delivery dates and eroding margins, among others.

So the contrast is plain to me only because I've had the benefit of working on both sides of this issue. I've worked with companies that are customer focused, and I've had the experience of working with companies that are competition focused. I've seen where the money is made and business relationships are established. And when I talk to company leaders, without exception, everyone agrees with this concept in principle. Because any road will seem like the right way to travel if you've been down it enough times.

Case in point: A customer has purchase order requirements for a quality system that demonstrates a ISO 9001:2008 level of consistency as evidenced by documented behavior. The supplier takes these requirements as demands, and constructs a paper kingdom to comply with the customers purchase order requirements. Sound familiar?

The cost of the added paper process is my focus. Since this company has been doing what they do for so long, and has been rewarded for doing it, it's really hard for them to understand how a manufacturing standard like ISO 9001:2008 can offer any meaningful suggestions for improvement. It's all about compliance, and the paper kingdom gets really expensive when margins are being challenged.

There is a big difference between discipline and a forced compliance, and this is where the work I do with organizations is designed to help them understand and develop a gradual discipline to get the cause and effect feed back they need to make really good decisions. There is no way a single standard such as ISO 9001:2008 can be expected to cover the uniqueness of all the organizations using it, so it has to be understood and applied with the each organizations end expectation in mind. There is a lot of trial and error potential in this type of an endeavor, so having a partner who has been down this road before can make a big difference as to whether the learning curve is flat or steep.

Business decisions made for improvement must show a positive financial return or they are not worth doing. We can help integrate the thought processes of ISO9001:2008 into your present business thinking so the positive returns are evident as cause and effect behavior. And if you are faced with creating the paper kingdom for compliance, give me a call and lets talk about it.

The ISO 9001:2008 standard isn't a suggestion...


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ISO 9001 Standards

ISO 9000 Standards - ISO 9000 Standard Software

ISO 9001 Standards Training Video

iso 9001 standard system standards facilitating mutual

• ISO standards - ISO 9000
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• About ISO/TC 176 - ISO/TC176 Web Site
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