Steps to Implementation, Maintenance Audits & Training

ISO matrix initiates a new Quality Management System (QMS) implementation with:
1. On-site training of our client’s staff to the requirements and expectations of the project. This includes a critical course on the introduction to the standard.
2. Next comes information gathering from the relevant departments to begin charting the company's internal interactions and determination of relevant existing documentation and procedures.
3. Creating a customized corporate Quality Manual that preserves the unique activities of each company is one of ISOmatrix's greatest strengths. Quality Manuals need to reflect the things that make your company special and ISOmatrix focuses on creating systems that take full advantage of our client company's competitive advantages from small Mom & Pops to Multi-facility, multi-nationals.
4. Level 2 - procedures are the next level of documentation that ISOmatrix can prepare. There are procedures required by specific standards and ISOmatrix focuses on creating a perfect merge of each unique business with the written requirments of the standard with two goals in mind:
o Meeting the requirements for certification
o Maintaining a simplified document path as a useful system component for each unique business
5. Level 3 - Work Instructions if requested. Once again, training on each Level is a critically important part of a successful implementation, so ISOmatrix performs on-site training to get each project off to the best possible result.
6. Based on Client request, ISOmatrix can stay involved through the deployment phase or hand it over to management.

How Will ISO 9001:2008 Relate To The Needs Of Specific Business Sectors?

ISO 9001:2008 remains compatible with existing management systems standards for specific business sectors like ISO/TS 16949, AS 9000/EN 9100 and TL 9000.
Users of a specific sector scheme should refer to the organization that is responsible for that sector scheme, e.g. for:

• ISO/TS 16 949 refer to the IATF,
• TL 9000 refer to the QuEST Forum
• For AS 9000/EN 9100 refer to the IAQG

How Does The New ISO 9001 Standard Affect Existing ISO 9001 Quality Management Systems?

As currently certified organizations start looking at ISO 9001:2008, they will wonder to what extent the changes will affect them. To a large extent, the new standard will not result in significant change to existing quality management systems (QMS).
ISO/TC 176 was careful in not making change for change sake. The changes that have been incorporated into this edition of the ISO 9001 standard include changes that should lead to a better understanding across a broader range of product types, including service organizations; use of deliberate wording to minimize the potential for incorrect user interpretation; and reflect nuances of similar word concepts. Lastly, some of the changes to specific clauses were made based on the 2004 International User Feedback Survey. This survey was conducted after the publication of ISO 9001:2000 and had invited respondents to identify areas they most wanted to see improved.

What Is The ISO 9001: 2008 Standard?

The latest edition of the ISO 9001 standard ISO 9001: 2008, Quality Management Systems Requirements, was officially published by (ISO) the International Organization for Standardization on November 14, 2008. It is the fourth edition of the ISO 9001 standard since it was first published in 1987.
ISO 9001:2008 is a standard that provides a generic set of requirements for organizations wishing to develop a quality management system (QMS). The ISO 9001:2008 standard focuses on improving an organizations business processes. It does not specify any requirements for product or service quality. Customers typically set product and service quality requirements. However, the expectation is that an organization with an effective ISO 9001 based QMS will indeed improve its ability to meet customer, statutory and regulatory requirements.

What are the workshop contents.

Workshop Contents
Introduction of the changes and transition to ISO 9001:2008
• Assessing your organisations current perception of ISO 9001
• Maximising the opportunity that change presents
• Creating a financial balance sheet of costs and benefits
• Introduction of tools for bringing about change in engagement and perception
• Creating a personal action plan for your organisation

Integrated Management Systems Course for TS 16949:2002,OHSAS 18001:2007,ISO 14001:2004 and ISO 9001:2008

Aims Management Consultants Training Services is proud to present a 5 days intensive Course on integrated management system. This Course is based largely on the requirements of TS 16949: 2002, OHSAS 18001: 2007, ISO 14001: 2004 and ISO 9001: 2000 standards. This course is designed with adequate technical contents for quality and environmental management and occupational health and safety systems professionals to gain important knowledge needed to manage and audit an integrated management system, while allowing quality, safety and environmental professionals to understand how management systems operate and how audits are carried out for this integrated management system.

ISO 9001:2008

May 2008, a revision of ISO 9001, the world’s most popular standard for quality management systems (over one million certificates issued in 170 countries), was submitted for approval.The International Organization for Standardization’s official press release (June 17, 2008) explained that “The proposed ISO 9001:2008 does not introduce additional requirements compared to the last edition in 2000 and does not change the intent of ISO 9001:2000.”
The November 2008 issue of Quality Digest magazine said ISO 9001:2008 “clarifies requirements in outsourcing, document control, and customer relations ... Many of the changes are designed to bring about better compatibility between ISO 9001 and the ISO 14001 environmental management systems standard.”

Why do I need to be certified to do this?

Having a certified system is a method of demonstrating to your stakeholders that you have this level of organisation. Often other organisations require ISO 9001 as a minimum requirement to submit tenders or bids. This is because it means that they don’t have to scrutinise your organisation as it’s already been done by an accredited third party.

Steps for Implementing Continuous Improvement

Implementing the ISO 9001:2008 is not just a one-time benefit for a company.
This is important because companies that do not continue to improve are soon overtaken by the competition.
Implementing an ISO 9001:2008 is a win-win proposition!
The ISO 9001 standard is an international model for quality management systems.
ISO 9001:2008 is designed around common business practices which are influenced by the size and structure of the company, their established objectives, the products and services they provide, and the processes used to meet customer requirements.
The intent of the standard is to provide guidelines for developing, implementing and improving a quality management system to enhance customer satisfaction and to consistently deliver quality products and services. The continual improvement of the company's overall performance should be a permanent objective.

Debate on the effectiveness of ISO 9000

The debate on the effectiveness of ISO 9000 commonly centers on the following questions:

• Are the quality principles in ISO 9001:2000 of value? (Note that the version date is important: in the 2000 version ISO attempted to address many concerns and criticisms of ISO 9000:1994).
• Does it help to implement an ISO 9001:2000 compliant quality management system?
• Does it help to obtain ISO 9001:2000 certification?

Description of the ISO 9001:2008

This course provides an overview of the ISO 9001:2008 quality standard. The specific requirements are interpreted for the manufacturing, software, and services industries. Class exercises at the end of each major ISO 9001:2000 clause help to reinforce application of the requirements.
Duration
This course is taught as a one-day class. For coverage of key implementation activities, documentation structure, audit preparation, and the registration process, attend our two-day Implementing ISO 9001:2008 course.

what are the new requirements of the new standard?

• Statutory requirements are given scale as any other legal or customer's requirements.
• The statutory requirements are including the suppliers as well.
• A purchased process is just like any other product that the organization purchased. If it's affecting the product it must be under the quality system.
• You may include two quality processes in one document and split one process to two documents.
• The management representative must be a member of the management.
• A requirement to ensure that trainings are suitable for the product in advance and not to check if the training was effective after it was taken.
• Information system in now officially considered as a substructure.
• Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.
• Measuring is considered as one of the activities of product realization.
• The product must be identifying not only on the shelves but also throughout the realization process.
• The management is now responsible for preventive and corrective actions regarding nonconformities that were discovered suring audit.

ISO 9001:2008 Quality system Documentation Description

Our two-day Quality System Documentation course is based on ISO 9001:2008 document and record control requirements, as well as, guidance from ISO 9004:2000, ISO/TR 10013:2001, ISO 90003:2004, and ISO 15489:2001. The course provides practical guidance on how to write readable and usable documents for quality management systems.
Lectures by experienced instructors, along with practical team exercises, will help you gain the necessary skills to evaluate and prepare quality manuals, procedures, instructions, and forms.

Why is the new version an amendment and not a revision?

ISO has been very clear about the form ISO 9001:2008 will take - it will contain no new requirements, making it an 'amendment' rather than a 'revision'. However, according to Chris Cox, who has been involved with ISO TC/176 as a principal expert since 1995 and is a member of the CQI Standards Development Group, 'many comments were received at the draft stage, urging a more detailed change to the standard'.
The committee kept changes to clarifications deemed necessary as a result of the comments received and to increase compatibility with ISO 14001 and the soon-to-be-revised ISO 9004. 'Comments rejected because they call for a major revision have been archived for review at the next full revision,' explains Chris.

Internal Auditor Training for ISO 9001:2008 Objectives.

Understand how to prepare, conduct, and follow-up on internal audits for ISO 9001.

• Internal Quality Systems Assessment? Discuss the elements of a quality system, interpretation of the requirements of ISO 9000, and what third-party assessment agencies look for.
• The Three Audit Phases-Planning, execution, and follow-up are examined closely using concepts detailed in ISO 19011.
• Planning and Auditing-How to prepare for an audit and how to manage your resources effectively.
• Conducting the Audit-How to collect objective evidence and document observations, including techniques for effective questioning and listening.

How is the Standard changed ?

The good news is that the 2000 version of the standard promises benefits that will apply equally to small firms as to large organisations. These include the following :

• Written in clear language; simple to use and less bureaucratic
• Applicable to all sizes of organisation and all product sectors - including service
• More emphasis on 'the processes' of a business
• Ability to reduce the scope, according to the type of organisation
• Compatible with related standards, such as ISO 14001 (Environmental)
• Provides a pathway to continual improvement

Why are customers embracing ISO 9001: 2008?

Companies who are being told to by their customers, Those whose competition is doing it and Those who want to steal a march on their competition. Also those whose current customers are happy with them but know that doors are shut to them in new areas which they want to break into or quote for as well as those who want to improve their businesses. It shows your customers and prospective customers that you care about them and the service you provide.

ISO 9001:2000 Documentation Requirements

ISO 9001 :2000 requires a variety of documents:
(1) Quality Manual
The Quality Manual describes the overall quality management system of the company. Writing the Quality Manual is usually the starting point of developing the ISO 9001 documentation. ISO 9001:2000 requires the Quality Manual in section 4.2.2
2) Six Quality Procedures

The Quality Procedures describe in relatively general terms the overall process flow, its interaction with related processes, as well as the distribution of authorities and responsibilities. Writing the Quality Procedures is usually regarded the most difficult part of developing the ISO 9001 documentation. ISO 9001:2000 requires the Quality Procedures in the following sections:

• ISO 9001:2000 section 4.2.3 (Control of Documents)
• ISO 9001:2000 section 4.2.4 (Control of Records)
• ISO 9001:2000 section 8.2.2 (Internal Audit)
• ISO 9001:2000 section 8.3 (Control of Nonconforming Product)
• ISO 9001:2000 section 8.5.2 (Corrective Action)
• ISO 9001:2000 section 8.5.3 (Preventive Action)

(3)Quality Policy

The Quality Policy is the top-level policy directive regarding quality and customer satisfaction. It is usually a short one- to two-paragraph statement. ISO 9001:2000 requires the Quality Policy in section 5.3.
(4) Quality Objectives

Quality Objectives are designed to support the Quality Policy. They are specific and measurable goals. As the goals are met, new goals are set. ISO 9001:2000 requires Quality Objectives in section 5.4.1.
(5) Process Flowchart

ISO 9001 requires "a description of the interaction between the processes of the quality management system". Though this description can be in an form, a flowchart is a very appropriate format. ISO 9001:2000 requires the "description" in section 4.2.2.

Validity of certifications to ISO 9001:2000 .

One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or recertifications) shall be to ISO 9001:2008.Twenty-four (24) months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.

What are the main changes?

In 2000, major changes were put in place and continue to remain important and valid. The current changes are more a clarification of points already in the standard rather than the inclusion of new requirements. Changes have also been made to be consistent with the current ISO 14001 revision (2004) in order to make the combination easier and more efficient.
The main changes are the following:

• Reinforcement of control over outsourced processes that affect product conformity to requirements
• Management representative has to be a member of the certified organisation and not an external individual
• Competence is much more a key issue in the new standard as it specifies that the competence of personnel affecting the performance of conformity to product requirements must be controlled by the organization.
• Additional guidance to explain the different methods on measuring and monitoring customer satisfaction
• Concerning the internal audits, the management of the audited units must ensure that necessary corrections and corrective actions are taken
• Clarification that information systems are included as a part of the company’s infrastructure, and therefore the management system.

The Impact on the ISO 9001:2000 Assessment.

The ISO 9001:2000 standard is a radical revision of the prior ISO 9000 standard. It requires companies that have previously been certified to update their current quality systems. It also changes the ground rules for all the organizations that are seeking or who will seek registration in the future. National standards bodies, registrars, consultants, and the other groups who support the standard must now contend with a new set of challenges and opportunities.
Like its predecessor, ISO 9001:2000 is really a series of three interrelated standards. Each has a different function: ISO 9000 deals with fundamentals and vocabulary; ISO 9001, the heart of the new revision, states the requirements for the new system; ISO 9004 provides guidance for implementation, and fleshes out ISO 9001.

What are the changes in ISO 9000:2008?

At this time, ISO 9000:2008 has not been published so we can only make an educated guess based on the drafts of the revisions that have been circulated. However, based on the drafts, we expect that ISO 9000:2008 will change only very little from the current ISO 9000:2000. There will be changes to the wording but little, if any, substantial changes to the actual requirements; in other words, we don't expect many additional requirements or removed requirements of ISO 9000.

What is this all about?

According to the rules of the International Organization for Standardization (ISO - the publisher of the ISO standards), the ISO 9000 standard undergoes review and revision every 6-8 years. In the past, ISO 9000 was revised in 1994 and in 2000. In the end of the year 2008 there will be another revision published, which will be called ISO 9000:2008.

Who should attend?

All persons interested in understanding the intent and requirements of the ISO 9001:2008 standard and how to apply its principles to establish a Quality Management System in their respective organizations.

Learning Objectives

• Understand ISO 9000 Quality Management Principles
• Learn the requirements and intent of the ISO 9001:2008 standard
• Know how to apply the ISO 9001:2008 requirements

Breathe new life into your Quality Management System!

Your organization will achieve ISO 9001:2008 registration quickly, cost effectively and efficiently.
We will document your Quality Manual, Procedures, set up all the required records and forms for you.

• Executive Overview
• Support you need for success
• Implementation training
• Techniques that ensure audits are Value-Added
• Sector specific solutions for Software, Hardware, Services, and Manufacturing industries
• Registrar selection

ISO 9001:2008 Vs ISO 9001:2000 new ISO 9000 Requirments

Congratulations to us. We have a new standard. ISO 9001: 2008. This is really an exciting moment for quality managers. we prepared here a list of the new requirements and comparison list between the ISO 9001:2000 and the new born ISO 9001:2008.
In order to celebrate this event in a way that only quality managers know how, we prepared here a comparison article between the ISO 9001:2000 and the new born ISO 9001:2008. We also included our comments regarding our experience and our perspective of things. At the end of it we will summon the new requirements freo the ISO 9001:2008 standard.

There will NOT likely be any significant changes to ISO 9001:2000 when it is revised in either 2008 or 2009. Here are some related facts that support

Since the re-write of ISO 9001 in 2000, ISO officials have been monitoring its implementation around the globe. Many companies have praised the change from the element to process approach, citing improved ease of integration with their current business processes. While more than 80% of companies worldwide indicate that they are satisfied with the changes made to ISO 9001, the International Organization for Standardization (ISO) continues to monitor suggestions for improving the standard.
The ISO Review Process requires a review of each standard at least every five years. Their commitment to continual improvement involves constant review of each standard, which for ISO 9001 has been conducted through surveys, focus groups and one-on-one discussions. Suggestions for changes have come from companies worldwide, ranging from international corporations to family businesses.

ISO 9001:2008 Certification/Registration

The prospect of achieving certification to a standard you have little knowledge of & may never have even read, can be daunting – to say the least. The man-hours spent interpreting these standards & attempting to create a compliant system soon accumulate & may not result in great success. The alternative of seeking help can be equally daunting, with so many consultancies offering you various solutions, costs & interpretations. At QM.UK we don’t try to re-invent the wheel, our consultants are fully trained to interpret the standard for you, using your specific sector knowledge to create the best system of working for you. Our philosophy is to rationalize procedure content & simplify your system. Interacting with directors, management & personnel we assume the responsibility of converting your shared knowledge into a working system, whilst providing in-house training on all elements of the system & its' subsequent management. We believe this is the most productive & cost-effective method of achieving ISO 9001 or 14001 registrations, whilst developing the necessary skills to effectively maintain them.

ISO 9001:2008 released finally.

Latest version of ISO 9001 standard was published on November 14, 2008 by the International Organization of Standardization. ISO 9001:2008 is the latest edition of the International Standard used by organizations in 175 countries as the framework for their quality management systems (QMS).
ISO 9001:2008, Quality management system – Requirements, is the fourth edition of the standard first published in 1987 and which has become the global benchmark for providing assurance about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships.

What is ISO 9001:2008 Quality Management System -Requirments .

The year 2008 revisions of the ISO 9000 family of quality management system standards have arrived. ISO 9001:2008 specifies requirements for quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements; and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

What is an ISO 9001 Compliant Quality System?

An ISO 9001 compliant quality system satisfies the requirements of the ISO 9001 standard but has not been formally assessed and registered by a third party registrar. This means that you could enjoy the benefits of an ISO 9001 Compliant Quality System without going through the expense normally associated with registration. You would be in a position to register at anytime should the need arise.

What are the Principles of ISO 9000.

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.

How to apply for accreditation.

• Submit application form, required documents and fee
• Pre-assessment: Initial review of application and requests for additional information or clarification

On-site Assessment

• Assessors identify any areas or items that do not meet the specific program requirements and suggest corrective action
• Additional audits and follow-up visits as set out in accreditation requirements

Approval

• Report prepared including recommendation about whether or not to grant accreditation
• Review by the Standards Council of Canada
• Final decision

Accreditation

• Upon approval, accreditation and trademark license agreements are signed
• Notice of accreditation posted to Standards Council of Canada website
  

What are the documents we need to send?

You need to send the following documents for us to completely upgrade:

• Quality Policy Statements
• Quality Objectives
• Quality Manual
• Quality Procedures
• Standard Work Instructions / Standard Work Methods (if any)
• Work Quality Plans (if any)
• Process Flow Charts (if any)
• Material Quality Plans (if any)
• Inspection and test Plan (if any)
• QA / QC plans (if any)
• Standard Forms

Implementation of accredited certification to ISO 9001: 2008

ISO and the IAF have agreed an implementation plan to ensure a smooth migration of accredited certification to ISO 9001: 2008, after consultation with international groupings representing quality system or auditor certification bodies, and industry users of ISO 9001 certification services.

What does this mean for you, if you are already ISO 9001:2000 certified?

There will be little impact on your audits, as the changes to the standard are very minor. This new revision will of course replaces ISO 9001:2000 but each organisation will be given two years after its publication to make any upgrades. There will not be any disruption to your organisation and our audit teams will guide you through the process and upgrade your certification during audits to make sure all changed items have no impact or have been clarified with your organisation during the audits.

ISO 9001:2008 has been Published

On 14 November 2008, the International Organization for Standardization (ISO) published ISO 9001:2008, the latest edition of the International Standard for quality management systems (QMS). The new version is the fourth edition of the standard that was first published in 1987.
ISO 9001:2008 contains no new requirements compared to the previous 2000 edition, which it replaces. It merely provides clarifications to the existing requirements of ISO 9001:2000 and introduces minor changes intended to improve consistency with the environmental management system standard, ISO 14001:2004.

Users of ISO 9001:2000 will have up to two years to upgrade their systems to ISO 9001:2008

All accredited certifications issued will be to ISO 9001:2008 by the end of 2009. By the end of 2010, existing certification issued to ISO 9001:2000 will no longer be valid. Customers will need the revised version of ISO 9001 in order to keep their certificates up to date.

ISO 9001 is the world’s most established quality framework.

ISO 9001 helps you to effectively manage your business and meet your customers' requirements
It is used by around 897,000 organizations in 170 countries worldwide, and sets the standard not only for quality management systems, but management systems in general.
It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation and continual improvement.

ISO 9001:2008 Lead Auditor Over view

This FIVE-DAY course provides an understanding and knowledge of auditing quality management systems to third party standards. The objective of an audit is not fault finding, but to identify opportunities for improvement. You learn to build on the skills of how to plan, structure and conduct an effective audit and to evaluate and communicate the findings. The course is designed to follow the stages in a live audit, including simulated audit interviews and role play closing meetings.

ISO 9001:2008 Transition Programme

Outline

• A look at the ISO 9001:2008 standard.
• An overview of the significant changes to the requirements of the standard.
• A discussion of the impact of these new requirements on clients’ systems and maintenance audits.
• A question and answer session to provide participants with interpretive information on how to approach the changes.

Objectives

Through lectures, discussions, and workshops, you will gain an understanding of:

• The underlying philosophy and the principles, concepts and requirements of the ISO 9001:2008 standard;
• How these may be applied within an organisation;
• The key differences between the revised series of standards and the 2000 and 2008 version;
• The implication of these differences.
  
  

ISO 9001:2008 Revision

The revised ISO 9001:2008 was published in November 2008. At this time, it is expected that all ISO 9001:2000 based standards such as AS9100 and ISO/TS 16949 will be revised accordingly with the exception of ISO 13485.
Amendments are mainly to clarify existing requirements and to further align ISO 9001 with the requirements of ISO 14001:2004. Therefore for most companies the transition will require little effort to comply. There will be a 24 month period of grace for companies to make the transition from ISO 9001:2000 to ISO 9001:2008. 12 months after publication all new certifications and re-certifications will be carried out to ISO 9001:2008.The table below summaries changes of ISO 9001:2008. Click on the link below to find out about ISO's ISO 9001:2008 implementation plan.