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ISO 9001 Implementation Guide

The following is an overview of the key steps in implementing a quality management system based on the ISO 9001 standard:

Get the latest copy of the ISO 9001 and ISO 9004 standards
Familiarize yourself with the requirements of the ISO 9001 standard and decide if certification to this standard makes good business sense for your organization. The two main objectives organization have in using the ISO 9001 standard is to improve the effectiveness of their business and to gain marketing advantage. Many larger organizations only deal suppliers that are certified to ISO 9001 or similar bsuiness standard.

The ISO 9004 standard provides useful guidelines in better understanding and implementing the ISO 9001 standard. To gain deeper insight into how the the requirements of the ISO 9001 standard should be interpreted and implemented, please read "Understanding ISO 9001".

Educate yourself in quality management
There is a variety of training courses available to gain deeper insight into the requirements for system development, implementation and auditing. Also read up on the subject matter. The more you read, the more informed you will be in making choices and developing your QMS. There is plenty of useful articles and courses on this website to get a good head start. Read everything I have made available to you. My objective is to provide you more than enough to enable you to successfully implement an effective quality management system.

Get management commitment and support
Without this, your chances of success is greatly diminished. Depending on the size of your roganization, there is usually significant effort, time and resources needed to undertake an ISO 9001 implementation project. You need management to step forward and provide the leadership, involvement, communication, support and review of such a project. In addition, management needs to provide the environment and motivation for employee participation and acceptance of change. Implementation of ISO 9001 controls involve the participation of all employees to ensure sucess. This is where using an ISO 9001 Consultant is really worth the money as they are experts in explaining to management and work force the importance and benefits of implementing ISO 9001. 

Consider using an ISO 9001 consultant
Experienced and expert consultants can fast track your QMS program development and implementation with realistic and effective strategies and solutions in a cost effective and timely manner. A consultant can provide focus and manage your implementation project. For more insights into using a consultant read "Many Reasons To Use An ISO 9001 Consultant" on how to use an We have the expertise to assist you. Call us for a no-obligation discussion of your needs. You should read "Tips On Using An ISO 9001 Consultant" before you use a consultant in your area.

Conduct a ‘Gap Assessment”
A gap assessment is an audit of your current management system practices, controls and documentation, to determine the extent to which it conforms to those required by the ISO 9001 standard. While a trained in-house quality practitioner can do this, it is best done by an consultant (ex CB auditor), with the experience of hundreds of such audits. The audit findings are presented in an audit report along with recommendations to address the gaps. The Gap Assessment is the starting point for planning your management system development.

Call us today at 905-593-8867 or email us at artjlewis@rogers.com for a no obligation review of your specific needs 

Plan - strategy, resources and project
The adoption of an QMS is a strategic decision for the organization. It is vital that your top management provides leadership, resources, involvement and support. In addition, you need to assemble a team to develop and implement your QMS.  You also need to plan your implementation steps, time line, responsibilities and resources needed. Here is a sample of an ISO 9001 Implementation Plan. As far as possible you should involve employees within each process in developing appropriate controls and documentation. Management can always fine-tune and put in proper format once everyone agrees on the controls. This way you ensure acceptance and ownership by employees instead of resistance to change.

Determine training needs
Training will be needed at various levels of the organization. The nature and scope of training will vary according to each level. There are a wide range of courses, workshops, and seminars available designed to meet these needs. We provide a number of these training courses. Call us for more information. Management should get training in an overview of ISO 9001, what it can do for the organization and their roles and responsibilities for implementing and maintaining it. The workforce should get training in all ISO controls that affect their process and interaction with other processes. It is understood that all employees get job-specific trainig.

Develop a QMS manual
Your QMS manual should describe the QMS policies and processes and their interaction. Through the manual, you will provide an accurate description of the organization and the best practice adopted to consistently satisfy customer expectations. Here is an example of a Quality Manual  for a small organization.

Develop procedures and needed documentation
Procedures describe the processes and activities of your organization, and the best practice for effective planning, operation and control of these processes. Other documentation could include work instructions, checklists, forms drawings, blueprints, schematics, flowcharts. Use any combination of these as you deem necessary based on the culture and complexity of your organization and stability and education of your work force. For more on documentation, read ISO 9001 Documentation.

Implement your QMS
Work to your implementation project plan. Communication and training are key to a successful implementation. Monitor progress and get management support to overcome hurdles along the way. Management should play an active role in this step to ensure that all project steps and timelines are met.

Consider a pre-assessment
Consider having a preliminary evaluation of the quality management system documentation and implementation by a Consultant or certification body. The purpose of this is to identify areas of non-conformity and allow you to correct these issues before you begin the formal certification process.

Select a certification body
Your business relationship with the certification body (Registrar) will be in place for many years, as your certification has to be maintained. Read our article onTips on selecting a Certification Body before you select your certification body or Registrar.

Maintain your ISO 9001 quality management system
Once your organization is ISO 9001 certified, your efforts do not stop. You must continue to use the controls and tools that the ISO 9001 standard prescribes to maintain and continually improve your quality management system. These include quality policy and objectives, control of nonconformity, corrective and preventive action, internal audit, management review. These tools are very powerful when used effectively. Again there is plenty of information on my website to learn more on this.

ISO 9001 Home
◦  ISO 9001:2015 FAQ
◦  Purpose of the Standard
◦  Scope of the Standard
◦  Normative References, Terms and Definitions
◦  Context of the organization
◦  Understanding the needs of interested parties
◦  Determining the Scope of your QMS
◦  QMS and its processes
◦  Leadership and Commitment
◦  Customer Focus
◦  Quality Policy
◦  Organizational roles, responsibilities and authorities
◦  Risk Based Thinking
◦  Quality Objectives
◦  Planning For Changes
◦  Resources - General
◦  clause 7.1.2 -People
◦  clause 7.1.3 Infrastructure
◦  Environment for the operation of processes
◦  Measuring and Monitoring Resources
◦  Organizational Knowledge
◦  Competence
◦  Awareness
◦  Communication
◦  Documented Information
◦  Operational Planning and Control
◦  Customer Communication
◦  Determining requirements related to products and services
◦  Design and Development Planning
◦  Customer Communication
◦  Review of requirements related to products and services
◦  Design & Development Inputs
◦  True False Questions
◦  Sample Test Questions
ISO 9001 Consulting
◦  How To Select An ISO 9001 Consultant
◦  Compelling Reasons To Use An ISO 9001 Consultant
◦  What Services Can An ISO 9001 Consultant Provide?
◦  How To Select a Certification Body (Registrar)
◦  What Is The Process Approach?
◦  Useful Resources To Help You Implement ISO 9001
◦  What Are Outsourced Processes?
◦  What Are Quality Objectives?
◦  What Is Continual Improvement?
◦  What Is Customer Satisfaction?
ISO 9001 Implementation Guide
◦  Free Resources To Help You Implement ISO 9001
◦  Quality Policy
◦  Quality System Documentation
ISO 9001 Certification

Understanding ISO 9001:2008