Integrated Solutions, Inc.

ISO 9001 Registration Project Plan

The plan you see, as well as the schemes for developing a good plan, were developed by custom book review service to improve operations and increase productivity.

 

 
 

Prepared By:

H & W Associates, Integrated Solutions, Inc.

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Approved By:

CEO /President, Integrated Solutions, Inc.

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Effective on Date of Signature below:

ISO 9001 Coordinator, Integrated Solutions, Inc.

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THIS DOCUMENT IS TO BE REGARDED AS THE OFFICial ISO 9001 Registration project plan within Integrated Solutions, Inc. IT IS TO BE MAINTAINED UNDER CHANGE CONTROL BY the Document Control Coordinator.

 

 

 

 

 

CHANGE SHEET

 

TITLE: ISO 9001 Registration project plan

 

DESCRIPTION OF CHANGE

ISSUE

DATE

SECTION

DESCRIPTION

 

1.0

 

 

2/28/97

 

 

All

 

 

Original issue

 

 

TABle of Contents

 

CHANGE SHEET

1.0 Introduction

2.0 Key Tasks and Milestones for Registration Plan

3.0 Strategy for Registration

    3.1 Commit to Registrar

    3.2 Internal Auditors

    3.3 Corrective Actions

    3.4 Pre-Assessments

    3.5 Pre-Assessment Corrections

    3.6 Final Preparation

    3.7 Registration Assessment

    3.8 Registration Corrective Action Plan

    3.9 Celebration

    3.10 Surveillance Visit or Re-assessment

4.0 Roles and Responsibilities

    4.1 Quality Representative

    4.2 Document Control Coordinator

    4.3 Internal Auditors

    4.4 Process Owners

    4.5 Key Employees

    4.6 Tools/Equipment/Software

5.0 Keys to Conformance to Standard

    5.1 Quality Manual

    5.2 Quality System Management Reviews

    5.3 Internal Audit System

    5.4 Corrective Actions

    5.5 Document Control

    5.6 Document your work

6.0 Assumptions, Risk and Contingencies

    6.1 Assumptions

    6.2 Risk

    6.3 Contingencies

     

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1.0 Introduction

 

 

The purpose of this plan is to provide specific information regarding the ISO 9001 Registration of Integrated Solutions, Inc.

 

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This plan is to guide the Company in conforming to ISO 9001 standards, and in registering and maintaining that conformance. ISO 9001 standards are the most comprehensive of the ISO 9000 series.

The ISO 9000 series embodies comprehensive quality management concepts and guidance, together with several models for external quality assurance requirements.... Certification demonstrates that a company has implemented an adequate quality system for products or services it offers. Gaining ISO 9000 registration:

 

 

1. Demonstrates that the Corporation have implemented a tightly coupled Quality System that implies integrity and provides the structure to produce good Quality products. Registering to ISO 9000 standards, however, is the beginning part of a larger total quality initiative; we intend to use this quality approach to lead us to the path in delivering competitive, superior or world class products to our customers.

 

2. Allows the recognition of the Company in domestically and internationally through the registrar as an ISO Certified organization. This registration implies a preferred supplier status. Customers are starting to evaluate suppliers based on ISO 9000 registration. This appears to become even more prevalent as time passes. Our competitors are also striving to become recognized as ISO 9000 registered businesses.

 

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2.0 Key Tasks and Milestones for Registration Plan

 

 

February 97 - Complete contract with Consultant

Select Quality Representative

Develop ISO 9001 Registration Project Plan

 

March 97 - Identify and document gaps in the Quality System

Perform Kick-off meeting

Complete key tasks:

 

 

April 97 - Review of existing processes.

Complete application to British Standards Institute (BSI)

Complete key tasks:

 

 

May 97 - Conduct internal audits by Consultant

Schedule Generating missing processes

Train Internal Auditors

Start Process Training

 

June 97 - Start internal audit by internal auditors

Conduct Reviews

Implement new processes

 

July 97- BSI Pre-Assessment

Define root-cause of findings

Set plan to correct them

Continue to complete all processes

Review and approve processes

Correct audit findings

 

August 97 Process training

Correct audit findings

Prepare for Assessment

 

September 97 - Initial Registration Visit from BSI

Prepare Corrective Action Plan to BSI

Plan Celebration

 

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3.0 Strategy for Registration

 

We have contracted with an ISO consultant to help attain ISO registration. H&W Associates were chosen and are actively involved in bringing us within compliance. H&W is to identify major gaps in the Integrated Solutions Inc. Quality System, and to direct the development of these processes to fill the gaps. H&W is also to review existing documents to identify improvements to bring them under compliance with the standard. We are aiming to have BSI Pre-Assessment in July and schedule for a late September 1997 Certification/Registration assessment. H&W will drive the corrective actions from the pre-assessment and implement our internal audit schedule to identify compliance and other opportunities for improvement.

 

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3.1 Commit to Registrar

 

British Standards Institute (BSI) , the premier ISO Registration body in the world has been selected as the Registrar. The Pre-Assessment is scheduled in July and Registration Assessment will be scheduled in September 1997.

 

 

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3.2 Internal Auditors

 

Internal audits is a requirement of ISO 9001. Internal audits need to be conducted on a regular and scheduled ongoing basis. The intent of the audits are to improve the Quality System. We will identify and train a minimum of 4 internal auditors.

 

These auditors need to be well respected, knowledgeable employees, or group leaders. There should be at least one from each key functions and a part of the regular auditing schedule.

 

H&W will train our Internal auditors. The training class will take two and a half days. A test will be taken at the end to certify the auditors. At the completion of the class, auditors will be assigned to conduct Internal audits appropriate for the auditing areas. This Audit class is scheduled in May 97. We expect training at least 4 auditors.

 

The resource required for the auditors is estimated at 12 hours per quarter. The time can be scheduled by the auditor and worked around their schedule. be concentrated in one week or over a month, which ever is more

 

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3.3 Corrective Actions

 

The internal audits will identify gaps and corrective actions needed to be ISO 9001 compliant. We will identify major gap first and then work on critical findings that affect our business. Process training will take place as appropriate. Most of the training will be done through Town Hall Meetings.

 

 

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3.4 Pre-Assessments

 

We schedule BSI to perform Pre-Assessment in July to determine readiness for the initial Certification/Registration assessment. The current time for the Pre-Assessment time should be about one day.

 

The BSI visit will be short and intense. The visit will not only be a training ground for our employees to experience the outside auditing pressure, but whether we are on plan for registration. They will identify issues with the Quality System that need to be addressed, so as to bring us under ISO compliance.

 

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3.5 Pre-Assessment Corrections

 

All of the Pre-Assessment findings will be recorded. Corrective action plan will be developed to address the root causes of the findings. If there are major non-conformities, we will address them with utmost urgency. We plan to have all major and minor non-conformities resolved prior to the registration visit.

 

We have processes and policies to address non-conformities, which involves designing an action plan to answer the root cause of each non-conformity. The lead auditors approve the corrective action plan to ensure the plan indeed addresses the root cause of all non-conformities.

 

We put special emphasis on no major non-conformities. One major non-conformity during a registration assessment will preclude registration.

 

Internal auditing findings and corrective actions are key to registration. If we establish a strong internal auditing and correction habit, we should handle the registration audit with ease.

 

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3.6 Final Preparation

 

Final preparation will include informal auditing of employees. These are mock audits to prepare and relax the employees for the real audit. Then town hall meetings will take place. These will take place every week or every other weeks leading up to registration and the week prior to the registration assessment. Every employee should attend these town hall meetings. These town hall meetings will not take longer than an hour. We will cover the latest quality news and share new processes and training.

 

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3.7 Registration Assessment

 

BSI will be assessing probably spend 2 days for the registration visit. They could audit all employees. However, they definitely will interview management and key employees. It is important to remember that they will be auditing the system, not the employee. There will be a guide with each BSI auditor. A guide’s job is to take the auditor where he needs to go, help the interviewee if clarification is needed and to take notes of any issues that the BSI auditor has not seen or documented. This will be used later to improve our system.

 

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3.8 Registration Corrective Action Plan

 

We will have 30 days to complete a corrective action plan to address any non-conformities found by BSI auditors during the registration assessment. Corrective actions do not need to be completed in 30 days, but the plan of what will be done must be. Once BSI accepts the plan, we will be officially certified and registered.

 

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3.9 Celebration

 

We should congratulate ourselves.

 

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3.10 Surveillance Visit or Re-assessment

 

After achieving initial Registration, a Surveillance Visit or re-evaluation (re-certification) is performed on a periodic basis (approximately every 6 months). This is a requirement of the registration body and the frequency of re-evaluation is determined by the chosen registrar. Re-evaluation ensures that we are adhering to the quality system previously put in place for initial Registration.

 

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4.0 Roles and Responsibilities

 

All employees included in the registration scope will have some responsibility for ISO 9001 compliance and the activities associated with the registration.

 

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4.1 Quality Representative

 

The role of the Quality Representative will be several. The first is the ISO Coordinator. The ISO standard refers to this individual as the ISO Management Representative. This person has a dotted line responsibility to Sr. Management with respect to ISO 9001. They will be the sole contact with the Registrar, and will coordinate any ISO 9001 consultants. The Quality Representative can also be the Internal Lead Auditor or designates the Lead Auditor and keep all related internal audit records.

 

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4.2 Document Control Coordinator

 

The role of Document Controller involves the tracking and storage of all Quality and Development documentation. This can be both hard copy and electronic. The WEB will be used for on-line storage and document numbering. This person will also assure the backup and offsite storage of the Quality and Development documents. They will also issue new numbers for new documents. It is not known at this time the resource requirement.

 

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4.3 Internal Auditors

 

The trained internal auditors will be visiting all of Company areas prior to the September assessment. The internal audit schedule is attached. The training of the internal auditors will take 2 and 1/2 days and the ongoing commitment will be approximately 12 hours per quarter. Upon completion of the training, the internal auditors will audit each unrelated areas. The only area they cannot audit is their own project. We recommend all project leaders be internal auditors.

 

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4.4 Process Owners

 

Managers or Project Leaders will serve as process owners and insure that key learning’s are included in improvements in the appropriate processes and implemented in their respective organizations. This should be handled as part of the regular staff meetings that are now being held and should not require any additional resources. We will also help to address any new processes during the town hall meetings.

 

 

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4.5 Key Employees

 

All key employees should be involved and attend Quality Management Review meeting run by the President of Integrated Solutions. These reviews may occurs every months. We will schedule the first one in April 1997. These meetings typically take about 2 hours per quarter and would be held in any place where all senior management can attend.

 

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4.6 Tools/Equipment/Software

 

Existing tools, equipment, and software should suffice. However, additional needs will be addressed as required.

 

 

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5.0 Keys to Conformance to Standard

 

The keys to conforming to the ISO 9000 standard are:

 

5.1 Quality Manual

 

Complete a Quality Manual describing how your quality system maps to the ISO 9001 standard. Review the Quality Manual twice a year with Sr. Management and discuss at the Quality System Management Reviews.

 

5.2 Quality System Management Reviews

 

Conduct regular Quality System Management Reviews. They will be held quarterly by The President, with the ISO 9000 Coordinator facilitating. The first one will be held in April 1997.

5.3 Internal Audit System

 

Develop an internal audit program and keep records. At least 4 internal auditors need to be trained. They need to be well respected individuals and this should be considered high visibility for strong performers in the organization.

 

5.4 Corrective Actions

 

Identify gaps in the quality system and close them. The gaps will be identified by internal audits. They need to be resolved by managers or project leaders in a timely manner. They will be tracked by the ISO Coordinator. The pre-assessment findings are part of the audit system. Corrections should address the root cause of the problems.

 

5.5 Document Control

 

Control all documentation is necessary. The ISO 9000 Coordinator will be the Document Control Coordinator.

 

5.6 Document your work

 

Say what you do, write it down and record that you did it! Then we look into improving it.

 

 

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6.0 Assumptions, Risk and Contingencies

 

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6.1 Assumptions

 

The Quality Representative (ISO 9000 Champion ) will be dedicated 50% of he/she time to the ISO 9001 registration effort. Upon registration, it will require 25% of the Quality Representative’s time.

 

The 4 Internal auditors will be of high caliber and well respected individuals, trained and ready to conduct audits no later than the beginning of June 1997. They will be allowed the 12 hours per quarter to conduct audits in groups other than their own.

 

Sr. Management will conduct Quality System Management Reviews (QSMR) quarterly starting on April 1997.

 

Key employees will develop and execute corrective action plans within 21 days, once internal/external audit findings have been reported.

 

 

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6.2 Risk

 

    1. Processes completion and implementation

 

One uncertainty will be the time to complete of all the required processes and have all employees use them. Other than all the ISO conformity process in Section 5, the following operational processes are needed:

 

Maintenance Process - how we support our customers

Contract Review - how we do business specially in contract agreement

Engineering Processes - how we develop software

Sub-contractors and Purchasing Process - how we hire sub-contractors or employees and purchase material

Configuration Management Process - How we make sure we can deliver the S/W to a particular customer

 

We will generate processes that are practical. Yet, the completion, approval, training and employees implementing them dictate the time we can register.

 

6.2.2 Internal auditors will need to be committed.

 

    1. Other risks

 

1. Missing Job description or objectives

2. No training records availability

  1. Missing meeting minutes for key meetings such as staff meetings, project meetings, design reviews, code inspections are not documented and kept as a record.

 

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6.3 Contingencies

 

We will only implement processes that are absolutely necessary to conduct prudent business practices and meet ISO 9000 standards requirement. Critical and continual evaluation of processes identified in documentation index are necessary to assure all needed processes are in place and being followed. We will train and communicate to everyone and make employees aware of these processes. Management, project leaders need to enforce processes usage, as appropriate.

 

If implementing the processes cannot be accomplished by May, we just have to delay the registration assessment.