Quality Management System Implementation Workbook
ISO 9001 Quality Management System Implementation Workbook and Project Planner. This detailed workbook provides a step by step guide to implementing ISO 9001.
This Quality Management System Implementation Workbookis comprised of 9 sections designed to help you implement your quality management system as easily as possible. It contains the following sections:
- Section 1: Introduction to QMS Implementation
- Section 2: ISO 9001:2008 Documentation Requirements
- Section 3: Project Plan
- Section 4: ISO 9001:2008 Document Templates
- Section 5: The Process of Implementing ISO 9001
- Section 6: Record Compliance Checklist
- Section 7: Quality Management System Compliance Checklist
- Section 8: Final Steps
- Section 9: ISO 9001 Certification Process
Section 1: Introduction
ISO 9001:2008 is a globally recognized quality management system standard for all organisations regardless of their size.
This Workbook provides a quick guide to implementing an ISO 9001: 2008 compliant quality management system.
At various stages throughout the workbook we offer comments and advice from years of experience working with ISO 9001 compliant Quality Management Systems.
In this section you will learn about the history and terminology of ISO 9001 including the requirements for a Quality Management System and sections of the ISO9001:2008 standard.
Section 2 ISO 9001:2008 Documentation Requirements
ISO 9001:2008 requires a “Documented quality management system”, and not a “system of documents”.
This section of the workbook provides guidance on the main objectives of your documentation and ISO 9001:2008 clause 4.2 Documentation requirements.
This is often an area of “misconception” that causes problems in that organizations believe that all documentation needs to be on paper in words.
The workbook provides guidance on the minimum content for a quality manual and the types of documents that are useful. It describes the disciplines involved in giving improved organizational performance.
This section also includes advice on the records specifically required by ISO 9001:2008.
You are free to develop other records that may be needed to demonstrate conformity of your processes, products and quality management system. Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.
Section 3: ISO 9001 Implementation Plan
Advice on developing an implementation plan for your ISO 9001 Quality Management System. A template that you can use is provided.
Section 4: Compulsory Document and Record Samples
In this section we provide extensive advice and examples of the compulsory documents and records required by ISO 9001:2008.
These include the following types of documents:
- Quality Manual, Quality Policy, Quality Objectives.
- Control of Documents, Control of Records, Internal Audit, Controlling Nonconformity, Corrective Action, Preventive Action, Management Review.
- Education, training, skills and experience, evidence that the realization processes and resulting product fulfill requirements, results of the review of customer requirements related to the product and actions arising from the review, design and development inputs relating to product requirements.
- Results of design and development reviews, verification, validation and any necessary actions.
- Results of the review of design and development changes and any necessary actions plus the results of supplier evaluations and any necessary actions arising from the evaluations.
- As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement.
- The unique identification of the product, where traceability is a requirement.
- Customer property that is lost,damaged or otherwise found to be unsuitable for use.
- Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist.
- Results of calibration and verification of measuring equipment.
- Validity of the previous measuring results when the measuring equipment is found not to conform to requirements.
- Internal audit results and follow-up actions.
- Indication of the person(s) authorizing release of product.
- Nature of the product nonconformities and any subsequent actions taken, including concessions obtained.
- Results of corrective and preventative action.
Section 5: Process of Implementing a Quality Management System
The Workbook provides guidance on steps for the Senior Management Team to follow in taking a process approach to developing your quality management system:
- Stage 1: Define the purpose of your company
- Stage 2: Define your Policies and Objectives
- Stage 3: Determine the processes in the your company
- Stage 4: Determine the sequence of the processes - Process Interaction Diagrams provided
- Stage 5: Define Process Ownership
- Stage 6: Define Process Documentation
- Stage 7: Define the Activities within Each Process
- Stage 8: Define the Monitoring and Measurement Requirement
- Stage 9: Define the resources needed
Section 6: Quality Management System Record Checklist
The workbook contains a checklist to ensure that you have the compulsory records required by ISO 9001:2008.
Section 7: Quality Management System Compliance Analysis
The Workbook contains a checklist that you should now use to check that your Quality Management System complies with the requirements of the ISO 9001:2008 Standard or identify gaps in your system that need to be filled.
Based on your findings you use the template provided to formulate an action plan.
Section 8: Final Steps Internal Auditing, Corrective Action, Preventative Action & Management Review
This part of the Workbook includes guidance on the following final steps:
- Internal auditing QMS verification
- Management review
- Taking corrective and preventative actions
- Corrective action
- Preventative action
Section 9: ISO 9001 Certification Process
The Workbook provides guidance on the last three simple steps to certification.
By Carl Barton - Managing Partner. (Google+)
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