How To Prepare ISO 9001 Documents: Complete Guide For QMS Compliance
Introduction
The most popular quality standard in the world is ISO 9001. It assists organisations to become better in their processes, provide the same outcomes and make customers happier. However, in order to have this system running well, there must be the proper documents, processes and records.Your quality management system will be based on your ISO 9001 documentation. It brings clarity, expectation, definition of responsibilities and assists you to maintain compliance. When your papers are well-written. Your employees understand what they should abide by, Your procedures are standardized.
What Will Be The Documents Needed In ISO 9001?
ISO 9001:2015 does not dictate a lengthy list of mandatory documents such as those in the past. Rather it is geared toward documented information that backs up your processes and demonstrates that your system is functioning.
The following are the necessary ISO 9001 documents that any organization should possess:
- Mandatory Documents
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Quality Management System (QMS) Scope.
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Quality Policy
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Quality Objectives
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Process Descriptions or Process Flowcharts.
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Documented Information that is needed by the standard.
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Documented Information Procedure Control.
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Personal Control of Nonconforming Outputs Procedure.
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Internal Audit Procedure
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Corrective Action Procedure.
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Records needed by each of the clauses (training records, monitoring records, performance evaluation etc).
- Ordinary Non-Compulsory, But Suggested Documents.
These make your audit easier and make certain that it is clear:
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Organisational Chart
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Roles & Responsibilities
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Risk and opportunity Register.
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Register of Customer Complaints.
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Supplier Evaluation Forms
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Training Matrix
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SOPs for operations
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Work instructions
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Templates and forms
The reason why most organisations like having such documents is that it structures their daily operations and makes them audit friendly.
How To Prepare ISO 9001 Documents, Step-by-step Guide.
The systematic approach makes it easier to prepare ISO 9001 documentation. This is just one of the easy ways you can do it even when you are at the bottom.
Step 1: Learn the ISO 9001 Requirements.
Prior to preparing documents, read and comprehend the 10 clauses of the ISO 9001:2015. You do not have to memorise the standard- simply know what each provision requires.
This gives you clarity on:
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What processes you need
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What documents to prepare
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These are some of the things that evidence auditors will verify.
With a prepared ISO 9001 Documentation Toolkit, this process takes even less time as all the items have been mapped to the clauses.
Step 2: Determine Processes of Your Organisation.
The ISO 9001 is founded upon the process approach. Begin by enumerating your key processes including:
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Sales
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Purchasing
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Production/Operations
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HR & Training
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Quality Control
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Customer Service
Once you are familiar with the processes, then you can tell what a process requires.
Step 3: Create a QMS Structure
Create a basic documentation framework to have your files sorted:
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Level 1: Manual / Policies
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Level 2: Procedures
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Level 3: SOPs / Work Instructions.
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Level 4: Forms and Records
This hierarchy simplifies documentation and makes it easy to be audited by the auditors.
Step 4: Author Core ISO 9001 Documents.
Begin with the simple documents:
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Quality Policy - a basic declaration of quality devotion.
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QMS Scope - determines the activities to be covered.
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Quality Objectives - quantifiable objectives.
These are the documents that make up your system.
Step 5: Work out Procedures and SOPs.
In the case of every process, develop a process that entails:
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Purpose
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Scope
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Responsibilities
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Step-by-step process
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Inputs and outputs
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Related forms/records
You need not make these documents complex, ISO 9001 does not need complex and long procedures.
Step 6: Forms and Records preparation.
Forms assist your team in doing things in a certain way and records show that some work has been carried out.
Examples:
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Customer Feedback Form
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Training Attendance Sheet
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Internal Audit Checklist
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Corrective Action Report
These are the most significant records of your audit since they indicate actual evidence of implementation.
Step 7: Train and Implement Your Team.
Paper work is not going to certify you. Your employees must:
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Understand the procedures
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Follow the forms
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Maintain records
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Know their roles
Carry out brief training and tell them what each document is about.
Step 8: Monitor, Review And Improve.
The ISO 9001 is concerned with continuous improvement. After implementation:
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Conduct internal audits
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Review performance
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Solve problems by taking corrective measures.
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Update documents as needed
This assists you to remain in compliance and be well ready to the external audit.
The Simplest Method Of Preparing The ISO 9001 Documents.
Documentation is very time-consuming to many organisations particularly new to ISO 9001. That is why ISO 9001 Document Toolkits pre-built are being used by thousands of businesses and they include:
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Every required and non-obligatory procedure.
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Ready-to-use forms
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Editable templates
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Process maps
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Guides for implementation
Using a toolkit, you can finish your QMS in days, not months. It also makes sure that your papers are as per the certification-body requirements. You can purchase a full, fully professional designed, ready-to-edit ISO 9001 Documentation Toolkit, right off our web site.
Conclusion
The task of preparing ISO 9001 documents may not appear easy in the beginning but with proper strategy it becomes easy. Pay attention to the requirements, process mapping, simple and clear documentation writing, and team training. The ISO 9001 documentation is not paperwork, but it is about constructing a robust system that enhances your organization.
