How to Implement ISO 9001 in 8 Steps

1. Familiarize Yourself with ISO 9001

2. Plan Everything out for Implementation
3. Identify Responsibilities, Policies, and Objectives
4. Develop Your Documentation
5. Launch Your Quality Management System
6. Review Your Performance
7. Assess and Register for Certification
8. Continual Improvement
It can be a daunting task to think about implementing an
entirely new system for your business. It's best not to look at
the big picture and how much you have to do. Implementing
ISO 9001 for your organization can take anywhere from six to
nine months, so it's best to focus on one step at a time to
ensure nothing is missed.

Continue reading to take a deeper look at these 8 steps and

learn how to effectively implement ISO 9001 in your business.

Step One: Familiarize Yourself with ISO 9001

You should absolutely purchase a copy of the ISO 9001
standard and review the key concepts. Everyone should have a
firm grasp on the requirements of the standard, the
documented procedure requirements, and the sort of
documents and records required of you.

ISO 9001 provides a structure for the core requirements of a

quality management system but is flexible so that it can suit all
types of businesses. It's important for you to understand how
the standard applies to your business specifically. This
flexibility will allow you to meet the requirements set out in a
way that makes sense for your organization.

Get Top Management on Board

It is essential when making any large changes to any business

that you and everyone involved in your Top Management
understand what it is you're trying to do.
Making sure that the people at the top of your
management understand what ISO 9001 means for your
business and why it's being implemented is absolutely
key to everything running smoothly. Without everyone
completely committed it becomes much more difficult to affect
change throughout the business.

Find out Where You Stand

Once you have everyone on board you should analyze your

current system and compare it to the ISO 9001 standard. You
should have a good working knowledge of how close or
far you are from meeting the standard requirements as
it is. With this data, you can easily create to-do lists on how to
modify your existing system to meet the standard.

Do a Gap Analysis

The purpose of this gap analysis is to identify the areas in your

company that require change in order to be compliant. 

Our Quality Manual Template includes a 18-page gap analysis

template which:

 presents an overview of the requirements of each section

 allows space for findings and noting implementation
actions
 questions are phrased to allow one word answers (yes/no)
In doing this, you ensure that everyone involved in
implementing the new system is on the same page. Make sure
to check with all of your Top Management before beginning the
next step just to be certain they understand the need for a new
Quality Management System and that they are 100%
committed to helping implement it.

Step Two: Plan Everything out for Implementation

Having a solid plan in place is essential to making the transition
to a new system. When you have the right people on the job
the process will be much easier to get through. Your team will
create a workable plan that will set your business up for
success.

Decide on an Implementation Team

To begin implementation, your Top Management should decide

on and create an implementation team to head the effort. This
team should be made up of managers from different areas of
your business. An implementation team will ensure the
success of your transition to the new Quality
Management System.

The implementation team should be headed by the

Management Representative that will oversee all parts of the
implementation process. This person should hold a perfect
understanding of the ISO 9001 standard. They will be the line
of communication between the implementation team and the
ISO 9001 registrar that will eventually certify your business.

The Management Representative should be a member of

management that is respected and has a passion for managing
and maintaining the Quality Management System far into the
future.

Identify Core and Support Processes

It will be much easier to map out a plan for meeting the

standards when you are aware of which processes within your
organization coordinate with which requirements. It's
extremely helpful to use flow charts and turtle diagrams
to figure out exactly how your business gets from Point
A to Point B when it comes to creating new products for
customers.

You can do something as sophisticated as using computer

software to define each step of the process, or simply use post-
it notes on a wall. Once you can see the entire process in front
of you, it's time to decide which of the items is a core process
and which is a support process.
Examples of core processes are things such as design and
delivery. These are the processes which contribute directly to
getting the customer what they want. Support processes are
not directly responsible for it but do help the core processes to
do their job. These processes are things like training and
facility maintenance.

- view sample process map

Create a Plan

In order to keep the transition to ISO 9001 running smoothly,

there should be a structured plan set into place. Using the to-
do list created from your analyses in step one, the
implementation team should create milestones and deadlines
to get things done.

Having a plan in place is key in implementing any system

in a timely and effective manner. Without ensuring things
are done at specific times under controlled conditions, they
may get pushed aside and take much longer.

Get Everyone Involved

With a plan set out before you, it's time to let everyone in on
the change. Every single person that works within your
organization should be aware that change is
coming. Hold seminars to let them in on the way things are
going to change and why.

Make sure when you introduce the concept of such a large

change that you tell your employees how it will affect
them. Include research that supports why implementing
ISO 9001 is a good thing for the business and for
them. Let them know how their work might be changed in the
process so that they are prepared.

Communication is key in implementing change. Keep everyone

in the loop so that they don't feel they are being jilted in any
way. Set up displays on notice boards that show the progress
being made. Listen to any concerns or complaints. Make
everything feel included.
Step Three: Identify Responsibilities, Policies, and
Objectives
The Quality Policy within your company is an integral part of
keeping your business committed to meeting objectives and
focusing on customer satisfaction. Your Quality Policy is one of
the key things that will be used to measure your organization
when determining the success of your Quality Management
System.

Define Your Quality Policy and Objectives

There is no set definition of quality that applies to all

businesses. Your definition of quality is one that is agreed
upon by your Top Management team. It should build on
your current values and identify objectives that are able to be
measured to determine quality.

Quality Objectives are the way that the quality of your

products will be measured. There isn't a specific way that
ISO 9001 asks for objectives to be documented. Your quality
objectives can be related to budget, business plans, or
management review. It's important that these objectives suit
both your business and your customers.

Once you have your Quality Policy in place you need to

communicate it effectively to all members of your organization.
You don't have to force the entire thing down their throat
verbatim, but make sure they know where they can find a copy
of the document if they should need it.

Try to shorten the key concepts of your Quality Policy

into a few short sentences or a handful of keywords that
make sense to employees at all levels. Do this for each
department depending on what part of the Quality Policy
directly correlates to the work they are doing. Put this
shortened version up on notice boards so that they are always
aware of it.
Establish New Roles and Responsibilities

Every area of your organization should have managers and

staff who are directly responsible for quality-related tasks and
upkeep. You can create entirely new roles for these people or
change already existing job descriptions to include the needed
responsibilities.

You should have staff in each department that is capable

of performing audits, maintaining documentation,
conduct management reviews, and implement any
needed changes. Make sure the people you choose to
undertake these responsibilities are fully aware of what the job
entails and how it relates to the Quality Management System.

Step Four: Develop Your Documentation

Keeping records of your Quality Management System is
required to be ISO 9001 certified. There are certain documents
you are required to keep and others which may just be helpful
in keeping everything running as it should.

Organizing and preparing your documentation is usually done

according to the importance of the documents.

At the top, you have your Quality Manual. This includes

your companies quality policy and objectives as well as how
your quality system functions. It will have descriptions of all of
the processes within your system and how they interact. You
should always go back and refer to your Quality Manual as you
implement changes to ensure all process descriptions are up to
date.

Second, there are procedure documents. These documents

detail all of the individual business processes and how they
operate. They will show how each process is designed and
controlled, including what checks are carried out to keep them
in line.
Third, there are work instructions. These are very specific
documents that detail the necessary instructions required to
perform every task within the business.

Last, you have your forms and records. These are exactly

what they sound like. Forms are used to collect information for
record-keeping purposes. Records are required to show how
your Quality Management System is operating and if it is up to
standard.

To help you with 90% of the documentation, I recommend

using a Quality Manual Template.

The Template includes everything you need for ISO 9001

documentation - quality policy, scope, what procedures you're
planning to implement, flow charts, objectives and forms that
ISO 9001 certification may require.

Make a List of Already Existing Documents

Your business probably already has extensive documentation

going over processes and procedures, as well as forms and
records.

It would benefit you to make a list of all of the

documents that already exist and note their current
status. Many of these documents may not be completed or up
to date or might be lacking specific details required by the ISO
9001 standard. This list will give you a good idea of where to
start in moving forward.

Create Templates for All Document Types

All of the documentation within your Quality Management

System should be uniform in style and format so they are easy
to navigate and read. Be sure to check what each type of
document is required to have in it so that you can
include these things in your template.
Having ready-made templates will make the daunting task of
documenting your Quality Management System a lot easier to
handle for everyone involved.

Implement a Document Control System

It is required that all documentation associated with your

Quality Management System is well controlled and up to date.
This ensures that your employees only have access to the most
recent version of all documents.

Your Documents & Records Should Include:

1. A letter code that identifies each type of document and a

sequential number
2. Revision control where each revision results in an increase
in the revision number
3. A change history summarizing all changes made to each
document
4. Signatures of who prepared and who approved the
document
5. The date of the version or revision
Step Five: Launch Your Quality Management System
Now it's time for the biggest step. You've done all of the work
required to set up your business for success in transitioning to
ISO 9001, all you have to do is launch your plan. You will start
to see changes come into action and you will have to be
mindful to ensure they go as planned.

Provide Employee Training

Every employee is crucial to keeping your Quality Management

System running as it should. It's time to train all of them on
the parts of the system that are specific to their area of work.
When they understand how their work affects the system they
will be helping to move your business in the right direction.

Training Should Teach Your Employees:

1. The procedures that apply to their work

 2. Which forms they should be using and how to complete
and process them
3. How to find the Quality Policy and how it relates to their
position
4. How to report issues so that they can be fixed
5. Where to find all relevant documents
Always go into training with a plan to equip each and every
member of your team with the tools they require to be an
effective part of your new Quality Management System.

Implement the System

Use your structured plan to begin putting your Quality

Management System into action. Keep a close eye on every
part of the plan as it begins to make sure things are moving
forward. Monitor process performance and start internal audits
to check that all standard requirements are being met.

It's essential to keep your implementation team on

task. The Management Representative should have a checklist
on hand at team meetings to review with everyone. Any
problems that arise during the implementation process should
be handled as promptly as possible.

This is also a good time to make sure documentation is being

developed properly. Work instructions and forms should all be
written and available to employees.

Audit the System

Two to three months after the documentation has been

prepared and things have started being implemented, you
should conduct internal audits to identify any problems within
the scope of your Quality Management System. Any corrective
measures that need to be taken should be taken without any
delays. If needed, documentation should be revised.

Auditors will ensure that all procedures are well

implemented, documented, and understood by the staff
carrying them out. They will check that the system meets
standard requirements, is effective, and is showing
improvement.

Never spring an audit on your employees. They should not feel

surprised or like they aren't being involved in the entire
transition process. Always plan the audits well in advance. Let
everyone know when the audit will take place and what
departments will be audited.

Step Six: Review Your Performance

After you have done your internal audit and your Quality
Management System has been up and running for six months
or so, you should review the progress your business is making.
This review will help your team identify any underlying issues
and the corrective actions that need to be taken to get
everything in line with requirements.

Conduct a Management Review

Management Review is a useful tool that will give you a precise

look at the performance of your Quality Management System
and any problems that have come about. You may find through
your review that changes need to made to your quality policy
or objectives.

Your Management Review Should Include:

1. Audit Results
2. Customer Feedback
3. Process Performance
4. Product Conformity
5. Status of Corrective Actions
6. Follow-Up Actions From Previous Reviews
7. Changes That Could Affect the System
8. Recommendations for System Improvement
With all of this information on hand, your team can successfully
correct the direction in which your system is headed so that it's
forward once more.
Implement System Changes

This is as straightforward as it gets. Once you have identified

the places where your Quality Management System needs
fixing, it's time to fix them. Take prompt action and get
everything corrected. Don't forget to revise the necessary
documentation related to anything you change.

If you neglect needed changes you will not be able to

register your system. Certification bodies prefer at least
three months of records related to refining your Quality
Management System.

Integrate reviews into your regular management system and

keep clear records of everything you review and change. It's
vital that you have all of your documents up to date. Continue
to ensure the result of your management reviews is functioning
as it should.

Step Seven: Assess and Register for Certification

Your Quality Management System has been up and running for
three to six months and everything seems stable and ready to
be registered. Now is the time for you to carry on with the
certification process to officially become ISO 9001 certified.

Registration Audit

Your registrar will perform a two-step audit to confirm your

business meets the requirements set out by the ISO 9001
standard.

They will first audit your documentation. This can take place

either at their personal office or within your organization. The
registrar will ensure that your documentation is all in
place and controlled in compliance with the standard. If
you don't have your documentation in order there's no real
reason to continue on with the rest of the audit.
If all of your documents meet the standard requirements, the
registrar will come to your business to audit your processes.

There is always the option of carrying out a pre-

assessment audit, which is basically like a practice
audit. Your registrar will assess your Quality Management
System around six weeks before registration takes place and
give you advice on any corrective actions that should be taken
before your audit. Some people find this advice invaluable to
the registration process.

Take Corrective Action

After your audit you will be given the opportunity to fix any
non-conformances that the registrar found. It is paramount
that you take any issues that do not comply with the ISO
9001 standard seriously and fix them without hesitation.

Common non-conformances found in audits are a lack of

proper training for internal auditors, reports of audits were not
completed or managed, or personnel were found to be auditing
their own work.

Receive Your Certification

Your registrar will perform a second audit to ensure that all of

the non-conformances that were found have been properly
taken care of. They will systematically evaluate your entire
Quality Management System against the standard to ensure it
meets all requirements.

There must be objective evidence that your system

conforms to the ISO 9001 standard and that all
procedures are being followed. The registrar will document
all of this before you become certified.

Certification generally lasts for three years. Receiving your ISO

9001 certificate isn't the end, though. Your registrar will
perform surveillance audits one or two times a year to ensure
your Quality Management System continues to meet the
standard.
Step Eight: Continual Improvement
It is required by the ISO 9001 standard that certified
companies continue to show improvement in the effectiveness
of their Quality Management System. You should always aim to
satisfy customers by identifying processes in your system
which can be improved.

Implement a system that makes continual improvement easy

for your team to carry out. It's as simple as following a
repeating four-step process for checking up on your Quality
Management System.

1. Plan out a time-line for internal audits and

management reviews. Make sure all objectives and
processes are well established and understood to deliver
results in compliance with your quality policy. Use feedback
from employees and customers to identify where things are
going wrong and put a plan into place to see that they are
fixed.

2. Create a small sample of changes you wish to

implement. Before you interrupt the flow of work by taking an
action, it would benefit you and your system to ensure the
change will actually work beforehand on a smaller scale.

3. Regularly check all products and processes against

policies and customer requirements. Report the results of
these checks. Check up on all key activities to ensure the
output is conforming.

4. Put successful changes into action. If a change did well

in testing then it's time to put it into the full system to improve
it. Involve everyone that will be affected by the changes in
making them. Ensure that all changes are documented and
that everything is up to date and meets requirements.

Implementing ISO 9001 Is Doable for You

Making such a large change can seem like moving mountains in
the beginning. It's difficult to know where to start or what
order to do everything in. But it doesn't have to be a hassle to
implement a new Quality Management System in your
business.

Just keep these 8 steps in mind:

1. Familiarize Yourself with ISO 9001

2. Plan Everything out for Implementation
3. Identify Responsibilities, Policies, and Objectives
4. Develop Your Documentation
5. Launch Your Quality Management System
6. Review Your Performance
7. Assess and Register for Certification
8. Continual Improvement
Once your new system is in place you will begin to see big
changes in how efficient your business is running.

Implementing ISO 9001 will offer you a practical way to

improve and monitor all parts of how your business operates.

Take a deep breath and set aside the time to get everything in
order. Don't overwhelm yourself by worrying about every step
of the implementation process at once. Focus on one step at a
time and before you know it your business will have a Quality
Management System to be proud of.