Iso 9001-quality-management-how-it-works

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ISO 9001Quality ManagementHow it works

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12602-BSI-ISO-PRODUCT-GUIDE-XDOC-220711:Guide 22/7/11 11:26

What is ISO 9001?ISO 9001 is the world’s most popular quality management

system standard. It covers how organizations should

manage their activities to be as efficient as possible, and it

concentrates on what organizations should do to make

sure that their customers’ requirements are met

consistently.

Why use this standard?ISO 9001 saves and makes you money. There is a great deal

of evidence to show that ISO 9001 helps organizations

improve customer satisfaction, reduce costs and operate

more efficiently with more involved and motivated staff.

Also companies can attract new business because a lot of

organizations look for ISO 9001 certification as evidence

that their suppliers are well-run companies.

Additionally, most organizations are interested in growing.

ISO 9001 puts robust structures in place to manage how

everything is done, and strip out wasted effort. This

gives managers more time to invest in making

money.

2Profit from more satisfied customers with BSI

Some background

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ISO 9001 has been designed so that it can be used by any

organization, large or small, whatever its products or

services. Here we explain some of the basics.

Management systemsA management system is simply the way an organization

manages it processes, people and other resources so that

its products or services meet organizational objectives and

customer requirements.

For example, your objective may be to satisfy your

customers’ quality requirements; or to comply with

statutory regulations; or to achieve specific turnover or

productivity targets.

A management system is usually a combination of policies,

processes, procedures, training, forms and records that

enable your business to operate effectively to meet its

objectives.

The ISO 9001 standardISO 9001 provides a set of requirements to be met when

you set-up and operate a quality management system.

These requirements constitute international best

practice for managing quality.

The requirements are a distillation of all

the best ideas from hundreds of

experts and users for more than 30

years. The standard is very well tried

and tested and regularly updated.

How organizations meet the

requirements is entirely up to them,

depending on what works best for

the individual company.

Plan–Do–Check–ActThe Plan-Do-Check-Act (PDCA) cycle is the operating

principle of all ISO management system standards. By

following this cycle, you can manage and continually

improve your organization’s effectiveness.

Plan – establish objectives and make plans (analyse your

organization’s situation, establish overall objectives, set

interim targets and develop plans to achieve them).

Do – implement your plans.

Check – measure/monitor your actual results against

planned objectives.

Act – correct and improve your plans to get better results.

Whether you are the managing director setting the

direction of the business, or an individual carrying out a

specific task, the PDCA cycle is very useful in achieving

continual improvement.

Understanding the basics



System approach to managementWhen you identify, understand and manage interrelated

processes as a system, it contributes to the organization's

effectiveness and efficiency in achieving its objectives.

Continual improvementContinually improving your organization's overall

performance should be a permanent objective.

Factual approach to decision makingEffective decisions are based on the analysis of data and

information.

Mutually beneficial supplier relationshipsAn organization and its suppliers are interdependent and a

mutually beneficial relationship enhances the ability of both

to create value.

The principles behind ISO 9001

ISO 9001 is built around eight management principles that

guide and inform everything in it. They are:

Customer focusYou need to understand current and future customer

needs. You should meet customer requirements and strive

to exceed customer expectations.

LeadershipLeaders establish unity of purpose and the direction of the

organization. Leaders should create and maintain an

environment where people can become fully involved in

achieving the organization's objectives.

Involvement of peoplePeople at all levels are the essence of an organization and

their full involvement enables their abilities to be used for

the organization's benefit.

Process approachYour desired result is achieved more efficiently when

activities and related resources are managed as a process.



Plan – management responsibilityThis part of ISO 9001 gives management a powerful

planning tool. The starting point is for managers to show

commitment to the successful operation of the

management system through being involved.

The individual requirements take managers through the

following sequence of activities:

Customer focus. Find out what the customer’s current and

future needs and expectations are at a strategic level. How

you do this is up to you.

Quality policy. Use the information gathered from the

customer to write a quality policy that is relevant to the

purpose of your organization.

Objectives. Establish measurable objectives for the

organization to help you achieve the aims of the quality

policy.

Plan the system. Allocate responsibilities and establish

effective processes to achieve your objectives.

Review the operation of the system at regularintervals. Improve it where necessary. Ensure appropriate

resources are provided.

ISO 9001 in more detail

Quality Management System Model reproduced with permission from ISO

CONTINUAL IMPROVEMENTOF THE QUALITY MANAGEMENT SYSTEM

MEASUREMENT,ANALYSIS ANDIMPROVEMENT

RESOURCEMANAGEMENT

MANAGEMENTRESPONSIBILITY

PRODUCTREALIZATION PRODUCT

CUSTOMERS

SATISFACTIONCUSTOMERS

REQUIREMENTSOUTPUTINPUT



InfrastructureThis involves the facilities and equipment you need to

perform effectively. Start by determining and providing

what is needed. Review this regularly.

Work EnvironmentHere you look at the conditions under which work is

performed and ensure that this is appropriate for meeting

customer’s requirements. Again, review this regularly.

6

Plan – resource managementThe resource management part of the standard makes sure

that you review and provide the resources needed to

implement and improve the system.

Resources are looked at in three ways: people,

infrastructure and work environment.

People• Decide the competencies and skills needed within the

organization.

• Then look at the people that you have and identify gaps

in existing competencies.

• Fill those gaps by providing training and coaching or

encouraging self-learning.

• Review how effective the actions taken have been in

helping you achieve the required competancies for the

business.

• Through these techniques you always know whether the

training you provide is actually adding value to the

organization and contributing to results.



Don’t worry if some of the topics here do not relate to you.

Remember, ISO 9001 is designed to be used by all types of

organizations. You simply concentrate on the areas relevant

to you.

Make sure at each stage that people understand their role

and are competent to carry out tasks in line with business

policies, procedures and objectives.


Do – product or service realizationYou now have the commitment and direction from

management and the necessary resources to do the job.

ISO 9001 goes on to give you a set of requirements for

managing the work you do. Start with planning. Plan the

journey from the point where the customer asks for

something, right through to delivery (and beyond if

necessary). Typically this involves defining the processes for:

• Sales

• Design and development

• Purchasing

• Production / operational / service activities

• Delivery



Check and act – measurement analysis andimprovementDon’t stop once you deliver to the customer. Go on to find

out whether the customer is satisfied. Take other

measurements of the system’s performance, analyse these

and identify the areas for improvement. Again, the

standard provides you with a set of requirements for

achieving this using tried and tested techniques.

Customer satisfactionThis involves the monitoring of customer perception. It

does not mean that you have to send questionnaires to

your customers. There are many different ways of

monitoring perception. You can use methods relevant to

your business.

Internal auditConduct reviews of your system to make sure that things

are going to plan.

Monitoring and measurement of productsand processesIndividual processes drive the system and it’s important

that they are operating effectively and efficiently. Products

should also be measured and monitored to ensure that you

are meeting the customer’s requirements.

Control of non-conforming productsIf something goes wrong, procedures should be in place

to ensure that the problem is controlled and dealt with

appropriately.

Analysis of dataUsing the standard effectively will produce data on how

effective your systems are. Use the data to find

improvements.

Continual improvementOne of the key objectives of ISO 9001is to make sure that

your organization improves. Using the results of the

analysis will help you to determine where those

improvements can be made.




1 Top management commitment is vital if the

system is to be implemented successfully. Make

sure senior managers are actively involved,

approve resources and agree the key processes in

the business.

2 Look at what systems, policies, procedures and

processes you have in place at the moment.

Then compare those with what ISO 9001 asks for.

You may be surprised at how much you already

do. ISO 9001 will allow you to keep the things

that work for you while refining those that don’t.

3 Make sure you have good internal

communication channels and processes within

the organization. Staff need to be involved and

kept informed of what’s going on.

4 Give some thought to how departments work

together. It’s important that the people within

your organization don’t work in isolation but

work as a team for the benefit of the customers

and the organization.

5 Don’t ignore the impact that introducing these

systems will have on your customers and

suppliers. Speak to them to gain insight as to

how they view your service and how they feel

improvements could be made.

6 Clearly lay out a well-communicated plan of

activities and timescales. Make sure everybody

understands them and their role in achieving

them.

7 The nature and complexity of your documentation

will depend on the nature and complexity of your

organization. ISO 9001 only defines the need for

six procedures. What you have in addition to this

is up to you. Consider using your IT systems or

software such as BSI’s Entropy® Software to

manage your system and documentation more

efficiently.

8 Make the achievement of ISO 9001 engaging

and fun. Use competitions, such as for the first

completed process. These will increase

motivation.

9 Train your staff to carry out audits of the system.

Auditing can help with an individual’s

development and understanding as well as

providing valuable feedback on potential

problems and opportunities for improvement.

10 And finally, if you feel that you are doing

something just for the sake of ISO 9001 and it

doesn’t add any value to you as a business,

question whether it’s necessary. Nine times out

of ten it won’t be needed.

Ten tips on making ISO 9001 effective for you

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1. Make contactGet in touch and tell us what you need, so that we can

sort out the best services for you. We’ll then give you a

proposal detailing the cost and time involved.

2. Complete BSI’s application formWe’ll assign you a Client Manager, who will be your point

of contact through the process – and beyond. They’ll have

an excellent understanding of your business area and will

support you as you move forward to the assessment and

certification of your quality management system.

3. Consider trainingWhether you’re seeking to implement a quality management

system or would like to increase your general awareness of

ISO 9001, there are a range of workshops, seminars and

training courses available.

4. Gap analysisWe can carry out an optional gap analysis, also called a

Pre-Assessment, of your existing management system

against the requirements of the standard and identify any

omissions or weaknesses that need resolving before formal

assessment.

5. Formal assessmentWe’ll do a two-stage assessment. First a desktop review of

your management system against ISO 9001 identifying any

omissions or weaknesses that need resolving before Stage 2

when we’ll conduct a full on-site assessment.

6. Certification and beyondOnce the assessment has been successfully completed,

we’ll issue a certificate of registration, clearly explaining the

scope of your management system. The certificate is valid

for three years, and your assessor will visit you regularly to

help you make sure that you remain compliant, and

support you in the continual improvement of your systems.

The key steps in getting certified to ISO 9001



BSI keeps you informedBSI’s publications draw on a wealth of expert knowledge

from across industry. They are particularly useful when you

are getting started. Standards and publications can be

purchased individually, as a kit, or as part of an annual

subscription.

Key ISO 9000 standards and publications are:

ISO 9000 – describes the fundamentals of quality

management and defines terms used in the ISO 9000

quality management ‘family’ of standards.

ISO 9001 – is the core document. It specifies the

requirements for a quality management system.

ISO 9004 – provides guidance to organizations to support

achieving sustained success with a quality management

approach.

BIP 2013 – understanding ISO 9001 and process-based

management systems.

BIP 2014 – creating a process-based management system

for ISO 9001

These standards and publications are available from our

online shop at www.bsigroup.com/shop.

Fast forward with BSI trainingBSI has a comprehensive range of ISO 9001 training

courses. Our introductory courses broaden general

awareness of customer-focused business practice, and our

implementation and auditing courses take that knowledge

further to drive change within your organization.

Our training comes in a number of formats including open

schedule courses, in-company training, eLearning modules

and distance learning qualifications. Visit

www.bsigroup.co.uk/trainingor call 0845 086 9000 for details.

Manage information with Entropy® SoftwareBSI’s Entropy® Software system is used by leading

companies at over 14,000 sites around the world to

improve their business performance and manage their risks.

For further information please visit

www.bsigroup.co.uk/entropy, call 0845 080 9000 or

email [email protected].

Show you meet the standard with certificationIndependent assessment by BSI will assure you and your

key stakeholders that your quality management system

meets the requirements of ISO 9001.

Before the formal certification assessments, BSI can perform

a gap-analysis (a review of what you do compared with the

standard’s requirements) to help identify the areas that need

to be tackled to achieve certification smoothly. You can also

use our online Self-Assessment Tool.

When your certification has been awarded by BSI you have

a market differentiator that is recognized worldwide. BSI

also works with you to promote your achievement. For

more information visit www.bsigroup.com/certificationor call 0845 080 9000 now to start your journey to be a

more successful business.

BSI supporting you every step of the way

- Assessment- Certification

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*BSI customers who reported cost savings from using ISO 9001 (Source: BSI Client Survey 2010)� Financial benefits of ISO 9001 have been shown by BSI customer research and independentresearch papers published by Management Science; V. 51;Journal of Business & EconomicsResearch; V. 6; International Journal of Quality and Reliability Management; V. 19; managentScience; V. 47; Accident Analysis & Prevention; V. 39 Journal of Operations Management; V. 24;Total Quality Management/University of Houston, Texas.

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