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Requirements for Quality Management Systems - certified with a simple
a simple overview of the ISO 9001 Standard and practical ISO 9001
This 'nutshell' version is for the 2008 version of ISO 9001. kit that won't break the
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4 Overall Requirements for the System
4.1 Establish a quality management system: develop it,
implement it and improve it.
4.2 Document the quality management system.
4.2.1 Create documents including a quality policy,
objectives, manual, procedures and records
4.2.2 Have a quality manual
4.2.3 Control documents
4.2.4 Create and maintain records of your system to show
that it works as described.
5 Requirements for Management
5.1 Demonstrate commitment to the quality management
system
Communicate the importance of quality
Establish a quality policy and objectives.
Plan and do reviews of your system.
Make sure adequate resources are available.
5.2 Focus on customers
Identify customer requirements.
Aim to enhance the satisfaction of your customers.
5.3 Adopt and use a quality policy
Define a suitable quality policy.
Commit to meeting the system's requirements and to
continual improvement.
Communicate and manage the quality policy.
5.4 Plan for quality
5.4.1 Set measurable objectives (aims/goals).
5.4.2 Have plans that are suitable to achieve the objectives
5.5 Define and communicate 'who does what'
5.5.1 Identify who has what responsibility and authority
5.5.2 Make a senior manager responsible for the quality
system overall
5.5.3 Have effective means of communicating internally.
5.6 Review the quality management system (management
review)
5.6.1 Review your system at planned intervals
5.6.2 I nclude reviews of customer feedback, performance
including nonconformity, results of audits, status of actions,
changes and improvements
5.6.3 Record outcomes from your reviews, including actions
and decisions.
6 Resource Requirements
6.1 Identify and provide the resources needed to implement,
maintain and improve the system, and enhance customer
satisfaction.
6.2 Make sure people are suitably competent
6.2.1 Anyone whose work affects product/service conformity
must be competent
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6.2.2 Decide what competencies are required, provide and

maintain them
6.3 Provide infrastructure: Identify what you need, provide
and maintain it.
6.4 Provide the work environment you need for
product/service conformity.
7 Requirements for Products or Services
7.1 Plan
Plan and develop the processes you need for your
products/services.
7.2 Have effective customer-related processes
7.2.1 Identify requirements that apply to your
products/services
7.2.2 Ensure you can supply or deliver before accepting an
order
7.2.3 Have effective arrangements to communicate with
customers.
7.3 Have effective processes for designing & developing
your products/services
7.3.1 Plan design/development.
7.3.2 Define what inputs are needed to
design/create/develop
7.3.3 Have a 'design' or plan in a form that enables you to
verify the output against it (see 7.3.5)
7.3.4 Review the design/plan at suitable points
7.3.5 Make sure the result meets the agreed & defined
requirements (verification)
7.3.6 Validate design (where practicable).
7.3.7 If changes to design occur, manage them.
7.4 Control any purchasing of goods, materials or services
that affects product/service conformity; 'purchasing' includes
outsourcing and subcontracting
7.4.1 Make sure what you buy meets the requirements you
specified; assess and monitor the suppliers you use.
7.4.2 Describe what you intend to purchase adequately.
7.4.3 Verify that what was purchased did meet the
requirements you set
7.5 Control operations
7.5.1 Have effective ways to control what you do (providing
products/ services)
7.5.2 Validate production/service provision where required.
7.5.3 Identify and track services/products where appropriate
7.5.4 Take care of any property supplied by customers
7.5.5 Care for products/components during storage/delivery,
etc.to make sure they stay in good condition
7.6 Control measuring and monitoring equipment
Identify what monitoring/measuring equipment and
processes your need for valid measurement results. If
equipment is required, choose & use equipment that is
suitable equipment. Make sure results are and remain
accurate.
8 Requirements for Analysis and Improvement
8.1 Have processes suitable to ensure your
services/products conform to requirements and to your
quality management system; include improvement.
8.2 Monitor and measure (as necessary) to work out if you
achieved the results you planned to
8.2.1 Monitor customer satisfaction.
8.2.2 Plan and implement a program of internal audit
8.2.3 Have appropriate ways to monitor and measure your
processes
8.2.4 Monitor and measure products/services at suitable
points.
Release final product/service only after requirements have
been met.
8.3 Control nonconformity (services/products not meeting

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ISO 9001 requirements in a nutshell Page 3 of 3

requirements)
Identify and control nonconformity suitably; includes written
procedure.
8.4 Analyse information from your system
Define the information needed to show your system is
working and to improve.
Collect, analyse and use the information.
8.5 Continually improve.
8.5.1 Improve your system.
8.5.2 Have a systematic approach to fix nonconformity and
stop it recurring.
8.5.3 Have a systematic approach to prevent potential
nonconformity or failures happening.

Note: the numbers correspond to the clause numbers in the

Standard. They start at #4 since the requirements
themselves are in sections 4 to 8 of the Standard.

Disclaimer: This is a simplified summary only. No

representation or warranty is made for the accuracy or the
completeness of the contents. We specifically disclaim any
implied warranties or fitness for any particular purpose and
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damage as a result of your acting or relying upon any of this
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