ISO 9001
in a Nutshell
An overview of the requirements in the ISO 9001: Standard (2008).
General Requirements for the Management System - clause 4
4.1 Establish and maintain a quality management system:
put it into action and improve it.
4.2 Document your 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 your documents; including written procedure
4.2.4 Have records to demonstrate that your quality management system
works as describes; manage records, including written procedure.
Requirements for Management - part 5
5.1 Demonstrate commitment to the system
Communicate the importance of
quality.
Establish the quality policy and objectives.
Review the system regularly.
Provide the resources (people, IT, equipment, tools, infrastructure etc)
needed for the system to work.
5.2 Focus on customers
Identify
customer requirements.
Aim to enhance the satisfaction of your
customer/s.
5.3 Set a
quality policy
Define a suitable quality policy.
Commit to meeting
requirements and continual improvement.
Communicate and manage the quality
policy.
5.4 Plan for quality
5.4.1 Set measurable objectives.
5.4.2 Perform
planning appropriate to achieve aims and objectives.
5.5 Define &
communicate 'who does what'
5.5.1 Identify responsibilities and authorities
5.5.2 Include a manager for the system
5.5.3 Make sure internal
communications are effective.
5.6 Review the system (management review)
5.6.1 Review your system at planned intervals
5.6.2 Include review
of customer feedback, performance of services, products & processes, nonconformity, audit
results, changes, improvements and actions raised
5.6.3 Make sure
outputs from review include any decisions on improvements.
Resource
Requirements - part 6
6.1 Identify and provide the necessary resources
6.2 Make sure
people are competent for their work if it affects quality
6.2.1 Provide people who are competent,
aware and trained.
6.2.2 Have ways to to maintain the competency of people.
6.3 Provide infrastructure
Identify what is needed for services/products; provide and maintain it.
6.4 Provide the necessary work environment
Identify and manage the work environment needed.
Requirements for Products or Services
("Realization') - part 7
7.1 Do the planning necessary for your services / products.
Plan and develop the processes you need for them.
7.2 Have
effective customer-related processes
7.2.1 Identify the requirements applying to your services / products
(customer + legal, statutory, contractual etc)
7.2.2 Before agreeing to supply, make sure you can meet the requirements
7.2.3 Have effective arrangements to
communicate with your customers.
7.3 Have effective processes for designing &
developing products/services
7.3.1 Plan for design and development.
7.3.2
Define what inputs are needed to design/create/develop
7.3.3 Produce or develop the 'design'
7.3.4 Review this at suitable points
7.3.5 Make sure the result meets requirements
(verification)
7.3.6 Validate where practicable.
7.3.7 If changes are necessary, manage them.
7.4 Control what and how you purchase (goods/materials/services; includes
outsourcing)
7.4.1 Specify what you require. Monitor supplier performance; assess
them at suitable intervals.
7.4.2 Describe
what you want to purchase.
7.4.3 Make sure what you buy meets your requirements (ie, make sure you
get what you specified).
7.5 Control your processes and operations
7.5.1 Operate under controlled conditions
7.5.2 Validate
the services/products (where required).
7.5.3 Identify products/services (where needed)
7.5.4 Take care of any property supplied
by customers, including IP
7.5.5 Make sure products/services remain fit for use, even during storage/delivery,
etc.
7.6
Identify
what you require for monitoring/measurement. Select
and use suitable equipment. Control the equipment, and make sure the results are accurate (calibration,
protection, validation).
Requirements for Analysis and Improvement - part 8
8.1
Review, analyse and improve performance
Plan and implement suitable
processes for this.
8.2 Have methods to monitor and measure performance/processes etc, to see
if you get the results you planned to.
8.2.1 Monitor customer
satisfaction.
8.2.2 Plan and implement a program of internal audit; including written
procedure
8.2.3 Monitor and measure processes appropriately
8.2.4 Monitor/measure services / products at
suitable points.
Release to final (to customer) only after requirements have
been met.
8.3 Control nonconformity.
Identify and control
nonconformity with suitable methods, including a written procedure.
8.4 Analyse
information from the system
Define the information needed to show your
system is working and to improve.
Collect and analyse that information.
8.5
Improve continually.
8.5.1 Improve your system.
8.5.2 Have a systematic
approach to fix nonconformity and stop it recurring, including written
procedure.
8.5.3 Have a systematic
approach to prevent potential nonconformity from happening, including
written procedure.
Note: the numbers correspond to the clause numbers of the Standard. They
start at #4 because the requirements themselves are in sections 4 to 8
of the Standard.
Disclaimer: This is a very simplified summary. 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 will not be
liable for any loss of profit or any other commercial damage as a result of
your acting or relying upon any of this information.
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