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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 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 the system.
Requirements for Management - part 5
5.1 Demonstrate commitment to the quality management system
Communicate the importance of
quality.
Establish a quality policy and objectives.
Conduct management
reviews.
Make sure resources are available.
5.2 Focus on customers
Identify
customer requirements. Aim to enhance customer satisfaction.
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 planning for products or services
Plan
and develop the processes you need for your products/services.
7.2 Have
effective processes regarding customers
7.2.1 Identify requirements that
apply to your products/services
7.2.2 Before committing to supply, ensure
you can meet the requirements
7.2.3 Have effective arrangements to
communicate with 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 purchasing of goods, materials or services, including
outsourcing.
7.4.1 Specify what is required. Assess & monitor suppliers.
7.4.2 Describe
what is to be purchased adequately.
7.4.3 Make sure what you buy/outsource meets
requirements.
7.5 Control operations
7.5.1 Have effective ways to control what you do (product / service)
7.5.2 Validate
provision of services/products where required.
7.5.3 Identify and track products/services where needed
7.5.4 Take due care of any property supplied
by customers, including IP
7.5.5 Look after products/components during storage/delivery,
etc.
7.6 Control devices used for measuring and monitoring
Identify
requirements for monitoring and measuring.
If you use devices, select
and use suitable ones. 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 to do this.
8.2 Monitor and measure to establish whether planned results are achieved
8.2.1 Monitor customer
satisfaction.
8.2.2 Plan and implement a program of internal audit
8.2.3 Monitor and measure processes appropriately
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 of product/service
Identify and control
nonconformity with suitable methods, including a 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.
8.5.3 Have a systematic
approach to prevent potential nonconformity from happening.
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.
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Updated
03-Jan-2010
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