ISO 9001 in a Nutshell
A simple overview of what's in the
ISO 9001:2008 Standard for quality management systems.
4 General Requirements for the Management System
4.1 Establish a quality management system:
develop it, make it a 'happening
thing' and continually improve it.
4.2 Document the system.
4.2.1 Create the documents you need to describe and operate
your system. This must include a quality policy, objectives, procedures and records
.
4.2.2 Have a quality manual
4.2.3 Have a systematic way to control documents.
4.2.4 Create and maintain records that show your system works.
5 Requirements for Management
5.1 Demonstrate commitment to the quality management system
Communicate the importance of
quality and set up a quality policy and objectives you can measure.
Plan and do reviews of the system.
Make sure you have sufficient resources (people, plant, equipment, tools, IT
etc).
5.2 Focus on customers
Identify
customer requirements. Work to increase customer satisfaction.
5.3 Adopt and use a
quality policy
Define a suitable policy. Commit to meeting
all relevant requirements (ISO 9001, legal & statutory related to your
services/products + any others you need) and continual improvement.
Communicate and manage the quality
policy.
5.4 Do planning for quality
5.4.1 Set measurable objectives (aims/goals).
5.4.2 Have plans for achieving your objectives
5.5 Define &
communicate 'who does what'
5.5.1 Identify who has what responsibility and authority
5.5.2 Make someone responsible overall for
the quality system at senior management level
5.5.3 Have effective ways to communicate internally.
5.6 Review the quality management system (management review)
5.6.1 Do reviews at planned intervals
5.6.2 Include at least: customer feedback, performance of
processes and products/services, failures & weaknesses (nonconformity
etc), audit results, actions, changes, improvements
5.6.3 Records of the reviews must exist and include actions and decisions.
6 Resource
Requirements
6.1 Decide what resources you need to operate your system and increase
customer satisfaction (including maintaining and
improving). Provide them.
6.2 Have competent people
6.2.1 Anyone whose work affects product/service conformity must be
competent for their work
6.2.2 Decide the competencies you need; make sure you get and maintain them
6.3 Provide infrastructure:
Identify what you need, provide and maintain it.
6.4 Provide the work environment needed to ensure your products/services
meet requirements.
7 Requirements for Products or Services
("Realization' Requirements)
7.1 Plan
Plan
and develop the processes needed for your services/products.
7.2 Have
effective processes related to customers
7.2.1 Identify the requirements that
apply to your products/services
7.2.2 Before promising to
supply, make sure you can.
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.
7.3.2
Define the inputs needed (includes all relevant requirements)
7.3.3 Have your 'design' (plan, model, prototype etc) in a form that enables
you to verify it (see 7.3.5)
7.3.4 Review the design/plan at suitable points
7.3.5 Make sure the design meets the input 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 purchase 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 is purchased met the
requirements.
7.5 Control your 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
products/services where appropriate
7.5.4 Take care of any property supplied
by customers
7.5.5 Look after products/components during storage/delivery,
etc.
7.6 Control measuring and monitoring equipment
Identify
what monitoring/measuring equipment and processes are needed to obtain valid
results.
If equipment is required, choose & use suitable equipment and ensure the results are
and remain accurate.
8 Requirements for Analysis and Improvement
8.1
Have processes that are suitable for ensuring conformity of
products/services and the quality management system, including improvement.
8.2 Monitor and measure to establish whether you achieved the results you
planned
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
Identify and control
product/service nonconformity with suitable methods, including a 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 from happening.
Note: the numbers correspond to the clause numbers of the Standard. They
start at #4 since the requirements themselves are set out in sections 4 to 8
of the Standard.
Disclaimer: This is a simplified summary only, from the current
(2008) version. 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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