FAQ: What are the requirements of ISO 9001?
This is a simple overview of what's in the ISO 9001:2008 Standard for quality management systems.
To get
certified to ISO 9001 you must meet all the applicable requirements.
ISO 9001 in a Nutshell
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 your system.
4.2.1 Create whatever documents you need to describe, manage & operate
your system. 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
your documents to make sure they are accurate and current.
4.2.4 Create and maintain records that show
that your system does work.
5 Requirements for Management
5.1 Demonstrate commitment to your quality management system
Communicate
how important quality is; have a policy on quality plus objectives you can measure.
Plan and do reviews of your system.
Make sure you
provide adequate resources for the system: people, plant, equipment, tools, IT etc.
5.2 Focus on your customers
Identify
their requirements. Aim to enhance their satisfaction.
5.3 Have and use a
quality policy
Define a policy
suitable for you. Include a commitment to meet
all relevant requirements - ISO 9001, legal & statutory related to your
services/products etc- and to continual improvement. Communicate your quality
policy.
5.4 Plan for quality
5.4.1 Set measurable objectives (aims/goals) for your quality system
and its services/products.
5.4.2
Plan for how to achieve them.
5.5 Define &
communicate 'who does what'
5.5.1 Identify who has what responsibility and authority in our
system
5.5.2 Have someone at senior management level be responsible for the
quality system overall
5.5.3 Have effective methods for communicating internally, including
about the quality system.
5.6 Review the quality management system (management review)
5.6.1 Schedule and do regular, periodic reviews
5.6.2 Include
in your reviews: customer feedback, how your processes and services/products
are performing, failures & weaknesses (nonconformity etc), results
from quality audits, actions from previous reviews, changes (whether
internal or external), improvements planned or suggested
5.6.3
Keep records from your reviews which include actions and decisions.
6 Resource
Requirements
6.1 Decide what resources you need and provide them. Include the
resources needed to operate your system, meet customer requirements, improve
and enhance customer satisfaction.
6.2 Have competent people
6.2.1 Make sure whoever does work that affects the quality or
conformity of yours services or products is competent for that work
6.2.2 Decide what competencies you need; make sure you get and maintain them
6.3 Provide whatever infrastructure you need:
identify what you need, provide and maintain it.
6.4 Provide the work environment you need for you products/services
to 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 (if you do design)
and for
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
can be verified against its requirements (see 7.3.5)
7.3.4 Review your plan/design at suitable stages
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; this includes
outsourcing and subcontracting
7.4.1 Specify your requirements and make sure you get what you
specified. Assess and monitor your suppliers.
7.4.2 Describe
what you intend to purchase appropriately.
7.4.3 Verify that what you purchased met the
requirements.
7.5 Control your operations
7.5.1 Have effective ways to
control what you do, ie, your services/products
7.5.2 Validate
production/service provision where required.
7.5.3 Identify and track
your services or products where required and/or needed
7.5.4 Take care of any property supplied
by customers, including confidential information
7.5.5 Look after your products/components during storage/delivery,
etc.
7.6 Control measuring and monitoring equipment
Identify
if you need monitoring/measuring equipment.
If equipment is required, choose & use suitable equipment; ensure the results
you get are valid and accurate.
8 Requirements for Analysis and Improvement
8.1
Have processes that are suitable for ensuring your services or products meet
requirements: of your customer, your quality management system including improvement,
and any others that apply (eg, legal, statutory, contractual).
8.2 Monitor /measure to determine if you got the results you intended and
planned for
8.2.1 Monitor the satisfaction of your customers satisfaction
8.2.2 Plan and implement a program of internal audit
8.2.3 Monitor and measure your processes appropriately
8.2.4 Monitor and measure your services/products at suitable stages, and
only release your final service/product once requirements are met.
8.3 Control nonconformity
Have suitable method/s to identify and control
product/service nonconformity; 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 that 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 very simplified summary for 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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