9/21/2019 MS ISO 9001: 2015 – Quality Management Systems

Scope of
standards? Quality Management Systems (QMS)

What does An organisation has established a systematic approach to instill quality by ensuring that their
certify to products meet customer requirements. This does not mean that the product is conforming to product
the standards. It means that the products are being produced through processes which have
standard consideration for quality in the aspects set out by the standard.
means?

Who should Any organisation of any size

apply?

Standards National Standards

used?
MS ISO 9001:2008 – Quality Management Systems – Requirements

(FIRST REVISION) (ISO 9001:2008, IDT)

or

MS ISO 9001:2008 – SistemPengurusanKualiti – Keperluan

(SEMAKAN PERTAMA) (ISO 9001:2008, IDT)

or
International Standard

ISO 9001:2015 - Quality Management Systems – Requirements

*The MS ISO 9000 family of standards on Quality Management is also available for further
reference. Please visit www.msonline.gov.my to get your standards.More ISO 9000 family
standards are available in www.iso.org.

Certification Certification process and cycle

cycle?

How to List of accredited certification body by Standards Malaysia can be accessed through the following
apply? URL
http://www.jsm.gov.my/cab-directories

*URL may change from time to time. Please revert to Standards Malaysia's website at
www.jsm.gov.my should the URL did not work.

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9/21/2019 MS ISO 9001: 2015 – Quality Management Systems

Scope of
standards? Quality Management Systems (QMS)

Benefit of
certification 1. QMS will help you to better manage your business to meet customer requirements. This will
result in better products, better customer service, satisfied customer and repeat orders
2. With proper implementation of the systems, your business will become more efficient and
productive thus will reduce errors and rework, reduce operation cost, time and use of
resources
3. The systems promote continual improvement, which will provide your business with the
competitive edge to compete in the market place and for those who have succeeded, to
become more successful and resilient
4. The systems also look into the needs of your human resource which will also increase staff
morale and commitment
5. Complying to standards provide you with the accolades for competitive edge
6. All of the above will increase profitability

QMS made Clause 4 – QMS Requirements

simpler
1. Establish Quality Management Systems based on process approach, implement and improve
2. Document your systems and explain how it works in your organisation through manual,
procedures, work instructions etc. and must include :

Quality Manual
Document Control Procedure to control documents used for QMS
Record Control Procedure to control records that are used for QMS

Clause 5 –Management Requirements

The management of your organisation need to :

1. Demonstrate management commitment by

communicating to staff on how important quality is and how does the QMS work for
the organisation
Setting a quality policy and objectives for your systems
providing adequate resources (people, infrastructure, fund etc.)
ensuring there is adequate planning to meet customer requirements
reviewing how the systems performs

2. Focus on customer by identifying and meeting their requirements

3. Establish Quality Policy and communicate to staff to engage commitment
4. Establish plan on how to develop, document, implement, maintain and ensure continual
improvement of your QMS
5. Set quality objectives, action plan to achieve them and how to measure the objectives
6. Identify responsibility and authority for QMS
7. Appoint Quality Management Representative
8. Have effective internal communication to communicate your QMS
9. Review input performance of QMS including customer feedback, performance,
nonconformity, audits, corrective and preventive actions, changes and any need to improve
10. Generate output from the management review which include management decision and way
forward for QMS

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9/21/2019 MS ISO 9001: 2015 – Quality Management Systems

Scope of
standards? Quality Management Systems (QMS)

Clause 6 – Resource Requirements

1. Identify resources needed for the systems and provide them for the QMS and to enhance
customer satisfaction
2. Ensure competency of human resource, identify what training are required and provide them.
Evaluate competency after training.
3. Identify required infrastructure to deliver product that meet customer requirement
4. Ensure conducive working environment for staff

Clause 7 – Product Realisation

1. Plan and develop the processes required for product and services to ensure customer
requirement are met
2. Control customer related processes by having effective processes and understanding what
requirement apply to your product. Have effective communication with customers
3. Control product design and development by ensuring proper planning for design and
development, identifying design and development input, generate design development
output, carry out design and development verifications and validations and manage changes
to design and development
4. Control purchasing and purchased products by controlling what you buy, outsourced or
subcontract (goods, materials or services) that will affect your product and services.
Establish control of your purchasing process, specify purchasing requirement and verify
purchased products
5. Manage your operations by ensuring that production or service provision are carried out
under controlled conditions, validate production and service provision processes (if required)
and if appropriate ensure traceability through unique identification of the product. Ensure that
your products and components continue to conform to requirements while they are being
processed internally or are being delivered to the intended destination
6. Control monitoring and measuring equipment by

establishing monitoring and measuring processes

identifying your organisation's monitoring and measuring needs and selecting the
suitable equipment
ensuring valid results by calibrating or verifying equipment within specified time prior to
use
safeguard equipment from adjustment
confirming that monitoring and measuring software is capable of doing the intended
task
Evaluating the validity of previous measurements should you discover that your
measuring or monitoring equipment is out-of-calibration.
protecting your equipment from damage and deterioration during handling,
maintenance and storage

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9/21/2019 MS ISO 9001: 2015 – Quality Management Systems

Scope of
standards? Quality Management Systems (QMS)

Clause 8 – Measurement, analysis and improvement

1. Establish monitoring and measurement process

2. Monitor and measure performance of QMS through customer satisfaction feedback, internal
audits, measuring key performance indicators of processes and characteristics of products at
suitable stagesand management review
3. Establish procedure on Internal Audit
4. Establish procedure on control non-conforming products
5. Identify data that can provide information that the QMS is working, collect, analyse and
provide findings for improvement
6. Continually improve effectiveness of QMS through quality policy and objectives, audit
results, analysis of data, corrective and preventive actions
7. Establish procedure on Corrective and preventive action

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