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 products
certify to 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
 Scope of
standards? Quality Management Systems (QMS)

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
 Scope of
standards? Quality Management Systems (QMS)

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.

Benefit of 1. QMS will help you to better manage your business to meet customer requirements. This will
certification 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
 Scope of
standards? Quality Management Systems (QMS)

2. Document your systems and explain how it works in your organisation through manual,
procedures, work instructions etc. and must include :
o Quality Manual
o Document Control Procedure to control documents used for QMS
o 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

o communicating to staff on how important quality is and how does the QMS work for the
organisation
o Setting a quality policy and objectives for your systems
o providing adequate resources (people, infrastructure, fund etc.)
o ensuring there is adequate planning to meet customer requirements
o 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
 Scope of
standards? Quality Management Systems (QMS)

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

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
 Scope of
standards? Quality Management Systems (QMS)

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
o establishing monitoring and measuring processes
o identifying your organisation's monitoring and measuring needs and selecting the
suitable equipment
o ensuring valid results by calibrating or verifying equipment within specified time prior to
use
o safeguard equipment from adjustment
 Scope of
standards? Quality Management Systems (QMS)

o confirming that monitoring and measuring software is capable of doing the intended
task
o Evaluating the validity of previous measurements should you discover that your
measuring or monitoring equipment is out-of-calibration.
o protecting your equipment from damage and deterioration during handling,
maintenance and storage

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