Summary of Changes

ISO 9001:2008
This International Standard promotes the adoption of a process approach when
developing, implementing and improving the effectiveness of a quality
management system, to enhance customer satisfaction by meeting customer
requirements.
ISO 9001:2015
Process approach strengthened/more explicit which incorporates the PlanDo-Check-Act (PDCA) cycle and risk-based thinking aimed at taking
advantage of opportunities and preventing undesirable results.

ISO9001:2008 : 8 sections
ISO9001:2015 : 10 sections.
Refer the Matrix.

PDCA Methodology
PLAN
Clause 6

DO
Clause 7, 8

CHECK
Clause 9

ACTION
Clause 10

establish the objectives of the system and its processes,

and the resources needed to deliver results in
accordance with customers requirements and the
organizations policies, and identify and address risks
and opportunities;

implement what was planned

monitor and (where applicable) measure processes and
the resulting products and services against policies,
objectives, requirements and planned activities, and
report the results;

take actions to improve performance, as necessary

Model of Process Based QMS

5.1.2 Determination of
Organization Context

5.1.2.1 EKSTERNAL
customer satisfaction,
ISSUES
legal compliances including
local statutory, requirements,
compliance to national,
international applicable
technical code and standards,
competing in term of best
delivery and pricing,
reputation in energy and
petroleum, natural oil and gas
market,
including cultural,
economic issues directly
affecting customer and supply
chain and
latest technology available in
the market

5.1.2.2 INTERNAL
ISSUES

cultural and social environment

around Cladtek offices,
plant, and facilities,
education and skill level of the
man power available around in
order to analysing and
improving their knowledge an
performance by means of
training, etc

5.1.3 Interested Parties

a) Customers: Products and services delivered on time and with the acceptable
quality in accordance with contractual agreement.
b) Accreditation Body: Products and service compliance to the code and
standard, specification, license agreement e.g. API, ASME.
c) Local, legal, and statutory bodies: Compliance to applicable regulation of
MIGAS, BAPETEN, DEPNAKER, BAPEDAL, etc.
d) Suppliers: Clear information related to purchasing, supplier performance, new
product, on time payment as per contractual agreement.
e) Shareholders and financers: Completing all projects on agreed time and within
the budget to maintain the business profitability and the development of the
company.
f) Employee Unions: Providing good and safe working environment to perform
their responsibilities, remuneration including rewards and benefit

ISO 9001 Risk Based Thinking

ISO 9001:2008

ISO 9001:2015

API Q1

The concept of risk-based thinking hidden.

a) Planning, b) Review, c) Preventive Action.
address risks and opportunities
increasing the effectiveness of the QMS
as a basis for QMS Processes and including the
potential impact on Product
Preventive Action & Preventive Maintenance Risk
Assessment Process
a documented procedure to identify and control risk
associated with impact on delivery and quality of
product.

We have already revised PR-15 to include the new requirements of

ISO9001:2015
All personnel are required to perform Assessment of the potential Risks
and Opportunities associated with their work.

5.1.6.2 QMS Processes Potential

Risk
5.1.6.2 QMS
Processes
Potential Risk

Failure of HR and training

processes;
Failure preparation of QMS,
Policy, Objective;
Failure preparation of
procedures like internal audit,
calibration, manufacturing
processes, preservation, data
analysis, management review

Risk Assessment

5.1.6.3 QMS
Processes
Potential
Opportunities
latest technology,
raw materials,
new products range,
new welding wires,
skilled manpower,
new machinery,
banking finance availability,
new markets,
new accreditation,
new customer
requirements,
Others desirable
possibilities

5.3.4 Organizational Knowledge

a. Lesson Learned from each projectProject close out meeting for each
completed project as per PR-02,
b. Archive of project documentation of running projects on DocCon
server,
c. Archive of project documentation of completed projects DocCon
MRB and Archive server,
d. Archive of management system documentation in QMSsafety
server
e. Intellectual property (documents).
f. External references document Proper handover and overlapping
during personnel resignations & retrenchment.

Thank You