1. What is ISO 9001:2015? What are its 10 key Element?
ISO 9001:2015 specifies requirements for a quality management system when an organization:
a) Needs to demonstrate its ability to consistently provide products and services that meet customer and
applicable statutory and regulatory requirements, and
b) Aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and applicable
statutory and regulatory requirements.
Section 1: Scope
This section defines the scope of the 9001:2015 standard. In summary, the scope includes
specifying requirements for a QMS of any organization.
Section 2: Normative References
The supporting standard referenced in ISO 9001:2015 and is indispensable for its application
is ISO 9000:2015 which covers terminology and fundamentals. This and other supporting
standards make up the 9000 series.
Section 3: Terms and Definitions
Terminology used throughout this standard comes directly from ISO 9000:2015, Quality
management systems – Fundamentals and vocabulary.
Section 4: Context of the Organization
Determine external and internal issues, the needs and expectations of interested parties,
quality management system scope and its processes.
Section 5: Leadership
Top management must demonstrate leadership and commitment, establish and communicate
a quality policy, and ensure responsibilities and authorities are assigned, communicated and
understood.
Section 6: Planning
Clause 6 covers Organizational Quality Management System planning to address
organizational risks, opportunities, changes and quality objectives.
Section 7: Support
Clause 7 covers the resources needed for the QMS this covers: providing resources, ensures
employees are competent and aware, and includes documented information to support your
quality management system.
Section 8: Operation
Clause 8 covers the plan and control processes needed to meet the requirements for products
and services (design and development, external providers, production and service provision,
release of products and services, nonconforming outputs).
Section 9: Performance Evaluation
ISO 9001 requires your organization’s QMS to monitor, measure, analyze, and evaluate your
quality management system. Learn More:
Section 09: Evaluating the Quality Management System’s Performance
Customer Satisfaction
Effective Management Review
ISO 9001 Internal Audit
Auditing without a Procedure
Section 10: Improvement
ISO 9001:2015 requirements for clause 10 are based around continual improvement. Select
opportunities for improvement, take action against nonconformities, implement corrective
actions as necessary, and continually improve your quality management system.
ISO 90001:2008 Mandatory Procedure total 6
1. CONTROL OF DOCUMENTS
2. CONTROL OF RECORDS
3. INTERNAL AUDIT
4. CONTROL OF NON-CONFORMING PRODUCTS
5. CORRECTIVE ACTION
6. PREVENTIVE ACTION
The latest version of ISO 9001:2015 does not require mandatory procedures BUT demanded
documented information for organizational Knowledge sharing and most of organization
preparing documented procedures for applicable process with in organization..
ISO 9001 Requirements - Documents and Records
Monitoring and measuring equipment calibration records
Records of training, skills, experience and qualifications
Product/service requirements review records
Record about design and development outputs review
Record about design and development inputs
Records of design and development controls
Records of design and development outputs
Design and development changes records
Characteristics of product to be produced and service to be provided
Records about customer property
Production/service provision change control records
Record of conformity of product/service with acceptance criteria
Record of nonconforming outputs
Monitoring measurement results
Internal audit program
Results of internal audits
Results of the management review
Results of corrective actions
How Many Procedures Should I Document?
As per ISO 9001 2015.
The latest version of ISO 9001:2015 does not require mandatory procedures BUT demanded
documented information for organizational Knowledge sharing and most of organization
preparing documented procedures for applicable process with in organization..
It is up to the organization how many procedures documented, there are no hard and fast
rules for ISO 9001-2015 but ISO 9001-2015
Some companies like to document all their operating procedures - we've seen documentation
with more than 40 procedures - but beware, the more procedures you document the more
work and internal audits you are creating for yourself and your company.
We recommend documenting the following procedures, which satisfies all the latest
requirements:
Control of Documented Information
Control of Risks & Opportunities
Control of Competence & Awareness
Control of Calibrated Equipment
Control of Design & Development
Control of Purchasing & Procurement
Control of nonconformity & Corrective Action
Control of Customer Satisfaction
Control of Internal Audits
Control of Management Reviews
3. What is Management Review Meeting?
A Management Review should cover the following topics: Discussion on the status of any issues from
the previous meeting. Changes to external and internal issues that affect the Management System.
Examination of the performance of the Management System.
Inputs
a) the status of actions from previous management reviews;
b) Changes in external and internal issues that are relevant to the quality management system;
c) Information on the performance and effectiveness of the quality management system, including trends in:
1. Customer satisfaction and feedback from relevant interested parties;
2. The extent to which quality objectives have been met;
3. Process performance and conformity of products and services;
4. Nonconformities and corrective actions;
5. Monitoring and measurement results;
6. Audit results;
[Link] performance of external providers;
d) the adequacy of resources;
e) the effectiveness of actions taken to address risks and opportunities (see 6.1);
f) Opportunities for improvement.
Outputs
a) Opportunities for improvement;
b) Any need for changes to the quality management system;
c) Resource needs.
4. Contents of NCR
1. Root Cause- What is the main reason of the nonconformance occurred.
2. Correction Action- it is immediate action taken.
3. Corrective action- it is pre-emptive action
4. Preventive Action- What are the measures that can be taken to prevent non-conformance from
happening again.
5. What are KPIs and how to maintain them?
Key Performance Indicators (KPI) are tools used to determine if an organization is meeting the
requirements of ISO 9001 and is are great for your QMS.
KPIs can be maintained
By controlling Non Conformances
By Following ITPs
By following Quality Procedures.
[Link] Audit & External Audit.
Internal Audit: A routine inspection within the company in which an assigned auditor assesses your
organization's processes and quality management system based on the criteria provided by the latest ISO
9001 standard. Performed by Company’s Lead Auditor or 3rd Party.
External Audit: It is assessment of QMS of a company by External Lead Auditor or 3rd Party. Company’s
quality records are evaluated by external auditor and status of Non Conformances are checked.
Audit Agenda;
The audit agenda is the time-table schedule for conducting the actual audit and sent to the auditee
(business unit being audited) well in advance of the audit to enable the auditee to make sure that the
required personnel and documentation of each section/unit (purchase, production, quality) to be audited are
ready when the auditor conducts the audit.
Below are the points to be included in Audit agenda.
Audit Objectives: To determine the extent of conformity and to identify areas of potential improvement of
the quality management system
Audit Scope: Document Control Center development and implementation
Audit Criteria: ISO 9001:2015, Project Execution Plan, Project Quality Plan, Schedule Q
(Reference documents)
Date(s) of Audit: September 11, 2019
Venue of Audit: Document Control center
Audit team: Asif, IRCA Registered Lead Auditor, Saudi Aramco Approved QMS Lead Auditor
Participants: See Attachment 2- Opening meeting attendance Logsheet
See Attachment 3 - Closing Meeting attendance Log sheet
What IS the PQP and Its Content?
A project quality plan (PQP), sometimes referred to as a quality management plan, quality assurance plan
or project quality management plan, is a project-specific quality plan that describes the activities,
standards, tools and processes necessary to achieve quality in the delivery of a project.
1-PURPOSE AND SCOPE. 2-NORMATIVE REFERENC 3-TERMS AND DEFINITIONS
4-QUALITY MANAGEMENT SYSTEM. 5.0 MANAGEMENT RESPONSIBILITY,
6.0 RISK MANAGEMENT 7.0 RESOURCE MANAGEMENT 8.0 PROJECT EXECUTION
9.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 10-Improvement.
Detailed tables as below.
Table of Content:
1-PURPOSE AND SCOPE.
2-NORMATIVE REFERENC
3-TERMS AND DEFINITIONS
4-QUALITY MANAGEMENT SYSTEM. This section included the below sub-section
General Requirements ........................................................................................................
4.1.1 Outsourcing ..................................................................................................................
4.1.2 Monthly Quality Management Report ..........................................................................
4.1.3 General DOCUMENTATION REQUIREMENTS ..........................................................
4.1.4 changes to the content of the project Quality Plan .......................................................
4.1.5 Control of Documents: ..................................................................................................
4.1.6 Control of Records ........................................................................................................
4.1.7 Storage of Records.
5.0 MANAGEMENT RESPONSIBILITY -This section includes the below sub-section.
5.1 Management Commitment ..................................................................................................
5.2 Customer Focus ..................................................................................................................
5.3 Quality Policy ......................................................................................................................
5.3.1 Organizational Roles, Responsibilities and Authorities ................................................
5.4 Quality Planning .................................................................................................................
5.4.1 Project Quality Objectives ............................................................................................
5.4.2 Quality Management System Planning ........................................................................
5.5 Responsibility, Authority and Communication ....................................................................
5.5.1 Organization and Responsibility ...................................................................................
5.5.2 Appointing a Quality ASSURANCE Manager/MR ........................................................
5.5.3 Internal Communication ................................................................................................
5.6 Management Review ..........................................................................................................
5.6.1 General .........................................................................................................................
5.6.2 Review Input .................................................................................................................
5.6.3 Review Output ..............................................................................................................
5.6.4 Contract Review ...............................................................................................
6.0 RISK MANAGEMENT ......... The purpose of risk management is to identify potential
problems before they
occur so that risk-handling activities may be planned and invoked as needed
across the life of the product or project to mitigate adverse impacts on
achieving objectives............................................................
7.0 RESOURCE MANAGEMENT ------This section included Below sub-sections.
7.1 Provision of Resources ......................................................................................................
7.2 Human Resources
Competence, Awareness, and Training ........................................................................
7.3 Infrastructure .......................................................................................................................
7.4 Work Environment ..............................................................................................................
8.0 PROJECT EXECUTION ...........................................................................................................
8.1 Planning of Project Execution .............................................................................................
8.2 Customers Related Processes ...........................................................................................
8.2.1 Determining Project Requirements ...............................................................................
8.2.2 Reviewing Project Requirements ..................................................................................
8.2.3 Customer Communication ............................................................................................
8.3 Design and Development ..................................................Excluded and ...............................................
8.3.1 Design and Development Planning ..............................................................................
8.3.2 Design Inputs ................................................................................................................
8.3.3 Design and Development Outputs ................................................................................
8.3.4 Design and Development Review .................................................................................
8.3.5 Design and Development Verification ...........................................................................
8.3.6 Design and Development Validation .............................................................................
8.3.7 Control of Design Changes ...........................................................................................
8.4 Purchasing ..........................................................................................................................
8.4.1 Purchasing Process ......................................................................................................
8.4.2 Purchase Information ....................................................................................................
8.4.3 Verification of Purchased Products ..............................................................................
8.5 Production and Service Provision .......................................................................................
8.5.1 Control of Production and Service Provision ................................................................
8.5.2 Validation of Processes for Production and Service .....................................................
8.5.3 Identification and Traceability .......................................................................................
8.5.4 COMPANY’s Property ..................................................................................................
8.6 CONTROL of Measuring & Testing Equipment ..................................................................
8.7 Construction ........................................................................................................................
8.7.1 Purpose of site inspection &test ..................................................................................
8.7.2 ITP for Site Quality Control ...........................................................................................
8.7.3 Description ....................................................................................................................
8.7.4 Special Process Procedures .........................................................................................
8.7.5 Fabrication ....................................................................................................................
8.7.6 Non-Destructive Testing ...............................................................................................
8.7.7 Testing and Pre-Commissioning ...................................................................................
9.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT .............................................................
9.1 General ...............................................................................................................................
9.2 Monitoring and Measuring ..................................................................................................
9.2.1 Customer Satisfaction ...................................................................................................
9.2.2 Internal Audits ...............................................................................................................
9.2.3 Monitoring and Measuring of Processes ......................................................................
9.2.4 Monitoring and Measuring of the Work .........................................................................
9.3 Control of Non-Conforming Product ....................................................................................
9.4 Analysis of Data ..................................................................................................................
9.4.1 General .........................................................................................................................
9.4.2 Quality Management Report .........................................................................................
9.5 Improvements .....................................................................................................................
9.5.1 Continual Improvement .................................................................................................
9.5.2 Corrective Action ..........................................................................................................
9.5.3 Prevent Potential Nonconformities ...............................................................................
9.5.4 Project Quality Records ...............................................................................................
9.5.5 Project Record book (PRB) ..........................................................................................
List of attachments.
10.0 APPENDIX # 1: LIST OF QUALITY SYSTEM DOCUMENTS ................................................
11.0 APPENDIX # 2: COMPARISON TABLE .................................................................................
12.0 APPENDIX # 3: IK ORGANIZATION CHART .........................................................................
13.0 APPENDIX # 4: PROJECT QUALITY ORGANIZATION CHART (IK) ....................................
14.0 APPENDIX #5 SAUDI ARAMCO TYPICAL INSPECTION PLAN(SATIP) ..............................
15.0 APPENDIX # 6: PROJECT AUDIT PLAN (INTERNAL) ..........................................................
16.0 APPENDIX #7: PROCUREMENT QUALITY CONTROL WORK FLOWCHART ....................
17.0 APPENDIX # 8: APPLICABLE PROCEDURE LIST ...............................................................
18.0 APPENDIX # 9: SEPCO QUALITY POLICY ............................................................................
19.0 APPENDIX # 10: ISO 9001:2015 CERTIFICATE ....................................................................
20.0 APPENDIX # 11: LIST OF QUALITY PLAN CONTROLLED COPY HOLDERS. ....................