Quality Management System

ISO/TS 29001:2003
Petroleum, Petrochemical and
natural gas industries

Some ISO standards for use in the

industry
ISO 10418
ISO 14693
ISO 15544
ISO 10439
ISO 10623
ISO 15589
ISO 15156
env.

Basic surface safety systems

Drilling equipment
Emergency response
Centrifugal compressors
Pipelines
Cathodic protection for pipelines
Cracking resistant material in H2S

ISO/ TC 67
TC 67 : Materials, equipment and offshore structure.
ISO/TS 29001 successfully published on 15 Sept 03
Based on TC 67/ WG2 experts recommendations
ISO TC 67 to gain experience in its use for 3-years
Systematic review in 2006
Liaison with CASCO and ISO TC/176

ISO/TC 67 Survey Results

Over 100 ISO standards issued by TC 67
ISO/ TS 29001 is technical supplement to ISO 9001
Collaboration between API & TC 67
does not address competitive or commercial matters
(price, warranties, guarantees)
Similar to API specification Q1 seventh edition
Similar to ISO/TS 16949 for automotive industry.

Applicability - upstream and

downstream
oil and gas industry - refineries, petrochemicals,
pipelines etc.
manufacturers of oil industry equipment
manufacturers of oil industry materials
service providers
purchasers of equipment
materials and services

Scope of Certification
Quality Management System requirements for the
petroleum, petrochemical & NG industry:
Design
Development
Production
Installation
Service

Certified companies worldwide

Petrol Industrial S/A, Brazil
Dresser Inc, USA
Smith Services, USA

List of certified equipments

Wellhead and Christmas Tree Equipment
Tubular Connections
Mechanical Oil Field Equipment

ISO/TS 29001
Quality objectives of the industry
Scope of (Petroleum, petrochemical or NG)
products
Processes employed
Size and structure of the organization

Goal of ISO/TS 29001

Continual improvement
Emphasis on defect prevention
Reduction of variation
Reduction of waste
Focus on supply chain and service providers

Benefits of Certification to ISO/TS

29001
Common & unique to industry
Sector specific and avoids multiple systems
Globally acceptable
Ensure high levels of operational integrity
Maintain revenue streams for companies and
national economies.
Eliminate company specific specifications.

Benefits of Certification to ISO/TS

29001
Reduce cost and delivery time
Quality management of goods suppliers & service
contractors.
Streamlines the controls over handling of hazardous
liquids and gases.
Optimize safety and environmental protection
Facilitate international trade
Appealing to purchasers, engineers and users.

Benefits to oil and gas regulators

Support for goal setting
Ensure functional regulations
Safer operations through better designs

Who Survives ?
Definitions

ISO 29001

Control
features

ISO 9001

Supplements

New
clauses
Notes

Adopted from ISO 9001:2000

New requirements explicitly
stated so that they can be audited.

What is new - Supplementary requirements

Makes Quality management more prescriptive

Additional preventive actions by the industries
Not specific to the oil & gas industry
Makes the requirements:

Specific
Unambiguous
Verifiable and auditable

New Supplementary requirements

Objectivity, impartiality and independence
Field nonconformity analysis
Frequency of management activities
Control features

Objectivity, impartiality and

independence

ISO 9001:2000 objectivity & impartiality

ISO/ TS 29001 - also independence' of audit process
Additional safeguards for purchased products &
services.
Design review independent approval of final design
Final acceptance independence of final acceptance
Internal audits independent auditors from process

Field nonconformity analysis

Field non conformity (NC) are nonconforming
products detected after delivery or use.
Tracking and analysis of field failures/ field
nonconformities
Provides invaluable information for effective
corrective and preventive actions

Frequency of management activities

ISO 9001:2000 planned intervals
ISO 29001
- specific minimum
frequencies
Management review annually
Internal audits annually
Record retention - 3-5 years

Terminology (ISO 29000)

Control Feature
Documented method to perform
an activity under controlled
conditions

Control features : Mandatory

SHALL ESTABLISH CONTROL FEATURES

7.1.1
Product realization process
7.2.2.1
Review of product requirements
7.3.1.1
Design of product
7.4.1.1
Purchasing and supplier selection
7.4.3.1
Verification of purchased product
7.5.1.1
Control of production & service activities

Control features : Mandatory

7.5.1.2

Process controls

7.5.2.1
7.5.3.1
7.5.3.3
7.5.4.1
7.5.5.1
7.6.1

Special process
Identification and trace ability
Identification of product status
customer property
Preservation of product
Calibration of devices

Control features : Mandatory

6.2.2.1

Identification of training needs

8.2.4.1
8.4.1
8.5.1.1

Monitoring of product characteristic

Data analysis techniques
Continual improvement

Quality Management Principle

comprehensive and fundamental rule or belief,
for leading and operating an organisation,
aimed at continually improving performance
over the long term by focusing on customers
while addressing the needs of all other
stakeholders
ISO/TC176/WG15

Quality Management Principles

Customer-Focused Organisation
Leadership
Involvement of People
Process Approach
System Approach by Management
Continual Improvement
Factual approach to decision making
Mutually beneficial supplier relationships

Customer - Focused Organisation

Understanding customer needs and expectations
Communicating these needs and expectations
throughout the organisation
Measuring customer satisfaction and acting on
results
Managing customer relationships

Leadership
Being proactive & leading by example
Establishing a clear vision of the organisations future
Providing people with required resources and freedom
to act with responsibility and accountability
Promoting open and honest communication
Educating, training and coaching people
Setting challenging goals and targets
Implementing strategy to achieve these goals and
targets

 Accept ownership
Involvement
ofandPeople
responsibility to solve problems
Actively seek opportunities to make improvements
Actively seek opportunities to enhance their
competencies, knowledge and experience
Freely share knowledge and experience in teams and
groups
Focus on creation of value for customers
Better represent the organisation to customers
Derive satisfaction from their work
Be enthusiastic and proud to be part of the organisation

Process Approach
Define Processes needed to achieve desired results
Identify & Measure Inputs & Outputs
Identify interfaces
Evaluate risk, consequence and impact on customers
Establish responsibility, authority and accountability
for managing processes
Consider methods, training, resources, etc to
achieve desired result

Input

Product
Realisation

Product
Output

System Approach
Define & Develop processes
Structure the System in most efficient way
Understand interdependencies of processes in
the system
Continually improve through measurement and
evaluation

Continual Improvement
Products, Processes & Systems
Incremental & Breakthrough Concepts
Periodic Assessment against established Criteria
Efficiency & Effectiveness of processes
Promote prevention-based activities
Provide training on continual improvement tools
Establish measures & goals to guide & track
improvements

Continual improvement

Plan
Quality
Management
System:
support to
achieve the
objectives

Act
Check

Do

l
a
u nt
n
i
t
e
n
m
o
C
ve
o
pr
Im

Achieve
objectives

Moving
target
Achieve
objectives

Continual improvement
Analysing and evaluating the existing situation
to
identify areas for improvement;
Plan
Establish the objectives for improvement;
Searching for possible solutions to achieve the
objectives;
Do
Act
Evaluating these solutions and making a
selection
Implementing the selected solution;
Check
Measuring, verifying,
analysing and evaluating
results
of the implementation to determine that the
objectives
have been met;

Factual Approach to DecisionMaking

Measuring & Collecting Data & Information
Ensure accurate, reliable & accessible
Analyse data and information
Understand value of Statistical Techniques
Make Decisions and Take Actions on results of
analysis

Mutually Beneficial Supplier

Relationships
Identify and Select key suppliers
Establish relationships that balance short-term gains
with long-term considerations
Create clear and open communications
Initiate joint development and improvement of
products and processes
Establish joint understanding of customers needs
Share information and future plans

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

Management
Responsibility

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Quality
Resource
Management
Management
System

Input

Product
Realisation

Measurement,
Analysis,
Improvement

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Output

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Introductory Sections
1
2
3

Scope
Normative Reference
Terms and Definitions

1. Scope
General
Application
Application Supplemental : exclusions

1.2.1 Applications - supplemental

Exclusions shall not affect

Organizations ability to provide product

Organizations responsibility to provide product
Customer requirements
Applicable regulatory requirements

Exclusion sub clauses

7.3
Design & development
7.5.1
Control of service provision
7.5.2
Validation of processes for production
and service provision
7.5.4
Customer property

ISO 9000:
Fundamentals and Vocabulary (normative)
QMS
Family
ISO 9001:

Requirements

ISO 9004:

Guidelines for Performance

Improvements

ISO 19011: Guidelines for Auditing Management

Systems
ISO 29001: Petroleum, petrochemical and natural
gas industries Sector specific quality
management systems Requirements of
product and service supply
organizations.

Terminology (ISO 9000)

Quality
ability of a set of inherent
characteristics of a product, system
or process to fulfil requirements of
customers and other interested
parties

Terminology (ISO 9000)

Requirement
need or expectation that is stated,
customarily implied or obligatory

Terminology (ISO 9000)

Quality Requirement
Requirement for
inherent characteristics
of a product, process or system

Terminology (ISO 9000)

Inherent Characteristic is part of the product
e.g. diameter of bolt
Assigned Characteristic (e.g. price of product)
is not an inherent characteristic

Terminology (ISO 9000)

Quality Improvement
part of quality management,
focused on increasing
effectiveness and efficiency

Terminology (ISO 9000)

Quality Objective
something sought, or aimed for,
related to quality

Terminology (ISO 9000)

1994

2000

Customer
Customer
Supplier
Organisation
Subcontractor
Supplier

Terminology (ISO 9000)

Procedure
specified way to carry out an
activity or a process

Terminology (ISO 9000)

Document
information and its support
medium

Terminology (ISO 29000)

ACCEPTANCE CRITERIA
Specified limits of acceptability for
process or product characteristics

Terminology (ISO 29000)

Calibration
Comparison and adjustment to a
standard of known accuracy

Terminology (ISO 29000)

Delivery
time and physical location at
which agreed transfer of
ownership occurs

Terminology (ISO 29000)

Design acceptance criteria

Defined limits placed on
characteristics of materials,
products or services

Terminology (ISO 29000)

Design validation
Process of proving a design by
testing to demonstrate conformity
of product

Terminology (ISO 29000)

Design verification
examining the result of design or
development to determine
conformity with requirements

Terminology (ISO 29000)

MANUFACTURING
ACCEPTANCE CRITERIA
Defined limits on characteristics
of products to achieve conformity
to manufacturing requirements

Terminology (ISO 29000)

SPECIAL PROCESS
Process where product conformity
cannot be verified by monitoring
or measurement

Terminology (ISO 29000)

TENDER
Offer made by an organization in
response to an invitation to
provide a product

4.1 QMS General Requirements

Establish, document, implement, maintain
and continually improve the effectiveness of
a quality management system

Establishing the System

determine processes needed
sequence and interaction
criteria and methods for operation and control
information available for operation and monitoring
measure, monitor, and analyse
implement action to achieve planned results and
continual improvement

4.2 General Documentation

Requirements
QMS shall include:

documented quality policy and objective

documented quality manual
documented procedures required by ISO
9001:2000
documents required by the organisation to ensure
effective planning operation and control of
processes

Types of Documents
Quality Policy and Objectives

d
e
Quality Manual
t
n
e
s
Scope of System
(incl
exclusions)
e
m
r
u
u
c
Procedures
or Reference
d to them
o
e
c
D
Description ofro
sequence/interaction of
P
processes

Types of Documents
ed
QualityentManuals

m resand externally, about the

information, both internally
u
o c ed u
D
organization's quality
management system
oc
r
P

Quality
edPlans
nt

e es
m
how the quality management
is applied to a specific
r
u usystem
c
ed
product,
or contract
Do project
c
o
Pr
t ed
Procedures
n
e es
m
how to operform
cu dur activities
D oce
Pr
t ed
n
e es
Records
m
u ur
c
o
objective evidence of activities
D oced performed or results achieved
Pr

4.2.2.1 Quality Manual Supplemental

Includes requirements of ISO 9001:2000
Address each specific requirement of ISO/TS
29001
Application of Supplemental requirements

Extent of Documentation
size of the organisation and type of activity
complexity and interaction of processes
competence of personnel

Control of Documents
Approve, Review, Update

d
e
t
n s
Ensure availability
e
e
m
r
u
Legible, Identifiable,
Retrievable
u
c
d
o
e
Control External
c
D Documents
o
r
Control ObsoletePDocuments

Identify Current Revision Status and changes

Records are a special type of document

4.2.3.1 Control of Documents supplemental

Appropriate identification of documents
Master list
Equivalent control feature
Current revision status

4.2.3.2 Control of document

changes - supplemental
Changes to document to be reviewed
Changes to document to be approved
Reviewing and approving by same functions
that performed the original documentation.

Control of Quality Records

To provide evidence of conformity to

requirements and system

d
e
Legible, identifiable, retrievable
t
n s
e
Retention time specified
e
m
r
u u
c
o
d
Disposition
specified
D oce
r
Requires a documented
procedure
P

4.2.4.1 Control of Records Supplemental

Identify functions responsible for collection &
maintenance of records

Obtaining, assembling and/or organizing applicable

documents.

Minimum record retention time of 5 years:

Applicable industry product standards

(may be longer if specified by the industry standard.)

Evidence of conformity to requirements

Effective operation of the quality management system

5.1 Management Commitment

Demonstrate Commitment to Development
Implementation & Continually Improving the
effectiveness of System (Including statutory and
regulatory requirements )
Communicating Importance of Meeting Customer
Requirements
Establishing Quality Policy & Objectives
Conducting Management Reviews
Providing Necessary Resources

5.2 Customer Focus

Requirements

(replaces needs and

expectations)

Aim of enhancing Customer

Satisfaction

5.3 Quality Policy

Appropriate to purpose for organisation

d
e
t
Commitment to Continually
Improve the
n
e
effectiveness of the
system
m
u
c
o
D

Framework for setting and reviewing Quality

Objectives

5.3.1 Quality Policy Supplemental

Top management shall document its approval of
the quality policy.

5.4 Planning
5.4.1 Quality Objectives
Measurable
Consistent with Policy
The objectives include those needed to meet
requirements for product

5.4 Planning
5.4.2 Quality Planning
Processes of the System
Resources needed
Continual Improvement
Change management

Notes on Quality Management

System Planning
5.6 Management Review
7.1 Planning of product realization
7.1.1
Planning of product realization supplemental
7.3.1
Design & Development Planning
7.5.1
Control of Production & service
provision
8.1 Measurement Analysis & Improvement General
8.2.2
Internal Audit

5.5 Responsibility, Authority

and Communication
5.5.1 Responsibility & Authorities
Top Management define and communicate
Responsibilities, Authorities & Inter-relations

5.5 Responsibility, Authority and

Communication
5.5.2 Management Representative
Only one member of management
Processes Established implemented & Maintained
Report to Top Management
Promote Awareness of Customer Requirements

5.5 Responsibility, Authority and

Communication
5.5.3 Internal Communications
Top management shall ensure communication
between various levels and functions regarding
effectiveness of system

5.6.1 Management Review General

Top management to review QMS periodically
Review to ensure

Suitability
Adequacy
Effectiveness

Assessing opportunities for improvement

Need for changes to QMS, policy & objectives

5.6.1 Management Review

General - Supplemental
Management review to be conducted at least
annually
Management review should include monitoring
of quality objectives

5.6 Management Review (Inputs)

Current Performance and Improvement Opportunities
Audit Results
Customer Feedback
Process/Product Conformance
Preventive/Corrective Actions
Actions from previous reviews
Planned changes
Recommendations for improvement

5.6.2.1 Review input - Supplemental

Reports of field nonconformities
Analysis of field nonconformities
Trends of product nonconformity (5.6.2 c with
8.4 c)
Changes to applicable petroleum, petrochemical
and natural gas industry standards.(5.6.2 f)

5.6 Management Review (Outputs)

Actions related to:
improvement of the QMS and its processes,
improvement of product related to customer
requirements,
resource needs

6.1 Resource Management

Determine & Provide in Timely Manner to

Implement, Maintain & Continually Improve

Processes
Enhance Customer Satisfaction

6.2 Human Resources

6.2.1 General:
Persons competent to perform work affecting quality
6.2.2 Competence Awareness & Training,
determine competency needs;
provide training or other actions;
evaluate effectiveness of training;
ensure awareness of relevance and importance of activities;
maintain records

6.2.2.1 Training - Supplemental

Training Process

Measure the awareness of personnel on relevance & importance of their

activities
Achievement of quality objectives
Training for contract or agency personnel
Frequency of training

Training of personnel

whose activities are addressed in QMS.

Job affects product quality

Control features for

identifying training needs

providing training

6.2.2.1 Training - Supplemental

Types of training

Quality Management System

Job related training

On the job training to personnel

New jobs
modified jobs

Personnel affecting quality should be informed

about the consequences to the customer of
nonconformity to quality.

6.3 Infrastructure
Determine, provide & Maintain

Buildings,Workspace and Utilities

Equipment, hardware & software

Supporting Services (transport or communication)

6.4 Work Environment

Identify & Maintain conditions to achieve
conformity of product
Note : The organization should maintain its
premises in :

order, cleanliness and repair

consistent with the product and manufacturing

process needs.

7. Product Realization
7.1 Planning of Realization Processes
Quality Objectives
Processes,Documentation,Resources
Facilities
Verification/Validation and Criteria for Acceptance
Records
Planning should be suitable for organisation,s
operations

7.1.1 Planning of product realization

- supplemental
Process to translate product requirements into
product realization.
Product requirements includes design &
development inputs/ outputs.
Organization SHALL:

Define methods
Establish control methods

7.2 Customer Related Processes

Identify Requirements
Review Requirements not stated but necessary
Any other requirement of organisation

7.2.1 Identification of Customer

Requirements
Specified by the customer
Not stated by the customer
Statutory and regulatory requirements
Additional requirements Obligations etc.

7.2.2 Review of Requirements

Tenders and Contracts
Requirements defined
Anomalies resolved
Ability confirmed
Amendments controlled
Internet sales addressed

7.2.2.1 Review of Requirements

related to product - Supplemental
The organization shall establish control features
to review requirements related to the product.

7.2.3 Customer Communication

product information
enquiries, contracts or order handling, including
amendments;
customer feedback, including customer
complaints

7.3 Design and/or Development

7.3.1 Planning
7.3.2 Inputs
7.3.3 Outputs
7.3.4 Review

7.3.5 Verification
7.3.6 Validation
7.3.7 Changes

7.3.1.1 Design & Development

Planning Supplemental
Control feature for design of product
Outsourced design and development to ensure
supplier meets requirements.
Objective evidence for supplier fulfilling design
& development requirements.

7.3.1.2 Design documentation

Supplemental

SHALL INCLUDE

Methods
Assumptions
Formulas
Calculations

7.3.2.1 Design & development

inputs - Supplemental
Includes customer specified requirements in
7.2.2
Product design input requirements shall be:

Identified
Documented
Reviewed

7.3.4.1 Design & development

review - Supplemental
Final design review to be conducted &
documented
Approving authority to be independent from
designer/ developer

7.3.5 Design & Development

verification - Notes
Design verification can include:
Conforming design results by alternative
calculations
Independent review of design output documents
Comparing new designs to similar proven
designs

7.3.6 Design & Development

validation - Notes
Prototype tests
Functional/ operational tests of production
products
Tests specified by industry standards
Tests specified by regulatory requirements
Final performance tests and reviews

7.3.7.1 Control of design &

Development changes Supplemental
Design & development changes
changes to design documents
controls as the original design and development

7.4 Purchasing
7.4.1 Purchasing Control
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product

7.4.1.1 Purchasing process Supplemental

Purchased product affect customer requirements
Products
Services
Control features for:
Purchasing process
Supplier selection

7.4.1.2 Criteria for supplier selection, evaluation and

re-evaluation
Inspection of suppliers final product at his
facility
Inspection of suppliers final product on
delivery
Surveillance of suppliers conformance to
purchasing requirements
Verification that the suppliers QMS is
internationally recognized.

Verification of QMS effectiveness

Verify continuity & effectiveness
of QMS of supplier:
Mergers
Acquisitions
affiliations

7.4.1.3 Supplier provided special

processes
Supplier to qualify & validate special process
(7.5.2)

7.4.2.1 Purchasing information Supplemental

Purchasing information
documented
describes the product to be purchased
includes requirements of 7.4.2
Type, class, grade or other precise information
Title/ positive identification
Applicable issues of specification/ drawings/ process
requirements/ inspection instruction/ other tech data

7.4.3.1 Verification of purchased

product - Supplemental
Control features for verification of purchased
product.

7.5 Production and Service

Provision
7.5.1 Control of production and service provision
Availability of information
Work Instructions, where necessary
Use & Maintenance of suitable equipment
Availability & Use of Monitoring & Measuring equipment
Implement Monitoring Activities
Processes for Release, Delivery & Post Delivery Activities

7.5.1.1 Production and Service

Provision - Supplemental
Control features for production and service
activities performed.

7.5.1.2 Process Controls

Documented process controls:

Routings
Travelers
Checklists
Process sheets etc.

Process controls to verify compliance to:

Quality plan
Control features
Reference standards/ codes

7.5.1.2 Process Controls

References of process control documents

Instructions
Workmanship
Acceptance criteria

Scope of process control documents

Processes
Tests
Inspections
Customers inspection hold
Witness points

7.5 Production & Service Provision

7.5.2 Validation of Processes
7.5.3 Identification & Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product

7.5.2.1 Validation of processes for

production and service provision supple
Establish control features
Qualification and validation of special
processes

7.5.3.1 Identification and trace

ability - Supplemental
Identification and trace ability requirements:

From organization
The customer
Applicable product specification

Control features for identification & trace

ability of product
All stages receipt, production, delivery &
installation

7.5.3.2 Identification and trace

ability Maintenance and
replacement
Identification and trace ability marks for

Maintenance requirements
Replacement requirements

Records of identifications and trace ability

7.5.3.3 Product Status Supplemental

Control features for identification of product
status

7.5.4.1 Customer property Supplemental

Control features for customer property:
Verification
Storage
Maintenance
Control

7.5.5.1 Preservation of product Supplemental

Control features to preserve product conformity
Identification
handling
Packaging
Storage
Protection
Product preservation from internal processing to delivery
Preservation for constituent parts of product

7.5.5.2 Periodic Assessment of

Stock - Supplemental
Detection of deterioration in product/ its
constituents
Stock assessment at specified intervals
Use of inventory management system
Optimization of inventory turn over time
Ensure stock rotation
Implement FIFO

7.6 Control of Monitoring &

Measuring Devices
Determine Measurements
Identify Devices Required
Use & Control
Where applicable
Calibrate or verified, Safeguard, Protect, etc
includes software

7.6.1 Control of Monitoring and

measuring devices - Supplemental
Control features for monitoring & measuring
devices:
Control
Calibrate
Maintain

7.6.1 Control of Monitoring and

measuring devices - Supplemental
Control features shall include:
Device type
Unique identification
Location
Frequency of checks
Check method
Acceptance criteria

7.6.2 Environmental conditions

Ensure suitable environmental conditions:

Calibration
Inspection
Measurements
Tests

7.6.2 Environmental conditions

Calibration/ verification records to include:

Equipment identification
Measurement standard for calibration
Out of specification readings
Assessment of out-ofspecification condition
Notification to customer if suspect product or
material has been dispatched

8. Measurement, Analysis &

Improvement
8.1 Planning
Define,Plan,Implement
Measurement & Monitoring Activities
Conformity of product and system Improve
effectiveness of system
Applicable Methodologies (inc Statistical Techniques)

8.2. Monitoring & Measurement

8.2.1 Customer Satisfaction (monitor customer

d
e
t
n s
e
8.2.2 Internal Audits m
e
r
u u
c
o
Monitoring/Measurement
d
D oce
r
8.2.3 Processes (correction
& corrective action)
P
perception to requirements fulfilment)

8.2.4 Product

8.2.1 Customer Satisfaction

Monitor Information
Customer Perception
Defined Methods

Proactive not Reactive

8.2.2 Internal Audit

Quality System

d
e
t
n s
Effectively Maintained
e
e
m
r
u u
Conforms to ISO9001
c
o
d
D oce
r
P
Effectively Implemented

8.2.2.1 Internal Audit Supplemental

Internal audit scheduled & conducted
ANNUALLY
Internal auditors independent of activity being
audited.

8.2.2.2 Submission of action plans

Response time for submission of action plan
shall be identified.
ISO 19011 has replaced ISO 10011

8.2.3 Monitoring & Measurement

of Processes
Suitable Methods
Realisation Processes
Demonstrate Ability
Achieve planned results
Correction and Corrective action

8.2.3 Monitoring & Measurement of

Processes - note
The organization should maintain records of the
effective dates of process changes

8.2.4 Monitoring &

Measurement of Product
Measure and monitor characteristics of the
product to verify that requirements are met
Appropriate Stages
Evidence of conformity (records)
No release/delivery until all OK (approved by
relevant authority)

8.2.4.1 Monitoring &

Measurement of Product Supplemental
Control features to monitor & measure
characteristics of product

8.2.4.2 Final acceptance of product

Final acceptance and product release by
independent personnel.
Independent personnel are those who have NOT
performed or directly supervised the production
of the materials or products.

8.3 Control of Nonconforming

Product
Related to Product

d
e
Identified and Controlled
t
n s
e
Prevent Unintended Use m
or Deliverye
r
u
u
c
o
d
Corrected and re-verified
D oce
r
Applies to post delivery
P problems which will require
appropriate action

8.3.1 Concession - Supplemental

Concessions shall be documented

8.3.2 Release of acceptance of

nonconforming product under
concession
A) Products not satisfying manufacturing
acceptance criteria (MAC):

Products satisfy design acceptance criteria

OR

Violated MAC is unnecessary to satisfy DAC

OR

Products are repaired or reworked to satisfy

MAC/DAC

8.3.2 Release of acceptance of

nonconforming product under
concession
B) Products not satisfying Design
Acceptance Criteria (DAC):

The original DAC are changed (as per 7.3.7)

AND
The materials or products satisfy the new
DAC

8.3.3 Field nonconformity analysis

Field non conformity (NC) are nonconforming
products detected after delivery or use.
Documented procedure for Field NC/product failure:

Identifying
Documenting
Reporting of incidents
Analysis of field NC

8.4 Analysis of Data

Customer Satisfaction
Conformance to Product Requirements
Characteristics and Trends of Processes, &
Products
Suppliers

8.4.1 Analysis of Data Supplemental

Control features for identification and use of the
techniques for the analysis of data.

8.5 Improvement

8.5.1 Planning for Continual Improvement

Plan and Manage the processes necessary for
continual improvement
(quality policy, quality objectives, audit
results, data, corrective/preventive action)

Continual Improvement
Defining, measuring and analysing existing situation;
Establishing objectives for improvement;
Searching for possible solutions;
Evaluating solutions;
Implementing selected solution;
Measuring, verifying, and analysing results of
implementation;
Formalising changes.

8.5.1.1 Continual improvement of

the organization
Organization shall define a process and
establish control features for continual
improvement
Refer to ISO 9004:2000 Annex B for guidance

8.5 Improvement
8.5.2 Corrective Action

d
e
t
n s
e
e
m
r
u u
c
o
d
D oce
r
P

Review Nonconformities (incl Complaints)

Determine Cause
Evaluate Need for Action
Determine & Implement Action including
prevention of recurrence
Record Results
Review Corrective action

8.5.2.1 Corrective Action Supplemental

Organization to ensure corrective action is
EFFECTIVE.

8.5.2.2 Corrective action response

times
Response times for the submission of an action
plan to address corrective action shall be
identified

8.5 Improvement
8.5.3 Preventive Action

d
e
t
n s
e
e
m
r
u u
c
o
d
D oce
r
P

Action
Implement Action
Record Results
Review Preventive action Identification
Determine Cause
Determine

8.5.3.1 Preventive action Supplemental

The organization shall ensure that any
preventive action is EFFECTIVE.