DOCUMENTATION REQUIREMENTS FOR ISO 9001:2008

M; Manual P; procedure D; Document R: Records Y= Impacted N=Not impacted

S Clause no Requirements Changes in Remarks
No /Title extent of
Documentation
M P D R
1 0.1 The design and implementation Y Review the
Introduction of the QMS is influenced by manual for risks
organizational environment, which may be
change in that and the risks encountered. A
associated with that period of 3 years
environment is reasonable.
2 0.1 General Statutory requirements and N N N N
regulatory requirements
mentioned together.
3 0.2 Process Organisation needs to Y N Include a section
Approach determine the processes (not on how to
just identify). determine
The processes have been processes from
recognised as producing customer
outcomes (not just outputs) requirements..
4 1.1 Scope- Note The product includes any Y Y Y Include a list of
General. intended output from product intended
realisation process outputs.
5 4.1 General Note has been added to define Y Y Y Include a section
Requirements the Outsourced processes: on outsourced
An outsourced process is a processes. List
process that the organisation is required and
needs in its QMS and which the records for
organisation chooses to have monitoring.
performed by an external
agency.
6 4.1 Quality The type and extent of control Y Y Y Same section to
management on outsourced processes shall specify the
system be defined within the QMS. measures for
General Ensuring control over each outsourced
Requirements outsourced process does not process
absolve the organization of its
responsibility of conformity to
all customer, statutory and
regulatory requirements. The
type and extent of control to be
applied to outsourced process
can be influenced by factors
such as a) Potential impact of
outsourced process on the
organization and its capability
to provide a product that
conforms to requirements. b)
the degree to which the control
for process is shared c) the
capability of achieving the
necessary control through 7.4
7 4.1 Quality The process covered under Y Process for
 management QMS include the processes for analysis and
system management activities like improvement.
General planning , provision of
requirements resources, product realization
and measurement analysis
and improvement.
8 4.2.3 Editorial clarification: N N N N There is a scope
Document A single document may for merger of 3
control address a requirement for 2 procedures
procedures or a requirement for
a procedure can be met with by
two documents.
9 4.2.4 Control Records shall be controlled Y Y Y Y Procedure needs
of Records to be revised
and list of
records required
at the originating
location.
10 6.2.1 Human Note has been added as Y List of people
Resource follows: Conformity to product who affect
requirements can be affected product indirectly
directly or indirectly by
personnel performing any task
within QMS.
11 6.2.2 The training should be provided Y Records of
Competence to achieve the necessary competences
Training and competence (earlier achieved
awareness requirement was to satisfy
competence needs)
12 6.3 Information system has been Y Y Y Monitoring the
infrastructure added in supporting services. Information
system
13 6.4 Work It has been elaborated as Y Y Y Factors like
Environment follows: Work environment temperature,
relates to those conditions lighting to be
under which work is performed monitored at
including physical specific locations
environmental and other factors and records kept
(such as noise, temperature,
humidity, lighting and weather)
14 7.2.1 Post delivery activities include, Y Review the
Requirements for example, actions under manual for this
related to warranty provisions, contractual requirement.
product obligations such as
maintenance services and
supplementary services such
as recycling or final disposal.
15 7.3.1 Design Note : Design and development Y Y Design and
and review, verification and development
Development validation have distinct plan must show
Planning purposes. They can be distinct reviews
conducted and recorded and verifications
separately or in any (apart from
combination as suitable for the validation)
 product and the organization.
16 7.3.3. Design Note: Information for production Y Design ouputs
and and service provision can should include
Development include details of preservation this information
outputs of product.
17 7.5.2 The organization shall validate Y Y Y Review the list of
Validation of ANY process for production processes for
processes and service provision where the validation
resulting output cannot be
verified by subsequent
monitoring and measurement
AND AS A CONSEQUENCE
DEFICIENCIES BECOME
APPARENT only after the
product or service has been
delivered.
18 7.5.4 Customer property includes Y Y Y Customer
Customer personal data. property list
property needs to be
modified , if
applicable.
19 7.5.5 The sentence on preservation N N N Y Records that
preservation says now ” in order to conformity was
of product maintain the conformity to maintained.
requirements.”
20 7.6 Control of Note : Confirmation of the Y Y Verification and
monitoring ability of the computer software configuration
and to satisfy the intended management is
measuring application would typically to be planned
equipment include its verification and and records
configuration management to kept.
maintain its suitability for use.
21 8.2.1 Monitoring customer perception Y Y Y Additional
Customer can include obtaining input from information on
perception sources such as customer customer
satisfaction surveys, customer perception
data on delivered product
quality, user opinion surveys,
lost business analysis
,compliments, warranty claims
dealer reports.etc
22 8.2.2 Internal Reference to ISO 19011 given. Y Y Checklists are to
audit be refined and
audits reoriented
as per
ISO19011.
23 8.2.2 Internal Management will ensure Y Y Y Audit NCs will
Audit CORRECTIONS and have corrections
CORRECTIVE ACTIONS ……. and corrective
actions.
24 8.2.3 When determining methods for Y Y Y Key processes
Monitoring monitoring of processes, it is and others need
and advisable that the organization to be defined.
measurement consider the type and extent of
 of processes monitoring and measurement
appropriate to each of its
processes in relation to their
impact on the conformity to
product requirements and on
the effectiveness of QMS.
25 8.3 Control of A para d is added to the list of Y Y Y Y Manual and
non ways to deal with the non procedure apart
conforming conforming product : from formats and
product d) by taking action appropriate records need to
to the effects or potential deal with
effects of the non conformity potential effects
when non conforming product of non
is detected after delivery or use conformities.
has started.
26 8.4 analysis Reference to the sections are Y N N Y Linkages and
of data added against the para a to d. accordingly
to give linkages within the records of
standard. analysis.
1. cust sat against 8.2.1
2.conformity to product
requirements 8.2.4
3. processes and products
8.2.3 and 8.2.4
4 suppliers 7.4
27 8.5.2 and Reviews have been specifically Y Y Y Y Reviews on
8.5.3 mentioned as reviews of effectiveness
Corrective effectiveness of need to be
action and corrective/preventive actions as emphasized.
Preventive the case may be.
action