DOCUMENTATION REQUIREMENTS FOR ISO 9001:2008 M; Manual P; procedure D; Document R: Records Y= Impacted N=Not impactedS No

Clause no /Title

Requirements Changes in extent of Documentation

Remarks

M P D R1 0.1

IntroductionThe design and implementation of the QMS is influenced by organizational environment, change in that and the risks associated with that environment

Y Review the manual for risks which may be encountered. A period of 3 years is reasonable.

2 0.1 General Statutory requirements and regulatory requirements mentioned together.

N N N N

3 0.2 Process Approach

Organisation needs to determine the processes (not just identify).The processes have been recognised as producing outcomes (not just outputs)

Y N Include a section on how to determine processes from customer requirements..

4 1.1 Scope-General.

Note The product includes any intended output from product realisation process

Y Y Y Include a list of intended outputs.

5 4.1 General Requirements

Note has been added to define the Outsourced processes: An outsourced process is a process that the organisation needs in its QMS and which the organisation chooses to have performed by an external agency.

Y Y Y Include a section on outsourced processes. List is required and records for monitoring.

6 4.1 Quality management systemGeneral Requirements

The type and extent of control on outsourced processes shall be defined within the QMS. Ensuring control over outsourced process does not 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

Y Y Y Same section to specify the measures for each outsourced process

7 4.1 Quality The process covered under Y Process for

management systemGeneral requirements

QMS include the processes for management activities like planning , provision of resources, product realization and measurement analysis and improvement.

analysis and improvement.

8 4.2.3 Document control

Editorial clarification:A single document may address a requirement for 2 procedures or a requirement for a procedure can be met with by two documents.

N N N N There is a scope for merger of 3 procedures

9 4.2.4 Control of Records

Records shall be controlled Y Y Y Y Procedure needs to be revised and list of records required at the originating location.

10 6.2.1 Human Resource

Note has been added as follows: Conformity to product requirements can be affected directly or indirectly by personnel performing any task within QMS.

Y List of people who affect product indirectly

11 6.2.2 Competence Training and awareness

The training should be provided to achieve the necessary competence (earlier requirement was to satisfy competence needs)

Y Records of competences achieved

12 6.3 infrastructure

Information system has been added in supporting services.

Y Y Y Monitoring the Information system

13 6.4 Work Environment

It has been elaborated as follows: Work environment relates to those conditions under which work is performed including physical environmental and other factors (such as noise, temperature, humidity, lighting and weather)

Y Y Y Factors like temperature, lighting to be monitored at specific locations and records kept

14 7.2.1 Requirements related to product

Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services and supplementary services such as recycling or final disposal.

Y Review the manual for this requirement.

15 7.3.1 Design and Development Planning

Note : Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination as suitable for the

Y Y Design and development plan must show distinct reviews and verifications (apart from validation)

product and the organization.16 7.3.3. Design

and Development outputs

Note: Information for production and service provision can include details of preservation of product.

Y Design ouputs should include this information

17 7.5.2 Validation of processes

The organization shall validate ANY process for production and service provision where the 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.

Y Y Y Review the list of processes for validation

18 7.5.4 Customer property

Customer property includes personal data.

Y Y Y Customer property list needs to be modified , if applicable.

19 7.5.5 preservation of product

The sentence on preservation says now ” in order to maintain the conformity to requirements.”

N N N Y Records that conformity was maintained.

20 7.6 Control of monitoring and measuring equipment

Note : Confirmation of the ability of the computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

Y Y Verification and configuration management is to be planned and records kept.

21 8.2.1 Customer perception

Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis ,compliments, warranty claims dealer reports.etc

Y Y Y Additional information on customer perception

22 8.2.2 Internal audit

Reference to ISO 19011 given. Y Y Checklists are to be refined and audits reoriented as per ISO19011.

23 8.2.2 Internal Audit

Management will ensure CORRECTIONS and CORRECTIVE ACTIONS …….

Y Y Y Audit NCs will have corrections and corrective actions.

24 8.2.3 Monitoring and

When determining methods for monitoring of processes, it is advisable that the organization

Y Y Y Key processes and others need to be defined.

measurement of processes

consider the type and extent of 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 non conforming product

A para d is added to the list of ways to deal with the non conforming product :d) by taking action appropriate to the effects or potential effects of the non conformity when non conforming product is detected after delivery or use has started.

Y Y Y Y Manual and procedure apart from formats and records need to deal with potential effects of non conformities.

26 8.4 analysis of data

Reference to the sections are added against the para a to d. to give linkages within the standard.1. cust sat against 8.2.12.conformity to product requirements 8.2.43. processes and products 8.2.3 and 8.2.44 suppliers 7.4

Y N N Y Linkages and accordingly records of analysis.

27 8.5.2 and 8.5.3 Corrective action and Preventive action

Reviews have been specifically mentioned as reviews of effectiveness of corrective/preventive actions as the case may be.

Y Y Y Y Reviews on effectiveness need to be emphasized.