Documentation Requirements For Iso 9001:2008

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

Clause no /Title

1

0.1 Introduction

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4 5

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7

Requirements

The design and implementation of the QMS is influenced by organizational environment, change in that and the risks associated with that environment 0.1 General Statutory requirements and regulatory requirements mentioned together. 0.2 Process Organisation needs to Approach determine the processes (not just identify). The processes have been recognised as producing outcomes (not just outputs) 1.1 ScopeNote The product includes any General. intended output from product realisation process 4.1 General Note has been added to define Requirements 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. 4.1 Quality The type and extent of control management on outsourced processes shall system be defined within the QMS. General Ensuring control over Requirements 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 4.1 Quality The process covered under

Changes in extent of Documentation M P D R Y

N

N

Y

N

N

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

N

Y

Y

Y

Y

Y

Y

Y

Y

Y

Y

Remarks

Include a section on how to determine processes from customer requirements.. Include a list of intended outputs. Include a section on outsourced processes. List is required and records for monitoring. Same section to specify the measures for each outsourced process

Process for

management system General requirements 8

4.2.3 Document control

9

4.2.4 Control of Records

10

6.2.1 Human Resource

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6.2.2 Competence Training and awareness

12

6.3 infrastructure

13

6.4 Work Environment

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

Note has been added as follows: Conformity to product requirements can be affected directly or indirectly by personnel performing any task within QMS. The training should be provided to achieve the necessary competence (earlier requirement was to satisfy competence needs) Information system has been added in supporting services.

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) 7.2.1 Post delivery activities include, Requirements for example, actions under related to warranty provisions, contractual product obligations such as maintenance services and supplementary services such as recycling or final disposal. 7.3.1 Design Note : Design and development and review, verification and Development validation have distinct Planning purposes. They can be conducted and recorded separately or in any combination as suitable for the

analysis and improvement.

N

N

N

N

There is a scope for merger of 3 procedures

Y

Y

Y

Y

Procedure needs to be revised and list of records required at the originating location. List of people who affect product indirectly

Y

Records of competences achieved Monitoring the Information system Factors like temperature, lighting to be monitored at specific locations and records kept

Y

Y

Y

Y

Y

Y

Y

Y

Review the manual for this requirement.

Y

Y

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

16

17

7.3.3. Design and Development outputs 7.5.2 Validation of processes

18

7.5.4 Customer property

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7.5.5 preservation of product

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7.6 Control of monitoring and measuring equipment

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8.2.1 Customer perception

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8.2.2 Internal audit

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product and the organization. Note: Information for production and service provision can include details of preservation of product. 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. Customer property includes personal data.

Y

Design ouputs should include this information

Y

Y

Y

Review the list of processes for validation

Y

Y

Y

N

Y

Customer property list needs to be modified , if applicable. Records that conformity was maintained.

Y

Y

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

Y

Y

Y

Additional information on customer perception

The sentence on preservation says now ” in order to maintain the conformity to requirements.” 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. 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 Reference to ISO 19011 given.

N

N

Y

Y

8.2.2 Internal Audit

Management will ensure CORRECTIONS and CORRECTIVE ACTIONS …….

Y

Y

Y

8.2.3 Monitoring and measurement

When determining methods for monitoring of processes, it is advisable that the organization consider the type and extent of

Y

Y

Y

Checklists are to be refined and audits reoriented as per ISO19011. Audit NCs will have corrections and corrective actions. Key processes and others need to be defined.

of processes

25

8.3 Control of non conforming product

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8.4 analysis of data

27

8.5.2 and 8.5.3 Corrective action and Preventive action

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. 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. Reference to the sections are added against the para a to d. to give linkages within the standard. 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 Reviews have been specifically mentioned as reviews of effectiveness of corrective/preventive actions as the case may be.

Y

Y

Y

Y

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

Y

N

N

Y

Linkages and accordingly records of analysis.

Y

Y

Y

Y

Reviews on effectiveness need to be emphasized.