Adequacy Audit Report for Quality Management Systems (Qms)

DOC : MSC-F6.2-01 (QMS)

ISSUE : 02

DATE : FEB 2009

PAGE : 1 OF 13

APPROVED BY: ADG

ADEQUACY AUDIT REPORT FOR QUALITY MANAGEMENT SYSTEMS (QMS)

AS PER IS/ISO 9001:2008

1.Auditor's Name and Designation:

2.Date(s) of the Adequacy Audit:

3. Application / Licence No. :

4. Name & Address of the organization:

5. Site(s) where QMS implemented:

(attach sheet, if required)

6. Product/Service Description & CPA Code:

7. QMS Manual/Document(s) of firm:

i) Title:

ii) Issue No. and date of issue, including:

Number of amendments (if any):

8. Findings of Adequacy Audit :Annexure attached, duly filled-in

9. Whether nonconformities found :

10. Additional information, if any :

11. Recommendations :

Signature

Name & Designation

MSCO( ) Date:

Recommendation and Points for Action:

Sign. of MSCO( )

DDG ( )Date

Actions on pending nonconformities, if any:

ANNEXURE

(Findings of Adequacy Audit, Clause 8 of Report)

IS/ISO 9001:2008
Clause /

Requirements

/ Reference to Cl. No. of firm’s doc / Complies (Yes/No) / Details of
Nonconformity, if any
4.1 / General requirements
a)Determination of processes needed for QMS and their application throughout the organization
b)Determination of sequence and interaction of these processes
c)Determination of criteria and methods needed to ensure that operation and control of these processes are effective
d)Ensuring availability of resources and information necessary to support operation of these processes
e)Monitoring, measuring (where applicable) and analysis of these processes
f)Implementation of actions to achieve planned results and continual improvement of processes
Ensuring control over outsourced processes, if any and defining type and extent of controls over such processes
4.2
4.2.1 / Documentation Requirements
General
a)Documented statements of quality policy and quality objectives
b)Quality Manual
c)Documented procedures and records required by IS/ISO 9001
d) Documents, including records, determined by the organization to ensure effective planning, operation and control of its processes
4.2.2 / Quality Manual
Establishing and maintaining Quality Manual that includes
a)Scope of QMS including details of and justification for any exclusions
b)Documented procedures established for QMS, or reference to them
c)Description of interaction between the processes of QMS
4.2.3 / Control of documents
Documented procedure established for defining controls needed to
a)approve documents for adequacy prior to issue
b)review and update as necessary and re-approve documents
c)identify changes and current revision status of documents
d)ensure availability of relevant versions of applicable documents at points of use
e)ensure that documents remain legible and readily accessible
f)ensuring identification of necessary documents of external origin and control of their distribution
g)prevent unintended use of obsolete documents and suitably identifying them if any for any purpose.
DOC. : MSC-F6.2-01 (QMS), ISSUE : 02, DATE : FEB 2009, PAGE : 2 OF 13, APPROVED BY: ADG
IS/ISO 9001:2008
Clause /

Requirements

/ Reference to Cl. No. of firm’s doc / Complies (Yes/No) / Details of
Nonconformity, if any
4.2.4 / Control of Records
Documented procedure established for defining controls of records with respect to
- Identification
- Storage
- Protection
- Retrieval
- Retention
- Disposition
Ensuring that records remain legible, readily identifiable and retrievable.
5.
5.1 / Management Responsibility
Top Management’s commitment for development and implementation QMS and continually improving its effectiveness by
a)Communication of importance of meeting customer, statutory and regulatory requirements
b)Establishing the quality policy
c)Ensuring establishment of quality objectives
d)Conducting Management review
e)Ensuring availability of resources
5.2 / Customer Focus
Top Management to ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction
5.3 / Quality Policy
Top Management to ensure the following with respect to its Quality Policy
a)appropriateness to the purpose of the organization
b)includes commitment to comply with the requirements and continual improvement
c)provides framework for establishing and reviewing quality objectives
d)communicated and understood within the organization
e)reviewed for continuing suitability
5.4
5.4.1 / Planning
Quality Objectives
Top Management to ensure that Quality Objectives, including those used to meet requirements for products, are
- established at relevant function & levels within the organization
- measurable and consistent with quality policy
5.4.2 / Quality Management System Planning
Top Management to ensure that
a)planning of QMS is carried out to meet the general requirements of QMS (cl. 4.1), as well as the quality objectives
b)Integrity of the QMS System is maintained when changes to itare planned and implemented.
5.5
5.5.1 / Responsibility, Authority and Communication
Top Management to ensure that responsibilities and authorities are defined and communicated within the organization
DOC. : MSC-F6.2-01 (QMS), ISSUE : 02, DATE : FEB 2009, PAGE : 3 OF 13, APPROVED BY: ADG
IS/ISO 9001:2008
Clause /

Requirements

/ Reference to Cl. No. of firm’s doc / Complies (Yes/No) / Details of
Nonconformity, if any
5.5.2 / Management Representative
Top Management to appoint a member of the organization’s management as Management Representative
Management Representative to have responsibility and authority that includes:
a)ensuring that processes needed for QMS are established, implemented and maintained
b)reporting to Top Management on performance of QMS and any need for improvement
c)ensuring promotion of awareness of customer requirements throughout the organization
5.5.3 / Internal Communications
Ensuring establishment of appropriate communication processes within the organization
Communication regarding effectiveness of QMS
5.6
5.6.1 / Management Review
Top Management to review the QMS at planned intervals to ensure its continuing suitability, adequacy and effectiveness
- Review to include assessing opportunities for improvement and need for changes to QMS including quality policy and quality objectives
- Records from management reviews to be maintained
5.6.2 / Review Input
Input to management reviews to include information on
a)Results of audits
b)Customer feedback
c)Process performance and product conformity
d)Status of preventive and corrective actions
e)Follow-up actions from previous management reviews
f)Changes that could affect the QMS
g)Recommendations for improvement
5.6.3 / Review Output
Output from management review to include any decisions and actions related to
a)Improvement of effectiveness of QMS and its processes
b)Improvement of product related to customer requirement
c)Resource needs
6.
6.1 / Resource Management
Provision of resources
Determine and provide the resources needed to:
a)implement and maintain QMS and continually improve its effectiveness
b)enhance customer satisfaction by meeting customer requirements
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IS/ISO 9001:2008
Clause /

Requirements

/ Reference to Cl. No. of firm’s doc / Complies (Yes/No) / Details of
Nonconformity, if any
6.2
6.2.1 / Human Resources
General
Competency of personnel performing work affecting conformity to product requirements directly or indirectly to be on the basis of appropriate education, training, skills and experience
6.2.2 / Competence, training and awareness
a)Determination of competence of personnel performing work affecting conformity to product requirements
b)Where applicable, provide training or taking other actions to achieve necessary competence
c)Evaluation of effectiveness of the actions taken
d)Ensuring that personnel are aware of relevance and importance of their activities and how they contribute to achieve the quality objectives
e)Maintain appropriate records of education, training, skills and experience
6.3 / Infrastructure
Determination, provision and maintenance of infrastructure needed to achieve conformity to product requirements. Infrastructure to include, as applicable:
a)Buildings, workspace and associated utilities
b)Process equipment (both hardware and software)
c)Supporting services (such as transport, communication or information system)
6.4 / Work Environment
Determining and managing the work environment needed to achieve conformity to product requirements.
7.
7.1 / Product Realization
Planning of Product Realization
Planning and developing processes needed for product realization. Planning to be consistent with requirements of other processes of QMS.
Determining the following, as appropriate:
a)Quality objectives and requirements for the product
b)Need to establish processes and documents, and to provide resources specific to the product
c)Required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance
d)Records needed to provide evidence that the realization processes and resulting products meet requirements.
Output of the planning to be in a form suitable for the organization’s method of operations.
DOC.:MSC-F6.2-01 (QMS), ISSUE : 02, DATE : FEB 2009, PAGE : 5 OF 13, APPROVED BY: ADG
IS/ISO 9001:2008
Clause /

Requirements

/ Reference to Cl. No. of firm’s doc / Complies (Yes/No) / Details of
Nonconformity, if any
7.2
7.2.1 / Customer-related Processes
Determination of requirements related to the product
Organization to determine
a)requirements specified by customer, including the requirements for the delivery and post-delivery activities
b)requirements not stated by the customer but necessary for specified or intended use, where known
c)statutory and regulatory requirements applicable to the product
d)any additional requirements considered necessary by the organization
7.2.2 / Review of requirements related to the product
Review of requirements related to product prior to commitment to supply product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) ensuring that:
a) product requirements are defined
b) contract or order requirements differing from those previously expressed are resolved
c) the organization has ability to meet defined requirements
Maintaining records of results and actions from review.
Where the customer provides no documented statement of requirement, the customer requirements to be confirmed before acceptance
Ensuring that relevant documents are amendedand relevant personnel are made aware of the changed requirements, when product requirements are changed.
7.2.3 / Customer communication
Determination and implementation of effective arrangements for communicating with customer in relation to
a)product information
b)enquiries, contracts or order handling including amendments
customer feedback, including customer complaints
7.3
7.3.1 / Design & Development
Design and development planning
Planning and controlling design and development of product
During the Design & Development planning, determining the
a) design and development stages
b)review, verification and validation that are appropriate to each design and development stage
c)responsibilities and authorities for design & development
Managing the interface between different groups involved in design and development toensure effective communication and clear assignment of responsibility.
Updation of planning output, as appropriate, as the design & development progresses
DOC. : MSC-F6.2-01 (QMS), ISSUE : 02, DATE : FEB 2009, PAGE : 6 OF 13, APPROVED BY: ADG
IS/ISO 9001:2008
Clause /

Requirements

/ Reference to Cl. No. of firm’s doc / Complies (Yes/No) / Details of
Nonconformity, if any
7.3.2 / Design and development inputs
Determining inputs relating to product requirement including:
a)functional and performance requirements
b)applicable statutory and regulatory requirements
c)where applicable information derived from previous similar designs
d) other requirements essential for design and development
Review of design developmentinputs for adequacy
Requirements to be complete, unambiguous and not in conflict with each other
7.3.3 / Design and Development Output
Outputs of design development to be in a form suitable for verification against the design development input and to be approved prior to release.
Design and development outputs to:
a)meet the input requirements for design & development
b)provide appropriate information for purchasing, production and service provision
c)contain or reference product acceptance criteria
d)specify the characteristics of the product that are essential for its safe and proper use
7.3.4 / Design and Development Review
Performing systematic reviews of Design & Development at suitable stages in accordance with planned arrangements to
a)evaluate the ability of the results of design & development to meet requirements
b)identify any problem and propose necessary actions
Participation by representatives of concerned functions in review
To maintain records of results of reviews and any necessary actions
7.3.5 / Design & Development Verification
Performing verification as per the planned arrangements.
To maintain records of results of verification and any necessary actions
7.3.6 / Design & Development Validation
Performing validation as per the planned arrangements.
Wherever practicable, validation completed prior to the delivery or implementation of the product
To maintain records of validation and any necessary actions
DOC. : MSC-F6.2-01 (QMS), ISSUE : 02, DATE : FEB 2009, PAGE : 7 OF 13, APPROVED BY: ADG
IS/ISO 9001:2008
Clause /

Requirements

/ Reference to Cl. No. of firm’s doc / Complies (Yes/No) / Details of
Nonconformity, if any
7.3.7 / Control of design and development changes
Identification and maintenance of records of changes to design & development
Changes to be reviewed, verified and validated as appropriate and approval before implementation
Review of design & development changes to include evaluation of the effect of the changes on constituent parts and product already delivered
To maintain records of results of review of changes and any necessary actions
7.4 7.4.1 / Purchasing
Purchasing process
Ensuring that purchased product conforms to specified purchase requirements
Type and extent of control on the supplier and purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or its final product
Criteria for selection, evaluation and re-evaluation of suppliers shall be established
To maintain records of results of evaluations and any necessary action
7.4.2 / Purchasing information
Purchasing information describing the product to be purchased, including, where appropriate,
a)requirements for approval of product, procedures, processes and equipment
b)requirements for qualification of personnel
c)quality management system requirements
Ensuring adequacy of specified purchase requirements prior to their communication to the supplier
7.4.3 / Verification of purchased product
Establishment and implementation of the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements
Stating the intended verification arrangements and method of product release in the purchasing information when the organization or its customer intends to perform verification at the supplier's premises.
DOC. : MSC-F6.2-01 (QMS), ISSUE : 02, DATE : FEB 2009, PAGE : 8 OF 13, APPROVED BY: ADG
IS/ISO 9001:2008
Clause /

Requirements

/ Reference to Cl. No. of firm’s doc / Complies (Yes/No) / Details of
Nonconformity, if any
7.5 7.5.1 / Production and service provision
Control of production and service provision
Planning and carrying out production and service provision under controlled conditions; including, as applicable:
a)availability of information that describes characteristics of the product
b)availability of work instructions, as necessary
c)use of suitable equipment
d)availability and use of monitoring & measuring equipment
e)implementation of monitoring and measurement
f)implementation of product release, delivery and post-delivery activities
7.5.2 / Validation of processes for production and service provision
Validation of processes where the resulting out-put cannot be verified by subsequent monitoring and measurement
Validation shall demonstrate the ability of these processes to achieve planned results
Establishing arrangements for these processes including as applicable for:
a) defined criteria for review and approval of the processes
b) approval of equipment and qualification of personnel
c) use of specific methods and procedures
d) requirements for Records
e) revalidation
7.5.3 / Identification and Traceability
Where applicable, identification of the product by suitable means throughout product realization
Identification of status of the product w.r.t. monitoring and measurement requirements throughout product realization
Where traceability is a requirement, unique identification of the product to be controlled and records maintained.
7.5.4 / Customer Property
Exercising care with customer property while it is under organization’s control or being used
Identification, verification, protection and safeguarding of customer property
Reporting to the customer and maintaining records if any customer property is lost, damaged or otherwise found unsuitable for use
DOC. : MSC-F6.2-01 (QMS), ISSUE : 02, DATE : FEB 2009, PAGE : 9 OF 13, APPROVED BY: ADG
IS/ISO 9001:2008
Clause /

Requirements

/ Reference to Cl. No. of firm’s doc / Complies (Yes/No) / Details of
Nonconformity, if any
7.5.5 / Preservation of products
Preserving the product during internal processing and delivery to the intended destinations
Preservation to include identification, handling, packaging, storage and protection, as applicable
Preservation to also apply to the constituent parts of a product.
7.6 / Control of monitoring and measuring equipment
Determining the monitoring & measurement to be undertaken and themonitoring measuring equipment needed to provide evidence of conformity of product
Establishing processes to ensure that monitoring & measurement can be carried out and are carried out in a manner i.e. consistent with the monitoring & measurement requirements
Where necessary to ensure valid results, measuring equipment to
a) be calibrated or verified or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded.
b) be adjusted or re-adjusted as necessary
c) be identified for determining calibration status
d) be safeguarded from adjustments
e) be protected from damage and deterioration during handling, maintenance and storage
Assessment and recording the validity of the previous measuring results when the equipment is found not to conform to requirements and taking appropriate action on the equipment and any product affected.
Maintaining records of result of calibration and verification
Confirmation of the ability of computer software to satisfy the intended application, prior to initial use and reconfirmed as necessary when computer software is used in the monitoring and measurement of specified requirements.
8.
8.1 / Measurement, analysis and improvement
General – Planning and implementation of monitoring, measurement, analysis and improvement processes needed to:
a) demonstrate conformity to product requirements
b) ensure conformity of the QMS
c) continually improve the effectiveness of QMS
Planning shall include determination of applicable methods, including statistical techniques, and the extent of their use.
DOC. : MSC-F6.2-01 (QMS), ISSUE : 02, DATE : FEB 2009, PAGE : 10 OF 13, APPROVED BY: ADG
IS/ISO 9001:2008
Clause /

Requirements

/ Reference to Cl. No. of firm’s doc / Complies (Yes/No) / Details of
Nonconformity, if any
8.2 8.2.1 / Monitoring and Measurement
Customer Satisfaction
Monitoring information relating to customer perception
Determination of methods for obtaining and using information relating to customer perception
8.2.2 / Internal Audit
Documented procedure established to define responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results
-Internal audits to be conducted at planned interval
-Planning audit programme according to status and importance of the processes and areas to be audited as well as results of the previous audits
-Audit criteria, scope, frequency and method of audit to be defined
-Selection of auditors and conduct of audits to ensure objectivity and impartiality of the audit process
-Auditors not to audit their own work
-Maintaining records of audits and their results
-Necessary corrections and corrective actions taken without undue delay to eliminate detected nonconformities and their causes