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Sunday, March 8, 2020

What to audit as per ISO? How to audit ISO audit?



Quality management systems as per ISO 9001:2015(E)
Environmental management systems as per ISO 14001:2015(E)

Check the declared procedure and understand the interested parties and customers for the party to whom you are auditing.

4.1 - External and internal issues – Annexure 1

4.2 / 4.3 - Needs and expectations of interested parties – Annexure 2 - compliance obligations, organizational units, functions and physical boundaries

5.2 / 5.2.1 / 5.2.2 – Document and Communicating the quality policy - environmental policy

6.1 / 6.1.1 / 6.1.2 - risks and opportunities – planed and Documented– Annexure 3 & Annexure 4. Environmental aspects and associated impacts shall be listed and maintained.

6.1.3 - Compliance obligations - compliance obligations related to its environmental aspect, determine how, implementing, maintaining and continually improving.

6.2 / 6.2.1 - information on the quality objectives – Written procedure needs to verify and inspect KPI (key Performance Indicator) and all formats. Environmental objective shall be measurable (if practicable), monitored, communicated and updated as appropriate.

6.3 – Inspect the JD of the team members.

7.1 / 7.1.2 - Inspect the JD of the team members.

7.1.3 – Details of resources like: building plan, equipment, Vehicles details

7.1.4 – Details of environment necessary for the operation like, social (e.g. non-discriminatory, calm, non-confrontational), psychological (e.g. stress-reducing, burnout prevention, emotionally protective) and physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise) shall be maintained.

7.1.5 – Document regarding Monitoring and measurement activities of resources. - EMS OBJECTIVES MONITORING SHEET PRODUCTION                                                                                                                     
7.1.6 - Organizational knowledge – Organizational chart, JD of members, Annexure-V Organizational Knowledge                                                                

7.2 – Competence - Documented information of members regarding appropriate education, training, or Experience, training, the mentoring - reassignment of currently employed persons, etc considering the environmental system.

7.3 - Awareness to be provided regarding quality policy to the members – certificate shall be shared.

7.4 / 7.4.1 - Communication - internal and external communications – QMS – EMS – certificates. As per procedure communications shall be maintained considering the environment system.

7.5 / 7.5.1 - Documented information – Procedure shall be maintained with the certificate copy considering the environment system.

7.5.2 - Creating and updating – As per procedure, all records shall be verified with title, date, author, or reference number, format, media, review and approval for suitability and adequacy.

7.5.3 - Control of Documented information – Master copy, Controlled copy, etc.

8.1 - Operational planning and control - outsourced processes are planned, documented and controlled considering the environment system.

8.2 - Emergency preparedness and response - planning actions to prevent or mitigate adverse environmental impacts from emergency situations, periodically test the planned response actions, periodically review and revise the process, information and training.

8.2.1 - Customer communication - handling enquiries, contracts, customer feedback, customer complaints, etc

8.2.2 - Determining the requirements for products and services - statutory and regulatory requirements – planed, documented and maintained.

8.2.3 - Review of the requirements for products and services – records regarding requirements specified by the customer, specified by the organization, statutory and regulatory requirements applicable, contract or order requirements – reviewed or not, any new requirements

8.2.4 - Changes to requirements for products and services – memos, e-mail, notice, etc.

8.3 - Design and development of products and services - documented information regarding why, what, when, how, where who needs it – input and output. Ex, new product planning - changing.

8.4 – Control of externally provided processes, products and services – Documents like: Company Process flow, Interaction process, Order processing Execution, etc

8.5 - Production and service provision – documents for products to be produced, the services to be provided, or the activities to be performed. Report for lost, damaged or otherwise found to be unsuitable for use product / service.

8.6 - Release of products and services - evidence of conformity with the acceptance criteria and traceability to the person(s) authorizing the release.

8.7 - Control of nonconforming outputs - documents information that: describes, actions taken, any concessions obtained, authority deciding the action of the nonconformity.

9.1.1 - Performance evaluation- Monitoring, measurement, analysis and evaluation – methods, criteria, appropriate indicators, when, analysed and evaluated

9.1.2 - Evaluation of compliance - determine the frequency of compliance, evaluate compliance and act if needed, maintain knowledge and understanding of its compliance status.

9.1.3 - Analysis and evaluation - Customer satisfaction by getting the feedback forms.

9.2 - Internal audit – planned, conducted and document maintained considering the environment system.

9.3 - Management review - opportunities for improvement, need for changes, resource needs - evidence of the results considering the environment system.

10.1 / 10.2 - Improvement - nature of the nonconformities, any subsequent actions taken and the results of any corrective action – old internal and external audit details shall be inspected considering the environment system.

Some of the Documents which can be maintained to run the organization are as follows:
1              Accident/Incident Register
2              Annual audit plan/MRM
3              Approval Note for Raw and Packing Material requisition
4              Approved Supplier List
5              Audit Nonconformance report
6              Audit observation sheets
7              Bagging Log Book -701 (report)
8              BOQ
9              Breakdown / Work Permit Slip
10           CA report
11           Calibration Agency list
12           Calibration History card                              
13           Check list for Relieving
14           Communication Register
15           Contingency plans
16           Continual Improvement
17           Contractor List / AMC List
18           Control change formats
19           Corrective action (CA Report)
20           Customer Complaint form
21           Customer Information
22           Customer Satisfaction Survey & analysis
23           Daily call reports
24           Damaged Material issue Slip
25           Design Input form
26           Design Validation / In house or Marketing Trial Application Report
27           Design verification report
28           Development activity plan and review
29           Dispatch Report
30           Dispatch status report
31           dispatch summery report
32           DO confirmation
33           Document / Records Issue change register
34           Document revision Change Register
35           Employee Skill matrix
36           Employee Training Need / Plan
37           Existing Prod Modification Proposal 
38           Existing Product Modification Proposal Review
39           Experiment Record/Register
40           Application form for Dealership
41           Formulation sheets
42           Goods Return Note
43           Grout Packing Report Q1 & Q2
44           Hazardous Waste Disposal Register
45           In process / FG rejection memo
46           In process / FG inspection Record
47           In process / FG specification
48           In process / finished goods specification  
49           Initial Environmental Review
50           Input data to product technical data sheet
51           Internal audit schedules
52           Internal Audit Summary Report
53           Internal Calibration Method
54           Internal Calibration Report 
55           Job Description
56           KPI Methods
57           KPI Monitoring
58           Leave Form
59           Legal Compliance register
60           Liquid Packing Report
61           List of Aspect and Impact
62           List of Chemicals and MSDS extract
63           List of core team members
64           List of Critical spares
65           List of Emergency contact
66           List of employees
67           List of Environment Management program
68           List of Equipment and calibration schedule
69           List of Equipment’s and calibration Schedule                                 
70           List of Fire Fight Trainers
71           List of First Aid trainers
72           List of internal auditors
73           List of Legal and another requirement
74           List of Training Faculty
75           loading and unloading register
76           Machine History Card
77           Maintenance Safety Tools list
78           Maintenance Tool list
79           Manufacturing Instructions
80           Marine Inland Declaration report
81           Master List of records / Forms
82           Master List of Documents
83           Master list of External Documents
84           Master List of Machines
85           Material Purchase Indent
86           Material Requisition Note
87           Materials shortage list
88           Mock Drill Record
89           MRM Agenda
90           MRM Circular
91           MRM minutes 
92           MSDS
93           NC Register
94           NDC form
95           New Material Requirement (To Purchase)
96           New product Proposal Review
97           Non – conformity format
98           Physical Stock statement
99           Plant dispatch report
100         PM Inspection record
101         PM rejection note (memo)
102         PM Sampling plan
103         PM Specification
104         Preventive Maintenance Check List
105         Product marketing Plan
106         Production Plan
107         Purchase order Template
108         Purchase Requisition Slip
109         Raw Material Specification
110         Recruitment procedure
111         Repro Material Issue Note
112         RM Inspection record
113         RM rejection note (memo)
114         RM Sampling plan
115         RM Specification
116         Safety Chart
117         Sampling plans for in process / Finish goods
118         Sand Drier Report Line
119         Significant Impact Study
120         Store Credit Note
121         Summary of Complaint report
122         Supplier Rating Format
123         Supplier registration / assessment form
124         Test methods
125         Time calibration sheets
126         Training Attendance
127         Training calendars
128         Training Feedback
129         Training history cards
130         Training Register (Details)
131         Vehicle arrival Status report
132         Verification (Inspection) / Counting sheet
133         WAM mixer and Mixing reporting
134         Weekly visit Report
135         Workmen performance monitoring






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