How to conduct Stage 1 and Stage 2 Audits · 2020-01-09 · guidelines for management systems auditing. • A clear explanation of the principles of management systems auditing. •

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How to conduct Stage 1 and Stage 2 Audits As per ISO 9001 – 2015 & ISO 19011

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Outline

• About 3FOLD Education Centre• Brief on ISO 9001:2015 and ISO 19011• Overview - Audit Process• Planning for state 1 audit• Conducting stage 1 audit• Making stage 2 audit plan• Making working documents• Conducting stage 2 audit• NCR reporting, Corrective action and • Audit report• Q &A• Certificate collection


About 3FOLD• Established in 2008

• Branches in Abu Dhabi and Dubai.

• Approved by KHDA, PMI, ASQ, IMA, AACE and CQI IRCA.

• An ISO 9001:2015 Certified Training Organization.


1. Scope 2. Normative references

3. Terms and definitions 4. Context of organization

5. Leadership 6. Planning

7. Support 8. Operation

9. Performance evaluation 10. Improvement

I N T R O D U C T I O N

Brief on ISO 9001:2015 Standard


Standard ISO 19011 :2011

ISO 19011 is an international standard that sets forth

guidelines for management systems auditing.

• A clear explanation of the principles of management systems auditing.

• Guidance on the management of audit programs.

• Guidance on the conduct of internal or external audits.

• Advice on the competence and evaluation of auditors.


Decide

Surveillance

Stage 2

Stage 1

Preparedness

Adequacy

2. Readiness

Conformity Assessment

3. Certification

CA & Improvements

4. Effectiveness

Commitment & Sign-Off

1. Contractual Process

Certification Roadmap


Planning of Audit – ISO 9001:2015


The Quality audit is define as “ a systematic & independent examination to determine whether Quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives”.

For certification it is termed as Stage 1 and Stage 2 Audits. Stage 1: Adequacy auditStage 2: Compliance audit

Remember:

“Say what you do and do what you say”

(1) Adequacy audit:- (System or Management audit)

determine the extend to which the documented

information adequately meet the requirements

of standard.

(2) Compliance audit:-

Which seeks to establish the extent to which the

documented system is implemented and

observed by the work force.

Audit – ISO 9001:2015 QMS


• Performed to determine the state of readiness

• Identify key areas and technical expertise and exclusions

• Conformity of the documented system with the audit standard and applicable legislation is assessed

• Deficiencies are reported for corrective action, prior to the Stage 2 Audit

Stage 1 Audit - Overview



Source: ISO/TC176/SC2









PROCESS A

PROCESS C

PROCESS B PROCESS D

Inputs to A

Inputs to B Outputs from A

Inputs to C Outputs from C

Outputs from B Inputs to D

Outputs from D

Outputs from other processes

Outputs from other processes




Resource Processes

Product Design

Process Design

Project Planning

Production

Management Processes

Measurem

ent, Analysis, and Im

provement

OI

IO

I O

I O

I O

I O

I O

I O

Resource Processes

Product Design

Process Design

Project Planning

Production

Management Processes

Measurem

ent, Analysis, and Im

provement

OI

IO

IO

I OI O

I OI O

I OI O

I OI O

I OI O

I OI O




PLAN: Establish the objectives and processes necessary to deliver results in accordance with customer, statutory and regulatory requirements and the organization's policies;

DO: Implement the processes;

CHEAK: Monitor and measure processes and product against policies, objectives and requirements for the product and report the results;

ACT: Take actions to continually improve process performance;”

Source: ISO/TC176/SC2/N544R3


• Verify context, issues, risk and scope

• Ensure adequacy of documented information

• Ensure scope, purpose, methods and team size is matching with application

• Assess readiness for stage 2 audit

• Focus on Stage 2 audit planning

• Ensure system is matured and improvement process

• Identify potential problems

Conducting Stage 1 Audit


Documented information needed to be maintained by the organization

for the purposes of establishing a QMS. These include:

− The scope of the quality management system (clause 4.3).

−Documented information necessary to support the operation of processes(clause 4.4).

− The quality policy (clause 5.).

− The quality objectives (clause 6.2).

−This documented information is subject to the requirements of

(clause 7.5)



Although ISO 9001:2015 does not specifically requires any of them,

examples of documents that can add value to a QMS may include: − Organization charts ,Process maps, process flow charts and/or

process descriptions, Procedures, Work and/or test instructions, Specifications, Documents containing internal communications, Production schedules, Approved supplier list, Test and inspection plans, Quality plan, Quality manual, Strategic plans − Forms



Sample audit planTiming Auditor 1 Auditor 2

08.00 Opening Meeting

08.30 Managing Director – Context, Interested Parties, Leadership and Planning

09.30Determination of requirements

Legal RequirementsPurchasing/suppliers

10.00 Production Planning/Risk Raw Material Stores

10.40 Production - Tablets Production - Steriles

12.30 Lunch

13.30 Process Nonconformity Corrective Action Dispatch/ Shipping

14.00 Laboratory Quality - Audits & Review

14.45 Maintenance Control of Documented Information

15.15 Calibration Continual Improvement Measurement Analysis

16.15 Training and Competence Corrective Actions

17.00 Report Preparation

17.45 Reporting Meeting.

Close


Preparing working document- Checklist

InquiriesEvidence and

Results

Production Area (8.1)

❖Interview Production Manager about production planning. Plan, results.

❖Observe equipment and settings

Employee interviews (5.2.2, 7.2)

❖Are you aware of the quality policy?

❖How does the policy relate to what you do?

❖What type of training have you had on QM?

• Question / Checkpoint

• Objective evidence

• Reference the requirements of audit

criteria

• Reference of documents / records

• Reference verifying documents (records)


• Conducting the Opening meeting

• Communication during the audit

• Collecting and verifying information

• Ensuring implementation as per documented information and standard requirements

• Preparing audit Conclusions

• Conducting the Closing meeting



Objective evidence

Objective evidence exists showing that:

►Positive Findings

►Opportunities for Improvement

►Observations

►Non-Conformances


Nonconformity Report (NCR)

NC Shall include:-

1. NC Statement (An element of the system which went wrong) What is

the Problem ? Describe clearly, concisely and factually.

2. The evidence (what , where or when actually was found) Where did it

occur or When it occur?

3. Why is it a non – compliance ? I.e., against which requirement ? The

requirement (what was supposed to be)


NCR and corrective action procedure – Audit Report


Re-Cap

• Brief on ISO 9001:2015 and ISO 19011

• Overview - Audit Process

• Planning & Conducting Stage 1 audit

• Planning & Conducting Stage 2 audit

• Making working documents

• NCR reporting, Corrective action

• Audit report


ANY QUESTION ?


Upcoming Schedule

•Course Title •Date •Frequency •Timing

•ISO 9001:2015 QMS LA•ISO 45001:2018 OHSMS

•May 25 to June29, 2018•May 12 to June 09, 2018

•5 Fridays•5 Saturday

•PM•AM


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