How to Prepare

for

Effective Surveillance

or

Re-certification

Audits

By

John R. Sedlak

Standard:  ISO 9001:2008

Copyright:  J&S Sedlak, LLC, October 2010 ©

Revised January 2015

 

About the Author

John R. Sedlak is Owner of Sedlak Consulting (J&S Sedlak, LLC) located in North Canton, OH.  His professional, engineering and quality control/quality assurance career spans more than forty years.  Prior to launching Sedlak Consulting, he was hired to launch Smithers Quality Assessments, Inc. located in Akron, OH, ultimately achieving the position of Vice President, COO.  He has also he held engineering, supervisory and management positions in various industries, including chemicals, electronics, home appliances, steel manufacture and fabrication, and gas and diesel engines.

Mr. Sedlak has significant quality, environmental, aerospace, health and safety experience in a broad range of industries, having worked for such corporations as Union Carbide Corporation, Republic Steel, The Hoover Company, Hercules Engines and Steere Enterprises.  He is an SQA certified lead auditor for a variety of standards.  He is an experienced auditor for:  ISO 9001, ISO 14001, AS9100, ISO/TS 16949, ISO 13485 and the Health and Safety standards (OHSAS 18001, Z10 and Z1000). 

In 2011, in recognition of his many contributions to the field of quality, Mr. Sedlak was honored by his peers by being granted the title of Fellow of the American Society for Quality (ASQ).  He holds a B.S. degree in industrial management from the University of Akron and is an ASQ certified quality engineer. Also, he has conducted numerous seminars and training classes on quality and environmental topics.
 

How to Prepare for Effective Surveillance or Re-certification Audits

Standard:  ISO 9001:2008 

There are five sections to this document:

I  Introduction: 

The following pages contain some basic information and forms to help an organization prepare for an effective surveillance or re-certification audit.  The organization is encouraged to use this information to its own betterment.  This document addresses those requirements that most certification bodies assess as part of each audit activity.  Use of the information contained in this document is optional but strongly encouraged.

 Much of the narrative contained in this document is focused on organizations that are in the manufacturing sector.  However, as warranted, examples are also provided for those organizations that are more service oriented.

 NOTE:  An “Effective” audit activity is one where the auditor can spend the maximum amount of time analyzing information and minimal time searching for information. 

II.  Core Requirements: 

Certain requirements of the standard provide proactive, ongoing support to the quality management system overall.  These requirements are termed “Core Requirements.”  Certification body auditors typically address these core requirements as part of each surveillance and re-certification assessment activity.  A tabular listing of these core requirements is listed below:

 “CB” = Certification Body, the registrar

 

Source

Records Needed

1

CB

Random shop floor audit (only if shop-floor-related processes, e.g., machining,  welding, plating, etc., are not scheduled).

2

CB

Evidence of use of CB Mark (logo), if applicable.

3

CB

Evidence of ISO-related statements in literature or media.

4

CB

Changes in “Business Conditions” since last audit activity.

5

4.2.2 c

Process maps or other descriptive views of the management system processes; need to demonstrate their sequence and interaction.

6

4.2.3

Direction to, and explanation of, all changes made to policies and procedures.

7

5.4.1

Quality objectives at relevant functions and levels, including data and actions.

8

5.6

Management review meeting minutes (inputs, outputs, conclusions regarding:  suitability, adequacy and effectiveness of the quality management system).

9

7.1

Control plans, or other requirement conveyance documents, for product being manufactured the day of audit, if applicable.

10

7.2.3c

Number and nature of customer complaints.

11

8.2.2

Internal audit schedule and results, including names and qualifications of internal auditors.

12

8.2.3

Monitor and/or measurement of the defined processes that make up the QMS.

13

8.4

Analysis of data.

14

8.5.1

Continual improvement efforts (examples of, including related data).

15

8.5.2

Corrective action documentation for last 12 months from:

·         internal audits (8.2.2)

·         internally identified process or product problems other than from internal audits (8.3)

·         customer complaints (7.2.3c)

·         Registrar - issued as part of most-previous audit.

16

8.5.3

Preventive actions

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