Training a group of people to conduct quality Management System (QMS) internal audit in your organization is not an easy task. More over if you are to conduct it internally under constraint of budget and time.
I still remember training a co-worker as auditor for the first time, at that moment my main concerned was his knowledge competency and ability to conduct audit independently.
In this post (a part of our Quality Management System post series) I’m going to share brief history of ISO 9001, standard requirements and what an auditor should look for as part of mandatory document sighting in an audit session. I did love to hear what you got to say on the topic. So please do comment how you find this post helping you.
This post is written to help you with tips in conducting training for effective Quality Management System audit (ISO 9001). By the end of few serials of post, you will gather 2 useful sets of material for practical use:-
- Auditor checklists (pre- audit and post audit)
- Quality Management Templates
Some days, its gets me down that people just uninterested to read the 30+/- page of ISO 9001 standard. Call me annoying kind, but very few of in-house trainees have mastered ways to interpret the standard requirements.
To keep you engage on the topic, I will write the serials in story based (Because ISO 9001 can be very dry subject) and the character in the post will represent people in your organisation by asking the commonly asked question.
Hope you enjoy reading my post,
Ricard Ricardo (General Manager) of newly setup large IT service provider in Singapore walks into Cindy Roff office (Admin Office Manager) room to share his new idea of educating every team leader as internal quality.
The narration below is between the Management and its team leader.
Cindy sends out an email indicating the company direction in educating team leader to be effective ISO 9001 internal quality auditor. A part form conveying management intent, she cover ed some few pointer about Quality Management System.
Brief history of ISO 9001
1. Basis understanding of ISO 9001 of standard will be starting point of your journey to be effective QMS auditor. In 1970, UK government officials felt that the contractually obligation of supplier to produce quality raw material should be passed to companies rather than UK government. During same time the government had employed 17,000 inspectors to inspect and assure product brought from many industries is fit for government use.
2. British standard 5750 serials evolved from supplier focus to customer focus in 1980s with introduction of ISO 9001:1987 under the flagship of International Standard of Organization (ISO). Most of the UK inspectors join ISO 9001 as certified assessor.
3. The adoption rate of ISO 9001 Standard has exceed more than 1,000,000 companies in year 2009 and European firms represent 47% of the overall world adoption market share. Just for your info- Republic of China alone has represented most large country in pushing for Quality adoption; as a result, there are 257,076 certified companies.
4. Nonetheless, it’s also worth knowing that the global growth rate is slowing down with single digit. This is mainly due to slow adoption in developed countries.
ISO 9001:2008 Quality management systems — Requirements
The standard requirement is consist of + or – 30 pages. Outline content as follow.
a. Page iv: Foreword
b. Pages v to vii: Section 0 introduction – This page s is worth reading to understand ISO system and its process approach (Plan, Do, Check, Act)
c. Pages 1 to 14: Requirements – Specifying scope, normative reference and the important term and definition (I would highly recommend you read this and truly understand the meaning)
d. Pages 2 to 14 cover the requirement for 5 audit areas.
i. Section 4: Quality Management System
ii. Section 5: Management Responsibility
iii. Section 6: Resource Management
iv. Section 7: Product Realization
v. Section 8: Measurement, analysis and improvement
6 Compulsory documents should be sighted in any Quality Management System Audit.
It will be good if you can have all these records handed to you before the audit session, I would prefer to have a copy two weeks in advance. This gives the QMS auditor some time to prepare audit questionnaire.
· Control of Documents (4.2.3)
· Control of Records (4.2.4) -
· Internal Audits (8.2.2)
· Control of Nonconforming Product / Service (8.3)
· Corrective Action (8.5.2)
· Preventive Action (8.5.3)
Getting updated Operating procedures, Business KPI and quality policy is also a plus point to help you in Audit preparation.
As promise, I will publish the next part of post How to train your ISO 9001 Quality Management System auditor? Next week.
I love to h ear what you got to say on the topic. So please do comment what you would like to see in next post, hope your comment will help other too.