Document Control for ISO 9001.2008

Beyond Efficiency

Session 21E

Barbara Butrym barbb@qpsinc.com

508-450-4241

Barbara Butrym:

Consultant and trainer for QPS Institute with over

25 years as a quality professional in Aerospace,

Telecommunications, Automotive and Medical

Device industries. Barbara is RAB certified

auditor and principal of BQA Quality Services.

Contact Info: barbb@qpsinc.com

508-450-4241

Document Control is a necessary evil

Since we gotta do it, how can we get value out

of it?

Once we get it running efficiently, what next?

What are some measurable goals?

What is ISO 9001:2008? ISO = International Organization for

Standardization

ISO has representation from 157

countries and has issued many

standards

ISO 9001:2008 is a model for a

quality management system.

What is a Quality Management

System?

A Quality Management System is a web of

interconnected processes that are used to

manage a business.

Why do we do this?

Standardization

Customer Requirements

Regulatory Requirements

Good Business Practices

What does ISO

Registration Require?

Say what we do

Do what we say

Prove it

Continually improve

Document Control 101

© Copyright 2002 Craig Cochran

Originally published in the June 2002 issue of Quality Digest

Document control is possibly the single most critical

quality assurance discipline.

Information in the form of documents drives nearly

every action in the organization,

The ability to control this information can make or

break the organization’s success.

Successful if it is simple, intuitive, and user-friendly.

The first step is to decide exactly what documents need

to be controlled.

REQUIREMENTS

ISO 9001:2000 Document Control (4.2.3)

1. Approve documents for adequacy prior to issue.

2. Review, update as necessary, and re-approve them.

3. Identify changes and current revision status.

4. Ensure documents are available at points of use.

5. Identify and control documents of external origin.

6. Ensure documents are legible and identifiable.

7. Prevent unintended use of obsolete documents.

8. Identify obsolete documents if they are retained.

Who Does this Affect?

Everyone in the company

Many of you will have some input into the creation

of documents that affect your jobs.

All of you will be responsible for knowing how to

access procedures you need to know to do your job.

All of you will be held accountable for following

procedures that affect your job.

All of you will be expected to participate in

continuous improvement.

What can you expect?

Training! A lot more training than you ever had in the past.

New systems for:

Document control

Configuration Control

Records Control

You may be asked to participate in writing procedures for your job. Feel free to volunteer!

What does a documented

procedure look like?

Anyway you want it to

Wordy formal printed documents, several pages

long

Visuals, photos, Digital images

Multilingual

Flow charts of any style

Any combination

None of the above

My Personal Favorites

Color Coded Flow Charts

Swim Lane Flow charts

Process Flow Charts

OH NO…..so what’s the difference?

4.2.3a Approval of documents

All controlled documents are to be written and maintained the process owner of the

document or the Quality Manager. Controlled documents written by process owners should

be approved by a senior member of staff who has relevant experience in the operation of the

process or the Quality Manager. Controlled documents written by the Quality Manager should

be approved by the process owner or a senior member of staff who has relevant experience in

the operation of the process.

4.2.3b Review and re-approval of documents

Documents will be reviewed when any amendment(s) to their content are required.

Amendments may be deemed necessary due to changes in either internal or external business

environment. Re-approval will transpire using the same approach as described in 4.2.3a.

Where possible the member of staff who approved the original document should re-approve

any subsequent versions.

4.2.3c Identification of changes and revision status of documents

An amendment control record will be maintained by the Quality Manager to record the details

of any amendments made to controlled documents.

4.2.3d Availability of applicable documents

Policies and procedures will be stored in read-only electronic format on the XXXX Intranet,

which is accessible by all members of staff. Members of staff that are not based at the main

office/warehouse site can access the Intranet using a VPN (Virtual Private Network)

connection from their company provided computers. The content of the Intranet will be

backed-up on to removable media on a daily basis and stored offsite.

Mark up the

procedure in the

control book with

the correction in

red

Initial and date the

entry

the authorized user

or

company president

Log the change

onto the Change

control log in the

control book

Return the

control book to

the control area

Are there more than 5

changes since the last

update of the

procedure?

Yes

No

Doc control will

make the changes

to the procedure

and update the

control book and

any copies

Initiate

QF305-1

is this a major

process change?No

Yes

Change to a procedure or form D305-001 revision issue

Notifications

needed?

Notify or train

affected partiesYes

No

Are there any

other controlled

copies?

Make same

change to All

Control copies

No

Yes

Document Control

What does control mean?

What do we have to control?

How are we going to do this?

Who is going to do this?

Where can you find documents you need?

What about paper copies?

Does the document …… guide the production of products ?

guide the verification, inspection, or testing?

define customer and/or product requirements?

used for controlling processes?

used for decision making?

used for collecting data that could be used later for decision

making within the scope of the management system (i.e., a

form)?

information on the document so critical that failure to keep it

updated would pose a risk

address or relate to a requirement from ISO 9001 or other

regulation?

Documents vs Records

A document is a living thing. The information

contained within a document is subject to change;

it can be revised.

A record, on the other hand, is history. The

information on a record can’t be changed,

because the record simply states what has already

happened.

Simply put, a record and a document are two

completely different things.

APPROVE

Who

What

When

Why

Controlled, documented and identified !!!!!

REVIEW

Use the internal audit process to review documents.

Audits are samples

The standard implies that all documents must be

reviewed.

If the organization intends to use its internal auditing process to

satisfy this requirement, then extra care would need to be made

during the scheduling and planning of audits to ensure that all

documents are sampled over an extended period of time.

REVISION STATUS

Current revision of the document.

For paper-based documents, the revision status normally ties

back to a master list or index that shows the current revision of

all documents.

For electronic documents, knowing the current revision is less

important because the most current version is usually served

automatically to all users.

Either way, the revision status must still be identified.

ACCESSIBLE

A document is no use if it is not accessible.

ISO 9001:2008 requires that “relevant versions

of applicable documents are available at points

of use.” This means that the most current version of documents

are accessible by the people who need them

Simply Put Know and demostrate how to access them

LEGIBLE

Legibility means that the documents can be read and

understood.

Clear,

Decipherable

Language/format appropriate for the user

EXTERNAL

An external document is something that is

published outside the organization, but which is

used by the organization within the scope of

management system.

The questions listed will help determine if an

external document should be controlled.

organization;

Examples of controlled external

documents Troubleshooting and/or calibration manuals published

by equipment manufacturers;

Test procedures, specifications, and/or engineering

drawings published by customers or other bodies;

Instructions, specifications, and/or procedures

published by suppliers;

Standards published by industrial organizations

applicable to the organization

What now?

Must be identified, and their distribution must

be controlled.

Must be reviewed when updated. This review

must be documented.

When PO calls out a specification a copy must

be available as well as evidence of it’s review

DISTRIBUTION

By definition a controlled document has its distribution

controlled

Knowing where they are located is critical to controlling the

information contained on them.

A distribution list simply defines the number of copies in

existence and where they are located.

OBSOLETE

1) their unintended use must be prevented

2) they must be identified if they are

retained.

Keep it simple!!!!!!

FORMS

Forms must be controlled.

The primary reason of having a form in the first

place is to create consistency in the way that data is

collected.

Consistency can only be enforced when everybody

is using the same form, and this is only achievable

through some type of document control. Case

closed.

ISO 9004 Guidance on

Documentation (4.2) The generation, use, and control of documentation should be

evaluated with respect to the effectiveness and efficiency of the

organization against criteria such as:

Functionality (e.g., speed of processing)

User friendliness; Resources needed

Policies and objectives

Requirements for managing knowledge

Benchmarking of documentation systems

Interfaces used by customers, suppliers, and interested parties

And, access for people in the organization and others should be based on

the organization’s communication policy.

Enhancements

Use PDF for consistency, ease in printing and

viewing and flexibility but most of all for

change protection

MS word for showing changes in documents

Master lists with hyperlinks

Access database

SUMMARY

BE CLEAR

BE CONCISE

BE VISUAL

BE SIMPLE

WRITE FOR THR READER NOT THE WRITER

US COMMON SENSE.

ASK WHAT IF I DON’T? AND YOU WILL

KNOW WHAT TO DO.

Questions?

Bibliography

Document Control 101

© Copyright 2002 Craig Cochran

Originally published in the June 2002 issue of

Quality Digest

ISO 9001.2008

PDF Advantages Over Word Documents

By K.C. Winslow, eHow Contributor, last updated

April 16, 2012