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SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS

MANUAL INCLUDES A LIST OF TOPICS AND FORMS

ISO 9001 Quality Procedures For Quality Management


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The Bizmanualz ISO 9001 Quality Procedures for Quality


Management Systems provides you with easy to use Quality
Procedures for ISO 9001 implementation. You will learn what ISO
9001 is all about, how to produce an ISO 9001 Quality Manual, and
how to write ISO 9001 Quality Procedures. The Bizmanualz ISO 9001
Manual comes with practical documentation in proper ISO format
and reflects 2008 changes to the standard. You also get a detailed
explanation of ISO 9000 and helpful information and guidance on
producing your own QMS quality manual.
Includes five (5) modules:
Choose your delivery
1. Introduction and Table of Contents
option:

Hard Cover Book plus CD


2. Guide to preparing a well written
containing all documents
manual
in editable Microsoft Word
3. A Sample Quality Manual covering
format and instant
common requirements and practices
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4. 23 Policies and 48 corresponding
or
forms

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Sample Policy from ISO 9001 Quality Procedures For Quality Management System s

Document #
QP1010

Quality Procedures Section: Record Control


Title
Print Date
RECORD CONTROL

Revision #
0.0

Prepared By

Date Prepared

Effective Date

Reviewed By

Date Reviewed

Standard
ISO
9001:2008,
clause 4.2.4

Approved By

Date Approved

Policy:

Records shall be established and maintained to provide evidence of the


effective operation of the Company's Quality Management System (QMS).

Purpose:

Demonstrate conformance to specified requirements and effective


operation of the QMS; describe/explain how QMS records are to be
maintained.
Records are generated and analyzed to determine if a given process is

SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS
MANUAL INCLUDES A LIST OF TOPICS AND FORMS

Document #
QP1010

Title
RECORD CONTROL

Print Date

achieving stated objectives and meeting process criteria and to determine


defects for correction or if a trend indicates corrective action is needed.
Scope:

This procedure applies to all records regardless of their form that serve
to record the Companys activities related to product/service quality and
are required to demonstrate implementation of and conformance to the
Companys QMS.

Responsibiliti
es:

Document Control is responsible for maintaining a list of the Company's


quality records and controlling quality record distribution.
All personnel are responsible for ensuring records they generate are
accurate, timely, and legible.

Definitions:

Record Anything retained to provide and preserve permanent evidence


of, or information about, an event (e.g., physical or electronic document,
photograph, or product sample).

Procedure:

1.0 IDENTIFICATION OF QUALITY RECORDS


1.1

Typically, when a form either hard copy or electronic is filled, it becomes a


quality record. Completed forms are controlled documents and are, therefore, part
of the Company's document control system (see QP1000 DOCUMENT CONTROL).

1.2

Each Company department or functional group shall be responsible for generating


and maintaining adequate records to demonstrate effective operations, as defined
specifically by each QMS procedure, and to show conformance to customer,
regulatory, and standards-based requirements.

1.3

Blank forms should be consistently formatted and grouped by department and/or


function. Blank forms may be centrally located or distributed to departments,
depending on the Company's needs. (The Company may choose to "distribute"
blank forms via its intranet, for standardization and control purposes.)

1.4

Quality records shall contain the following, at a minimum:

1.5

When the record was created (date and, if necessary, time of day);

Information on the thing, situation, or event; and

A unique record identifier.

Document Control shall maintain a QP1010-1 QUALITY RECORDS LIST, a complete


list of the Company's quality records. The QP1010-1 should contain the following
for each quality record:

A unique identifier (e.g., sequentially numbered ID);

A description of the record;

SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS
MANUAL INCLUDES A LIST OF TOPICS AND FORMS

The location of the quality record;

Minimum retention time; and

Directions for record disposition.

NOTE: Records required by ISO 9001 are indicated with the applicable
clause number on the QP1010-1 sample form at the end of this procedure.

2.0 RECORD GENERATION


2.1

Every employee may generate quality records in the course of performing their
normal duties (e.g., production monitoring logs, receiving logs). Such records
should be identified within an appropriate QMS procedure.
Electronic records of quality management activity may be generated
automatically (see QP1210 MONITORING AND MEASUREMENT OF PROCESS,
QP1220 MONITORING AND MEASUREMENT OF PRODUCT; also see Reference
"C").

2.2

All quality records must be accurate, timely, legible, and readily accessible for
reference and verification purposes.

2.3

Hardcopy quality records should be completed in ink or on word processing


software, to help ensure legibility and to help protect them from unauthorized
change. Electronic quality records should be write-protected and access restricted
to enforce change control; Document Control or other manager-department
authorized by Top Management should control access to electronic records.

2.4

Individual quality records should not be changed, as a rule. If necessary, changes


or corrections to hardcopy records should be made with a single line through the
incorrect entry. The change/correction should be written in ink and dated and
initialed by the person making the change. Correction fluid or tape should not be
used.
Electronic records should not be changed. Instead, "corrections" should be
initiated by Management. Disposition of old electronic records (purging,
reversing, archiving, etc.) should be a matter of Company policy.

3.0 RECORD MAINTENANCE


3.1

3.2

The authority associated with a particular quality record (e.g., Production Manager
for production records) shall ensure that records are maintained in an environment
that prevents their damage, deterioration, alteration, or loss.

Document Control shall control access to hardcopy, electronic, and other


records (see References").

Relative to their importance to the Company, records should be backed up


periodically in accordance with business, customer, and
statutory/regulatory requirements.

Document Control shall ensure that quality records are readily retrievable.

SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS
MANUAL INCLUDES A LIST OF TOPICS AND FORMS

3.3

Records shall be made available for customer and/or regulatory review, in


accordance with all contractual and regulatory requirements.

Records shall be made available to auditors, as required by ISO 9001 and


other applicable standards (e.g., ISO 14001).

Records shall be available to employees for the purposes of monitoring,


measurement, and trend analysis.

Inactive quality records may be archived before minimum retention times


are reached, if circumstances warrant. Archived records must be
controlled and maintained and should be reasonably retrievable.

Quality records shall be retained for no less than the period of time required by
applicable statutes, regulations, and/or contractual requirements. Unless otherwise
indicated, quality records shall be disposed after their minimum retention time is
attained (see QP1010-1 QUALITY RECORDS LIST).
Effectiveness Criteria:

Quality records verify the Company's conformance to requirements

Records are accurate and up-to-date

References:
A. ISO 9001:2008, Quality Management Systems-Requirements, International
Organization for Standardization (ISO), Nov., 2008.
B. Statutory/Regulatory Requirements
The Company should be familiar with and be able to demonstrate
conformance to applicable statutes and regulations pertaining to
recordkeeping and control of records. Examples of laws governing
recordkeeping include:

The Eighth European Union (EU) Directive;

Financial Instruments and Exchange Law (Japan);

The Public Company Accounting Reform and Investor Protection Act of


2002, also known as "Sarbanes-Oxley" or "SOX" (USA); and

Title 40, Code of Federal Regulations, Protection of the Environment (USA).

C. Computer and Network Policies, Procedures, and Forms, Bizmanualz


(ABR34M, ISBN-10 #1-93159106-7).
Forms/Records:
Form #

Record/Form/Activity Name

Required by ISO 9001:2008

Satisfies
ISO 9001
Clause

SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS
MANUAL INCLUDES A LIST OF TOPICS AND FORMS

Form #

Record/Form/Activity Name

Satisfies
ISO 9001
Clause

Other Forms/Records
QP1010-1

Quality records list

Revision History:
Revisio
n

Date

0.0

MM/DD/YY

Description of changes
Initial Release

Requeste
d By

SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS
MANUAL INCLUDES A LIST OF TOPICS AND FORMS

QP1010-1 QUALITY RECORDS LIST


ISO 9K
Clause

Record1

Location2

Minimum
Retention3

5.6.1

Management Review records

Administration

3 years

6.2.2(e)

Records of employee training, education, skills, and


experience

Employee files
(HR)

Employment
plus 3 years

7.1(d)

Product Realization records (evidence that realization


process, product meet requirements)

Project file

3 years

7.2.2

Record of product requirement review (prior to


committing to customer, review their requirements and
keep record of review)

Project file

3 years

7.3.2

Record of design & development (D&D) inputs


pertaining to product requirements

Project file

3 years

7.3.4

Record of results of D&D reviews

Project file

3 years

7.3.5

Record of results of D&D verification and necessary


actions

Project file

3 years

7.3.6

Record of results of D&D validation and necessary


actions

Project file

3 years

7.3.7

Record of results of D&D change reviews (i.e.,


changes after the product is released)

Project file

3 years

7.4.1

Record of results of supplier evaluations (and


necessary actions arising from evaluations)

Supplier file

3 years

7.5.2(d)

Records to demonstrate validation of processes where


process output (product) cannot be verified by
subsequent monitoring/measurement (and deficiencies
appear only after product/service is delivered/in use)

Product file

3 years

7.5.3

Product identification record (where traceability is a


requirement)

Product file

3 years

7.5.4

Records of customer property that is lost, damaged, or


found unsuitable for use

Customer file

3 years

7.6

Results of calibration (verification) of monitoring &


measuring (M&M) devices

Maintenance

3 years

1 Records on this list are required by ISO 9001 (clause numbers are in first column);
seek the advice of qualified legal counsel regarding statutory/legal recordkeeping
requirements.
2 Location indicates who has responsibility for maintaining the files as much as
where theyre kept.
3 Retention periods shown are guidelines; your customer, regulatory, etc.,
requirements may differ.

SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS
MANUAL INCLUDES A LIST OF TOPICS AND FORMS

ISO 9K
Clause

Record

Location

Minimum
Retention

7.6

Validity of previous measurement results when M&M


devices are found not conforming to requirements (i.e.,
are not accurate)

Maintenance

3 years

7.6(a)

Basis for calibration & verification of M&M devices


where no international, national, or industry standard
exists

Maintenance

3 years

8.2.2

Internal Audit reports (results of the audit and followup activities)

Quality

3 years

8.2.4

Record of person(s) authorizing release of a product (or


service) to customers

Project file

3 years

8.3

Nature of product nonconformities and actions taken as


a result (e.g., nonconformance report, correction
report), including concessions obtained

Quality

3 years

8.5.2

Records of results of corrective actions

Quality

3 years

8.5.3

Records of results of preventive actions

Quality

3 years

SAMPLE POLICY FROM ISO 9001 QMS POLICIES, PROCEDURES AND FORMS
MANUAL INCLUDES A LIST OF TOPICS AND FORMS

ISO 9001 Quality Procedures For Quality Management Manual:


23 Prewritten Policies and Procedures
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.

Quality Procedures
Document control
Record control
Internal audits
Control of non-conforming
product/material
Corrective action
Preventive action
Management reviews
Competence, training, and awareness
Sales orders
Project definition
Design and development
Design change

13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.

Vendor evaluation
Preproduction planning
Manufacturing
Identification and traceability
Customer property
Control of monitoring and measuring
equipment
Process monitoring and measurement
Customer satisfaction
Data analysis and continual improvement
Receiving and inspection
Purchasing

48 Corresponding Forms and Records


1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.

Document Request
Document Control File
Quality Records List
Audit Program
Audit Plan
Quality Audit Checklist
Final Audit Report
Nonconformance Report
Nonconforming Material Log
Return Goods Authorization
Corrective Action Report
Corrective Action Log
Preventive Action Report
Preventive Action Log
Management Review Meeting
Employee Competence Matrix
Employee Development Plan
Group Training Record
Individual Training Record
Sample Job Descriptions
Customer Order Form
Project Plan
Design Review Checklist
Design Completion Checklist for
Electromechanical Devices

25. Design Completion Checklist for NonElectromechanical Devices


26. Sample verification checklist
27. Product test
28. Engineering change notice
29. Approved vendor list
30. Vendor audit checklist
31. Critical vendor-contractor evaluations
32. Vendor performance log
33. Product design release
34. Inspection/testing checklist
35. Product release authorization
36. Material return notice
37. Calibration record
38. Calibration database
39. Post-sale satisfaction report
40. Customer satisfaction survey
41. Customer service log
42. Receiving log
43. First article inspection report
44. Receiving inspection report
45. Purchase requisition
46. Purchase order form
47. Purchase order log
48. Purchase order follow-up