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ISO 9001:2008 Documentation Guide

ISO 9001:2008 requires organizations to document their quality management system in several key areas: a quality policy and objectives, a quality manual, and documented procedures for various processes like internal audits, handling nonconforming products, and corrective and preventive actions. It also mandates that organizations maintain records related to many clauses, such as management reviews, training, product design and development, supplier evaluations, calibration of measuring equipment, internal audits, and corrective and preventive actions. To prepare for ISO 9000 registration, an organization should perform gap analyses of its procedures, records, processes and work instructions and ensure everything required is in place and up-to-date.

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33 views3 pages

ISO 9001:2008 Documentation Guide

ISO 9001:2008 requires organizations to document their quality management system in several key areas: a quality policy and objectives, a quality manual, and documented procedures for various processes like internal audits, handling nonconforming products, and corrective and preventive actions. It also mandates that organizations maintain records related to many clauses, such as management reviews, training, product design and development, supplier evaluations, calibration of measuring equipment, internal audits, and corrective and preventive actions. To prepare for ISO 9000 registration, an organization should perform gap analyses of its procedures, records, processes and work instructions and ensure everything required is in place and up-to-date.

Uploaded by

ganandmail
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

ISO 9001: 2008 Required Documentation

Quality Documents
Quality policy (clause 4.2.1.a)
Quality objectives (clause 4.2.1.a)
Quality manual (clause 4.2.1.b)

Documented Procedures:
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of
clause 4.2.3

Records required by ISO 9001:2008

Clause Record required

5.6.1 Management reviews

6.2.2 (e) Education, training, skills and experience


Must maintain records of education, training, skills, and experience; there is a
procedure

7.1 (d) Evidence that the realization processes and resulting product fulfill requirements
Records needed to provide evidence that the realization (existing) processes
and resulting product (service) meet requirements.

7.2.2 Results of the review of requirements related to the product and actions arising from
the review.
The organization shall review the customer requirements of the service. This
review must be conducted prior to commitment to customer. Need records of
the results of the review.

7.3.2 Design and development inputs relating to product requirements

7.3.4 Results of design and development reviews and any necessary actions

7.3.5 Results of design and development verification and any necessary actions

T: (802) 324-6709
[Link]
Located in the Greater Burlington, VT Area
7.3.6 Results of design and development validation and any necessary actions

7.3.7 Results of the review of design and development changes and any necessary
actions

7.4.1 Results of supplier evaluations and any necessary actions arising from the
evaluations
Records of evaluating suppliers must be maintained

7.5.2 (d) As required by the organization to demonstrate the validation of processes where the
resulting output cannot be verified by subsequent monitoring or measurement
Need records to validate a process where you cannot monitor or measure
easily

7.5.3 The unique identification of the product, where traceability is a requirement

7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
Must maintain records re: customer property issues

7.6 (a) Basis used for calibration or verification of measuring equipment where no
international or national measurement standards exist

7.6 Validity of the previous measuring results when the measuring equipment is found
not to conform to requirements

7.6 Results of calibration and verification of measuring equipment

8.2.2 Internal audit results and follow-up actions

8.2.4 Indication of the person(s) authorizing release of product.


Need a record of how service gets released (approved). This could include
daily inspection records, etc.

8.3 Nature of the product nonconformities and any subsequent actions taken, including
concessions obtained

8.5.2 Results of corrective action

8.5.3 Results of preventive action

T: (802) 324-6709
[Link]
Located in the Greater Burlington, VT Area
Documents which are not necessarily required but can be offered as supporting
the organization’s processes. This documentation should be minimized.

• Process maps, process flow charts and/or process descriptions


• Organization charts
• Specifications
• Work and/or test instructions
• Documents containing internal communications
• Production schedules
• Approved supplier lists
• Test and inspection plans
• Quality plans

STEPS FOR ISO 9000: 2008 Registration Preparation:

1. Perform Gap analysis on required procedures and quality manual, policy, and
objectives.
2. Write any procedures which are required
3. Perform gap analysis on required records
4. Work with staff to produce required records as necessary
5. Perform a gap analysis on the process(es)
6. Work with staff to ensure processes and work instructions are in place, up to date,
used
7. Work with staff to do an internal audit, and correct non-conformances

T: (802) 324-6709
[Link]
Located in the Greater Burlington, VT Area

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