Patsy Brown Brown & Associates Quality Consulting, Inc. Pine Bluff, AR Documents. Standards ISO 9001:2008 ISO 22000:2005 PAS 220:2008

Transcription

1 Patsy Brown Brown & Associates Quality Consulting, Inc. Pine Bluff, AR Documents Standards ISO 9001:2008 PAS 220:2008 Supporting Documentation ISO 9000:2005 ISO 22004:2005 ISO 19011:2002

2 ISO 22004:2005 ISO 9001:2008 ISO 22004:2005 ISO 9001:2008

3 ISO 22004:2005 ISO 9001:2008 ISO 22004:2005 ISO 9001:2008

4 Clause 2, Normative Reference ISO 9000 listed as the normative reference Clause 3, Terms and Definitions ISO 9000 listed as source for definitions Additional definitions listed for food safety and HACCP Analogous to Quality Management System

5 Clause 4.1 General Requirements Establishment of the Management System Focus on: Identification of Food Safety Hazards Communication Evaluation Outsourcing Requirements ISO 9001:2008 Establishment of the Management System Focus on: Defining Processes and Criteria for Evaluation Resources Improvement Outsourcing Requirements Clause General (Documentation) a. Documented food safety policy and objectives b. Documented procedures and records (required by ISO 22000) c. Documents needed by the organization ISO 9001:2008 a. Documented quality policy and objectives b. Quality Manual c. Documented procedures and records (required by ISO 9001) d. Documents needed by the organization

6 Clause Control of Documents Document control Review of changes PRIOR to implementation Documented procedure covering 7 key points ISO 9001:2008, clause Document control Documented procedure covering the same 7 key points Clause Control of Records Establishment of records Specific requirements for records Documented procedure covering 6 key points ISO 9001:2008, clause Establishment of records Specific requirements for records Documented procedure covering the same 6 key points

7 Clause 5.1 Management Commitment a. Food safety supported by business objectives b. Communicating importance c. Establishing food safety policy d. Conducting management reviews e. Ensuring available resources ISO 9001:2008 a. Communicating importance b. Establishing quality policy c. Ensuring establishment of quality objectives d. Conducing management reviews e. Ensuring available resources

8 Clause 5.2 Food Safety Policy a. Appropriate b. Conformity to requirements and regulations c. Communicated d. Reviewed for continued suitability e. Addresses communication f. Supported by measurable objectives ISO 9001:2008 clause 5.3 a. Appropriate b. Conformity to requirements and continual improvement c. Framework for objectives d. Communicated e. Reviewed for continued suitability Combine? Don t Combine?

9 Clause 5.3 Management System Planning a. Planning to meet requirements b. Maintaining integrity of food safety management system ISO 9001:2008 clause 5.4 Quality objectives established at relevant levels and functions Planning a. Planning to meet requirements b. Maintaining integrity of quality management system Clause 5.4 Responsibility and Authority Top management definition and communication of: Authorities Responsibilities Designation of responsibility for food safety Designation of personnel for initiating and recording food safety actions ISO 9001:2008 clause 5.5 Top management definition and communication of: Authorities Responsibilities

10 Clause 5.5 Food Safety Team Leader Top management appointment of a Food Safety Team Leader to: Manage food safety team Ensure training/ education of food safety team Ensure FSMS is established and updated Report performance to top management ISO 9001:2008 clause Top management appointment of a Management Representative to: Ensure processes are established Report performance to top management Promote awareness of customer requirements Clause 5.6 Communication requires in 5.6.2: Communication about Food Safety Issues Communication with Food Safety Team ISO 9001:2008 clause Communication processes within the organization Communication regarding the effectiveness of the Quality Management System

11 Clause 5.8 Management Review clause 5.8 Regularly scheduled reviews to ensure continued suitability, adequacy, and effectiveness Specified Inputs Specified Outputs ISO 9001:2008 clause 5.6 Regularly scheduled reviews to ensure continued suitability, adequacy, and effectiveness Specified Inputs Specified Outputs

12 Clause 6.1 Provision of Resources Focused on: Food Safety Management System ISO 9001:2008 Focused on: Quality Management System Enhancing Customer Satisfaction Clause 6.2 Human Resources Focused on: Food Safety Training Contracts for External Experts Competence Requirements Additional requirements for food safety and communication ISO 9001:2008 Focused on: Quality Requirements Competence Requirements

13 Clause 6.3 and 6.4 Infrastructure Addressed through PRPs Work Environment ISO 9001:2008 Infrastructure: Buildings, Workspace, and Utilities Process Equipment Support Services Work Environment

14 Clauses No Requirements Analogous to ISO 9001:2008 Requirements ISO Contains Requirements for: Pre requisite Systems Definition of Products and Processes for Hazard Analysis Conduct of Hazard Analysis Development of HACCP Plans Clause 7.9 Traceability Traceability Requirements Specified ISO 9001:2008, clause Traceability Requirements Specified ONLY if Traceability is Required by the Organization, the Customer, or Regulatory Entities

15 Clause Corrections Requirements: Documented Procedure Records, including information about: Correction Approval Nature of Nonconformity Causes and consequences Traceability information for nonconforming lots Corrective Action, per Clause Corrective Action Compared to ISO 9001:2008, clause Requirements for corrective action for both the food safety and quality management systems technically equivalent

16 Clause Handling Unsafe Product Documented Procedure General Evaluation for Release Disposition of Nonconforming Product ISO 9001:2008, clause 8.3 Documented Procedure Options: Taking action to eliminate nonconformity Authorizing release Taking action to preclude intended use Taking appropriate action when product has already been shipped

17 Clause 8.3 Control Monitoring/Measuring Compared to ISO 9001:2008, clause 7.6 Requirements for control of monitoring and measuring equipment in both the food safety and quality management systems technically equivalent (SIO 9001:2008, clause 7.6) Clause Internal Audit Compared to ISO 9001:2008, clause Requirements for auditing both the food safety and quality management systems technically equivalent Training needs for auditing differ, based on system being audited

18 Clause Continual Improvement uses: Communication Management Review Internal Audit Evaluation of Individual Verification Results Analysis of Results of Verification Activities Validation of Control Measure Combinations Corrective Actions FSMS Updating ISO 9001:2008 uses: Quality Policy Quality Objectives Audit Results Analysis of Data Corrective Actions Preventive Actions Management Review Annex A Cross References between and ISO 9001:2008 are provided for information